CA2028348A1 - Double tip drug dispensing and metering device - Google Patents

Double tip drug dispensing and metering device

Info

Publication number
CA2028348A1
CA2028348A1 CA002028348A CA2028348A CA2028348A1 CA 2028348 A1 CA2028348 A1 CA 2028348A1 CA 002028348 A CA002028348 A CA 002028348A CA 2028348 A CA2028348 A CA 2028348A CA 2028348 A1 CA2028348 A1 CA 2028348A1
Authority
CA
Canada
Prior art keywords
tip
dropper
metering device
inch
dispensing
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.)
Abandoned
Application number
CA002028348A
Other languages
French (fr)
Inventor
John E. Allegretti
Thomas E. Schlaudecker
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Merck and Co Inc
Original Assignee
Merck and Co Inc
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Merck and Co Inc filed Critical Merck and Co Inc
Publication of CA2028348A1 publication Critical patent/CA2028348A1/en
Abandoned legal-status Critical Current

Links

Classifications

    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D47/00Closures with filling and discharging, or with discharging, devices
    • B65D47/04Closures with discharging devices other than pumps
    • B65D47/06Closures with discharging devices other than pumps with pouring spouts or tubes; with discharge nozzles or passages
    • B65D47/18Closures with discharging devices other than pumps with pouring spouts or tubes; with discharge nozzles or passages for discharging drops; Droppers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/0008Introducing ophthalmic products into the ocular cavity or retaining products therein
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes

Abstract

TITLE OF THE INVENTION
DOUBLE TIP DRUG DISPENSING AND METERING DEVICE

ABSTRACT OF THE INVENTION

A NOVEL DOUBLE TIP DRUG DISPENSING AND METERING
DEVICE HAVING A BELLOWS OR CONVENTIONAL SQUEEZE BODY
CONTAINER BETWEEN SAID DOUBLE TIPS, ADAPTED TO HOLD
AT LEAST TWO SUBSTANCES IN SOLUTION WHICH ARE
REQUIRED TO BE SEPARATED UNTIL JUST PRIOR TO
DISPENSATION.

Description

TITLE OF T~ INV~NTION
DOUBLE TIP DRUG DISPENSING AND METERING DEVICE

BACKGROUND OF T~E INVE~TION
Many drugs, particularly those used in treatment of various eye disorders, are administered in drop form. The drops of liquid are intended to free-fall onto the eye surface, where it is distributed across the exposed eye. Dosage of these ophthalmic drugs i6 often crucial. For example, lower than prescribed levelæ of the drugs can result in failure of treatment and conse~uent progression of the disease and higher levels can result in intractable side effects which can also interfere with successful resolution.

Complicating the administration of these drugs is the fact that they are often required several times a day and thus to be practical, must be administered by the patient rather than medical personnel who are formally trained in drug delivery.
Patient administration of such drugs has resulted in two seriou~ problems, namely, bottle contamination and flow rate which must be solved for medications to be successfully administered.

Container devices having multiple compartment~ for ~eparately enclosed materials to be mi~ed prior to use are described in ~.S. Pat. Nos.
3,340,873; 3,354,883; 3,397,694; 3,411,503;
4,331,146; 4,412,836; and 4,330,531, having a thin lo diaphrame-type membrane separating the two compartments. These sy~tems are not considered entirely reliable due to its ability to maintain a fluid-tight seal between the compartments. U.S. Pat.
No. 3,464,414 discloses a rigid walled two chambered mixing vial utilizing hydraulic preRsure to dislodge a plug member between the two chambers.

SUMMARY OF T~ INVENTION

This invention relates to a double tip drug .
- dispensing/metering device adapted to hold at least two substances in solution which are required to be segregated until just prior to dispensation, and to provide a means for i~ vitro mixing and dispensing of 2s the mixture. Accordingly, a mixture having a limited effective shelf-life once mixed may be preserved for a specific or indefinite period by maintaining separately the components with or without a preservative until use is desired. While one of the constituents muæt be liquid, the other component may be a liquid or a solid. ~owever, the solid component must be in solution prior to entrance into the device.

8185P -3- 17g34 Liquid dropper dispensers find use in many medicinal areas, particularly ophthalmic medication where contamination is a concern. Often dropper dispensers are of a plastic "squeeze" type whereby liquid is forced out by squeezing the dispen#er and residual liquid and air are drawn into the dispenser when it is permitted to expand. Therefore, it is an object of this invention to provide a double tip dispensing/metering device wherein the upper tip æerves as a dispensing/metering device and the lower tip serves aæ a means of diluent(s) transfer which i~
operable without the limitations presented in the prior art.

