CA1317882C - Gelatin coated caplets and process for making same - Google Patents
Gelatin coated caplets and process for making sameInfo
- Publication number
- CA1317882C CA1317882C CA000559224A CA559224A CA1317882C CA 1317882 C CA1317882 C CA 1317882C CA 000559224 A CA000559224 A CA 000559224A CA 559224 A CA559224 A CA 559224A CA 1317882 C CA1317882 C CA 1317882C
- Authority
- CA
- Canada
- Prior art keywords
- caplet
- holding means
- gelatinous
- coating
- medicament
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Lifetime
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
- A61J3/07—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
- A61J3/005—Coating of tablets or the like
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23G—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
- A23G3/00—Sweetmeats; Confectionery; Marzipan; Coated or filled products
- A23G3/02—Apparatus specially adapted for manufacture or treatment of sweetmeats or confectionery; Accessories therefor
- A23G3/20—Apparatus for coating or filling sweetmeats or confectionery
- A23G3/24—Apparatus for coating by dipping in a liquid, at the surface of which another liquid or powder may be floating
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23J—PROTEIN COMPOSITIONS FOR FOODSTUFFS; WORKING-UP PROTEINS FOR FOODSTUFFS; PHOSPHATIDE COMPOSITIONS FOR FOODSTUFFS
- A23J3/00—Working-up of proteins for foodstuffs
- A23J3/04—Animal proteins
- A23J3/06—Gelatine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
- A61J3/10—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of compressed tablets
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/2873—Proteins, e.g. gelatin
Abstract
ABSTRACT
A novel capsule-like medicament, method for producing such medicaments and apparatus are-disclosed. The method provides a procedure for coating solid cores, such as caplets, with gelatinous coatings to produce a shiny, capsule-like medicament.
Such medicaments are achieved by individually dipping and drying first one end, and then the other end, of each caplet to provide a coating which is smoother and easier to swallow than an uncoated caplet. The production of these capsule-like medicaments is readily facilitated by simple and inexpensive modifications which can be made to existing empty gelatin capsule making equipment.
A novel capsule-like medicament, method for producing such medicaments and apparatus are-disclosed. The method provides a procedure for coating solid cores, such as caplets, with gelatinous coatings to produce a shiny, capsule-like medicament.
Such medicaments are achieved by individually dipping and drying first one end, and then the other end, of each caplet to provide a coating which is smoother and easier to swallow than an uncoated caplet. The production of these capsule-like medicaments is readily facilitated by simple and inexpensive modifications which can be made to existing empty gelatin capsule making equipment.
Description
~1317882 GELATIN COATED CAPLETS AND
FIE~D OF THE INVENTION
This invention relates to coated medicaments and processes for providing gelatinous coverings for such medicaments.
This invention is also directed to novel apparatus for producing such medicaments.
BACKGROUND O~ TBE_INVENTION
Until recently, the pharmaceutical industry has celied upon empty gelatin capsules for the encapsulation of medicinal agents as a popular method for administering drugs. Hard capsules are not new. As early as 1848, Murdock introduced the two-piece, hard gela~in capsule. Capsules are tasteless, easily administered and easily filled either extemporaneously or in large quantities commercially. ~lany patients find it easier to swallow capsules than tablets, therefore preferring to ~ake this orm whenever 15' possible. This preference has prompted pharmaceutical manufacturers to market certain products in capsule form even though tbey are also available in tablet orm.
Empty gelatin capsules are typically made from ~elatin-glycerin, pure gelatin, starch or sugar gelatin, or other soluble gela~in combinations. See Remington's Practice of , Marti~ & Cook, 17th edition, pp. 1625-1630.
Capsules serve as adequate housings for powders, masses, liquids, ~`
; pellets and oils and offer improved palatability and convenience.
Generally, empty hard gelatin capsules are manufactured using automated equipment. This equipment employs rows of stainless steel pins, mounted on bars or plates, which are dipped .~
~3~7882 into a gelatin solution maintained at a uniform temperature and fluidity. The pins are then withdrawn from ~he gelatin solution, are rotated and then inserted into drying kilns through which a strong blast of filtered air with controlled humidity is forced.
A crude capsule half is thus formed over each pin during drying.
~ach capsule half is then stripped, trimmed to uniform length, filled and ~oined to an appropriate mating half. Such hard cap~ule makin~ systems are sold by Cherry-~urxell of Cedar Rapids, IA.
During most of this century, empty gelatin capsules were a popular do~age form for prescription and over-the-counter (OTC) drugs. However, in the early 1980's there was an unexpected increase in tampering with the contents of those capsules, resulting in several widely publicized deaths. This curtailed consumer demand for these products, caused ubiquitous concern regarding safety among those in the pharmaceutical community, and idled much of the industry's hard capsule making equipment.
Improved gelatin caps~les and tamper-resistant packaging were then developed, but were expensive to produce and were not foolproof.
Once the threat of capsule tampering was recognized, many manufacturers withdrew their capsule products from the market, often rep]acing them with solid, oblong-shaped medicaments referred to commonly as caplet~. Caplets are solid oblong tablets which are sometimes coated with material such as cellulose. Typically, this coating is applied using coating-pan systems such as the ~Vector-Freund Hi-Coate~s~, sold by Vector Corporation, 575 4~th St~eet, Marion, Iowa, or the ~GC-1000R sold by Glatt Air Techniques, ~0 Spear Road, ~amsey. N~w Jersey.
131~3~2 - - -A coating-pan system has a peroeated pan or a drum which revolves in a manner similar to a standard clothes dryer. The `
system includes an air-atomization, spray gun which is inserted into the center of the drum for spraying a fine mist of coating material A batch of solid medicaments or caplets is typically introduced into the cylindrical panr wherein said batch i~s caused to tumble. The tumbling ac~ion tends to smooth out some of the rough edges on the caplets prior to coating with organic or aqueous film solutions ~lhich may contain solid additives. Coating pans generally produce consistent coating tlllcknesses and weigllts but are capable of providing only one color coating. Coatings produced by this method are often thin, offering poor coverage of medica~ent imperfections and rough edges not removed by the tumb]ing operation. Unless time is taken to build up a thicker coat, defects on ~he solid core resul~ :in a medicament that does not exhibi.t a pleasing appearance and rnay be perceived as being h~rder to swallow. Moreover, coating abrasion occurring during tumbling produces a surface finish on these medicaments that fails to exhibit the shiny surface that consumers and those in the art have associated with ease of swallowability. Applicant has pan coat~d c~plets with gelatin on an experimental basis and has measured coatlng thicknesses of only about 6 mils. Moreover, these pan coated gelatin caplets were not observed to be as shiny as caplets coated hy a dipping process.
Swallowability, the ability to pass through the fauces, pharnyx and esophagus into the stomach, is dependent on the physical characteristics o~ the medicament as well as psychological ~actors. See Stedman's Medical Dictionary ~nderso Publishing Co., 5th edition, p.l377~ Physical characteristics, such as 1317~8~
me~icament shape, size an~ sur~ace finish, can be correlated with esophageal adherence and swallowability. With ~espect to psychological factors, swallowing is normally volitional in adults, and muscular contractions of the throat are understood to be under the control of the individual at a subconscious level.
See Stedman's, at 1377. Consumer surveys suggest ~hat a shiny, capsule-like appearance has a special appeal to users as beiny easier to swallow. In addition, surveys indicate that consumers perceive capsule products to be more sffective, thereby add:ing a possible additional placebo factor to their actual effectiveness.
Solid medicaments comprising gelatin in their coatings have been taught in a number o~ abstracts. The abstract of J.A.
Glassman, U.S. 3,228~786, for instance, is directed to peroral capsules and tablets and a method for manufacturing same.
~lassman discloses delayed release, compartmental medicaments with gelatin coatings, and includes treatments for tablets or pellat coatings. The abstract of Japanese patent 52041213, assigned to Freund Industry Ltd., discloses a process for coating tablets with a solution containing gelatin as a film-forming agent. The abstract of Japanese patent 69027916, assigned ~o Sankyo Co. Ltd., is directed to gelatin coated tablets and a process for making same. The process of this patent includes feeding raw tablets at continuous intervals into a support. The tablets are immersed in a coating solution which can comprise gelatin. They are then recovered and held on a holder. Excess coating solution deposited at the lower surface of the tablet is removèd by an eliminating plate, and finally the tablet i5 released into a cooling solution from which it is recovcred and dried ~o ~roduce a seamless coated tablet. The abstract of Japanese patent 65009992, _q _ ~ICP-4 ~3~78~2 assi~ned to Konishi, is directed to a film-coating method using gelatin for coating tablets in a coating pan. ~he gelatin described in this abstrac~ is pre-treated with water in a pressure-cooker at ~ 120-140F for 30-40 ~inutes to reduce the adhesive properties of the gelatin to allow coating of the tablet. The abstract of Japanese patent 65009994, also assigned to Ronishi, is directe~ to coating tablets in a coating pan with an emulsion including a mixture of hot water, gelatin, a surface active agent and a mem~er selected from a group consisting o~ fats and oils, paraffin and wax. The use of the emulsion described in this patent abstract allows tablets to be coated with gelatin in the same manner as coating tablets with sugar. See also the abstract of an article by Richardson entitled ~ranciscus Pill Coater~, Pharm. Hist., 28: 90-91 ~2)19B6. This abstract is directed to the Franciscus Pill Coater, one of the later refinements of the gelatin-coated process that appealed to the practicing pharmacists in the ]9th century. Other abstracts also disclosing coatings for solid medicaments comprising gelatin include those for: Japanese patent 60084215, assigned to Shinetsu Chemical Industries, U.S. patent 4,238,510, assigned to Liesavers, Inc., and Japanese patent 69026677, assigned to Daiichi Seiyaku Co. Ltd.
