Method for forming pharmaceutical capsules from hydrophilic polymers

• US 4,738,817 A
• Filed: 09/19/1986
• Issued: 04/19/1988
• Est. Priority Date: 11/17/1983
• Status: Expired due to Fees

• Current Assignee: Warner-Lambert Company (Pfizer Inc.)
• Original Assignee: Warner-Lambert Company (Pfizer Inc.)
• Inventors: Gillow, Louis S., Raible, Thomas, Bodenmann, Hans-Ulrich, Tomka, Ivan, Wittwer, Fritz
• Primary Examiner(s): Morris, Theodore
• Application Number:
  US06/910,106
• Time in Patent Office: 578 Days
• Field of Search: 264/328.1, 264/328.14, 206/530, 206/531, 206/532
• US Class Current: 264/328.14
• CPC Class Codes: A61J 2200/20 Extrusion means, e.g. for producing pharmaceutical forms
• CPC Class Codes: A61J 2205/20 Colour codes
• CPC Class Codes: A61J 2205/30 Printed labels
• CPC Class Codes: A61J 2205/40 by shape or form, e.g. by using shape recognition
• CPC Class Codes: A61J 3/07 into the form of capsules or similar small containers for oral use
• CPC Class Codes: A61J 3/071 into the form of telescopically engaged two-piece capsules
• CPC Class Codes: A61J 3/072 Sealing capsules, e.g. rendering them tamper-proof
• CPC Class Codes: A61K 9/2072 characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms A61K9/0004, A61K9/0056, A61K9/0065 take precedence
• CPC Class Codes: A61K 9/4808 characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release capsules filled with granules or microparticles A61K9/16; filled with microcapsules or coated microparticles A61K9/50; with mixture of different granules, microcapsules, (coated) microparticles A61K9/5084
• CPC Class Codes: A61K 9/4816 Wall or shell material
• CPC Class Codes: A61K 9/4825 Proteins, e.g. gelatin gelatin capsule shells with substantial amounts of other macromolecular substances A61K9/4816
• CPC Class Codes: B29C 65/00 Joining or sealing of preformed parts , e.g. welding of plastics materials; Apparatus therefor general aspects of processes or apparatus for joining preformed parts B29C66/00; using porous material formed by internal pressure generated therein for joining preformed parts B29C44/1228, B29C44/326
• CPC Class Codes: B29C 65/561 using screw-threads being integral at least to one of the parts to be joined
• CPC Class Codes: B29C 65/565 involving interference fits, e.g. force-fits or press-fits B29C65/66 takes precedence
• CPC Class Codes: B29C 65/58 Snap connection
• CPC Class Codes: B29C 66/112 Single lapped joints
• CPC Class Codes: B29C 66/1122 Single lap to lap joints, i.e. overlap joints B29C66/45, B29C66/472, B29C66/52272 take precedence
• CPC Class Codes: B29C 66/114 Single butt joints
• CPC Class Codes: B29C 66/1162 Single bevel to bevel joints, e.g. mitre joints
• CPC Class Codes: B29C 66/118 Single monotone curved joints
• CPC Class Codes: B29C 66/1222 : comprising at least a lapped joint-segment
• CPC Class Codes: B29C 66/1224 : comprising at least a butt joint-segment
• CPC Class Codes: B29C 66/12425 : Other specific interlocking undercuts not provided for in B29C66/12421 - B29C66/12423
• CPC Class Codes: B29C 66/12443 : having the tongue substantially in the middle
• CPC Class Codes: B29C 66/12445 : having the tongue on the side
• CPC Class Codes: B29C 66/12449 : being asymmetric B29C66/12445 takes precedence
• CPC Class Codes: B29C 66/12464 : being V-shaped
• CPC Class Codes: B29C 66/1282 : comprising at least one overlap joint-segment
• CPC Class Codes: B29C 66/12841 : comprising at least two butt joint-segments
• CPC Class Codes: B29C 66/131 : Single flanged joints, i.e. one of the parts to be joined being rigid and flanged in the joint area
• CPC Class Codes: B29C 66/1312 : Single flange to flange joints, the parts to be joined being rigid the parts to be joined being flexible B29C66/133
• CPC Class Codes: B29C 66/14 : the joint having the same thickness as the thickness of the parts to be joined B29C66/1142 takes precedence
• CPC Class Codes: B29C 66/242 : said joint lines being closed, i.e. forming closed contours
• CPC Class Codes: B29C 66/24221 : being circular B29C66/51 takes precedence
• CPC Class Codes: B29C 66/24223 : being oval
• CPC Class Codes: B29C 66/24241 : forming a triangle
• CPC Class Codes: B29C 66/24244 : forming a rectangle
• CPC Class Codes: B29C 66/53423 : said substantially flat extra element being rigid, e.g. a plate B29C66/53425 takes precedence
• CPC Class Codes: B29C 66/53461 : joining substantially flat covers and/or substantially flat bottoms to open ends of container bodies
• CPC Class Codes: B29C 66/5414 : said substantially flat extra element being rigid, e.g. a plate B29C66/5416 takes precedence
• CPC Class Codes: B29C 66/542 : joining hollow covers or hollow bottoms to open ends of container bodies
• CPC Class Codes: B29C 66/543 : joining more than two hollow-preforms to form said hollow articles
• CPC Class Codes: B29C 66/545 : one hollow-preform being placed inside the other
• CPC Class Codes: B29C 66/612 : Making circumferential joints
• CPC Class Codes: B29C 66/71 : characterised by the composition of the plastics material of the parts to be joined welding bar compositions B29C65/125
• CPC Class Codes: B29C 66/73117 : Tg, i.e. glass transition temperature
• CPC Class Codes: B29C 66/73772 : the to-be-joined areas of both parts to be joined being amorphous
• CPC Class Codes: B29C 66/73921 : characterised by the materials of both parts being thermoplastics
• CPC Class Codes: B29K 2089/00 : Use of proteins, e.g. casein, gelatine or derivatives thereof, as moulding material
• CPC Class Codes: B29L 2031/7174 : Capsules
• CPC Class Codes: C08L 2666/02 : Organic macromolecular compounds, natural resins, waxes or and bituminous materials
• CPC Class Codes: C08L 3/02 : Starch; Degradation products thereof, e.g. dextrin

