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Claims for Patent: 4,798,725

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Claims for Patent: 4,798,725

Title: Sustained release capsule
Abstract:The invention involves a sustained release pharmaceutical capsule for oral administration comprising, in a capsule shell, a particulate mixture comprising an active drug ingredient which is a weak acid, neutral, or a weak base, polyvinylpyrrolidone, and carboxyvinylpolymer.
Inventor(s): Patel; Vikram S. (Norwich, NY)
Assignee: Norwich Eaton Pharmaceuticals, Inc. (Norwich, NY)
Application Number:06/874,732
Patent Claims: 1. A sustained release pharmaceutical capsule for oral administration comprising a particulate mixture, in a capsule shell which is soluble in a gastrointestinal juice, said particulate mixture comprising:

(a) from about 0.01% to about 90% of an active drug ingredient which is a weak acid, neutral, or a weak base;

(b) from about 5% to about 96% of polyvinylpyrrolidone; and

(c) from about 4% to about 40% of carboxyvinylpolymer; wherein said polyvinylpyrrolidone and said carboxyvinylpolymer occur substantially entirely in separate particles of said particulate mixture.

2. The capsule of claim 1 wherein said particulate mixture comprises from about 10% to about 70% of polyvinylpyrrolidone.

3. The capsule of claim 1 wherein said particulate mixture comprises from about 15% to about 60% of polyvinylpyrrolidone.

4. The capsule of claim 2 wherein said particulate mixture comprises from about 5% to about 25% of carboxyvinylpolymer.

5. The capsule of claim 3 wherein said particulate mixture comprises from about 10% to about 70% of said active drug ingredient and from about 5% to about 15% of carboxyvinylpolymer.

6. The capsule of claim 2 wherein said particulate mixture comprises from about 10% to about 70% of said active drug ingredient and from about 7% to about 10% of carboxyvinylpolymer.

7. The capsule of claim 4 wherein said carboxyvinylpolymer has a molecular weight of at least about 1,250,000, and said capsule shell is a hard gelatin capsule shell which is soluble in gastric juice.

8. The capsule of claim 5 wherein said carboxyvinylpolymer has a molecular weight of about 3,000,000 and is a polyacrylic acid cross-linked with about 1% of polyallyl sucrose having an average of about 5.8 allyl groups for each molecule of sucrose.

9. The capsule of claim 6 wherein said carboxyvinylpolymer has a molecular weight of about 3,000,000 and is a polyacrylic acid cross-linked with about 1% of polyallyl sucrose having an average of about 5.8 allyl groups for each molecule of sucrose.

10. The capsule of claim 8 wherein said polyvinylpyrrolidone has a molecular weight of from about 7,000 to about 700,000.

11. A process for producing a sustained release pharmaceutical capsule for oral administration comprising the steps of:

(1) preparing a particulate mixture, said particulate mixture comprising:

(a) from about 0.01% to about 90% of an active drug ingredient which is a weak acid, neutral, or a weak base;

(b) from about 5% to about 96% of polyvinylpyrrolidone; and

(c) from about 4% to about 40% of carboxyvinylpolymer; wherein said polyvinylpyrrolidone and said carboxyvinylpolymer occur substantially entirely in separate particles of said particulate mixture.

(2) filling said particulate mixture into a capsule shell which is soluble in a gastrointestinal juice.

12. The process of claim 11 wherein said particulate mixture comprises from about 10% to about 70% of said active drug ingredient, from about 10% to about 70% of polyvinylpyrrolidone, and from about 5% to about 15% of carboxyvinylpolymer.

13. The process of claim 12 wherein said carboxyvinylpolymer has a molecular weight of at least about 1,250,000, and said capsule shell is a hard gelatin capsule shell which is soluble in gastric juice.

14. The process of claim 11 wherein said particulate mixture comprises from about 10% to about 70% of said active drug ingredient, from about 10% to about 70% of polyvinylpyrroline having a molecular weight of from about 7,000 to about 700,000, and from about 7% to about 10% of carboxyvinylpolymer having a molecular weight of about 3,000,000, said carboxyvinylpolymer being a polyacrylic acid cross-linked with about 1% of polyallyl sucrose having an average of about 5.8 allyl groups for each molecule of sucrose.
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