Several patents have disclosed the concept of coating pills by dipping half the surface of the pill at a time.
zs Richards, V.S. Patent No. 599,865 is directed to a process and - apparatus for dipping pills wherein an adhesive bearing bar is u.sed to hold the pills before dipping the~ into gelat~n. This process requires great ca~e in maintaining the consist~ncy of che adhesive material, i.e. wax, so that each pill will adhere to the flipping-bar. The specification oP Richards also warns that great care must be taken not to dip the pills so deep as to get any o~
~cp-~
the gelatin upon the wax, which may ruin its adhesive eapacity.
The method of Richards additionally is labor intensive, and therefore, i5 more expensive by today's standards. Clark, U.S.
Patent No. 724,436, is directed to a pill coating machine that employs pill-bars having a series o perforations for receiving pills. Each perforation is adapted for suction, whereby the pill is held in position during the dipping operation. Banker, U.S.
Patent No. 3,896,762, discloses a rotary immersion coating that similarly employs suction to hold solid medicaments prior to passing these medicaments through a coating bath. ~ihile Clark and Banker provide apparatus for holding and dipping medicaments, neither discloses that the final product will exhibit a capsule-like appearance with or without a seam. Moreover, applicant has tested vacu~m holding apparatus and has discovered that the suction tends to attract some of the gelatin into the holder, producing an irregular seam. Vacuum holding systems such as these also require significant power consumption~ are often complicated and uncertain in their action, and necessitate expensive and sensitive vacuum equipment. Finally Oddo, U.S.
Patent 3,045,641, disclo es appara~us for color-coding tablets that utilizes a rotating resilient roller impregnated with a coating substance, whereby tablets are passed beneath the roller on a conveyor and are deeply impressed into the resilient roller surface. This patent does not disclose the use of gelatin or the use of a dipping process to produce a thick capsule-like coating Although these gelatin coated medicaments and processes have achieved some commercial success in the ~arketplace, a need remains ~or a coated medicament which is at least as ~amper-resistant as a caplet while providing the ease of swallowability of a capsule. There is also a need for a less expensive 1~11 7~82 medicament coating method capable of producing a multi-colored, capsule-like coating which is perceived by the consuming public to be more effec~ive.
SUMMARY OF THE INVENTION
The present invention provides a novel method for coating solid cores, such as capletsj with gelatinous coatin~s to produce simulated capsule-like medicaments. Such capsule like medicaments are achieved by individually dipping and drawing first one end and then the other end of each caplet to provide a medicament which is observed to be similar to a regular capsule. The production of such capsules is readily facilitated by simple and inexpensive modifications which.may be made to existing, hard capsule, production ~qui.pment o~ by similarly designed newer equipment. In particular, the preferred apparatus of the present invention replaces the peior art steel pins of a standard capsule production machine with novel caplet holding means having caplet channels therein for receiving, individua].ly gripping and transferring caplets during various stages of the herein described coating process. Also included, are novel caplet designs which readily ~acilitate the method of this invention. As a result, novel capsule-like medicaments are provided having smooth, relatively thick, shiny, multi-colored gelatinous coatings thereon. These ~ medica~ents are pleasing to the eye, and should be perceived by : consumers as easier to swallow and more effective than prior art c~plet medica~ents, while providing ~uch greater tamper resistance than conventional capsules.
It is~ therefore, an object of this invqntion to provid~
a simulated, capsule-like medicament having a gelatinous coating capable of being ~rovided in two or more colors.
:1 3~7~82 It is another object of this invention to provide a simulated, capsule-like medicament that is tamper-resistant.
It is another object of this invention to provide a simulated, capsule-like medicament that provides greater ease in Swallowing and i5 perceived to be more effective than pan-coated pharmaceutical equivalents.
It is still another object of this invention to provide a novel and less expensive method and apparatus for adapting existing hard capsule equipment ~or manufacturing gela~in coated ' 10 c~plets .
It is still another object of this invention to provide a heavy layer of gelatin as a single coating to cover imperfectionS
inherent on the caplet core.
~ 1ith these and other objects in view, which will become lS apparent to one ski]le~ in the art as the description proceeds, this invention resides in ~he novel construction, combination, arrangements of parts an~ methods substantially as hereinafter d~scribed and more particularly defined by the attached claim~.
BR I EF DE SCR I PTI ON OF THE DRAWI NGS
The accompanying drawings illustrate a complete embodiment of the invention according to the best mode so far devised for the practical application of the principles thereof, an~ in which:
FIG l is a diagrammatic view of the manufacturing sequence for providing a gelatin coating on caplets illustrating how the caplets are inserted, how the gelatinous coating is plieA to the first and second ends of the caplet, anA how the caplet6 are ~ried and ejected ----` 1 3 ~ 2 PIG. lA is a partial diagrammatic view of an alternative manufacturing sequence illustrating an alternative transferring method.
FIG. lB i5 a partial diagrammatic view of an alternatiYe manufacturing ~equence illustrating an alternative holding means and transferring method.
FIG. 2 is an enlarged detail of a cross-sectional view of the holding means 26 of ~ig. 1 with a caple~ being dipped in a gelatinous material, said caplet being retained by ~O~-rings 100 an~ 102;
FIG. 3 is an enlarged detail of a transverse cross-sectional view of an alternate holding means illustrating a flat spring 202s FIG. 4 is an enlarged detail of a longitudinal cross-sectional view of a caplet being retained by flat spring 202 of FIG. 3, tak~n through line 4-4;
FIG. S is an enlarged detail 3f a transverse cross-sectional view of an alternative holding means embodiment i]lustrating a spring retention means 200;
FIG. 6 is an enlarged top view of an uncoated caplet;
PIG. 7 is an enlarged detail of a transverse view of the caplet of FIG. 6;
FIG. 8a-d are enlarged details of transverse views of caplets illustrating various coating patterns.
FIG. 9 is an enlarged longitudinal view of an alternative shape for an uncoated caplet.
FIG. 10 is an enlarged detail of a transverse view of the caplet of FIG. 9.
FIG. llla) and (b) are enlarged details of the longitudinal cross-section views of the alternative holding means of FIG. lB showing how the ends of the caplet are held.
-`- ~31~82 DETAILED DESCRIPTION OF THE INVENTION
_ . _ _ _ The present invention provides a novel method for coating caplets with gelatinou~ coatingC to produce simulated capsule-like medicaments. The sub~ect method may be performed by ~odifying existing machines originally intended to fabricate empty gelatin capsules or by newer similarly designed apparatus.
The novel process of this invention comprises the steps of providing a holding means having a caplet channel defined therein and inserting a irst end of a caplet into said caplet channel while leaving the second end of the caplet exposed. The holding means is then manipulated relative to a bath of gelatinous coating to dip the second exposed end of each caplet into that bath. The resulting gelatinous coating on the second exposed end of the caplet is then permitted, and preferably caused, to dry to form a coated end. During the drying process the caplet may be rotated to assist in uniformly distributing gelatin during deying. Once dry, the coated tsecond) end of the caplet is then displaced through the caplet channel to expose its uncoated first end. ~ gelatinous coating is then applied to the uncoated first end of said caplet. The coating applied to the first end of the caplet is then permitted (or preferably caused) to dry, again with rotation if desired for the purpose of spreading the coating evenly. In accordance with the preferred embodiment method, the baths of gelatinous coating in~o which the caplet ends are dipped may be of different colors, to thereby create a simulated 2-piece capsule look to the finished caplets with seams about their transverse axes.
A substantial advantage of the present invention is that existing hard capsule manufacturing rnay be readily adapted for the purpose of producing the coated caplet products of the present 3~7882 invention. In the preferred embodiment apparatus of the present invention~ the conventional bars of such machines having stainless steel capsule-forming protuberances mounted thereon are replaced with bars having a plurality of cylindrical holding means mounted thereon. Each holdlng means receives, retains and facilitates the transfer of an individual caplet. The apparatus is fitted with a caplet feeder to feed caplets into each holding means. The holding means may, for example, be a cylinder which is open at both ends and which comprises a retaining means, such as ~o~-rings or a spring biased retainer for the purpose of holding each caplet in position during the dipping process. The feeding means is preferably associated with an inserting means, which may be a simple channel and plunger assembly, for inser~ing a first end of each caplet into an appropriate holding means. The feeding meanq ensures that each caplet is inserted a sufficient distance to cause the second end of the caplet to appropriately protrude therefrom during the upcoming dipping process. Once each bar is ; loaded with caplets, it then proceeds to a dip station where the ; gela~inous coating is applied to the exposed ends of the caplets protruding therefrom, whereupon the bar is rotated through a first drying means for permitting the gelatinous coating to dry to form a coated second end. In a preferred embodiment apparatus, the second gripping means also comprise substantially cylindrical holders which are open at both ends, having central bores defined therethrough. In this embodiment, these second holders are - axially aligned with the bores of the first holders, at the transfer positions, whereupon a plunger or other means is used to ~isplace the half-coated caplets through and out of the 'b~cks~ of the first holders and into the ~backs~ of the second holders, and ~ICP-4 `` 1317~82 then through the second holders until the remaining uncoated ends of the caplets are exposed for subsequent dipping. The dipping and drying processes are then repeated (preferably with a different colored gelatinous coating), whereupon a caplet ejeetion S means pushes the caplets out of the second holders.
In another preferred embodiment, the ~fronts" of the second hol~er means are aligned with the ~fronts~ of the first holder means, whereupon the caplets are mechanically ~ransferred from the first to the second holders without the need ~or an additional alignment device. In still another embodiment, a single holding means iq used for dipping bo~h ends of the caplet, whereby, after dippin~ the second end, ~he caplet is transferred through this single holding ~eans to expose the uncoated first end. This holder is then shifted to the second gelatinous coating bath which preferably contains a different color gelatin for dipping the first end of the caplet.
