WO1988001160A1

WO1988001160A1 - Tamper evident capsule and insert device

Info

Publication number: WO1988001160A1
Application number: PCT/US1986/002642
Authority: WO
Inventors: Raymond J. Hughes
Original assignee: Hughes Raymond J
Priority date: 1986-08-19
Filing date: 1986-12-08
Publication date: 1988-02-25
Also published as: KR880701538A; EP0303640A1; JPH01501843A; CN86209770U; CN87105670A; AU1248388A

Abstract

A tamper-proof capsule, a tamper-proof capsule insert (10), and a method for making plural chamber hard cap and body type capsules each consisting of two or more cooperational separately formed component capsules, dissimilar in transverse cross section, which are fixed in position relative to each other, having at least one inner component capsule (21) positioned within an outer capsule; providing thereby plural chamber capsules, each having at least one transparent, clear, or translucent body part chamber (15) to contain medicament or any other desired substance or device, and at least one other transparent, clear, or translucent body part chamber to contain a cooperational ingestible, disintegratable capsule insert device (10) which it externally visible to the sighted user or consumer, providing thereby a tamper-evident capsule. The device will be useful to prevent contamination of medicament capsules.

Description

TAMPER EVIDENT CAPSULE AND INSERT DEVICE

This is a continuation-in-part of application Serial No. 739,62^, filed May 31, 1985.

FIELD OF INVENTION

The present invention relates to methods for making hard cap and body type capsules and insert devices, and more particularly to improved method for making plural chamber hard capsule and cooperational tamper evident ingestible disintegratable capsule ohamber.insert device, and to the steps for inserting the device therein.

DISCUSSION OF PRIOR ART

In the heretofore, the sole means for making plural chamber hard capsules has been the invention titled "Apparatus For Making Capsule Having Plural Chambers (As amended)" disclosed in application Serial No. 739,62^, filed May 31, 1985 in the United States Patent and Trademark Office; Notice of Allowance mailed May 20, 1986.

The cooperational, tamper evident, ingestible, disintegratable capsule insert device disclosed and claimed in the present invention, entitled "Flex- Alert Capsule Insert" is the subject of Disclosure Document No. 1^5,200, filed January JO, 1986 in the United States Patent and Trademark Office.

OBJECTS

Accordingly, it is an object of the present invention to provide a method for making plural chamber hard cap and body type capsules, by combining at least two separately formed cooperational capsules which are dissimilar in transverse cross section and which are fixed in place, one within another, and in appro- priate relative position to each other; each capsule so combined having more than one chamber, to contain in at least one chamber any desired quantity of pharmaceutical, dietary, or nutritional substance or unit of device for human or other animal consumption or use, and to contain in at least one other cham¬ ber of sufficient size 4nd of equal or lesser capacity, and of suitable config¬ uration and design, a cooperational ingestible, contrasting, distinctive, dis¬ integratable, insert device; or an appropriate quantity of other bland, inert, or otherwise innocuous ingestible cooperational substance of a distinctive color, multicolor, or varicolor, which contrasts in appearance with the pharmaceutical, dietary, or nutritional substance or unit of device so contained, and which may be of any appropriate composition, consistency, and degree of glissance, which provides thereby, after such insertion, an externally visible means for the sighted user or consumer to detect, before use, through the clear, transparent, or translucent wall of its body or base part whether the capsule has been open¬ ed after its original filling and closure, by means of contrasting visible evi¬ dence of its reopening, in the form of changed physical appearance of the frag¬ mented disintegratable insert device; in this manner providing a capsule vehicle which is tamper evident.

It is also an. object of the present invention to provide means whereby a r pre-formed strip of hard capsule forming film, made of methylcellulose, gelatin, or other suitable material is positioned within the cleft of a plural chamber hard capsule clef dipping mold pin prior to dipping the dipping pin into a dipping solution, the strip of pre-formed hard capsule forming film being of appropriate dimensions and configuration to fit and cooperate within the peri¬ phery of the dipping pin cleft and having readily detachable means of its temp¬ orary retention therein, for and during the dipping and drying stages of the plural chamber hard capsule film forming operation, and its subsequent release therefrom; and to provide also a means of attachment of the pre-formed hard film strip within and to the main body of the hard capsule which is formed by the dipping and drying operation.

