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
  • A61J3/07—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
  • A61J3/071—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 into the form of telescopically engaged two-piece capsules
  • A61J3/072—Sealing capsules, e.g. rendering them tamper-proof

Definitions

• 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.
• 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-izirements of the federal Consumer Product Safety Commission. These statutes and their regulations include such definitions and standards by reference.
• 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, ...
• 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).
• 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.
• 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.
• 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.
• 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.
• 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 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.
• FIGS. 8 and 9 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.
• 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.
• FIGS 12 and 13 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.
• 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.
• 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.
• 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.
• 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.

Applications Claiming Priority (2)

Publications (1)

Family

ID=25409006

Family Applications (1)

Country Status (6)

Families Citing this family (7)

Family Cites Families (4)

• 1986
  • 1986-12-08 AU AU12483/88A patent/AU1248388A/en not_active Abandoned
  • 1986-12-08 WO PCT/US1986/002642 patent/WO1988001160A1/en unknown
  • 1986-12-08 CN CN198686209770U patent/CN86209770U/zh not_active Expired - Lifetime
  • 1986-12-08 JP JP62501232A patent/JPH01501843A/ja active Pending
  • 1986-12-08 EP EP88901499A patent/EP0303640A1/de not_active Ceased
• 1987
  • 1987-08-19 CN CN198787105670A patent/CN87105670A/zh active Pending
• 1988
  • 1988-04-19 KR KR1019880700433A patent/KR880701538A/ko not_active Application Discontinuation

Non-Patent Citations (1)

Also Published As

Similar Documents

Legal Events