The subjec~ apparatus and method may be further understood wi~h reference to the figures. FIG. 1 1llustrates, diagram~atically, the preferred method and apparatus for dippin~
solid caplets into a gelatinous material embodying the teachings of this invention. A holding means is first provided having a caplet channel 106 defined therein, which can take any form having a cross-section si2ed to slidably mate with said caplet 16. The caplet lfi having a first and second end, 110 and 104 bf FIG 2, is inserte~ using inserting means 20 into said caplet channel 106 while leaving the second end of the caplet 104 exposed. Next, a ~elatinous coating, known to those in ~he phar~aceutical arts, is applied by first application means 28 to the exposed second end 104 of the caplet, ~he extent to which the second end 104 can be ~CP-4 ~ 3 ~ 2 coated is dependant upon the desired color configuration and ~seam~ requirements. The half-coated caplet is then dried using the first drying means 30 and 32 which permi~s the gelatinous coating on the second end 104 to dry, forming a coated second end. The capl~t 16 is then displaced through said caplet channel 106 to expose the first end 110 preferably using a gripping means illustrated in the e~bodiment of FIG. 1 as transfer means 12, alignment means 18 and second holding ~eans 15. The caplet 16 is then coated with a gelatinous material on its first end 110 by second application means 38 which is then dried by second drying means 34 and 36, resulting in a dry caplet substantially covered in gelatin. Accordingly, this invention provides novel means for providing simple and inexpensive modifications to existing hard capsule equipment to manufacture simulated capsule-like medicaments. This invention teaches preferred process sequences that supplement and partially replace otherwise standard empty gelatin capsule techniques and parameter~ that are known to the art. For example, gelatin materials used for the coatings of this invention may be any of ~he well known types utilized in the art of manufacturing empty capsules and coated medicaments.
Referring again to FIG. 1, the caplet 16 is fed into insertin~ means 20 by feeder 11. The feeder 11 preferably comprises a chute attached to a reservoir. ~lternatively, mechanical means or pneumatic means may be developed or this ; 25 purpose. In one embodiment, a 20-40 wide channel vibrational feeder has been deemed useful. It is expected that those in the art could readily adapt current automation technology to develop a means for ~eeding caplets into inserting means 20 of this invention. In the preferred embodiment, plungers displace caplets into each of a series of molding means spaced apart along a bar -- ~3~78~2 mount, shown in end cross seotion in F~G. 1, i.e., holding means 26. Each caplet l6 is then inserted into a first holding means 26 using plunger 2n. Both the first and second holding means 26 and 15 are pre~e~ably cylindrical, having caplet channels 106 having a cross-section sized to slidably mate with the caplet 16 to permit passage of the caplet 16. However, in the embodiment of FIG~ lA, these channels, or more preferably, bores, can extend through the holding means with one cross-section sized to slidably mate with caplet and another cross~section sized to receive only a plunging ~eans~ ThiS design is ~ade possible due to the fact that the caplets can be transferred without displacing them through the entire length of the holding means in the method embodiment of FIG. lA.
Included with one holding means embodiment of this invention, are retaining means for retaining the caplet at least during the first gelatinous coating application step. As shown by the embodiments ~ound in FIGS. 2-5, tbe reta.ining means can comprise a plurality of recessed rubber ~O~-rings 100 and 102, a flat spring 202 fixed by pin 204 and having convex side facing the 2Q caplet, or a resilient spring 200. As shown in FIG. 3 the flat spring 202 may be extended to enable external manipulation o~ the retaining means. The choice of retaining means is not critical and any known securing or resilient device may be used. However, it is important that the retaining means provide enough clearance to pass the gelatin coated end, yet securely hold the uncoated end.
In~erting means 20 preferably comprises a plunging meanc having at lea~t an end portion 22 disposed to abut the caplet 16 to effect displacement o~ the caplet 16 into the bore 106 of the first holding means 26.
~lcp-~
~317~82 In a preferred embodiment, a plurality of holding means are mounted on a fixture which can be transferred by the mechanical pushing means of a hard gelatin capsule assembly line.
In such an embodiment, inserting means 20 has multiple plunging means having a plurality of end portions 22 disposed to abut multiple caplets to effect displacement thereof into the fixture.
In one embodiment, 10 to 50 holding means, preferably 20 to 40, and most preferably 30 holding means are attached to the fixture.
A plurality of said fixtures can be fed into a conventional hard-capsule manufacturing assembly which can accommodate a~out 1500 to 1800 fixtures at a time.
The caplet coating process of FIG. 1 next applies a gelatinous coating to the second exposed end 104 of said caplet 16 A first application means 28 is employed for this purpose.
In th~ prefereed embodiment of this invention, groups of 4 or more fixtures are fed into a dipping means and vertically lowered into a gelatinous material such as methyl cellulose, calcium alginate or gelatin. The depth of the dip i.s preferably cam-regulated to the desired capsule size, color scheme, and ~seam~ requirements.
As indicated in FIG. 8a-d, the color scheme can be bifurcated as depicted by caplet coatings 304 and 306, and a seam 302 or 300 can be provided by overlapping the gelatinous coatings on the irst and second ends 110 and 104.
~he coatings on the first and second ends 110 and 104 of the caplet, when preferably dipped in gelatin can include plasticizers such as glycerin or sorbitol, water, preservatives, coloring agents, and opacifying agents. See !~emin~on's Practice , pages 1625 to 1630, The preferred gelatin solution should be maintained at a uniform temperature and a constant ~3~ 7~82 degree of fluidity If the gelatin solution varies in viscosity, it will correspondingly decrease or increase the thickness of ~he coating. Acceptable gelatin compositions can contain small amounts of methyl cellulose, polyvinyl alcohols, and denatured gelatins to modify their solubility or produce a enteric effect.
Common sources of gelatin contemplated by this invention include animal bones, hide portions and frozen pork skin. Grades of - gelatin that are appropriate for this invention include pharmaceutical grade, food grade, Type A and Type B. Although the coatings herein provided can be made from any of these sources or grade~, those le~rned in the art o~ capsule making are aware that the usual practice is to use a mixture of grades and sources as dictate~ by availability and cost considerations. Di~ferences in the physical properties of finished capsules as a function of the lS type o gelatin used are slight. Reference may also be made to ~The Theory and Practice of Industrial Pharmacy, by Lackman, Liberman and King (1970) pages 389-398, published by Lea and Febiger, Philadelphia, PennsylVania. In a preferred ~ odiment of.this invention, a gelatin mixture is prepared using 40% by weight bone (150 bloom), 20% hy weight hyde (245 bloom) and 40% pork skin (270 bloom~. This mixture has a viscosity of 500cp as measured on a Brookfield Chromatograph, at an operating temperature of 130F.
Coloring can be added to the coatings to produce opaque or transparent colors such as red, white, pink, green, reddish brown, blue, ye'low and black Colored medicaments are necessary to give a specialty product a distinctive appearance. Titanium dioxide is of~en added to the gelatin to form white medic3ments, or to make an opaque colored coating.
0 -]6-~J
~L3~78~2 rlcP-4 Still referring to FIG. 1, a~ter coating the second encl ]04, the yelatinous coating is permitted to dry ~o form a coated second end. It is important to the teachings of this invention that the caplet 16 is permitted to dry without contacting other objec~s, thus producing a shiny, simulated capsule-like finish on said caplet. In the prefeered embodiment, a group of ixtures is raised from the gelatin and elevated to the first drying means, compri~ing rotating means 30 and kiln means 32. Pr~ferably, the caplets are rotated to distribute the coating on the caplet. In a most preferred apparatus, the fixtures are automatically revolved after dipping to spread the gelatin more evenly over the caplet ends and eliminate excess accrual at the end~. See Sindl, U.S.
Patent No. 1,872,190. The caplets are then fed into a kiln drying means 32.
referably, 5-60 fixtu~es con~aining caplets enter the drying kiln, where they move under drying ducts_ Air volume, temperature and humidity are controlled in thekiln and are set to conventional process parameters known to those in the industry.
"
When the gelatinous coating on the second end 104 of the caplet is dry, it is displaced through the caplet channel lOÇ to ~......................... .
ex~ose the first end 110 using a gripping means illustrated in the embodiment of FI~. 1 as transfer means 12, alignment means 18 and second holding means 15. In o~e preferred emhodiment, the transfer means ~2 comprises an end portion 14 disposed to abut said caplet to effect displacement of said caplet from a the first holding means 26 to the second holding means 15. The caplet is then preferably displaced through the caplet channel or bore 106 of the first holding means 26, throu~h the alisnment means 18 and into said second holding means 15 to expose the uncoatecl first end ~10 o~ the caplet 16.
: ~ -17-,;~ i Alternatively, as depicted in FIG. lA, when the gelatinous coating on the second end 104 is dry, it can be displaced through the caplet channel 106 to expose the first end 110 by transferring the caplet from the ~front~ of a first holding s means to the ~front~ of a second holding means, thus eliminating the need for alignment means 18 of FIG. 1. It is also envisioned that a single holding means 210 like the one illustrated in FIG.
llta) and (b) could replace the use of the two holding means 26 and 15 of FIGS. 1 and lA by providing for the displacement of ~he caplet through a central bore 201. Three ~oU-rings 203, 205 and 2 are shown in PIGS. ll(a) and (b) for retaining the caplet during the process of coating the second and first ends 104 and 110 using a single holding means 210. However, other retaining means, as previously described for the holding means 26 and 15 of FIG. 1, may also be employed for this purpose. As illustrated, in the embodiment of FIG. lB, by transferring bars containing a plurality of holding means 210 from the left side of the diagram~atic view of the process of ~IG. 1 to the right side, the need for a second holding means is eliminated.
A~ter displacing the caplet through the caplet channel 106, the protruding first end is ready for the application of a gelatinous coating which is illustrated on the right side of FIG.
1. As indicated in the above preferred embodiments, groups of 4 or more fixtures can be fed into a dippins means 38 and vertically lowered into a gelatinous material, preferably containing a different color dye or pigment for providing a distinctive appearance, As indicated in FIG. 8, a seam 300 or 302 can now be provided by overlapping the dried coating on the ~econd end 104.
Through careful selection of gelatin color schemes, the seam can -` 1 317882 exhibit a ~ifferent color than the ends of the caplet, i.e., green and yellow coatings on the ends can be overlapped to form a blue seam. The gelatinous coating on the first end is then permitted to dry without contacting okher objects, as previously described for the second end ]04. Separate rotating means 34 and kiln means 36 are illustrated in FIG. 1 for drying the coating on the first end. However, those in the art may find it convenient to use the same drying apparatus used in drying the secon~ end 104.