It is also an object of the present invention to provide a tamper-evident capsule and cooperational chamber insert device which is an immediate container for dispensing, administering, and delivering any dietary, nutritional, or pharmaceutical substance or device, or medicament, which vehicle meets certain definitions and standards as set forth in the unified United States Pharmacop¬ eia XX and National Formulary XV. The unified United States Pharmacopeia XX and National Formulary XV are recognized as official compendia in numerous statutes, among which are the federal Food, Drug, and Cosmetic Act and the Poison Prevention Packaging Act, and which include certain standards and re- luirements of the federal Consumer Product Safety Commission. These statutes and their regulations include such definitions and standards by reference. Specifically, certain definitions excerpted from the Poison Prevention Pack¬ aging Act which, among others, are met by the present invention are as follows: "Sec. 2. For the purpose of this Act — "(2) The term "household substance" means any substance which is customarily produced or distributed- for sale for consumption or use, or customarily stored, by individuals in or about the household and which is —

"(c) a food, drug, or cosmetic as those terms are defined in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321);

"(3) The term "package" means the immediate container or wrapping in which any household substance is contained for consumption, use, or storage by indi¬ viduals in or about the household, ... "

Safety standards and other consumer directed considerations and objectives which, among others, are met by the present invention are as follows:

"Although special packaging should not be difficult for normal adults to open, it is recognized that some individuals having physical limitations, e. g., some elderly persons or arthritics, may have difficulties." (USP XX - P. 1020). "Stability considerations should include not only the speci ic compendial requirements, but also changes in physical appearance of the product that would warn users of the product that its continued integrity is questionable. " (USP. XX - P. 1023).

"The stability parameters of a drug dosage form can be influenced by en¬ vironmental conditions of storage ( ... ), as well as the package components." (USP XX - P. 1023).

" ... it is recognized that control beyond the dispenser or seller is dif¬ ficult." (USP XX - P. 1023).

Accordingly, it is a further object of the present invention to provide a method for making and inserting in at least one chamber of a plural chamber capsule a cooperational fragmented disintegratable insert device of suitable configuration and size, and of any appropriate consistency, composition, and degree of glissance, which provides thereby, after such insertion, an extern¬ ally visible means for the sighted user or consumer to detect, before use, through the clear, transparent, or translucent wall of its body or base part whether the capsule has been opened after its original filling and closure, by means of contrasting visible evidence of re-opening, in the form of changed physical appearance of the fragmented disintegratable insert device; in this manner providing a capsule which is tamper evident.

It is also an object of the present invention to provide a relatively low cost means of making a cooperational disintegratable plural chamber capsule in¬ sert device by re-use of the excess, scrap, or waste material, ordinarily approximately 20^ to 2Wo of the capsule materials used, remaining after drying and trimming of dip molded h.ard capsules made by conventional method. In a preferred, embodiment of the present invention, such excess, scrap, or waste material is shredded or granulated or pulverized and agglomerated or otherwise suitably composited, and processed and formed to provide the desired coopera¬ tional disintegratable capsule chamber insert device for insertion into a plur¬ al chamber capsule, and by this means to form a tamper-evident plural chamber capsule.

Further objects and advantages of the present invention will become ap¬ parent from a consideration of the drawings and ensuing description thereof.

DRAWINGS

In the drawings: FIGS. 1 and 2 are a plan view and longitudinal section view taken along line 2-2, respectively, of a plural chamber capsule cooperational disintegratable insert device assembly, with removable, withdrawable, temporary retention cover 13 in place;

FTG. 3 is a- longitudinal section view of the plural chamber capsule coopera¬ tional insert device taken along the line' 2-2 of FIG. 1, having the removable, ' withdrawable, temporary flexible retention cover 13 removed;

FIG. - is a perspective illustration of a plural chamber capsule cooperational disintegratable insert device assembly having a withdrawable, temporary flexi¬ ble retention cover 13 in place; the insert device positioned after lateral flexure and resultant fragmentation, by insertion into a corresponding coop¬ erational capsule chamber body part, and prior to removal or withdrawal of the temporary flexible retention cover 13;

FIG. 5 is a perspective illustration of a plural chamber capsule cooperational fragmented disintegratable insert device in place after lateral flexure and. result4 t fragmentation and insertion within a corresponding capsule chamber, and after removal of the temporary withdrawable flexible retention cover 13; FIGS. 6 and are an elevational and sectional view through line 7-7, respect¬ ively, of a plural chamber hard capsule mas±e by combining two sep.arate coop¬ erational capsules of different sizes, one capsule within the other; the inner capsule being a dissimilar irregular figure in transverse cross section general outline;

