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Claims for Patent: 5,912,013

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Claims for Patent: 5,912,013

Title: Advanced drug delivery system and method of treating psychiatric, neurological and other disorders with carbamazepine
Abstract:The present invention relates to a composition and method of treating a patient by administering carbamazepine in a pharmaceutical dosage form capable of maintaining the patient's blood concentration at from about 4 .mu.g/ml to about 12 .mu.g/ml over at least a 12 hour period, where the blood concentration of carbamazepine does not vary by more than 60 percent.
Inventor(s): Rudnic; Edward M. (North Potomac, MD), Belendiuk; George W. (Potomac, MD), McCarty; John (Biscayne Park, FL), Wassink; Sandra (Frederick, MD), Couch; Richard A. (Germantown, MD)
Assignee: Shire Laboratories, Inc. (Rockville, MD)
Application Number:08/426,394
Patent Claims: 1. A pharmaceutical composition comprising a robust pellet containing carbamazepine, said pellet containing carbamazepine in an amount of at least seventy weight percent and including a binder containing a high number average molecular weight polyvinylpyrrolidone in an amount of about 5 wt. %.

2. A pharmaceutical composition comprising:

a sustained release robust pellet containing carbamazepine, said pellet containing carbamazepine in an amount of at least seventy weight percent and including a binder containing a high number average molecular weight polyvinylpvrrolidone in an amount of about 5 wt. %.

3. A pharmaceutical composition comprising:

an enteric release robust pellet containing carbamazepine, said pellet containing carbamazepine in an amount of at least seventy weight percent and including a binder containing a number average molecular weight polyvinylpyrrolidone in an amount of about 5 wt. %.

4. The composition of claim 1 wherein said polyvinylpyrrolidone has a number average molecular weight of at least 100,000.

5. The composition of claim 2 wherein said polyvinylpyrrolidone has a number average molecular weight of at least 100,000.

6. The composition of claim 2 and further comprising a coating material, wherein said coating material is present in an amount of from about 1.0% (w/w) to about 25% (w/w).

7. The composition of claim 6 wherein said coating material is present in an amount of from about 10% (w/w) to about 20% (w/w).

8. The composition of claim 2 wherein said polyvinylpyrrolidone has a number average molecular weight of at least 100,000.

9. The composition of claim 3 and further comprising a coating material, wherein said coating material is present in an amount of from about 1.0% (w/w) to about 25% (w/w).

10. The composition of claim 9 wherein said coating material is present in an amount of from about 10% (w/w) to about 20% (w/w).
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