Finally, the caplet may be ejected from the second holder means 15 after the first end 110 is dry. Removal of the coated caplet 16 can be effected by ejection means 25 which preferably is similar in structure to inserting means 20 and transfer means 12, ïn that it comprises an end portion disposed to abut said caplet. Removing the caplet can be accomplished by plunging horizontally as in FIGS. 1 and lA or by plunging the caplet out of the holding means vertically as in FIG. lB. The ejected caplet, now coated in gelatinous material, is then ready for printing and packaging.
In view of the above it is expected that a novel, simulated capsule-like medicament can be produced~ The gelatin coated medicament of this inventi.on which can be p~uduced by the above method comprises a solid ~aplet having a first and a second end, wherein a first gelatinous coating is provided on said second end, and a second gelatinous coating is provided on said first end of the caplet~ The caplet generally is at least 2.5 times longer than it is wide, and ideally comprises a cylindrical shape. The first and second gelatinous coatings substantially cover the caplet to form a simulated capsule-like medicament with a seam about a transverse axis of the medicament. As previously 13~78~2 discussed, the first and second ends 110 and 104 of the caplet can be coated with gelatinous coatings of different colors to provide a distinctive appearance for specialty products. A preferred color scheme for the medicament of this invention includes a caplet which is coated in a red and white gelatinous mateeial. It has been discovere~ ~hat absorption of the gelatinou~ coating or the moisture in the gelatinous coating by the solid caplet may be reduced b~ applying a conventional precoat secllant to caplet prior to dipping into a gelatinous material. See ~aker, U.S. Patent 3,185,626, which is herein incorporated by reference. Without a precoat sealant, it is possible that some of the gelatinous coating or moisture in the coating would seep into the caplet, resulting in a duller surface. The gelatinous coatings of this invention are generally provided in substantially uniform thicknesses of about 5 to 40 mils, preferably about 10 to 30 mils, and most preferably from 15 to 25 mils. However, it may be understood by those familiar with coating processes that the coating thickness may be varied to provide a smoother, easier to swallow, caplet.
Gelatin coated caplets have been produced using the above method, wherein the second applied gelatinous coating partially overlaps the first applied gelatinous coating forming a capsule-like seam circumscribing the medicament at about a midway point of a longitudinal access of the medicament.
Gelatin coated caplets can be supplied in a variety of shapes and sizes, from 000, the largest size which can be swallowed, to 5, which i~ the smallest. Larger sizes can also be ma~e available for use in veterinary medicine. FIGS. 6, 7, 9 and 10 illustrate two of the preferred shapes for caplets. FIGS. 6 and 7, show in top and transverse views respectively, an oblong .
caplet having a raised portion circumscribing its perimeter.
FIGS. 9 and lO illustrate in longitudinal and transverse views another preferred embodiment having a cylindrical center portion and rounded ends having a transverse diameter slightly less than that of the cylindrical center portion. These novel caplet designs facilitate the dipping method herein provided since they are easily held by the above retaining means and can be manufactured using conventional compression molding equipment.
From the foregoing it can be realized that this invention provides a simulated capsule-like medicament, a method for manufacturing this medicament, and apparatus used in the me~hod. The advantages over the prior art are: increased tamper-resistance over hollow capsules, increa~ed swallowability over pan-coated medicamentR, variable color scheme capability not available with pan-coate~ medicaments, less expensive operating costs and a greater perception by the consuming public that gelatin coated caplets are more effective. Although various embodiments have been illustrated, this was for the purpose of describing, but not limiting, the invention. Various modifications, which will become apparent to one skilled in the art, are within the scope of this invention described in the attached claims.
FIE~D OF THE INVENTION
This invention relates to coated medicaments and processes for providing gelatinous coverings for such medicaments.
This invention is also directed to novel apparatus for producing such medicaments.
BACKGROUND O~ TBE_INVENTION
Until recently, the pharmaceutical industry has celied upon empty gelatin capsules for the encapsulation of medicinal agents as a popular method for administering drugs. Hard capsules are not new. As early as 1848, Murdock introduced the two-piece, hard gela~in capsule. Capsules are tasteless, easily administered and easily filled either extemporaneously or in large quantities commercially. ~lany patients find it easier to swallow capsules than tablets, therefore preferring to ~ake this orm whenever 15' possible. This preference has prompted pharmaceutical manufacturers to market certain products in capsule form even though tbey are also available in tablet orm.
Empty gelatin capsules are typically made from ~elatin-glycerin, pure gelatin, starch or sugar gelatin, or other soluble gela~in combinations. See Remington's Practice of , Marti~ & Cook, 17th edition, pp. 1625-1630.
Capsules serve as adequate housings for powders, masses, liquids, ~`
; pellets and oils and offer improved palatability and convenience.
Generally, empty hard gelatin capsules are manufactured using automated equipment. This equipment employs rows of stainless steel pins, mounted on bars or plates, which are dipped .~
~3~7882 into a gelatin solution maintained at a uniform temperature and fluidity. The pins are then withdrawn from ~he gelatin solution, are rotated and then inserted into drying kilns through which a strong blast of filtered air with controlled humidity is forced.
A crude capsule half is thus formed over each pin during drying.
~ach capsule half is then stripped, trimmed to uniform length, filled and ~oined to an appropriate mating half. Such hard cap~ule makin~ systems are sold by Cherry-~urxell of Cedar Rapids, IA.
During most of this century, empty gelatin capsules were a popular do~age form for prescription and over-the-counter (OTC) drugs. However, in the early 1980's there was an unexpected increase in tampering with the contents of those capsules, resulting in several widely publicized deaths. This curtailed consumer demand for these products, caused ubiquitous concern regarding safety among those in the pharmaceutical community, and idled much of the industry's hard capsule making equipment.
Improved gelatin caps~les and tamper-resistant packaging were then developed, but were expensive to produce and were not foolproof.
Once the threat of capsule tampering was recognized, many manufacturers withdrew their capsule products from the market, often rep]acing them with solid, oblong-shaped medicaments referred to commonly as caplet~. Caplets are solid oblong tablets which are sometimes coated with material such as cellulose. Typically, this coating is applied using coating-pan systems such as the ~Vector-Freund Hi-Coate~s~, sold by Vector Corporation, 575 4~th St~eet, Marion, Iowa, or the ~GC-1000R sold by Glatt Air Techniques, ~0 Spear Road, ~amsey. N~w Jersey.
131~3~2 - - -A coating-pan system has a peroeated pan or a drum which revolves in a manner similar to a standard clothes dryer. The `
system includes an air-atomization, spray gun which is inserted into the center of the drum for spraying a fine mist of coating material A batch of solid medicaments or caplets is typically introduced into the cylindrical panr wherein said batch i~s caused to tumble. The tumbling ac~ion tends to smooth out some of the rough edges on the caplets prior to coating with organic or aqueous film solutions ~lhich may contain solid additives. Coating pans generally produce consistent coating tlllcknesses and weigllts but are capable of providing only one color coating. Coatings produced by this method are often thin, offering poor coverage of medica~ent imperfections and rough edges not removed by the tumb]ing operation. Unless time is taken to build up a thicker coat, defects on ~he solid core resul~ :in a medicament that does not exhibi.t a pleasing appearance and rnay be perceived as being h~rder to swallow. Moreover, coating abrasion occurring during tumbling produces a surface finish on these medicaments that fails to exhibit the shiny surface that consumers and those in the art have associated with ease of swallowability. Applicant has pan coat~d c~plets with gelatin on an experimental basis and has measured coatlng thicknesses of only about 6 mils. Moreover, these pan coated gelatin caplets were not observed to be as shiny as caplets coated hy a dipping process.
Swallowability, the ability to pass through the fauces, pharnyx and esophagus into the stomach, is dependent on the physical characteristics o~ the medicament as well as psychological ~actors. See Stedman's Medical Dictionary ~nderso Publishing Co., 5th edition, p.l377~ Physical characteristics, such as 1317~8~
me~icament shape, size an~ sur~ace finish, can be correlated with esophageal adherence and swallowability. With ~espect to psychological factors, swallowing is normally volitional in adults, and muscular contractions of the throat are understood to be under the control of the individual at a subconscious level.
See Stedman's, at 1377. Consumer surveys suggest ~hat a shiny, capsule-like appearance has a special appeal to users as beiny easier to swallow. In addition, surveys indicate that consumers perceive capsule products to be more sffective, thereby add:ing a possible additional placebo factor to their actual effectiveness.
Solid medicaments comprising gelatin in their coatings have been taught in a number o~ abstracts. The abstract of J.A.
Glassman, U.S. 3,228~786, for instance, is directed to peroral capsules and tablets and a method for manufacturing same.
~lassman discloses delayed release, compartmental medicaments with gelatin coatings, and includes treatments for tablets or pellat coatings. The abstract of Japanese patent 52041213, assigned to Freund Industry Ltd., discloses a process for coating tablets with a solution containing gelatin as a film-forming agent. The abstract of Japanese patent 69027916, assigned ~o Sankyo Co. Ltd., is directed to gelatin coated tablets and a process for making same. The process of this patent includes feeding raw tablets at continuous intervals into a support. The tablets are immersed in a coating solution which can comprise gelatin. They are then recovered and held on a holder. Excess coating solution deposited at the lower surface of the tablet is removèd by an eliminating plate, and finally the tablet i5 released into a cooling solution from which it is recovcred and dried ~o ~roduce a seamless coated tablet. The abstract of Japanese patent 65009992, _q _ ~ICP-4 ~3~78~2 assi~ned to Konishi, is directed to a film-coating method using gelatin for coating tablets in a coating pan. ~he gelatin described in this abstrac~ is pre-treated with water in a pressure-cooker at ~ 120-140F for 30-40 ~inutes to reduce the adhesive properties of the gelatin to allow coating of the tablet. The abstract of Japanese patent 65009994, also assigned to Ronishi, is directe~ to coating tablets in a coating pan with an emulsion including a mixture of hot water, gelatin, a surface active agent and a mem~er selected from a group consisting o~ fats and oils, paraffin and wax. The use of the emulsion described in this patent abstract allows tablets to be coated with gelatin in the same manner as coating tablets with sugar. See also the abstract of an article by Richardson entitled ~ranciscus Pill Coater~, Pharm. Hist., 28: 90-91 ~2)19B6. This abstract is directed to the Franciscus Pill Coater, one of the later refinements of the gelatin-coated process that appealed to the practicing pharmacists in the ]9th century. Other abstracts also disclosing coatings for solid medicaments comprising gelatin include those for: Japanese patent 60084215, assigned to Shinetsu Chemical Industries, U.S. patent 4,238,510, assigned to Liesavers, Inc., and Japanese patent 69026677, assigned to Daiichi Seiyaku Co. Ltd.
