Method for forming pharmaceutical capsules from starch compositions

• US 4,738,724 A
• Filed: 09/19/1986
• Issued: 04/19/1988
• Est. Priority Date: 11/04/1983
• Status: Expired due to Fees

• Current Assignee: Warner-Lambert Company (Pfizer Inc.)
• Original Assignee: Warner-Lambert Company (Pfizer Inc.)
• Inventors: Tomka, Ivan, Wittwer, Fritz, Gillow, Louis S., Raible, Thomas, Bodenmann, Hans-Ulrich
• Primary Examiner(s): Morris, Theodore
• Application Number:
  US06/909,525
• Time in Patent Office: 578 Days
• Field of Search: 264/328 B, 264/328.14, 264/328.15, 264/328.18, 264/328.1, 206/530, 206/531, 206/532, 106/213
• US Class Current: 106/206.1
• 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 45/0001 characterised by the choice of material
• 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 66/12449 : being asymmetric B29C66/12445 takes precedence
• CPC Class Codes: B29C 66/12463 : being tapered
• CPC Class Codes: B29C 66/12469 : being asymmetric
• 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 66/2276 : Other specific local geometries of interlocking undercuts not provided for in B29C66/2272 - B29C66/2274 tongue and groove joints or tenon and mortise joints comprising other specific interlocking undercuts B29C66/12425
• 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 66/73793 : soluble, e.g. water-soluble
• CPC Class Codes: B29K 2003/00 : Use of starch or derivatives as moulding material
• CPC Class Codes: B29K 2995/0059 : Degradable
• 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 3/00 : Compositions of starch, amylose or amylopectin or of their derivatives or degradation products
• CPC Class Codes: C08L 3/02 : Starch; Degradation products thereof, e.g. dextrin

Abstract

Novel injection molded pharmaceutical capsules of starch 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 for making a starch /water pharmaceutical capsule which comprises:

(a) providing a composition consisting essentially of starch/water mixture having a water content in the range of about 5 to 30% by weight based on the weight of starch and water;

(b) heating said starch/water composition at elevated pressure above its glass transition temperature and melting point while maintaining said water content, to form a melt;

(c) further heating and plasticizing said molten starch-water composition to dissolve the starch in the water to form an essentially molecularly dispersed solution of the melt;

(d) injection molding the plasticized starch at an elevated pressure and temperature into a mold;

(e) forming the capsule into a multichambered configuration;

(f) ejecting the molded capsule from the mold.

2. The method of claims 1 which further comprises adding at least one of a lubricant, a dyestuff, a pigment, a coloring agent, or mixtures thereof, to the composition.

3. The method of claim 1 wherein the composition is plasticized at a temperature of between about 80°

C. and 240°

C.

4. The method of claim 3 wherein the composition is plasticized at a temperature of between about 110°

and 180°

C.

5. The method of claim 1 wherein starch is formed into a melt by extrusion.

6. The process of claim 5 wherein extrusion occurs at a pressure between about 6 times 10⁷, N/m² and 3 times 10⁸, N/m².