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Claims for Patent: 4,772,473

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Claims for Patent: 4,772,473

Title: Nitrofurantoin dosage form
Abstract:The invention involves a combination sustained release/rapid release pharmaceutical capsule for oral administration of nitrofurantoin comprising, in a capsule shell, a first layer of a first particulate mixture comprising nitrofurantoin, polyvinylpyrrolidone and carboxyvinylpolymer; and a second layer of a second particulate mixture comprising macrocrystalline nitrofurantoin.
Inventor(s): Patel; Vikram S. (Norwich, NY), Welles; Harry L. (Norwich, NY)
Assignee: Norwich Eaton Pharmaceuticals, Inc. (Norwich, NY)
Application Number:06/874,943
Patent Claims: 1. A controlled release pharmaceutical composition for oral administration of nitrofurantoin to a human subject, comprising:

(1) a first layer of a first flowable, particulate mixture consisting essentially of

(a) from about 10% to about 90% of nitrofurantoin

(b) from about 5% to about 86% 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 first particulate mixture; and

(2) a second layer of a second flowable, particulate mixture comprising macrocrystalline nitrofurantoin;

in a capsule shell which is soluble in gastrointestinal juice, wherein said composition, when administered to said subject, provides rapid release and sustained release of nitrofurantoin with low incidence of nausea and emesis.

2. The capsule of claim 1 wherein said first particulate mixture comprises from about 10% to about 70% of polyvinylpyrrolidone, and said capsule shell is soluble in gastric juice.

3. The capsule of claim 1 wherein said first particulate mixture comprises from about 15% to about 60% of polyvinylpyrrolidone, and said capsule shell is a hard gelatin capsule shell which is soluble in gastric juice.

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

5. The capsule of claim 3 wherein said first particulate mixture comprises from about 20% to about 70% of nitrofurantoin acid, or a hydrate thereof, and from about 5% to about 15% of carboxyvinylpolymer.

6. The capsule of claim 2 wherein said first particulate mixture comprises from about 30% to about 70% of nitrofurantoin acid, or a hydrate thereof, 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.

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 polyacryllic 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 where said polyvinylpyrrolidone has a molecular weight of from about 7,000 to about 700,000.
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