Several patents have disclosed the concept of coating pills by dipping half the surface of the pill at a time.
zs Richards, V.S. Patent No. 599,865 is directed to a process and - apparatus for dipping pills wherein an adhesive bearing bar is u.sed to hold the pills before dipping the~ into gelat~n. This process requires great ca~e in maintaining the consist~ncy of che adhesive material, i.e. wax, so that each pill will adhere to the flipping-bar. The specification oP Richards also warns that great care must be taken not to dip the pills so deep as to get any o~
~cp-~
the gelatin upon the wax, which may ruin its adhesive eapacity.
The method of Richards additionally is labor intensive, and therefore, i5 more expensive by today's standards. Clark, U.S.
Patent No. 724,436, is directed to a pill coating machine that employs pill-bars having a series o perforations for receiving pills. Each perforation is adapted for suction, whereby the pill is held in position during the dipping operation. Banker, U.S.
Patent No. 3,896,762, discloses a rotary immersion coating that similarly employs suction to hold solid medicaments prior to passing these medicaments through a coating bath. ~ihile Clark and Banker provide apparatus for holding and dipping medicaments, neither discloses that the final product will exhibit a capsule-like appearance with or without a seam. Moreover, applicant has tested vacu~m holding apparatus and has discovered that the suction tends to attract some of the gelatin into the holder, producing an irregular seam. Vacuum holding systems such as these also require significant power consumption~ are often complicated and uncertain in their action, and necessitate expensive and sensitive vacuum equipment. Finally Oddo, U.S.
Patent 3,045,641, disclo es appara~us for color-coding tablets that utilizes a rotating resilient roller impregnated with a coating substance, whereby tablets are passed beneath the roller on a conveyor and are deeply impressed into the resilient roller surface. This patent does not disclose the use of gelatin or the use of a dipping process to produce a thick capsule-like coating Although these gelatin coated medicaments and processes have achieved some commercial success in the ~arketplace, a need remains ~or a coated medicament which is at least as ~amper-resistant as a caplet while providing the ease of swallowability of a capsule. There is also a need for a less expensive 1~11 7~82 medicament coating method capable of producing a multi-colored, capsule-like coating which is perceived by the consuming public to be more effec~ive.
SUMMARY OF THE INVENTION
The present invention provides a novel method for coating solid cores, such as capletsj with gelatinous coatin~s to produce simulated capsule-like medicaments. Such capsule like medicaments are achieved by individually dipping and drawing first one end and then the other end of each caplet to provide a medicament which is observed to be similar to a regular capsule. The production of such capsules is readily facilitated by simple and inexpensive modifications which.may be made to existing, hard capsule, production ~qui.pment o~ by similarly designed newer equipment. In particular, the preferred apparatus of the present invention replaces the peior art steel pins of a standard capsule production machine with novel caplet holding means having caplet channels therein for receiving, individua].ly gripping and transferring caplets during various stages of the herein described coating process. Also included, are novel caplet designs which readily ~acilitate the method of this invention. As a result, novel capsule-like medicaments are provided having smooth, relatively thick, shiny, multi-colored gelatinous coatings thereon. These ~ medica~ents are pleasing to the eye, and should be perceived by : consumers as easier to swallow and more effective than prior art c~plet medica~ents, while providing ~uch greater tamper resistance than conventional capsules.
It is~ therefore, an object of this invqntion to provid~
a simulated, capsule-like medicament having a gelatinous coating capable of being ~rovided in two or more colors.
:1 3~7~82 It is another object of this invention to provide a simulated, capsule-like medicament that is tamper-resistant.
It is another object of this invention to provide a simulated, capsule-like medicament that provides greater ease in Swallowing and i5 perceived to be more effective than pan-coated pharmaceutical equivalents.
It is still another object of this invention to provide a novel and less expensive method and apparatus for adapting existing hard capsule equipment ~or manufacturing gela~in coated ' 10 c~plets .
It is still another object of this invention to provide a heavy layer of gelatin as a single coating to cover imperfectionS
inherent on the caplet core.
~ 1ith these and other objects in view, which will become lS apparent to one ski]le~ in the art as the description proceeds, this invention resides in ~he novel construction, combination, arrangements of parts an~ methods substantially as hereinafter d~scribed and more particularly defined by the attached claim~.
BR I EF DE SCR I PTI ON OF THE DRAWI NGS
The accompanying drawings illustrate a complete embodiment of the invention according to the best mode so far devised for the practical application of the principles thereof, an~ in which:
FIG l is a diagrammatic view of the manufacturing sequence for providing a gelatin coating on caplets illustrating how the caplets are inserted, how the gelatinous coating is plieA to the first and second ends of the caplet, anA how the caplet6 are ~ried and ejected ----` 1 3 ~ 2 PIG. lA is a partial diagrammatic view of an alternative manufacturing sequence illustrating an alternative transferring method.
FIG. lB i5 a partial diagrammatic view of an alternatiYe manufacturing ~equence illustrating an alternative holding means and transferring method.
FIG. 2 is an enlarged detail of a cross-sectional view of the holding means 26 of ~ig. 1 with a caple~ being dipped in a gelatinous material, said caplet being retained by ~O~-rings 100 an~ 102;
FIG. 3 is an enlarged detail of a transverse cross-sectional view of an alternate holding means illustrating a flat spring 202s FIG. 4 is an enlarged detail of a longitudinal cross-sectional view of a caplet being retained by flat spring 202 of FIG. 3, tak~n through line 4-4;
FIG. S is an enlarged detail 3f a transverse cross-sectional view of an alternative holding means embodiment i]lustrating a spring retention means 200;
FIG. 6 is an enlarged top view of an uncoated caplet;
PIG. 7 is an enlarged detail of a transverse view of the caplet of FIG. 6;
FIG. 8a-d are enlarged details of transverse views of caplets illustrating various coating patterns.
FIG. 9 is an enlarged longitudinal view of an alternative shape for an uncoated caplet.
FIG. 10 is an enlarged detail of a transverse view of the caplet of FIG. 9.
FIG. llla) and (b) are enlarged details of the longitudinal cross-section views of the alternative holding means of FIG. lB showing how the ends of the caplet are held.
-`- ~31~82 DETAILED DESCRIPTION OF THE INVENTION
_ . _ _ _ The present invention provides a novel method for coating caplets with gelatinou~ coatingC to produce simulated capsule-like medicaments. The sub~ect method may be performed by ~odifying existing machines originally intended to fabricate empty gelatin capsules or by newer similarly designed apparatus.
The novel process of this invention comprises the steps of providing a holding means having a caplet channel defined therein and inserting a irst end of a caplet into said caplet channel while leaving the second end of the caplet exposed. The holding means is then manipulated relative to a bath of gelatinous coating to dip the second exposed end of each caplet into that bath. The resulting gelatinous coating on the second exposed end of the caplet is then permitted, and preferably caused, to dry to form a coated end. During the drying process the caplet may be rotated to assist in uniformly distributing gelatin during deying. Once dry, the coated tsecond) end of the caplet is then displaced through the caplet channel to expose its uncoated first end. ~ gelatinous coating is then applied to the uncoated first end of said caplet. The coating applied to the first end of the caplet is then permitted (or preferably caused) to dry, again with rotation if desired for the purpose of spreading the coating evenly. In accordance with the preferred embodiment method, the baths of gelatinous coating in~o which the caplet ends are dipped may be of different colors, to thereby create a simulated 2-piece capsule look to the finished caplets with seams about their transverse axes.
A substantial advantage of the present invention is that existing hard capsule manufacturing rnay be readily adapted for the purpose of producing the coated caplet products of the present 3~7882 invention. In the preferred embodiment apparatus of the present invention~ the conventional bars of such machines having stainless steel capsule-forming protuberances mounted thereon are replaced with bars having a plurality of cylindrical holding means mounted thereon. Each holdlng means receives, retains and facilitates the transfer of an individual caplet. The apparatus is fitted with a caplet feeder to feed caplets into each holding means. The holding means may, for example, be a cylinder which is open at both ends and which comprises a retaining means, such as ~o~-rings or a spring biased retainer for the purpose of holding each caplet in position during the dipping process. The feeding means is preferably associated with an inserting means, which may be a simple channel and plunger assembly, for inser~ing a first end of each caplet into an appropriate holding means. The feeding meanq ensures that each caplet is inserted a sufficient distance to cause the second end of the caplet to appropriately protrude therefrom during the upcoming dipping process. Once each bar is ; loaded with caplets, it then proceeds to a dip station where the ; gela~inous coating is applied to the exposed ends of the caplets protruding therefrom, whereupon the bar is rotated through a first drying means for permitting the gelatinous coating to dry to form a coated second end. In a preferred embodiment apparatus, the second gripping means also comprise substantially cylindrical holders which are open at both ends, having central bores defined therethrough. In this embodiment, these second holders are - axially aligned with the bores of the first holders, at the transfer positions, whereupon a plunger or other means is used to ~isplace the half-coated caplets through and out of the 'b~cks~ of the first holders and into the ~backs~ of the second holders, and ~ICP-4 `` 1317~82 then through the second holders until the remaining uncoated ends of the caplets are exposed for subsequent dipping. The dipping and drying processes are then repeated (preferably with a different colored gelatinous coating), whereupon a caplet ejeetion S means pushes the caplets out of the second holders.