FIGS. 8.and 9 are an elevational and sectional view through the line 9-9, re¬ spectively, of a plural chamber hard capsule made by combining two cooperation¬ al capsules of different sizes, one within the other; the inner capsule being a dissimilar octagon in transverse cross section general outline; FIGS. 10 and 11 are an elevational and sectional view through line 11-11, re- spectively, of a plural chamber hard capsule made by combining two separate cooperational capsules of different sizes, one within the other; the inner capsule being a dissimilar trapezoid in transverse cross section general outlin FIGS. 12 and 13 are a plan and longitudinal section view through line 13-13, respectively, of a plural chamber hard capsule inner chamber wall forming film insert strip.

DESCRIPTION

In a preferred embodiment, referring to FIG. 1, the cooperational disin¬ tegratable plural chamber capsule insert device assembly consists of highly glissant friable tablets, or otherwise composited and formed granules, pellets, or particles 10, separated by highly glissant interstitial filler or separator strips 12 having bending stress point fracture dimples, cruciform scores, notches, or depressions I at interstitial intersections, with a highly gliss¬ ant removable, withdrawable temporary flexible retention cover 13 overlaying the insert device assembly, which is flat in general profile outline prior to lateral flexure, to provide, upon bending, an appropriate curvature and frag¬ mentation of the insert device for its insertion into a corresponding coopera- tional capsule cha ~mber 15; and which insert device bears upon a flexible sup- porting base mat or tray 11. ,

In the immediate foregoing embodiment, the plural chamber capsule coopera¬ tional insert device proper is ingestible for humans and other animals and is made of methylcellulose, gelatin, starch, or other suitable material or com¬ bination thereof, with appropriate additives such as diluents, binders, disin¬ tegrators, glidants, lubricants, and FDA or equivalent approved food coloring as may be necessary or desired to formulate the components of the plural cham¬ ber capsule cooperational insert device. Such basic ingredient materials and additives are commonly used in the manu acture of pharmaceutical capsules. The removable, withdrawable temporary retention cover 13 is made of flexible material such as plastic or metal and is re-usable after withdrawal following insertion of the cooperational insert device into the corresponding capsule chamber 15.

Referring to FIG. 2, the plural chamber capsule cooperational insert de¬ vice assembly is made in a configuration and of appropriate dimensions to fit within and cooperate with, and to conform to the corresponding configuration, curvature, and dimensions of a cooperational chamber 15 of a plural chamber capsule FIGS, and 5, upon bending or flexure, and insertion and containment of the insert device FIG. 1 therein. The lateral bending or flexure of the insert device FIG. 1 prior to or at time of its insertion into the cooperation¬ al capsule chamber 15 is accomplished in such a manner as to cause fracturing of the brittle or friable contrasting interstitial delineating or separating filler strips 12 at at least several intersectioπal bending stress fracture points: 1.- without readily obvious displacement, distortion, or disarrangement thereof^*, and providing thereby at least several retained small separate frag¬ ments of the contrasting interstitial delineating or separating filler strips 12. Upon said insertion of the cooperational capsule insert device FIG. 1, the thin, temporary removable flexible retention cover 13 is withdrawn; and as a result of such withdrawal, a curved space equal to its thickness is provided between the curved inner surface of the outer wall of the capsule cooperational chamber 15 in. which the disintegratable insert device FIG. 3 h s been inserted, and the curved opposing surface of the capsule insert device FIG. 3-

In an equally preferred embodiment, referring to FIGS. 6 and.7, which are views in elevation and transverse cross section along line 7-7, respectively, the present invention provides means to make a plural chamber hard capsule FIG. 6 consisting of two separately formed component capsules in cooperational combination, which are of different appropriate sizes and which are dissimilar in transverse cross section; i. e., the larger outer component capsule 21 is circular or elliptical in general outline and the smaller inner component cap¬ sule 22 is irregular in general outline; e. g., having at least one general outline segment in the form of an arc, curve, crescent, notch,^',or angular breaks. The inner component capsule 22 is inserted, aligned, and fixed in place by suit¬ able means in appropriate position relative to the outer component capsule 21, forming thereby at least one smaller chamber 15 and the larger chamber 23; the smaller chamber 15 being provided by the resultant formation of, and within, a space between the inner surface of the outer component capsule 21 wall and a noncontiguous outer surface area of the inner component capsule 22 wall.

