Polymer composition for injection molding

• US 4,673,438 A
• Filed: 11/08/1985
• Issued: 06/16/1987
• Est. Priority Date: 02/13/1984
• Status: Expired due to Term

• Current Assignee: Novon International Incorporated
• Original Assignee: Warner-Lambert Company (Pfizer Inc.)
• Inventors: Tomka, Ivan, Wittwer, Fritz
• Primary Examiner(s): Morris, Theodore
• Application Number:
  US06/796,517
• Time in Patent Office: 585 Days
• Field of Search: 264/328.1, 264/38.18, 264/330, 106/126, 106/128, 106/130, 106/213, 424/14, 424/19
• US Class Current: 106/145.1
• CPC Class Codes: A61J 3/07 into the form of capsules or similar small containers for oral use
• CPC Class Codes: A61K 9/4816 Wall or shell material
• CPC Class Codes: B29C 45/0001 characterised by the choice of material
• 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 3/00 Compositions of starch, amylose or amylopectin or of their derivatives or degradation products

Abstract

Capsules and other shaped products formed from a moldable starch composition in an injection molding device is disclosed in the present invention. The composition comprising starch having a molecular mass range of 10,000 to 20,000,000 Dalton, and a water content range from 5 to 30% by weight. The starch contains about 0 to 100% of amylose, and about 100 to 0% of amylo-pectin.

Claims

1. A process for forming starch into an article using an injection molding technique which process comprises:

(A) maintaining a starch/water composition at a water content between 5-30% by weight of the composition under controlled conditions of temperature and pressure,

(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) injecting the starch/water melt into a mold cavity while maintaining said predetermined water content,

(e) cooling the composition in the mold to form a molded product at a temperature below the glass transition temperature of said composition and,

(f) ejecting the molded product from said mold.

2. A process according to claim 1 wherein the elevated temperatures in each step is in the range from 80°

to 240°

C.

3. A process according to claim 1 or 2 wherein the elevated pressure is in the range from 600×

10⁵ to 30000×

10⁵ Newton/square meter.

4. A process according to claim 1, 2 or 3 wherein the starch is derived from a corn, wheat, potato, rice or tapioca starch or a mixture thereof.

5. A process according to any one of claims 1 to 4 wherein the native starch is mixed with at least one number of a class consisting of an extenders, a plasticizers, a lubricants and coloring agents.

6. A process according to claim 1 wherein a plasticizer is present in an amount of from 0.5 to 40% based upon the weight of the starch.

7. A process according to claim 1 wherein a lubricant is present in an amount of 0.001 to 10% based on the weight of the starch.

8. A process according to claim 1 or 6 wherein a coloring agent is present in an amount of from 0.001% to 10% based on the weight of the starch.

9. A process according to claim 1 wherein an extender is added and chosen from sunflower proteins, soybean proteins, cotton seed proteins, peanut proteins, blood proteins, egg proteins, rape seed proteins and acetylated derivatives thereof;

gelatin, crosslinked gelatin, vinylacetate, polysaccharides such as cellulose, methylcellulose, hydroxypropyl-cellulose, hydroxypropylmethylcellulose, hydroxymethyl-cellulose, hydroxyethylcellulose, sodium carboxy methycellulose, polyvinylpyrrolidone, agar-agar, gum arabic, guar, dextran, chitin, polymaltose, polyfructose, pectin, alginates, alginic acids, monosaccharides preferably glucose, fructose, saccharose; and

oligosaccharides lactose, bentonite, silicates, carbonates and bicarbonates.

10. A process according to claim 6 wherein the plasticizer is chosen from:

polyethylene glycol and low molecular weight organic plasticizers, including glycerol, sorbitol, dictylsodium sulphosuccinate, triethyl citrate, tributyl citrate, 1,2 propyleneglycol, mono-, di-, and tri-acetates of glycerol.

11. A process according to claim 7 wherein the lubricant is chosen from:

lipids;

unsaturated and saturated plant fatty acids and salts thereof;

stearates of aluminum, calcium, magnesium and tin;

talc and silicones.

12. A process according to claim 11 wherein the lubricant is a glyceride, a phospholipide or a mixture thereof in an amount of from 0.001-10% by weight of the starch.

13. A process according to any one of claims 1, 2, 3, 4, 6, 7, or 9 wherein the starch is mixed with one or more polymer having enteric properties and being chosen from:

hydroxypropylmethylcellulosephthalate (HPMCP), cellulose-acetylphthalate (CAP), acrylates and methacrylates, polyvinylacetatephthalate (PVAP), phthalated gelatin, succinated geltin, crotonic acid, and shellac.

14. An injection molded article made according to the process of claims 1, 2, 3, 4, 6, 7 or 9.

15. A capsule whenever produced by a process as claimed in any one of claims 1, 2, 3, 4, 6, 7 or 9.

24. A process according to claim 6 wherein plasticizer is present from 0.5-10% by weight.

16. A starch/water composition characterized in that said composition is obtained by

(a) maintaining a starch/water composition at a water content of 5-30% by weight of the composition under controlled conditions of temperature and pressure,

(b) heating said starch/water composition under 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 melt as a molecularly dispersed solution of said melt.

17. A composition according to claim 16 characterized in that said composition is held at a temperature of 80°

-240°

C.

18. A composition according to claim 17 characterized in that said composition is held at a pressure of 600×

10⁵ to 3000×

10⁵ N/M².

19. A molded article formed from a composition according to any one of the claims 16, 17 or 18.

21. A composition according to claim 17 wherein the temperature is greater than 100°

C.

22. A composition according to claim 16 wherein the water content is between 15 and 22%.

23. A composition according to claim 16 wherein the water content is between 15 and 19%.

20. A self-sustaining molded article made from starch having a microstructure formed by heating a starch-water mixture wherein the water content is between 5 and 30% by weight beyond the glass transition and melting temperatures of starch to form a melt as a molecularly dispersed solution and cooling said melt to minimize shrinkage.