In another preferred embodiment, the ~fronts" of the second hol~er means are aligned with the ~fronts~ of the first holder means, whereupon the caplets are mechanically ~ransferred from the first to the second holders without the need ~or an additional alignment device. In still another embodiment, a single holding means iq used for dipping bo~h ends of the caplet, whereby, after dippin~ the second end, ~he caplet is transferred through this single holding ~eans to expose the uncoated first end. This holder is then shifted to the second gelatinous coating bath which preferably contains a different color gelatin for dipping the first end of the caplet.
The subjec~ apparatus and method may be further understood wi~h reference to the figures. FIG. 1 1llustrates, diagram~atically, the preferred method and apparatus for dippin~
solid caplets into a gelatinous material embodying the teachings of this invention. A holding means is first provided having a caplet channel 106 defined therein, which can take any form having a cross-section si2ed to slidably mate with said caplet 16. The caplet lfi having a first and second end, 110 and 104 bf FIG 2, is inserte~ using inserting means 20 into said caplet channel 106 while leaving the second end of the caplet 104 exposed. Next, a ~elatinous coating, known to those in ~he phar~aceutical arts, is applied by first application means 28 to the exposed second end 104 of the caplet, ~he extent to which the second end 104 can be ~CP-4 ~ 3 ~ 2 coated is dependant upon the desired color configuration and ~seam~ requirements. The half-coated caplet is then dried using the first drying means 30 and 32 which permi~s the gelatinous coating on the second end 104 to dry, forming a coated second end. The capl~t 16 is then displaced through said caplet channel 106 to expose the first end 110 preferably using a gripping means illustrated in the e~bodiment of FIG. 1 as transfer means 12, alignment means 18 and second holding ~eans 15. The caplet 16 is then coated with a gelatinous material on its first end 110 by second application means 38 which is then dried by second drying means 34 and 36, resulting in a dry caplet substantially covered in gelatin. Accordingly, this invention provides novel means for providing simple and inexpensive modifications to existing hard capsule equipment to manufacture simulated capsule-like medicaments. This invention teaches preferred process sequences that supplement and partially replace otherwise standard empty gelatin capsule techniques and parameter~ that are known to the art. For example, gelatin materials used for the coatings of this invention may be any of ~he well known types utilized in the art of manufacturing empty capsules and coated medicaments.
Referring again to FIG. 1, the caplet 16 is fed into insertin~ means 20 by feeder 11. The feeder 11 preferably comprises a chute attached to a reservoir. ~lternatively, mechanical means or pneumatic means may be developed or this ; 25 purpose. In one embodiment, a 20-40 wide channel vibrational feeder has been deemed useful. It is expected that those in the art could readily adapt current automation technology to develop a means for ~eeding caplets into inserting means 20 of this invention. In the preferred embodiment, plungers displace caplets into each of a series of molding means spaced apart along a bar -- ~3~78~2 mount, shown in end cross seotion in F~G. 1, i.e., holding means 26. Each caplet l6 is then inserted into a first holding means 26 using plunger 2n. Both the first and second holding means 26 and 15 are pre~e~ably cylindrical, having caplet channels 106 having a cross-section sized to slidably mate with the caplet 16 to permit passage of the caplet 16. However, in the embodiment of FIG~ lA, these channels, or more preferably, bores, can extend through the holding means with one cross-section sized to slidably mate with caplet and another cross~section sized to receive only a plunging ~eans~ ThiS design is ~ade possible due to the fact that the caplets can be transferred without displacing them through the entire length of the holding means in the method embodiment of FIG. lA.
Included with one holding means embodiment of this invention, are retaining means for retaining the caplet at least during the first gelatinous coating application step. As shown by the embodiments ~ound in FIGS. 2-5, tbe reta.ining means can comprise a plurality of recessed rubber ~O~-rings 100 and 102, a flat spring 202 fixed by pin 204 and having convex side facing the 2Q caplet, or a resilient spring 200. As shown in FIG. 3 the flat spring 202 may be extended to enable external manipulation o~ the retaining means. The choice of retaining means is not critical and any known securing or resilient device may be used. However, it is important that the retaining means provide enough clearance to pass the gelatin coated end, yet securely hold the uncoated end.
In~erting means 20 preferably comprises a plunging meanc having at lea~t an end portion 22 disposed to abut the caplet 16 to effect displacement o~ the caplet 16 into the bore 106 of the first holding means 26.
~lcp-~
~317~82 In a preferred embodiment, a plurality of holding means are mounted on a fixture which can be transferred by the mechanical pushing means of a hard gelatin capsule assembly line.
In such an embodiment, inserting means 20 has multiple plunging means having a plurality of end portions 22 disposed to abut multiple caplets to effect displacement thereof into the fixture.
In one embodiment, 10 to 50 holding means, preferably 20 to 40, and most preferably 30 holding means are attached to the fixture.
A plurality of said fixtures can be fed into a conventional hard-capsule manufacturing assembly which can accommodate a~out 1500 to 1800 fixtures at a time.
The caplet coating process of FIG. 1 next applies a gelatinous coating to the second exposed end 104 of said caplet 16 A first application means 28 is employed for this purpose.
In th~ prefereed embodiment of this invention, groups of 4 or more fixtures are fed into a dipping means and vertically lowered into a gelatinous material such as methyl cellulose, calcium alginate or gelatin. The depth of the dip i.s preferably cam-regulated to the desired capsule size, color scheme, and ~seam~ requirements.
As indicated in FIG. 8a-d, the color scheme can be bifurcated as depicted by caplet coatings 304 and 306, and a seam 302 or 300 can be provided by overlapping the gelatinous coatings on the irst and second ends 110 and 104.
~he coatings on the first and second ends 110 and 104 of the caplet, when preferably dipped in gelatin can include plasticizers such as glycerin or sorbitol, water, preservatives, coloring agents, and opacifying agents. See !~emin~on's Practice , pages 1625 to 1630, The preferred gelatin solution should be maintained at a uniform temperature and a constant ~3~ 7~82 degree of fluidity If the gelatin solution varies in viscosity, it will correspondingly decrease or increase the thickness of ~he coating. Acceptable gelatin compositions can contain small amounts of methyl cellulose, polyvinyl alcohols, and denatured gelatins to modify their solubility or produce a enteric effect.
Common sources of gelatin contemplated by this invention include animal bones, hide portions and frozen pork skin. Grades of - gelatin that are appropriate for this invention include pharmaceutical grade, food grade, Type A and Type B. Although the coatings herein provided can be made from any of these sources or grade~, those le~rned in the art o~ capsule making are aware that the usual practice is to use a mixture of grades and sources as dictate~ by availability and cost considerations. Di~ferences in the physical properties of finished capsules as a function of the lS type o gelatin used are slight. Reference may also be made to ~The Theory and Practice of Industrial Pharmacy, by Lackman, Liberman and King (1970) pages 389-398, published by Lea and Febiger, Philadelphia, PennsylVania. In a preferred ~ odiment of.this invention, a gelatin mixture is prepared using 40% by weight bone (150 bloom), 20% hy weight hyde (245 bloom) and 40% pork skin (270 bloom~. This mixture has a viscosity of 500cp as measured on a Brookfield Chromatograph, at an operating temperature of 130F.
Coloring can be added to the coatings to produce opaque or transparent colors such as red, white, pink, green, reddish brown, blue, ye'low and black Colored medicaments are necessary to give a specialty product a distinctive appearance. Titanium dioxide is of~en added to the gelatin to form white medic3ments, or to make an opaque colored coating.
0 -]6-~J
~L3~78~2 rlcP-4 Still referring to FIG. 1, a~ter coating the second encl ]04, the yelatinous coating is permitted to dry ~o form a coated second end. It is important to the teachings of this invention that the caplet 16 is permitted to dry without contacting other objec~s, thus producing a shiny, simulated capsule-like finish on said caplet. In the prefeered embodiment, a group of ixtures is raised from the gelatin and elevated to the first drying means, compri~ing rotating means 30 and kiln means 32. Pr~ferably, the caplets are rotated to distribute the coating on the caplet. In a most preferred apparatus, the fixtures are automatically revolved after dipping to spread the gelatin more evenly over the caplet ends and eliminate excess accrual at the end~. See Sindl, U.S.
Patent No. 1,872,190. The caplets are then fed into a kiln drying means 32.
referably, 5-60 fixtu~es con~aining caplets enter the drying kiln, where they move under drying ducts_ Air volume, temperature and humidity are controlled in thekiln and are set to conventional process parameters known to those in the industry.
"
When the gelatinous coating on the second end 104 of the caplet is dry, it is displaced through the caplet channel lOÇ to ~......................... .
ex~ose the first end 110 using a gripping means illustrated in the embodiment of FI~. 1 as transfer means 12, alignment means 18 and second holding means 15. In o~e preferred emhodiment, the transfer means ~2 comprises an end portion 14 disposed to abut said caplet to effect displacement of said caplet from a the first holding means 26 to the second holding means 15. The caplet is then preferably displaced through the caplet channel or bore 106 of the first holding means 26, throu~h the alisnment means 18 and into said second holding means 15 to expose the uncoatecl first end ~10 o~ the caplet 16.
: ~ -17-,;~ i Alternatively, as depicted in FIG. lA, when the gelatinous coating on the second end 104 is dry, it can be displaced through the caplet channel 106 to expose the first end 110 by transferring the caplet from the ~front~ of a first holding s means to the ~front~ of a second holding means, thus eliminating the need for alignment means 18 of FIG. 1. It is also envisioned that a single holding means 210 like the one illustrated in FIG.
llta) and (b) could replace the use of the two holding means 26 and 15 of FIGS. 1 and lA by providing for the displacement of ~he caplet through a central bore 201. Three ~oU-rings 203, 205 and 2 are shown in PIGS. ll(a) and (b) for retaining the caplet during the process of coating the second and first ends 104 and 110 using a single holding means 210. However, other retaining means, as previously described for the holding means 26 and 15 of FIG. 1, may also be employed for this purpose. As illustrated, in the embodiment of FIG. lB, by transferring bars containing a plurality of holding means 210 from the left side of the diagram~atic view of the process of ~IG. 1 to the right side, the need for a second holding means is eliminated.