In another embodiment, referring to FIGS. 8 and 9, which are views in ele¬ vation and transverse cross section along line 9-9 respectively, the present invention provides means to make a plural chamber hard capsule FIG. 8 consist¬ ing of two separately formed component capsules in cooperational combination, which .are of different appropriate sizes and which are dissimilar in transverse cross section, i. e., the larger outer component capsule 21 is circular or elliptical in general outline and the smaller inner component capsule -Z is equilateral; octagonal, for example, in general outline. The inner component capsule 2 is inserted, aligned, and fixed by suitable means in place in appro¬ priate position relative to the outer component capsule 21, forming thereby at least one smaller chamber 15 and larger chamber 23; the smaller chamber 15 be¬ ing provided by the resultant formation of, and within, a space between the in¬ ner surface of the outer component capsule 21 wall and a noncontiguous outer surface area of the inner component capsule 2k wall.

In a further embodiment, referring to FIGS. 10 and 11, which are views in elevation and transverse cross section along line 11-11 respectively, the pre¬ sent invention provides a means to make a plural chamber hard capsule FIG. 10, consisting of two separately formed component capsules in cooperational combin¬ ation, which are of different appropriate sizes and which are dissimilar in transverse cross section; i. e., the larger outer component capsule 21 is circular or elliptical in general outline and the smaller inner component cap¬ sule 25 is nonequilateral; trapezoidal, for example, in general outline. The inner component capsule 25 is inserted, aligned, and fixed by suitable means in place in appropriate position relative to the outer component capsule 21, forming thereby at least one smaller chamber 15 and larger chamber 23, the smaller chamber 15 being provided by the resultant formation of a space be¬ tween the inner surface of the outer component capsule 21 wall and a noncon¬ tiguous outer surf ce area of the inner component-capsule 25 wall.

A further preferred embodiment of the present invention, referring to FIGS 12 and 13, which are views in plan and longitudinal section along line 13-13, respectively, provides a means whereby a pre-formed strip of hard capsule form¬ ing film FIG. 12, made methylcellulose, gelatin, or other suitable material, is positioned within the cleft of a plural chamber hard capsule cleft dipping pin (not shown) prior to dipping said dipping pin in a dipping solution; said strip of pre-formed hard capsule forming film FIG. 12 being of appropriate dimensions and configuration to fit and cooperate within the periphery of the dipping pin cleft, and having readily detachable means of temporary retention therein; e. g. , at least one notch 26, ridge, crimp, crease, groove, hole, or combination thereof, at or near the periphery of the hard capsule film strip, and having an appropriate corresponding opposite formation on one or both sur¬ faces of the dipping pin cleft wall (not shown) to retain said hard capsule forming film strip FIG. 12 in position for and during dipping and drying stages of. the plural chamber hard capsule film forming operation; and providing also a means of attachment, e. g., a notch or notches 27, a hole or holes, or a com¬ bination thereof, at appropriate locations at or near the edges of the pre¬ formed hard capsule film strip FIG. 12, by inflow and filling, during immer¬ sion, of said notches 27 or holes or combination thereof by heated dipping so¬ lution and resultant thermally induced capillary action or physical bonding or local consolidation of said hard capsule film strip with the main body of a hard capsule formed by said dipping operation, at and to the inner surface of the outer wall of the plural chamber hard capsule body part which is formed thereby; and providing also a ready means of detachment and release from the dipping pin cleft wall for ejection of said inserted film strip from said dip¬ ping pin integrally and unitarily with the hard capsule body part in the sub¬ sequent stripping operation. OPERATION

