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Claims for Patent: 5,006,344

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Claims for Patent: 5,006,344

Title: Fosinopril tablet formulations
Abstract:Shelf stable tablets containing fosinopril sodium are prepared by employing either sodium stearyl fumarate or hydrogenated vegetable oil as the lubricant. The tablets can contain conventional excipients such as fillers, binders, and disintegrants as well as an optional diuretic.
Inventor(s): Jerzewski; Robert L. (East Millstone, NJ), Wong; Thomas M. (North Brunswick, NJ), Gryziewicz; Lewis J. (North Brunswick, NJ), Jain; Nemichand B. (Monmouth Junction, NJ), Thakur; Ajit B. (East Brunswick, NJ)
Assignee: E. R. Squibb & Sons, Inc. (Princeton, NJ)
Application Number:07/543,639
Patent Claims: 1. A stable tablet comprising on a weight percentage basis from about 1% to about 25% fosinopril sodium, up to about 25% of a diuretic, from about 30% to about 90% of a filler, from about 2% to about 10% of a disintegrant, from about 1% to about 5% of a binder, or from about 5% to about 15% of a single agent which is both binder and disintegrant, and from about 0.3% to about 4% of a lubricant selected from the group consisting of sodium stearyl fumarate and hydrogenated vegetable oil.

2. The tablet of claim 1 wherein said lubricant is sodium stearyl fumarate.

3. The tablet of claim 2 wherein said filler is lactose or a blend of lactose and microcrystalline cellulose, said disintegrant is selected from the group consisting of sodium carboxymethyl starch, cross linked sodium carboxymethyl starch, crospovidone, cross linked sodium carboxymethylcellulose, sodium starch glycolate, and mixtures thereof, said binder is selected from the group consisting of povidone, hydroxypropyl cellulose, and mixtures thereof, and said single agent which is both binder and disintegrant is pregelatinized starch.

4. The tablet of claim 3 containing from about 1% to about 25% by weight of chlorthalidone.

5. The tablet of claim 4 wherein said filler is lactose, said disintegrant is crospovidone, and said binder is povidone.

6. The tablet of claim 5 containing on a weight percentage basis about 10% fosinopril sodium, about 3.75% chlorthalidone, about 79.5% lactose, about 2.25% povidone, about 3.5% crospovidone, and about 1% sodium stearyl fumarate.

7. The tablet of claim 5 containing on a weight percentage basis about 6.67% fosinopril sodium, about 5% chlorthalidone, about 81.58% lactose, about 2.25% povidine, about 3.5% crospovidone, and about 1% sodium stearyl fumarate.

8. The tablet of claim 5 containing on a weight percentage basis about 5% fosinopril sodium, about 7.5% chlorthalidone, about 80.5% lactose, about 2.25% povidone, about 3.75% crospovidone, and about 1% sodium stearyl fumarate.

9. The tablet of claim 5 containing on a weight percentage basis about 5% fosinopril sodium, about 25% chlorthalidone, about 62.5% lactose, about 3.0% povidone, about 3.5% crospovidone, and about 1% sodium stearyl fumarate.

10. The tablet of claim 5 containing on a weight percentage basis about 5% fosinopril sodium, about 5% chlorthalidone, about 82.5% lactose, about 3% povidone, about 3.5% crospovidone, and about 1% sodium stearyl fumarate.

11. The tablet of claim 3 wherein the only active ingredient is fosinopril sodium.

12. The tablet of claim 11 wherein said filler is a mixture of lactose and microcrystalline cellulose, said disintegrant is crospovidone, and said binder is povidone.

13. The tablet of claim 12 containing on a weight percentage basis about 2.5% fosinopril sodium, about 69.75% lactose, about 20% microcrystalline cellulose, about 3.5% crospovidone, about 2.25% povidone, and about 2% sodium stearyl fumarate.

14. The tablet of claim 12 containing on a weight percentage basis about 5% fosinopril sodium, about 67.25% lactose, about 20% microcrystalline cellulose, about 3.5% crospovidone, about 2.25% povidone, and about 2% sodium stearyl fumarate.

15. The tablet of claim 12 containing on a weight percentage basis about 10% fosinopril sodium, about 62.25% lactose, about 20% microcrystalline cellulose, about 3.5% crospovidone, about 2.25% povidone, and about 2% sodium stearyl fumarate.

16. The tablet of claim 12 containing on a weight percentage basis about 2.5% fosinopril sodium, about 71.5% lactose, about 20% microcrystalline cellulose, about 3.5% crospovidone, about 2% povidone, and about 0.5% sodium stearyl fumarate.

17. The tablet of claim 3 containing from about 1% to about 25% by weight of hydrochlorothiazide.

18. The tablet of claim 17 wherein said filler is lactose or a blend of lactose and microcrystalline cellulose, said disintegrant is cross linked sodium carboxymethylcellulose or sodium starch glycolate, said binder is povidone, and said single agent which is both binder and disintegrant is pregelatinized starch.

19. The tablet of claim 18 containing on a weight percentage basis about 6.6% fosinopril sodium, about 4.2% hydrochlorothiazide, about 79.2% lactose, about 2.0% povidone, about 5.0% cross linked sodium carboxymethylcellulose, and about 3.0% sodium stearyl fumarate.

20. The tablet of claim 18 containing on a weight percentage basis about 5.0% fosinopril sodium, about 6.25% hydrochlorothiazide, about 78.75% lactose, about 2.0% povidone, about 5.0% cross linked sodium carboxymethylcellulose, and about 3.0% sodium stearyl fumarate.

21. The tablet of claim 18 containing on a weight percentage basis about 10.0% fosinopril sodium, about 6.25% hydrochlorothiazide, about 56.25% lactose, about 20.0% microcrystalline cellulose, about 2.0% povidone, about 3.5% sodium starch glycolate, and about 2.0% sodium stearyl fumarate.

22. The tablet of claim 18 containing on a weight percentage basis about 5.0% fosinopril sodium, about 6.25% hydrochlorothiazide, about 61.75% lactose, about 20.0% microcrystalline cellulose, about 2.0% povidone, about 3.5% sodium starch glycolate, and about 1.5% sodium stearyl fumarate.

23. The tablet of claim 18 containing on a weight percentage basis about 10.0% fosinopril sodium, about 6.25% hydrochlorothiazide, about 53.75% lactose, about 20.0% microcrystalline cellulose, about 8.0% pregelatinized starch, and about 2.0% sodium stearyl fumarate.

24. The tablet of claim 18 containing on a weight percentage basis about 5.0% fosinopril sodium, about 6.25% hydrochlorothiazide, about 59.25% lactose, about 20.0% microcrystalline cellulose, about 8.0% pregelatinized starch, and about 1.5% sodium stearyl fumarate.
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