A~ter displacing the caplet through the caplet channel 106, the protruding first end is ready for the application of a gelatinous coating which is illustrated on the right side of FIG.
1. As indicated in the above preferred embodiments, groups of 4 or more fixtures can be fed into a dippins means 38 and vertically lowered into a gelatinous material, preferably containing a different color dye or pigment for providing a distinctive appearance, As indicated in FIG. 8, a seam 300 or 302 can now be provided by overlapping the dried coating on the ~econd end 104.
Through careful selection of gelatin color schemes, the seam can -` 1 317882 exhibit a ~ifferent color than the ends of the caplet, i.e., green and yellow coatings on the ends can be overlapped to form a blue seam. The gelatinous coating on the first end is then permitted to dry without contacting okher objects, as previously described for the second end ]04. Separate rotating means 34 and kiln means 36 are illustrated in FIG. 1 for drying the coating on the first end. However, those in the art may find it convenient to use the same drying apparatus used in drying the secon~ end 104.
Finally, the caplet may be ejected from the second holder means 15 after the first end 110 is dry. Removal of the coated caplet 16 can be effected by ejection means 25 which preferably is similar in structure to inserting means 20 and transfer means 12, ïn that it comprises an end portion disposed to abut said caplet. Removing the caplet can be accomplished by plunging horizontally as in FIGS. 1 and lA or by plunging the caplet out of the holding means vertically as in FIG. lB. The ejected caplet, now coated in gelatinous material, is then ready for printing and packaging.
In view of the above it is expected that a novel, simulated capsule-like medicament can be produced~ The gelatin coated medicament of this inventi.on which can be p~uduced by the above method comprises a solid ~aplet having a first and a second end, wherein a first gelatinous coating is provided on said second end, and a second gelatinous coating is provided on said first end of the caplet~ The caplet generally is at least 2.5 times longer than it is wide, and ideally comprises a cylindrical shape. The first and second gelatinous coatings substantially cover the caplet to form a simulated capsule-like medicament with a seam about a transverse axis of the medicament. As previously 13~78~2 discussed, the first and second ends 110 and 104 of the caplet can be coated with gelatinous coatings of different colors to provide a distinctive appearance for specialty products. A preferred color scheme for the medicament of this invention includes a caplet which is coated in a red and white gelatinous mateeial. It has been discovere~ ~hat absorption of the gelatinou~ coating or the moisture in the gelatinous coating by the solid caplet may be reduced b~ applying a conventional precoat secllant to caplet prior to dipping into a gelatinous material. See ~aker, U.S. Patent 3,185,626, which is herein incorporated by reference. Without a precoat sealant, it is possible that some of the gelatinous coating or moisture in the coating would seep into the caplet, resulting in a duller surface. The gelatinous coatings of this invention are generally provided in substantially uniform thicknesses of about 5 to 40 mils, preferably about 10 to 30 mils, and most preferably from 15 to 25 mils. However, it may be understood by those familiar with coating processes that the coating thickness may be varied to provide a smoother, easier to swallow, caplet.
Gelatin coated caplets have been produced using the above method, wherein the second applied gelatinous coating partially overlaps the first applied gelatinous coating forming a capsule-like seam circumscribing the medicament at about a midway point of a longitudinal access of the medicament.
Gelatin coated caplets can be supplied in a variety of shapes and sizes, from 000, the largest size which can be swallowed, to 5, which i~ the smallest. Larger sizes can also be ma~e available for use in veterinary medicine. FIGS. 6, 7, 9 and 10 illustrate two of the preferred shapes for caplets. FIGS. 6 and 7, show in top and transverse views respectively, an oblong .
caplet having a raised portion circumscribing its perimeter.
FIGS. 9 and lO illustrate in longitudinal and transverse views another preferred embodiment having a cylindrical center portion and rounded ends having a transverse diameter slightly less than that of the cylindrical center portion. These novel caplet designs facilitate the dipping method herein provided since they are easily held by the above retaining means and can be manufactured using conventional compression molding equipment.
From the foregoing it can be realized that this invention provides a simulated capsule-like medicament, a method for manufacturing this medicament, and apparatus used in the me~hod. The advantages over the prior art are: increased tamper-resistance over hollow capsules, increa~ed swallowability over pan-coated medicamentR, variable color scheme capability not available with pan-coate~ medicaments, less expensive operating costs and a greater perception by the consuming public that gelatin coated caplets are more effective. Although various embodiments have been illustrated, this was for the purpose of describing, but not limiting, the invention. Various modifications, which will become apparent to one skilled in the art, are within the scope of this invention described in the attached claims.
Claims (70)
1. A method for coating a caplet with a gelatinous coating to produce a simulated capsule-like medicament comprising:
(a) providing a holding means having a caplet channel defined therein (b) inserting a first end of said caplet into said caplet channel while leaving a second end of said caplet exposed;
(c) applying a gelatinous coating to said second exposed end of said caplet;
(d) permitting said gelatinous coating to dry to form a coated second end;
(e) displacing said caplet through said caplet channel to expose said first end;
(f) applying a gelatinous coating to said first end of said caplet, said gelatinous coatings on said first and second ends substantially covering said caplet; and (g) permitting said gelatinous coating on said first end to dry, forming a simulated capsule-like medicament.
(a) providing a holding means having a caplet channel defined therein (b) inserting a first end of said caplet into said caplet channel while leaving a second end of said caplet exposed;
(c) applying a gelatinous coating to said second exposed end of said caplet;
(d) permitting said gelatinous coating to dry to form a coated second end;
(e) displacing said caplet through said caplet channel to expose said first end;
(f) applying a gelatinous coating to said first end of said caplet, said gelatinous coatings on said first and second ends substantially covering said caplet; and (g) permitting said gelatinous coating on said first end to dry, forming a simulated capsule-like medicament.
2. The method of claim 1 further comprising the step of providing a pre-coated caplet to reduce absorption of moisture and said gelatinous coatings by said caplet.
3. The method of claim 1 wherein said steps (c) and (f) coat said first and second ends of said caplet with gelatinous coatings of different colors.
4. The method of claim 1 wherein said steps (c) and (f) coat said caplet ends in a red and a white gelatinous material.
5. The method of claim 1 wherein said steps (c) and (f) coat said caplet ends to a thickness of about 5 to 40 mils,
6. The method of claim 1 wherein said steps (c) and (f) coat said caplet ends to a thickness of about 10 to 30 mils.
7. The method of claim 1 wherein said steps (c) and (f) coat said caplet ends to a thickness of about 15 to 25 mils.
8. The method of claim 1 wherein said first holding means is selected to comprise a retaining means for retaining said caplet in position at least during step (c).
9. The method of claim 1, wherein said displacing step comprises transferring said caplet from said first holding means to a second holding means.
10. The method of claim 1 wherein said caplet channel is selected to comprise a cross-section sized to slidably mate with said caplet,
11. The method of claim 9 wherein said caplet channel is selected to comprise a central bore extending through the length of said first holding means to permit passage of said caplet through at least a portion of said bore.
12. The method of claim 11 wherein said central bore is selected to comprise a transverse cross-section that is generally circular.
13. The method of claim 11 wherein said transferring step comprises displacing said caplet through said central bore.
14. The method of claim 13 wherein said transferring step comprises aligning said first and second holding means and displacing said caplet from said first holding means to said second holding means.
15. The method of claim 14 wherein said aligning step positions said second holding means proximate with said first holding means for displacing said caplet from the front of said first holding means to the front of said second holding means to expose said first end of said caplet.
16. The method of claim 9 wherein said second holder is selected to have a central bore extending through its length to permit passage of said caplet through at least a portion of said bore.
17. The method of claim 16 wherein said second holding means is selected to comprise a second retaining means for retaining said caplet at least during step (f).
18. The method of claim 16 wherein said transferring step displaces said caplet until said first end protrudes out of said second holder.
19. The method of claim 1 wherein said gelatinous coating is selected to comprise gelatin.
20. The method of claim 11 wherein said inserting step comprises activating a plunging means, said plunging means including an end portion disposed to abut said caplet to effect displacement into said bore of said first holding means.
21. The method of claim 1 wherein said inserting step comprises disposing multiple caplets into a fixture comprising a plurality of holding means.
22. The method of claim 21 wherein said inserting step comprises simultaneously introducing said multiple caplets into said fixture, said introducing step exposing a second end of said multiple caplets.
23. The method of claim 21 wherein said inserting step comprises activating a plunging means, said plunging means including a plurality of end portions disposed to abut said multiple caplets to effect displacement thereof into said fixture.
24. The method of claim 21 wherein said disposing multiple caplets step comprises providing a fixture having said holding means mounted thereon.
25. The method of claim 24 wherein said fixture comprises 10 to 50 holding means.
26. The method of claim 24 wherein said fixture comprises 20 to 40 holding means.
27. The method of claim 22 wherein said holding means comprise cylindrical bores therein for gripping said caplets.
28. The method of claim 27 wherein said bores extend through said holding means for passage therethrough of said caplets.
29. The method of claim 1 wherein said coating steps (c) and (f) each comprise dipping said caplet into a gelatinous material and withdrawing said caplet, said dipping producing a wet, gelatinous coating on said first and second ends of said caplet.
30. The method of claim 29 wherein said dipping step comprises vertically dipping said caplet into a bath of gelatinous material.
31. The method of claim 1 wherein steps (b), (c) (f) and (g) are performed to produce gelatinous coatings on said first and second ends of said caplet which overlap each other.
32. The method of claim 1 wherein at least one of said permitting steps (d) and (g) comprise positioning said caplet to permit said gelatinous coating to dry without contacting other objects, to form a shiny, simulated capsule-like finish.
33. The method of claim 32 wherein said positioning comprises rotating said caplet to distribute said coating on said caplet.
