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Claims for Patent: 6,342,247

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Claims for Patent: 6,342,247

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; Divvakant S. (Robbinsville, NJ)
Assignee: Sanofi-Synthelabo (Paris, FR)
Application Number:09/686,378
Patent Claims: 1. A pharmaceutical composition, wherein said composition comprises, based on weight: (a) from about 20 to about 70% irbesartan or a pharmaceutically acceptable salt thereof, (b) from about 1 to about 70% diluent, (c) from about 2 to about 20% binder, (d) from about 1 to about 10% disintegrant, (e) from about 0.1 to about 5% antiadherent, (f) from about 0.2 to about 5% lubricant, (g) from about 0.2 to about 6% surfactant, and optionally (h) up to about 2% coloring agent wherein said diluent is lactose hydrous and microcrystalline cellulose; said binder is pregelatinized starch or povidone; said disintegrant is croscarmellose sodium; said antiadherent is silicon dioxide; said lubricant is magnesium stearate; and said surfactant is poloxamer 188; and wherein a tablet formed from said composition has a dissolution performance such that about 80% or greater of the irbesartan or salt thereof contained in said tablet dissolves within 30 minutes.

2. The pharmaceutical composition of claim 1, wherein a tablet formed from said composition has a dissolution performance such that about 85% or greater of the irbesartan or salt thereof contained in said tablet dissolves within 30 minutes.

3. A pharmaceutical composition of claim 1 comprising, based on weight, about 20 to 50% irbesartan; about 1 to 70% diluent; about 10 to 20% binder; about 4 to 8% disintegrant; about 0.25 to 5.0% antiadherent; about 0.5 to 1.5% lubricant; and about 1 to 6% surfactant.

4. A pharmaceutical composition of claim 1, comprising, based on weight, about 50% irbesartan; about 10.25% lactose hydrous; about 15.0% pregelatinized starch; about 5.0% croscarmellose sodium; about 3.0% poloxamer 188; about 15% microcrystalline cellulose; about 0.75% silicon dioxide; and about 1.0% magnesium stearate.

5. A pharmaceutical composition of claim 1, comprising, based on weight, about 50% irbesartan; about 10.25% lactose hydrous; about 15.0% pregelatinized starch; about 5.0% croscarmellose sodium; about 3.0% poloxamer 188; about 13% microcrystalline cellulose; about 2.75% silicon dioxide; and about 1.0% magnesium stearate.

6. A pharmaceutical composition of claim 1, comprising, based on weight, about 50% irbesartan; about 20.25% lactose hydrous; about 5.0% povidone K-30; about 5.0% croscarmellose sodium; about 3.0% poloxamer; about 15% microcrystalline cellulose; about 0.75% silicon dioxide; and about 1.0% magnesium stearate.

7. A pharmaceutical composition of claim 1, comprising, based on weight, about 50% irbesartan; about 20.25% lactose hydrous; about 5.0% povidone K-30; about 5.0% croscarmellose sodium; about 3.0% poloxamer; about 13% microcrystalline cellulose; about 2.75% silicon dioxide; and about 1.0% magnesium stearate.

8. A tablet formed from the composition of claim 1.

9. A tablet formed from the composition of claim 4.

10. A tablet formed from the composition of claim 5.

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

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

13. A tablet of claim 8, wherein the total weight of said tablet is from about 50 to about 600 mg.
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