It is another object of this invention to provide a double tip dispensing/metering device that is operable by a patient in need of medication comprised of components which must be separated until use is required.

It is a further object of this invention to provide a double tip dispen6ing/metering device adaptable to be used with a variety of dispensing means.
Additional objects of this invention will be apparent to persons of ordinary ~kill in the art upon reading the following detailed description and appended claims and upon reference of the accompanying drawings.

~TAILED DES~RIPTIOp OF THE INVENTIO~
It has been found that affixing a second (base) dropper tip to a single upper dropper tip ~i,;3~

dispensing/metering device permits two separate substances to be pre-mixed at the deæired~time thereby increasing the individual æhelf-life prior to mixing of each substance and reducing contamination when mixing is desired along wi~h obtaining a metered delivery of the ~olution (wet/wet or wet/dry) through the upper dropper tip. The dispensing/metering device disclosed herein maintains the desired liquid(s) and/or solid drug substances in solution thereby enhancing the desired flow rate of said drug when passing through said upper tip of such device.
As previously mentioned, patient administration of drugs has resulted in two serious problems, namely, (1) bottle contamination and (2) flow rate, which must be solved for these medications to be successfully administered. More detailed discussions of the problems are provided below:

OTTLE ~ONTA~ IIQ~

Ideally, the pendent drop formed at the tip ~O of conventional dropper bottles should be allow~ed to free-fall to the surface of the eye. In addition, the distance between the dropper tip and the surfaces of the eye should be kept reasonably close. This is important so that the momentum acguired by the free-falling drop will not be so great as to cause the drop to splatter on impact with the eye surface.
These conditions: a free-falling pendent drop being discharged close to the eye surface, are readily accomplished by a trained professional. They are substantially more difficult when the drug is self-administered. Gauging such 6hort distances is phyæiologically difficult due to the inability to ~4, ~

focus, and in addition, the anticipation of impacting drop often cau6eæ a blink and subseguent 10~8 of portions of the drop. As a result, the user may permit the dropper tip to inadvertantly contact the eye surface.
In either case, ~mall amounts of eye liquids can thus be inadvertently permitted to comingle with the liquid of the drop to be delivered. When the pressure on the delivery bottle i8 relieved a small amount of the mixed liquids may be drawn back into the bottle. With time, the bacteria originally present in the eye, both normal and pathological, will be permitted access to a medium which may cause them to proliferate. Thus, subsequent drops of medication may re-introduce to the eye either excessive levels of typically present bacteria, or large numbers of pathogens. Neither situation is acceptable.

; To cope with the problem of contamination, drug manufacturers often introduce an antibacterial agent to the drug bottle. I~ most cases, this agent or preservative can only be very effective at supressing the growth of bacterial contaminants within the bottle for a specified period of time.
Unfortunately, there exists a significant population of patients for whom these preservativ2s represent ocular irritants, or in more severe cases cause allergic reactions. Such untoward ocular reactions prohibit the~e patients from acce~sing the drug in this kind of packaging. For these patients, single-use, non-pre~erved drug packaging is a partial answer, but at a significantly increased cost and inconvenience.

~ ~iJ ~J3~
8185P -6- 17~34 (2) FLOW RATE

Dosage of ophthalmic drugs are regulated on the basis of drops applied to the eye. Formation of the drops is directly related to the flow rate of the liquid from the bottle. The drops fall from the dropper tip when the weight of the pendent drop exceeds the surface tension forces holding the drop to the dropper tip. In the ideal case, each drop should be identical to the previous one. However, in practice, other factors intervene to cause significant variation in drop æize. One of the most significant i8 the rate of drop formation. If the drop is formed rapidly,~ more liquid can be "injected" into the body of to drop as it is-beginning to break free. These drops will be larger, and thus will carry more drug, than if the bottle were ~queezed very slowly. In extreme circumstances, the d-rug may be ejected in a steady stream.

The method and device of ~his invention -overcomes three (2) serious problems, namely, it enhances uncontrolled flow rate and prolongs the shelf-life of at least two substances which are required to be separated prior to mixing and dispensing. Contamination of the liguid in the dropper bottle is overcome by several features incorporated into the dropper tip itself. In addition, these features act to restrict the rate of drop formation, irrespective of the variable pressure which may be brought to bear on the bottle wallæ by the user. Thus, with the flow rate metered, the drops possess a substantially more repeatable li~uid volume.

A method for practicing the concepts of the invention diæclosed herein is to hold at least two substances which are required to be separated until just prior to dispensation, and provide a means for in vitrQ mixing and dispensing of the mixture. The upper tip of the device disclosed herein functions as a dispensing/metering device and the lower tip functions as a transfer system for diluent(~) to enter into said device. The upper and lower tips are terminal components of a single device having an inner bellows or conventional squeeze body chamber containing the mixture for application.