34. The method of claim 1 wherein at least one of said permitting steps (d) and (g) comprises kiln-drying said caplet.
35. The method of claim 9 further comprising the step of ejecting said caplet from said second holder after said first end is dry.
36. The method of claim 35 wherein said ejecting step comprises providing an ejection means including an end portion disposed to abut said caplet to effect displacement of said caplet out of said second holding means.
37. A simulated capsule-like medicament comprising:
(a) a solid caplet having a first and a second end, said caplet comprising a generally cylindrical shape;
(b) a first gelatinous coating provided on said second end of said caplet;
(c) a second gelatinous coating provided on said first end of said caplet, said first and second gelatinous coatings substantially covering said caplet to form a simulated capsule-like medicament with a seam about a transverse axis of said medicament.
(a) a solid caplet having a first and a second end, said caplet comprising a generally cylindrical shape;
(b) a first gelatinous coating provided on said second end of said caplet;
(c) a second gelatinous coating provided on said first end of said caplet, said first and second gelatinous coatings substantially covering said caplet to form a simulated capsule-like medicament with a seam about a transverse axis of said medicament.
38. The medicament of claim 37 wherein said first and second ends of said caplet are coated with gelatinous coatings of different colors.
39. The medicament of claim 37 wherein said caplet ends ace coated in a red and a white gelatinous material.
40. The medicament of claim 37 wherein said caplet is pre-coated to reduce absorption of moisture and said gelatinous coatings by said caplet.
41. The medicament of claim 37 wherein said first and second gelatinous coatings are provided in thicknesses of about 5 to 40 mils.
42. The medicament of claim 37 wherein said caplet comprises a width and a length, wherein said length is at least 2.5 times the width,
43. The medicament of claim 37 wherein said first and second gelatinous coatings are provided in thicknesses of about 15-25 mils.
44. The medicament of claim 37 wherein said first and second gelatinous coatings comprise gelatin.
45. The medicament of claim 37 wherein said second gelatinous coating partially overlaps said first gelatinous coating forming a capsule-like seam circumscribing said medicament at about a midway point of a longitudinal axis of said medicament.
46. An apparatus for coating a caplet with a gelatinous material to produce a capsule-like medicament comprising:
(a) inserting means for inserting a first end of said caplet into a first holding means while leaving a second end of said caplet exposed: said first holding means having a caplet channel defined therein for permitting the passage of said caplet;
said holding means further comprising retaining means for holding said caplet;
(b) first application means for applying a gelatinous coating to said second exposed end of said caplet;
(c) first drying means for permitting said gelatinous coating to dry to form a coated second end;
(d) gripping means for displacing said caplet through said caplet channel to expose said first end;
(e) second application means for applying a gelatinous coating on said first end of said caplet; and (f) second drying means for permitting said gelatinous coating on said first end to dry, forming a simulated capsule-like medicament.
(a) inserting means for inserting a first end of said caplet into a first holding means while leaving a second end of said caplet exposed: said first holding means having a caplet channel defined therein for permitting the passage of said caplet;
said holding means further comprising retaining means for holding said caplet;
(b) first application means for applying a gelatinous coating to said second exposed end of said caplet;
(c) first drying means for permitting said gelatinous coating to dry to form a coated second end;
(d) gripping means for displacing said caplet through said caplet channel to expose said first end;
(e) second application means for applying a gelatinous coating on said first end of said caplet; and (f) second drying means for permitting said gelatinous coating on said first end to dry, forming a simulated capsule-like medicament.
47. The apparatus of claim 46 wherein said gripping means comprises transfer means for transferring said caplet from said first holding means to a second holding means.
48. The apparatus of claim 47 wherein said caplet channel comprises a cross-section sized to slidably mate with said caplet.
49. The apparatus of 47 wherein said first holding means comprises a central bore extending through its length to permit passage of said caplet through said bore.
50. The apparatus of claim 49 wherein said central bore comprises a transverse cross-section that is generally circular.
51. The apparatus of claim 46 wherein said first holding means comprises a first retaining means for retaining said caplet in position at least during coating.
52. The apparatus of claim 49 wherein said transfer means comprises alignment means for aligning said first and second holding means during a displacement of said caplet from said first holding means to said second holding means.
53. The apparatus of claim 47 wherein said transfer means comprises plunging means for displacing said caplet through a portion of said caplet channel into a second holding means.
54. The apparatus of claim 47 wherein said second holding means comprises a central bore extending therethrough to permit passage of said caplet through said bore.
55. The apparatus of claim 54 wherein said second holding means comprises a second retaining means for retaining said caplet at least during coating.
56. The apparatus of claim 46 wherein said gelatinous coating comprises gelatin.
57. The apparatus claim 49 wherein said inserting means comprises plunging means having an end portion disposed to abut said caplet to effect displacement into said bore of said first holding means.
58. The apparatus of claim 46 wherein said inserting means comprises a fixture comprising a plurality of holding means for receiving a multiple of caplets.
59. The apparatus of claim 58 wherein said inserting means further comprises plunging means having a plurality of end portions disposed to abut said multiple of caplets to effect displacement thereof into said fixture.
60. The apparatus of claim 58 wherein said fixture comprises a plurality of holding means mounted thereon.
61. The apparatus of claim 60 wherein said fixture comprises 10 to 50 holding means.
62. The apparatus of claim 61 wherein said fixture comprises 20 to 40 holding means.
63. The apparatus claim 60 wherein said holding means comprise cylindrical bores therein for gripping said caplets.
64. The apparatus of claim 63 wherein said bores extend through said holding means for passage therethrough of said caplets.
65. The apparatus of claim 46 wherein said first and second application means (c) and (f) comprise dipping means for producing a wet, gelatinous coating on said first and second ends of said caplet.
66. The apparatus of claim 65 wherein said dipping means comprises dipping means for vertically dipping said caplet into a bath of gelatinous material.
67. The apparatus of claim 46 wherein at least one of said first and second drying means (d) and (g) comprises rotating means for distributing said coating on said caplet.
68. The apparatus of claim 46 wherein at least one of said first and second drying means (d) and (g) comprises kiln means for drying said caplet.
69. The apparatus of claim 46 further comprising ejection means for removing said caplet from said second holder after said first end is dry.
70. The apparatus of claim 69 wherein said ejection means comprises an end portion disposed to abut said caplet to effect displacement of said caplet out of said second holding means.
Applications Claiming Priority (2)
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|---|---|---|---|
| US016,914 | 1987-02-20 | ||
| US07/016,914 US4820524A (en) | 1987-02-20 | 1987-02-20 | Gelatin coated caplets and process for making same |
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| Publication Number | Publication Date |
|---|---|
| CA1317882C true CA1317882C (en) | 1993-05-18 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA000559224A Expired - Lifetime CA1317882C (en) | 1987-02-20 | 1988-02-18 | Gelatin coated caplets and process for making same |
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-
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- 1987-02-20 US US07/016,914 patent/US4820524A/en not_active Expired - Lifetime
-
1988
- 1988-02-04 IN IN99/CAL/88A patent/IN165927B/en unknown
- 1988-02-08 NZ NZ223449A patent/NZ223449A/en unknown
- 1988-02-18 CA CA000559224A patent/CA1317882C/en not_active Expired - Lifetime
- 1988-02-18 PT PT86786A patent/PT86786B/en not_active IP Right Cessation
- 1988-02-19 BR BR8800680A patent/BR8800680A/en not_active IP Right Cessation
- 1988-02-19 PH PH36533A patent/PH24779A/en unknown
- 1988-02-19 GR GR880100096A patent/GR1000236B/en not_active IP Right Cessation
- 1988-02-19 ZA ZA881189A patent/ZA881189B/en unknown
- 1988-02-19 MX MX010477A patent/MX167754B/en unknown
- 1988-02-19 DE DE88301401T patent/DE3882550T2/en not_active Expired - Lifetime
- 1988-02-19 ES ES88301401T patent/ES2042731T3/en not_active Expired - Lifetime
- 1988-02-19 EP EP88301401A patent/EP0279682B1/en not_active Expired - Lifetime
- 1988-02-19 JP JP63035422A patent/JP2683010B2/en not_active Expired - Lifetime
- 1988-02-19 IE IE46188A patent/IE63265B1/en not_active IP Right Cessation
- 1988-02-20 KR KR88001776A patent/KR960008471B1/en not_active IP Right Cessation
- 1988-02-22 AU AU12045/88A patent/AU604845B2/en not_active Ceased
- 1988-05-05 US US07/190,616 patent/US5314537A/en not_active Expired - Lifetime
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1994
- 1994-04-21 HK HK37294A patent/HK37294A/en not_active IP Right Cessation
Also Published As
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|---|---|
| AU1204588A (en) | 1988-08-25 |
| ZA881189B (en) | 1989-10-25 |
| EP0279682A2 (en) | 1988-08-24 |
| PH24779A (en) | 1990-10-30 |
| ES2042731T3 (en) | 1993-12-16 |
| IE880461L (en) | 1988-08-20 |
| PT86786A (en) | 1988-03-01 |
| JP2683010B2 (en) | 1997-11-26 |
| HK37294A (en) | 1994-04-29 |
| EP0279682A3 (en) | 1989-10-18 |
| DE3882550T2 (en) | 1993-11-18 |
| IN165927B (en) | 1990-02-10 |
| KR880009625A (en) | 1988-10-04 |
| NZ223449A (en) | 1990-12-21 |
| AU604845B2 (en) | 1991-01-03 |
| JPS63255067A (en) | 1988-10-21 |
| DE3882550D1 (en) | 1993-09-02 |
| GR880100096A (en) | 1988-12-16 |
| GR1000236B (en) | 1992-05-12 |
| IE63265B1 (en) | 1995-04-05 |
| EP0279682B1 (en) | 1993-07-28 |
| US4820524A (en) | 1989-04-11 |
| US5314537A (en) | 1994-05-24 |
| PT86786B (en) | 1992-05-29 |
| MX167754B (en) | 1993-04-12 |
| BR8800680A (en) | 1988-10-04 |
| KR960008471B1 (en) | 1996-06-26 |
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