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Claims for Patent: 5,994,348

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Claims for Patent: 5,994,348

Title: Pharmaceutical compositions containing irbesartan
Abstract:Pharmaceutical compositions containing irbesartan, alone or in combination with a diuretic, providing tablets with a high relative amount of active agent and excellent wetting and disintegration properties.
Inventor(s): Ku; Cathy C. (Martinsville, NJ), Sprockel; Omar L. (Bridgewater, NJ), Lang; Beth A. (Bedminster, NJ), Desai; Divyakant S. (Robbinsville, NJ)
Assignee: Sanofi (Paris, FR)
Application Number:09/081,685
Patent Claims: 1. A pharmaceutical composition comprising, based on weight: (a) from about 20 to about 70% irbesartan or a pharmaceutically acceptable salt thereof, and (b) about 2 to about 33% hydrochlorothiazide, wherein the total weight % of irbesartan or salt thereof and hydrochlorothiazide does not exceed about 85%, said composition being free povidone and poloxamer.

2. A pharmaceutical composition of claim 1 comprising, based on weight: (a) from about 20 to about 70% irbesartan, (b) from about 2 to about 33% hydrochlorothiazide, wherein the combined loading of (a) and (b) does not exceed about 85%, (c) from about 1 to about 70% diluent, (d) from about 2 to about 20% binder, (e) from about 1 to about 10% disintegrant, (f) from about 0.1 to about 5% antiadherent, (g) from about 0.2 to about 5% lubricant, and, optionally (h) up to about 2% coloring agent.

3. A pharmaceutical composition of claim 2, wherein

the diluent is one or more compounds selected from the group consisting of dibasic calcium phosphate, lactose hydrous, lactose anhydrous, and microcrystalline cellulose;

the binder is one or more compounds selected from the group consisting of alginic acid, sodium alginate, carboxymethylcellulose sodium, ethylcellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, methylcellulose, gelatin, starch and pregelatinized starch;

the disintegrant is one or more compounds selected from the group consisting of alginic acid, sodium alginate, carboxymethylcellulose sodium, microcrystalline cellulose, powdered cellulose, croscarmellose sodium, pregelatinized starch, sodium starch glycolate, and starch;

the antiadherent is one or more compounds selected from the group consisting of silicon dioxide, magnesium trisilicate, and talc;

the lubricant is one or more compounds selected from the group consisting of calcium stearate, glyceryl monostearate, glyceryl palmitostearate, magnesium stearate, sodium lauryl sulfate, sodium stearyl fumarate, zinc stearate, stearic acid, hydrogenated vegetable oil, polyethylene glycol, sodium benzoate, and talc; and when present, the coloring agent is one or more ferric oxides.

4. A pharmaceutical composition of claim 2, comprising, based on weight, about 20 to 50% irbesartan; about 2 to 20% hydrochlorothiazide; about 1 to 70% diluent; about 10 to 20% binder; about 4 to 6% disintegrant; about 0.5 to 1.0% antiadherent; and about 0.5 to 1.5% lubricant.

5. The pharmaceutical composition of claim 4, wherein said diluent is lactose hydrous and microcrystalline cellulose; said binder is pregelatinized starch; said disintegrant is croscarmellose sodium; said antiadherent is silicon dioxide; and said lubricant is magnesium stearate.

6. A pharmaceutical composition of claim 1, comprising, based on weight, about 50% irbesartan; about 8.33% hydrochlorothiazide; about 4.72% lactose hydrous; about 15.0% pregelatinized starch; about 5.0% croscarmellose sodium; about 15% microcrystalline cellulose; about 0.75% silicon dioxide; about 1.0% magnesium stearate; about 0.1% ferric oxide, red; and about 0.1% ferric oxide, yellow.

7. A pharmaceutical composition of claim 1, comprising, based on weight, about 50% irbesartan; about 4.17% hydrochlorothiazide; about 88% lactose hydrous; about 15.0% pregelatinized starch; about 5.0% croscarmellose sodium; about 15% microcrystalline cellulose; about 0.75% silicon dioxide; about 1.0% magnesium stearate; about 0.1% ferric oxide, red; and about 0.1% ferric oxide, yellow.

8. A pharmaceutical composition of claim 2, comprising, based on weight, about 50% irbesartan; about 8.33% hydrochlorothiazide; about 1.72% lactose hydrous; about 15.0% pregelatinized starch; about 5.0% croscarmellose sodium; about 3% sodium lauryl sulfate; about 15% microcrystalline cellulose; about 0.75% silicon dioxide; about 1.0% magnesium stearate; about 0.1% ferric oxide, red; and about 0.1% ferric oxide, yellow.

9. A pharmaceutical composition of claim 2, comprising, based on weight, about 50% irbesartan; about 4.17% hydrochlorothiazide; about 5.88% lactose hydrous; about 15.0% pregelatinized starch; about 5.0% croscarmellose sodium; about 3% sodium lauryl sulfate; about 15% microcrystalline cellulose; about 0.75% silicon dioxide; about 1.0% magnesium stearate; about 0.1% ferric oxide, red; and about 0.1% ferric oxide, yellow.