~RIEF D~SCRIPTION OF THF DR~WINGS

For a more complete understanding of the invention, reference should be made to the embodiment illustrated in greater detail in the accompanying drawings and described below by way of example of the invention.
In the drawings:

Figure I shows a cross-sectional view of the upper dropper cap with tamper-evident (T/E) collar that screws onto ~aid upper dropper tip.

Figure II shows a cross-sectional view of the upper dispensing/metesing dropper tip to be ,7 ~

permanently affixed to a common bellows or conventional ~queeze chamber.

Figure III shows a cross-sectional view of a bellows or conventional squeeze chamber having permanently affixed a lower dropper transfer tip with reverse threaded means for attachment of the base cap.

Figure IV shows a cross-sectional view of the device disclosed herein having permanently affixed the upper and lower dropper tips having a common bellows or conventional squeeze chamber.

Figure V shows a cross-sectional view of a the base reverse thread screw cap which covers the lower transfer tip and serves as a base for the dispensing/metering device.

; It ~hould be under~tood that the drawings are not nece~sarily to scale and that the embodiments are sometimes illustrated by graphic symbols, phantom lines, diagrammatic representations and fragmentary views. In certain instances, details which are not necessary for an understanding of the present invention or which render other details difficult to perceive may have been omitted. It should be further understood, o~ course, that the invention is not necessarily limited to the particular embodiments illustrated herein.

In general, the dispensing/metering device described herein consists of an upper T/E cap (1) having screw on threaded attachment (2) and T/E
collar (2a) for convering upper tip (3) as shown in Figure II. The upper cap i8 used primarily as a ~ 8 protective cover for the upper-tip of the device.
Figure II consists of a metered dropper tip having orifice (3) being connected to dropper chamber (4) and connecting screw threads (5) for allowing the upper cap deæcribed in Figure I to attached and cover said upper tip of Figure II. Upper tip (Figure II) iæ permanently connected (preferably by sonic welding or the use of an adhesive system) to lower attachment arm (6) of Figure II and the upper bellow (8) of Figure III thereby connecting both upper and lower dropper tips as shown in Figure IV. Said lower (base) dropper tip have conventional squeeze or bellow walls (9) reverse thread screws (10) for attachment of base cap (Figure V), transfer tip channel (11) for entrance of medicinal(s) into storage bellow chamber (9) through sealed tip orifice (12) being located at the base of lower dropper orifice tip (12) which connects with passage channel (11) .

In Figure 3, the base dropper transfer tip (12) of the device disclosed herein iæ covered by a reverse thread screw cap Figure V having reverse threads screw (13) and tip seal (14) for permanently sealing the lower tip after transfer of the medicinal(s) (wet/wet or wet/dry) into storage chamber (9).

The dispensing/ metering device discloæed herein is useful in administering at least two substances which are required to be separated until just prior to dispensation. Said device consistæ of two dropper tips, the upper tip serving aæ a dispensing/metering device tip and the lower tip serving as a transfer device for subætance(æ) required to be æegregated until time for pre-mixin2.

~?J ~3 ;~

In pr~cticing the concept of this invention, at least two diluents (wet/wet or wet/dry~ are separately pre-mixed with or without a preservative until complete solution iæ obtained. The diluents are then transferred into the bellow or conventional squeeze body container (6 and 9) via lower base transfer orifice tip (12) of the te~ice. If one of said diluent(s) is a solid, then complete solution is required before transfering through said base transfer tip. It is not critical as to which diluent is first transferred into the bellows or conventional lo squeeze body container (6 and 9). In fact, the diluents can be pre-mixed and then transferred into the body container of the device and stored until treatment is desired.

In Figure II, the orifice progressively gets larger from its inception to point (3). The lower part of the orifice (3) has a dimension of from 0.002 to 0.010 ~ 0.001 inch, preferable from 0.004 to 0.008 ~ 0.001 inch and most preferable 0.006 + 0.001 inch.
^-0 The upper part of orifice (3) at point (3) has a demension of 0.060 to 0.10 + 0.005 inch, preferable 0.075 to 0.25 + 0.005 inch and most preferable 0.093 + 0.005 inch.

In Figure III, one skilled in the art can readily appreciate that the dimensions of transfer tip channel (11) which connects to orifice (12) is not critical. In practicing the concept of this in~ention, it is found that dimensions in the range of 0.015 to 0.040 ~ 0.005 inch are applicable with 0.023 + O.OOS inch being preferred.

