Hydrophilic polymer compositions for injection molding

• US 4,655,840 A
• Filed: 02/05/1985
• Issued: 04/07/1987
• Est. Priority Date: 03/26/1982
• Status: Expired due to Fees

• Current Assignee: Warner-Lambert Company (Pfizer Inc.)
• Original Assignee: Warner-Lambert Company (Pfizer Inc.)
• Inventors: Tomka, Ivan, Wittwer, Fritz
• Primary Examiner(s): Morris, Theodore
• Application Number:
  US06/698,264
• Time in Patent Office: 791 Days
• Field of Search: 260/118, 260/117, 106/184, 106/197.1, 106/197.2, 106/125-130, 106/136, 536/91, 524/22, 524/23, 264/297.2, 264/328.1
• US Class Current: 106/135.1
• CPC Class Codes: A61J 2200/20 Extrusion means, e.g. for producing pharmaceutical forms
• 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: C08L 89/06 derived from leather or skin , e.g. gelatin

Abstract

A moldable hydrophilic polymer composition, preferably gelatin, for use in an injection molding device preferably controlled with a microprocessor. The composition has a molecular mass range of 10,000 to 2,000,000 Dalton or a molecular mass range of 10,000 to 2,000,000 and 10,000,000 to 20,000,000 Dalton. The composition has a water content range from 5 to 25% percent by weight.

Claims

1. A molded hydrophilic gelatin-water containing shaped article of manufacture wherein the water content is in the range of from about 5% to about 25% by weight of the hydrophilic gelatin, said shaped article being formed directly:

(a) from a hydrophilic gelatin-water solution at temperatures in the range of from 50°

C. to about 190°

C. and elevated pressures, wherein the water content was maintained in the range of about 5 to 25% by weight of the hydrophilic gelatin;

(b) by reducing the temperature of said hydrophilic gelatin-water solution during molding to below the glass transition temperature of said hydrophilic gelatin;

whereby said molded article exhibits a self sustaining shape and negligible reversible elastic deformation of the hydrophilic gelatin.

3. The article or capsule of claims 1 or 2 wherein the gelatins have (a) a molecular mass of 10,000 to 2,000,000 daltons and (b) molecular mass ranges of 10,000 to 2,000,000 and 10,000,000 to 20,000,000 daltons.

4. The article or capsule of claim 3 wherein the water is present and maintained at a predetermined amount in the range of about 10 to about 20% by weight of the gelatin.

5. The composition of claim 3 wherein extenders are present, said extenders being selected from the group consisting of vegetable proteins including sunflower proteins, soybean proteins, cotton seed proteins, peanut proteins, rape seed proteins;

lactose;

gum arabic;

acrylates;

methacrylates;

cellulose and water soluble derivatives of cellulose including hydroxyethylcellulose, cellulose acetate phthalate (CAP), hydroxypropyl cellulose, hydroxypropyl methylcellulose, hydroxypropyl methylcellulose phthalate (HPMCP), methylcellulose, sodium carboxymethyl cellulose, hydroxymethyl cellulose;

acryic acid polymers;

polyvinylpyrrolidone;

shellac;

bentonite;

vinylacetate polymers;

polyvinylacetatephthalate;

phtalated gelatin;

succinated gelatin;

crotonic acid polymers; and

polysaccharides incluing agar-agar.

6. The article or capsule of claims 1 or 2 wherein extenders are present, said extenders being selected from the group consisting of vegetable proteins including sunflower proteins, soybean proteins, cotton seed proteins, peanut proteins, rape seed proteins, blood proteins, egg proteins, and acetylated derivatives thereof, alginates, lactose, gum arabic, cellulose and water soluble derivatives of cellulose including hydroxyethylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, hydroxymethylcellulose, acrylic acid polymers, polyvinylpyrrolidone, bentonite, vinylacetate polymers, agar-agar and other water soluble polysaccharides.

8. The article or capsule of claims 1 or 2 wherein a crosslinking agent is added just prior to pressure molding.

9. The article or capsule of claims 1 or 2 wherein a plasticizing agent is present.

10. The article or capsule of claims 1 or 2 wherein a lubricating agent is present.

11. The article or capsule of claims 1 or 2 wherein a coloring agent is present.

12. The article of claim 1 wherein the water is present in the amount of about 10 to about 20% by weight of the gelatin.

2. A capsule capable of being self sustaining, having as its basic structural component a material which is in the form of a hydrophilic gelatin having its microstructure defined by said gelatin having been subjected to temperatures beyond its glass transition point and its melting point prior to shaping by injection molding.

7. The capsule of claim 2 wherein the capsule parts are subjected to minimal deformation during forming.

16. The capsule according to claim 2 wherein the moisture content is between 5 and 25% as the polymer was heated past the melting and glass transition points.

13. An injection molded hydrophilic gelatin water containing shaped article of manufacture wherein said article as ejected from the mold has a water content in the range of from about 5% to about 25% by weight of the hydrophilic gelatin and exhibits an essentially amorphous gelatin structure.

14. The article of claim 13 wherein the hydrophilic gelatin is a gelatin selected from those gelatins which have (a) a molecular mass of 10,000 to 2,000,000 daltons and (b) molecular mass ranges of 10,000 to 2,000,000 and 10,000,000 to 20,000,000 daltons.

15. The article of claim 14 wherein the water is present in the amount of about 10 to about 20% by weight of the gelatin.

17. A hydrophilic gelatin-water composition having no phase separation of the water from the hydrophilic gelatin water mixture at a water content of between about 5 and 25% by weight of the hydrophilic gelatin, said mixture being obtained by:

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

(b) heating the hydrophilic gelatin with said water while maintaining said predetermined water content to form a melt;

(c) further heating the hydrophilic gelatin and water above its glass transition temperature and above its melting point to dissolve the melt in the water and achieve a melt as a molecularly dispersed solution.