In a typical operation of the present invention, a plural chamber hard capsule FIG. 5 is made tamper evident when, after insertion of a cooperational disintegratable ingestible insert device into a clear, transparent, or translu¬ cent capsule chamber 15, the temporary retention cover 13 is withdrawn, the re¬ sulting effect of the provision of the curved space made by said withdrawal, together with a relatively high degree of glissance of the components 10, 11, and 12 of the capsule insert device FIG. 3 is to provide a means whereby, after the cooperational insert device FIG. 3 is inserted in the smaller capsule cham¬ ber 15, when the capsule, after its filling and closure, is opened, and its base part 21 is rotated from a vertical position, causing or permitting its contents to empty out totally or partially, both gravity and the relative ab¬ sence or diminution of surface friction will cause the cooperational fragmented insert device FIG. 3 to empty out simultaneously from the capsule chamber 15. Fragmentation of the interstitial filler or separator strip 12 and the rela¬ tively high degree of friability of the component tablets, granules, pellets, or particles 10 will effect disintegration of the insert device FIC. 3 as a result of shear, stress, impact upon another surface, or the disintegrating ef- feet of grasp of the said components by fingers or implement. The disintegrat¬ ed cooperational device FIG. 3, therefore, will not be capable of integrated - re-insertion into the capsule chamber 15 in its original assembled structure, pattern, or design. The disintegration within, or absence of the cooperational insert device FIG. 3 from the capsule chamber 15 thereafter, would be readily apparent and externally visible through the clear, transparent, or translucent outer wall of the capsule chamber 15 and wall of the body part of the capsule FIG. 5; by such means providing a "tell-tale" tamper evident change in its phys¬ ical appearance, giving warning to the sighted user or consumer that the cap¬ sule, after its original filling and closure, may have been tampered with, and therefore, the continued integrity of its content is questionable. (Cf. USP XX - P. 1023).

As used in this specification, "inner component capsule" means one or more than one inner component of a cooperational capsule combination consisting of an outer capsule and inner capsule assembly, each of the assembly members being separately formed, for making plural chamber hard capsules of the type used for containing medicaments; and each of said inner component members having a trans¬ verse cross section which is dissimilar to a corresponding cross section of the larger, outer capsule component member in general outline.

While the above description contains many specifities, these should not be construed as limitations on the scope of the present invention, but rather as exemplifications of preferred and other embodiments thereof; many other varia- tions, modifications, and changes are possible which are within the scope and spirit of the present invention.

Claims

I claim:

1. A plural chamber hard capsule made of methylcellulose, gelatin, or other suitable material, consisting of at least two separately made cooperational hard capsules of appropriate different sizes, said capsules being dissimilar in transverse cross section general outline; made, for example, by placing, aligning, and fixing body and cap parts of the smaller hard capsule within the corresponding two parts of the larger hard capsule, thereby forming separate chambers between the inner surface of the outer capsule wall and the noncon¬ tiguous outer surface areas of the inner capsule wall.

2. According to claim 1, a plural chamber hard capsule made, for example, by placing, aligning, and fixing the body and cap parts of a cooperational capsule which is an equilateral figure having three or more sides in transverse cross section general outline; an octagon, for example; within the corresponding two parts of a hard capsule which is circular in transverse cross section general outline; thereby forming separate chambers of equal size between the inner sur¬ face of the cuter capsule wall and the noncontiguous outer surface areas of the inner capsule wall.

3. According to claim 1, a plural chamber hard capsule made, for example, by placing, aligning, and fixing the body and cap parts of a cooperational hard - capsule which is nonequilateral in transverse cross section general outline; a trapezoid, for example; within the corresponding two parts of a hard capsule which is circular or elliptical in transverse cross section general outline; thereby forming a separate chamber or chambers between the inner surface of the outer capsule wall and the noncontiguous outer surface area or areas of the inner capsule wall. k . According to claim 1, a plural chamber hard capsule made, fcr example, by placing, aligning, and fixing the bcdy and cap parts of a cocperational smaller hard capsule which is dissimilar to the larger outer hard capsule in transverse or other plane cross section general outline, taken along any axis; spiral, for example; within the corresponding two parts of the larger hard capsule, thereby forming separate chambers between the inner surface of the outer capsule wall and the noncontiguous outer surface area, or areas of the inner capsule wall.

5. A plural chamber hard capsule made by improved means; more particularly, by positioning a pre-formed strip of hard capsule forming film, ma.de of suitable material such _.^ methylcellulose or gelatin, within a cleft of a plural chamber hard capsule cleft dipping pin, prior to dipping said dipping pin in a dipping solution; said strip of pre-formed hard capsule forming film being of appro¬ priate dimensions and. configuration to fit and cooperate within the periphery of said dipping pin cleft, and having readily detachable means of temporary retention of said film strip therein; such as at least one notch, ridge, crimp, crease, groove, or hole, or combination thereof, at or near the periphery of said hard film strip, and having appropriate corresponding opposite formation on one or both surfaces of said dipping pin cleft wall, to retain said hard capsule forming film strip in position for and during dipping and drying stages of the plural chamber capsule film forming operation; and providing also a mean of attachment, e. g., a notch or notches, a hole or holes, or a combination thereof, at appropriate locations at or near the edges of said pre-formed hard capsule film strip, by inflow and filling, during immersion, of said notch or notches, or hole or holes, or combination thereof by heated dipping solution and resultant thermally induced capillary action or physical bonding or local consolidation of said hard capsule film strip with the main body of a hard cap¬ sule formed by said cleft pin mold dipping and drying operation, at and to the inner surface of the outer wall of the plural chamber hard capsule body part which is formed thereby; and providing also a means of ready detachment and re¬ lease from said dipping pin cleft wall for ejection of said inserted film strip from dipping pin integrally and unitarily with the hard capsule body part in the subsequent stripping operation.

