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Details for Patent: 7,108,864

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Details for Patent: 7,108,864

Title:Tablet formation
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)
Filing Date:Sep 06, 2000
Application Number:09/656,364
Claims:1. A non-sustained release non-chewable tablet composition comprising (a) a rapidly precipitating drug which is a salt form of a poorly soluble free base that is prone to supersaturation when introduced in water or simulated physiological fluid at body temperature, and more than 90% of it precipitates out within 60 min after coming into contact with said water or simulated physiological fluid at body temperature, with the proviso that the drug is not delavirdine mesylate, is the sole active pharmaceutical ingredient in said composition and is present in an amount from about 5 to about 60%; (b) a polymeric binder present in an amount of from 2 to about 25%; (c) a superdisintegrant in an amount from about 6 to about 40%; and (d) a lubricant present in an amount up to about 5%; and wherein the rapidly precipitating drug, polymeric binder, superdisintegrant and lubricant are mixed and compressed into a tablet without heating, solvent or grinding.

2. A non-sustained release, non-chewable tablet composition according to claim 1, wherein the rapidly precipitating drug is selected from clindamycin hydrochloride, clonidine hydrochloride, diphenhydramine hydrochloride, fluphenazine hydrochloride, hydromorphone hydrochloride, naloxone hydrochloride, oxytetracycline hydrochloride, phenylephrine hydrochloride, pheniramine maleate, tetracycline hydrochloride, verapamil hydrochloride, propoxyphene hydrochloride, hydrocodeine bitartrate, acyclovir sodium, albuterol sulfate, ampicillin sodium, benztropine mesylate, benzphetamine hydrochloride, bupivacaine hydrochloride, bupropin hydrochloride, clorphenamine maleate and chlorpromazine hydrochloride.

3. A non-sustained release, non-chewable pharmaceutical tablet composition according to claim 1 where the polymeric binder is selected from the group consisting of: hydroxypropyl methylcellulose, PVP, hydroxypropyl cellulose, methylcellulose, hydroxyethylcellulose, carbopol, sodium carboxymethylcellulose.

4. A non-sustained release, non-chewable pharmaceutical tablet composition according to claim 1 wherein the polymeric binder is hydroxypropyl methylcellulose.

5. A non-sustained release, non-chewable pharmaceutical tablet composition according to claim 1 wherein the polymeric binder is PVP.

6. A non-sustained release, non-chewable pharmaceutical tablet composition according to claim 1 where the polymeric binder is present in the amount as follows for: hydroxypropyl methyl cellulose of from about 5 to about 20%, PVP 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%.

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

8. 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%.

9. A non-sustained release, non-chewable pharmaceutical tablet composition according to claim 8 where the superdisintegrant is present in an amount of from about 10 to about 30%.

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

11. A non-sustained release, non-chewable pharmaceutical tablet composition according to claim 10 where the microcrystalline cellulose is selected from the group consisting of microcrystalline cellulose coarse powder microcrystalline cellulose medium powder and microcrystalline cellulose 200.

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

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

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

15. A non-sustained release, non-chewable pharmaceutical tablet composition according to claim 14 where the lactose is selected from the group consisting of lactose monohydrate spray process standard, lactose monohydrate, lactate anhydrous, lactose dihydrate, DMV lactose.

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

17. A non-sustained release, non-chewable pharmaceutical tablet composition according to claim 14 where the lactose is present in an amount of from about 5 to about 20%.

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

19. A non-sustained release, non-chewable pharmaceutical tablet composition according to claim 18 where the flow agent is selected from the group consisting of colloidal silicon dioxide and talc.

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

21. A non-sustained release, non-chewable pharmaceutical tablet composition according to claim 18 where the flow agent is present in an amount from 0.25 to about 2%.

22. A non-sustained release, non-chewable pharmaceutical tablet composition according to claim 1 where the lubricant is selected from the group consisting of magnesium stearate and stearic acid.

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

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

25. A non-sustained release, non-chewable pharmaceutical tablet composition according to claim 1 where the rapidly precipitating drug is present in an amount of from about 10 to about 40%.

26. A non-sustained release, non-chewable tablet composition according to claim 4, wherein the polymeric binder is hydroxypropyl methylcellulose of from about 5 to about 20%.

27. A non-sustained release, non-chewable tablet composition according to claim 1, wherein the mixing is accomplished in a high shear mixer.
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