Claims (4)

1. A double tip dispensing and metering device comprising:
a. an upper and lower dropper tip separated by a common bellows or conventional squeeze storage chamber, b. a plugging means for selectively sealing the lower dropper tip, and c. a means for dispensing the substance from said device.
2. The device of Claim 1, wherein said upper dropper orifice channel ranges lower to upper progressively from 0.002 to 0.010 ? 0.005 inch to 0.075 to 0.25 ? 0.005 inch.
3. The device of Claim 2, wherein said lower range is from 0.004 to 0.008 ? 0.001 inch and said upper range is from 0.060 to 0.10 ? 0.005 inch.
4. The device of Claim 3, wherein said lower range is 0.006 ? 0.001 inch and said upper range is 0.093 ? 0.005 inch.
CA002028348A 1989-10-25 1990-10-23 Double tip drug dispensing and metering device Abandoned CA2028348A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US426,629 1989-10-25
US07/426,629 US5002206A (en) 1989-10-25 1989-10-25 Double tip drug dispensing and metering device

Publications (1)

Publication Number Publication Date
CA2028348A1 true CA2028348A1 (en) 1991-04-26

Family

ID=23691576

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002028348A Abandoned CA2028348A1 (en) 1989-10-25 1990-10-23 Double tip drug dispensing and metering device

Country Status (15)

Country Link
US (1) US5002206A (en)
EP (1) EP0425025B1 (en)
JP (1) JPH0651047B2 (en)
AR (1) AR242907A1 (en)
AT (1) ATE117536T1 (en)
AU (1) AU643404B2 (en)
BR (1) BR9005361A (en)
CA (1) CA2028348A1 (en)
DE (1) DE69016350T2 (en)
DK (1) DK0425025T3 (en)
ES (1) ES2070268T3 (en)
FI (1) FI905227A0 (en)
NO (1) NO904612L (en)
PE (1) PE10591A1 (en)
PT (1) PT95656B (en)

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US5246145A (en) 1990-05-03 1993-09-21 Nalge Company Liquid dropper spout having lockable pivoted closure cap
US5328058A (en) 1990-05-03 1994-07-12 Nalge Company Dropper bottle assembly with squeeze cap
US5303869A (en) * 1993-07-19 1994-04-19 H. D. Hudson Manufacturing Company Multiple nozzle on a flexible strap for a garden sprayer
US6098852A (en) * 1999-01-27 2000-08-08 Automatic Liquid Packaging, Inc. Tip for liquid drop dispensing container
JP4681306B2 (en) * 1999-08-17 2011-05-11 参天製薬株式会社 Manufacturing method of eye drop container
JP3971329B2 (en) * 2002-10-23 2007-09-05 ロート製薬株式会社 Nozzle structure of liquid container
EP1838580A1 (en) * 2005-01-13 2007-10-03 Bormioli Rocco & Figlio S.p.A. A process for sterile packaging of containers with drop-dispensers, and means for actuating the process
TW200722113A (en) * 2005-08-31 2007-06-16 Novartis Ag Contact lens care product
KR100862057B1 (en) 2007-10-04 2008-10-09 금호석유화학 주식회사 Asphalt modifier compositions improved melting for asphalt and modified asphalt using it
US8695850B2 (en) 2009-03-06 2014-04-15 Insite Vision Incorporated Tip arrangement for a dropper bottle
WO2012140493A1 (en) * 2011-04-14 2012-10-18 Promed Research Centre A closure cap for bottle container
US20220387256A1 (en) * 2021-06-03 2022-12-08 Kent Byron Vial With Metered Dispenser

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Also Published As

Publication number Publication date
BR9005361A (en) 1991-09-17
ES2070268T3 (en) 1995-06-01
PT95656B (en) 1998-07-31
EP0425025B1 (en) 1995-01-25
JPH0651047B2 (en) 1994-07-06
DE69016350T2 (en) 1995-08-10
AU6498590A (en) 1991-05-02
DE69016350D1 (en) 1995-03-09
EP0425025A1 (en) 1991-05-02
AU643404B2 (en) 1993-11-11
PT95656A (en) 1991-08-14
ATE117536T1 (en) 1995-02-15
DK0425025T3 (en) 1995-03-27
JPH03212383A (en) 1991-09-17
AR242907A1 (en) 1993-06-30
FI905227A0 (en) 1990-10-24
NO904612L (en) 1991-04-26
PE10591A1 (en) 1991-03-30
US5002206A (en) 1991-03-26
NO904612D0 (en) 1990-10-24

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Legal Events

Date Code Title Description
FZDE Discontinued