10. A tablet formed from the composition of claim 6.

11. A tablet formed from the composition of claim 7.

12. A tablet formed from the composition of claim 8.

13. A tablet formed from the composition of claim 9.

14. A tablet of claim 11, wherein the total weight of said tablet is from about 50 to about 600 mg.

15. A pharmaceutical composition comprising irbesartan or a pharmaceutically acceptable salt thereof, hydrochlorothiazide, and a binder which is starch and/or pregelatinized starch, said composition being free of povidone and poloxamer.

16. A pharmaceutical composition of claim 15, wherein said binder is pregelatinized starch.

17. A tablet formed from the composition of claim 16.

18. A pharmaceutical composition, prepared by mixing components comprising from about 20 to about 70% by weight irbesartan or a pharmaceutically acceptable salt thereof with one or more pharmaceutically acceptable excipients, and, in addition, about 2 to about 33% hydrochlorothiazide, wherein the total weight % of irbesartan or salt thereof and hydrochlorothiazide mixed does not exceed about 85%, said composition being free of povidone and poloxamer.

19. A pharmaceutical composition of claim 18 prepared by mixing components comprising, based on weight: (a) from about 20 to about 70% irbesartan, (b) from about 2 to about 33% hydrochlorothiazide, wherein the combined loading of (a) and (b) does not exceed about 85%, (c) from about 1 to about 70% diluent, (d) from about 2 to about 20% binder, (e) from about 1 to about 10% disintegrant, (f) from about 0.1 to about 5% antiadherent, and (g) from about 0.2 to about 5% lubricant, and, optionally (h) up to about 2% coloring agent.

20. A pharmaceutical composition of claim 19, wherein

the diluent is one or more compounds selected from the group consisting of dibasic calcium phosphate, lactose hydrous, lactose anhydrous, and microcrystalline cellulose;

the binder is one or more compounds selected from the group consisting of alginic acid, sodium alginate, carboxymethylcellulose sodium, ethylcellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, methylcellulose, gelatin, starch and pregelatinized starch;

the disintegrant is one or more compounds selected from the group consisting of alginic acid, sodium alginate, carboxymethylcellulose sodium, microcrystalline cellulose, powdered cellulose, croscarmellose sodium, pregelatinized starch, sodium starch glycolate, and starch;

the antiadherent is one or more compounds selected from the group consisting of silicon dioxide, magnesium trisilicate, and talc;

the lubricant is one or more compounds selected from the group consisting of calcium stearate, glyceryl monostearate, glyceryl palmitostearate, magnesium stearate, sodium lauryl sulfate, sodium stearyl fumarate, zinc stearate, stearic acid, hydrogenated vegetable oil, polyethylene glycol, sodium benzoate, and talc; and

when present, the coloring agent is one or more ferric oxides.

21. A pharmaceutical composition of claim 19, prepared by mixing components comprising, based on weight, about 20 to 50% irbesartan; about 2 to 20% diuretic; about 1 to 70% hydrochlorothiazide; about 10 to 20% binder; about 4 to 6% disintegrant; about 0.5 to 1.0% antiadherent; and about 0.5 to 1.5% lubricant.

22. The pharmaceutical composition of claim 21, wherein said diuretic is hydrochlorothiazide; said diluent is lactose hydrous and microcrystalline cellulose; said binder is pregelatinized starch; said disintegrant is croscarmellose sodium; said antiadherent is silicon dioxide; and said lubricant is magnesium stearate.

23. A pharmaceutical composition of claim 18, prepared by mixing components comprising, based on weight, about 50% irbesartan; about 8.33% hydrochlorothiazide; about 4.72% lactose hydrous; about 15.0% pregelatinized starch; about 5.0% croscarmellose sodium; about 15% microcrystalline cellulose; about 0.75% silicon dioxide; about 1.0% magnesium stearate; about 0.1% ferric oxide, red; and about 0.1% ferric oxide, yellow.

24. A pharmaceutical composition of claim 18, prepared by mixing components comprising, based on weight, about 50% irbesartan; about 4.17% hydrochlorothiazide; about 8.88% lactose hydrous; about 15.0% pregelatinized starch; about 5.0% croscarmellose sodium; about 15% microcrystalline cellulose; about 0.75% silicon dioxide; about 1.0% magnesium stearate; about 0.1% ferric oxide, red; and about 0.1% ferric oxide, yellow.

25. A pharmaceutical composition of claim 18, prepared by mixing components comprising, based on weight, about 50% irbesartan; about 8.33% hydrochlorothiazide; about 1.72% lactose hydrous; about 15.0% pregelatinized starch; about 5.0% croscarmellose sodium; about 3% sodium lauryl sulfate; about 15% microcrystalline cellulose; about 0.75% silicon dioxide; about 1.0% magnesium stearate; about 0.1% ferric oxide, red; and about 0.1% ferric oxide, yellow.

26. A pharmaceutical composition of claim 18, prepared by mixing components comprising, based on weight, about 50% irbesartan; about 4.17% hydrochlorothiazide; about 5.88% lactose hydrous; about 15.0% pregelatinized starch; about 5.0% croscarmellose sodium; about 3% sodium lauryl sulfate; about 15% microcrystalline cellulose; about 0.75% silicon dioxide; about 1.0% magnesium stearate; about 0.1% ferric oxide, red; and about 0.1% ferric oxide, yellow.
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