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Claims for Patent: 6,177,101

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Claims for Patent: 6,177,101

Title: Delavirdine high strength tablet formulation
Abstract:Disclosed is a non-sustained release pharmaceutical tablet composition which comprises a rapidly precipitating drug in an amount from about 5 to about 60% and at least one member selected from the group consisting of a binder in an amount of from about 2 to about 25% and a superdisintegrant in an amount from about 6 to about 40% where the rapidly precipitating drug, "binder" and superdisintegrant are mixed and compressed into a tablet without heating, solvent or grinding.
Inventor(s): Martino; Alice C. (Kalamazoo, MI), Bates; Ashley H. (Sorrento, AU), Morozowich; Walter (Kalamazoo, MI), Lee; E. John (Kalamazoo, MI)
Assignee: Pharmacia & Upjohn Company (Kalamazoo, MI)
Application Number:09/327,135
Patent Claims: 1. A non-sustained release, non-chewable tablet composition which comprises delavirdine mesylate, and only delavirdine mesylate as the active pharmaceutical ingredient, in an amount from about 200 mg to about 300 mg, microcrystalline cellulose, and at least one binder selected from the group consisting of hydroxypropyl methylycellulose, polyvinylpyrrolidone, hydroxypropyl cellulose, methylcellulose, hydroxyethylcellulose, carbopol or sodium carboxymethylcellulose in an amount of from about 2 to about 25% (wt/wt) and a superdisintegrant in an amount from about 6 to about 40% (wt/wt) where the delavirdine mesylate, microcrystalline cellulose, binder and superdisintegrant are mixed and compressed into a tablet without heating, solvent or grinding.

2. A non-sustained release non-chewable pharmaceutical tablet composition according to claim 1 where the binder is hydroxypropyl methylcellulose.

3. A non-sustained release non-chewable pharmaceutical tablet composition according to claim 1 where the binder is polyvinylpyrrolidone.

4. A non-sustained release non-chewable pharmaceutical tablet composition according to claim 1 where the binder is present in an amount as follows for:

hydroxypropyl methylcellulose of from about 5 to about 20%,

polyvinylpyrrolidone from about 2 to about 15%,

hydroxypropyl cellulose from about 5 to about 20%,

methylcellulose from about 5 to about 20%,

hydroxyethylcellulose from about 5 to about 20%,

carbopol from about 3 to about 20%,

sodium carboxymethylcellulose from about 3 to about 20%.

5. A non-sustained release non-chewable pharmaceutical tablet composition according to claim 1 where the superdisintegrant is croscarmellose sodium, sodium starch glycolate, L-hydroxypropyl cellulose.

6. A non-sustained release non-chewable pharmaceutical tablet composition according to claim 1 where the superdisintegrant is present in an amount of from about 6 to about 35%.

7. A non-sustained release non-chewable pharmaceutical tablet composition according to claim 6 where the superdisintegrant is present in an amount of from about 10 to about 30%.

8. A non-sustained release non-chewable pharmaceutical tablet composition according to claim 1 which contains microcrystalline cellulose in an amount up to about 50%.

9. A non-sustained release non-chewable pharmaceutical tablet composition according to claim 1 where the microcrystalline cellulose is selected from the group consisting of

microcrystalline cellulose coarse powder,

microcrystalline cellulose medium powder and

microcrystalline cellulose 200.

10. A non-sustained release non-chewable pharmaceutical tablet composition according to claim 8 where the microcrystalline cellulose is microcrystalline cellulose N.F. coarse powder.

11. A non-sustained release non-chewable pharmaceutical tablet composition according to claim 1 where the microcrystalline cellulose is present in an amount of from about 10 to about 40%.

12. A non-sustained release non-chewable pharmaceutical tablet composition according to claim 1 which contains lactose in an amount up to about 80%.

13. A non-sustained release non-chewable pharmaceutical tablet composition according to claim 12 where the lactose is selected from the group consisting of lactose monohydrate spray process standard, lactose monohydrate, lactose anhydrous, lactose dihydrate, lactose.

14. A non-sustained release non-chewable pharmaceutical tablet composition according to claim 12 where the lactose is N.F. monohydrate spray process standard lactose.

15. A non-sustained release non-chewable pharmaceutical tablet composition according to claim 11 where the lactose is present in an amount of from about 5 to about 20%.

16. A non-sustained release non-chewable pharmaceutical tablet composition according to claim 1 which contains a flow agent in an amount up to 5%.

17. A non-sustained release non-chewable pharmaceutical tablet composition according to claim 16 where the flow agent is selected from the group consisting of colloidal silicon dioxide and talc.

18. A non-sustained release non-chewable pharmaceutical tablet composition according to claim 16 where the flow agent is colloidal silicon dioxide N.F.

19. A non-sustained release non-chewable pharmaceutical tablet composition according to claim 1 where the flow agent is present in an amount from 0.25 to about 2%.

20. A non-sustained release non-chewable pharmaceutical tablet composition according to claim 1 which contains a lubricant in an amount up to 5%.

21. A non-sustained release non-chewable pharmaceutical tablet composition according to claim 20 where the lubricant is selected from the group consisting of magnesium stearate and stearic acid.

22. A non-sustained release non-chewable pharmaceutical tablet composition according to claim 20 where the lubricant is magnesium stearate.

23. A non-sustained release non-chewable pharmaceutical tablet composition according to claim 1 where the lubricant is present in an amount of 0.25 to about 2%.

24. A non-sustained release non-chewable pharmaceutical tablet composition which is:

TBL Amount (from about to about) Item % delavirdine mesylate 10-40 hydroxypropyl methylcellulose 5-20 croscarmellose sodium 6-35 microcrystalline cellulose 10-50 lactose 0-15 colloidal silicon dioxide 0-5 magnesium stearate 0-5 methylcellulose and croscarmellose sodium are mixed and compressed into a tablet without heating, solvent or grinding.

25. A non-sustained release pharmaceutical tablet composition according to claim 24 which is:

TBL Amount (from about to about) Item %. delavirdine mesylate 30.2 hydroxypropyl methylcellulose 11.3 2910 U.S.P. 3 cps croscarmellose sodium N.F. 16.6 Type A microcrystalline Cellulose N.F. 30.0 coarse powder lactose NF monohydrate spray 10.7 process standard colloidal silicon dioxide N.F. 0.23 magnesium stearate N.F. powder 0.76 food grade-V bolted.

26. A non-sustained release, non-chewable, pharmaceutical tablet composition which comprises: delavirdine mesylate, and only delavirdine mesylate as the active pharmaceutical ingredient, in an amount from about 200 mg to about 300 mg, microcrystalline cellulose, and a superdisintegrant in an amount from about 28 to about 35% (wt/wt) where the delavirdine mesylate, microcrystalline cellulose and superdisintegrant are mixed and compressed into a tablet without heating, solvent or grinding.

27. A pharmaceutical tablet composition according to claim 26 where the siperdisintegrant is present in an amount of 30% (wt/wt).
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