Abstract

Novel injection molded pharmaceutical capsules of gelatin having a cap member, a body member, means to form a plurality of compartments therein, and means for locking the cap and body members together to form a tamper-resistant connection.

Claims

1. A method of making a molded capsule consisting essentially of a hydrophilic gelatin/water mixture wherein the water content is in the range of from about 5 to about 25% by weight of the hydrophyllic gelatin which comprises:

(a) heating the hydrophyllic gelatin/water mixture to form a melt;

(b) maintaining said water content during said heating;

(c) further heating the hydrophyllic melt and water to a temperature to dissolve the melt in the water and achieve a homogeneous dispersion on a molecular level while maintaining said predetermined water content;

(d) injecting the dissolved hydrophyllic melt into a mold cavity while maintaining a said water content;

(e) cooling the hydrophyllic gelatin melt in said mold;

(f) forming a multichambered molded product at a temperature below the glass transition temperature range of the hydrophyllic gelatin while maintaining said predetermined water content;

(g) ejecting the molded product of said hydrophyllic gelatin from said mold.

2. A method for making pharmaceutical capsules consisting essentially of gelatin and water comprising a cap member and a body member each having at least one open end and sidewall means;

and means located in each sidewall means for connecting said cap and body members together, said connecting means being configured and arranged to face each other to achieve, after connection of said cap and body members, a separation resistant connection;

which method comprises;

mixing a gelatin/water composition with water in the predetermined amount between about 5 and 25% by weight of the gelatin/water composition;

heating the gelatin/water composition with said water at a temperature between about 50° and

190°

C. while maintaining said predetermined water content to form a melt;

further heating the hydrophilic polymer melt and water to a temperature between about 110° and

180°

C. to dissolve the melt in the water and achieve a homogeneous dispersion on a molecular level while maintaining said predetermined water content;

injecting the dissolved gelatin/water composition melt into a mold cavity while maintaining said predetermined water content;

cooling the gelatin/water composition melt in said mold;

forming a multichambered molded product having an essentially amorphous polymer structure at a temperature below the glass transition temperature range of the gelatin/water composition while maintaining said predetermined water content; and

ejecting the molded product of said gelatin/water composition from said mold, whereby said injection molded capsule exhibits a self sustaining shape and negligible reversible elastic deformation of the hydrophilic polymer.

3. A method for making molded mixture consisting essentially of hydrophilic gelatin and water pharmaceutical capsules comprising a cap member and a body member each having at least one open end and sidewall means;

and means located in each sidewall means for connecting said cap and body members together, said connecting means being configured and arranged to face each other to achieve, after connection of said cap and body members, a separation resistant connection; and

means for forming two or more compartments in the interior spaces defined by said body and cap members;

which method comprises;

mixing the hydrophilic gelatin/water polymer with water in a predetermined amount between about 5 and 25% by weight of the hydrophilic polymer;

heating the hydrophilic polymer with said water at a temperature between about 110° and

180°

C. while maintaining said predetermined water content to form a melt;

further heating the hydrophilic polymer melt and water to a temperature between about 50° and

190°

C. to dissolve the melt in the water and achieve a homogeneous dispersion on a molecular level while maintaining said predetermined water content;

injecting the dissolved hydrophilic polymer melt into a mold cavity while maintaining said predetermined water content;

cooling the hydrophilic polymer melt in said mold;

forming a multichamber molded product having an essentially amorphous polymer structure at a temperature below the glass transition temperature range of the hydrophilic polymer while maintaining said predetermined water content; and

ejecting the molded product of said hydrophilic polymer from said mold, whereby said injection molded capsule exhibits a self sustaining shape and negligible reversable elastic deformation of the hydrophillic polymer.