6. A means whereby a cooperational suitably pre-flexed and fragmented capsule chamber insert device assembly is inserted.into a plural chamber hard capsule body part chamber in a step during an operation to fill another separate' cha_mbe of said capsule with a medicament, pharmaceutical device or other substance; said step occurring prior to, simultaneous with, or subsequent to actual said capsule filling; a removable flexible retention cover next is withdrawn; and a corresponding capsule cap part is positioned next in sequence for closure; and closure of the capsule and containment of said cooperational insert device and the nutritional, dietary, or pharmaceutical substance or device, or medicament, or other substance within their respective chambers.

7• A plural chamber hard capsule cooperational disintegratable insert device consisting of three or more layers, each having a high degree of glissance: the base layer being a thin, flexible, nonfragmented strip formed of ingestible material of appropriate composition and consistency; the intermediate layer or layers being appropriately generally flexible, and having components of appro¬ priate degrees of brittleness, fragility, friability, density, and consistency; the uppermost layer being a withdrawable temporary retention cover formed of flexible material such as plastic or metal; all said insert device components being of any appropriate size, pattern, and configuration, flat in profile prior to lateral flexure; said flexure being a me^"ans to provide fragmentation at bending stress fracture points, and curvature of said insert device assembly to fit and cooperate within and conform to the curvature of a corresponding plural chamber capsule chamber; and consisting in a desired number of layers, between the base and retention cover layers, of friable tablets, or otherwise composited granules, pellets, or particles separated by interstitial filler or separator strips having bending stress point fracture dimples, notches, cruci¬ form,scores, or depressions at interstitial intersections.

8. A method for making a cooperational disintegratable plural chamber hard cap¬ sule insert device whereby the components thereof are assembled in layered flat strips and wherein all components except the withdrawable temporary retention cover are made of and formed from methylcellulose, gelatin, or other suitable ingestible material or combination thereof, with appropriate additives such as diluents, binders, disintegrators, glidants, lubricants, and FDA or equivalent approved food coloring necessary or desired to formulate the said components of said insert device; all said components having a high degree of glissance; made in configuration and of appropriate dimensions to fit and cooperate within and to conform to a corresponding configuration, curvature, and dimensions of a chamber of a plural chamber hard capsule upon bending or flexure of said device assembly and subsequent insertion and containment of said device therein; said withdrawable temporary retention cover being made of flexible material such as plastic or metal.

9. 'An ingestible tamper-evident dose or unit delivery device consisting of a plural chamber hard capsule cap and clear, transparent, or translucent body cap¬ sule to contain nutritional, dietary, or pharmaceutical substance or ^"device or medicament in at least one of its chambers, and a cooperational ingestible, fragmented, disintegratable, highly glissant, insert device contained, after insertion, within a corresponding chamber of said plural chamber hard cap and body type capsule, said insert device being externally visible through the clear, transparent, or translucent outer wall of said plural chamber capsule. 10..A method for dispensing, administering, and delivering any desired quantity or unit of nutritional, dietary, or pharmaceutical substance or device, or med¬ icament, whereby said substance or device is deposited within a clear, trans¬ parent, or translucent body part chamber of a plural chamber hard capsule; a cooperational externally visible disintegratable fragmented capsule insert de¬ vice is inserted into a separate clear, transparent, or translucent, body part chamber of said plural chamber hard capsule; the said- capsule closed thereafter by positioning the corresponding hard capsule cap part thereon; by said method providing, after said capsule closure, an externally visible means of detection to the sighted user or consumer, before use, when said capsule has been opened after original filling and closure, by means of contrasting visible evidence of capsule reopening, in the form of changed physical appearance of the then dis¬ integrated said cooperational insert device; and thereby, by said method, pro¬ viding a capsule which is tamper evident to the sighted user or consumer.