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Details for Patent: 6,521,261

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Details for Patent: 6,521,261

Title: Pharmaceutical excipient having improved compressibility
Abstract:A microcrystalline cellulose-based excipient having improved compressibility, whether utilized in direct compression, dry granulation or wet granulation formulations, is disclosed. The excipient is an agglomerate of microcrystalline cellulose particles and from about 0.1% to about 20% silicon dioxide particles, by weight of the microcrystalline cellulose, wherein the microcrystalline cellulose and silicon dioxide are in intimate association with each other. The silicon dioxide utilized in the novel excipient has a particle size from about 1 nanometer to about 100 microns. Most preferably, the silicon dioxide is a grade of colloidal silicon dioxide.
Inventor(s): Sherwood; Bob E. (Amenia, NY), Staniforth; John H. (Bath, GB), Hunter; Edward A. (Glenham, NY)
Assignee: Edward Mendell Co., Inc. (Patterson, NY)
Filing Date:Oct 16, 2001
Application Number:09/981,319
Claims:1. A pharmaceutical composition comprising: an excipient including microcrystalline cellulose in intimate association with 0.1% to 20% w/w silicon dioxide; and an active agent, wherein the pharmaceutical composition is formed by mixing the excipient, the active agent, and water to form a mixture, and then drying the mixture to obtain the pharmaceutical composition.

2. A method for preparing a pharmaceutical composition, comprising: mixing an excipient, an active agent, and water to obtain a mixture; and drying the mixture to obtain the pharmaceutical composition, wherein the excipient includes microcrystalline cellulose in intimate association with 0.1% to 20% w/w silicon dioxide.

3. A tablet comprising: an excipient including microcrystalline cellulose in intimate association with 0.1% to 20% w/w SiO.sub.2 ; and an active agent, wherein the tablet is formed by mixing the excipient, the active agent, and water to form a mixture, and then drying and tabletting the mixture.

4. The pharmaceutical composition of claim 1, wherein said silicon dioxide has an average primary particle size from about 1 nm to about 100 .mu.m, and said excipient has a bulk density of from about 0.35 g/ml to about 0.6 g/ml.

5. The pharmaceutical composition of claim 4, wherein said silicon dioxide has an average primary particle size from about 5 nm to about 40 .mu.m.

6. The pharmaceutical composition of claim 4, wherein said silicon dioxide is derived from colloidal silicon dioxide.

7. The pharmaceutical composition of claim 4, wherein said silicon dioxide is included in an amount of from about 0.5% to about 10% by weight, based on the weight of said microcrystalline cellulose.

8. The pharmaceutical composition of claim 4, wherein said silicon dioxide is included in an amount of from about 1.25% to about 5% by weight, based on the weight of said microcrystalline cellulose.

9. The pharmaceutical composition of claim 4, wherein said excipient particles have an average particle size of from about 10 .mu.m to about 1,000 .mu.m.

10. The pharmaceutical composition of claim 4, wherein said excipient particles have an average particle size of from about 10 .mu.m to about 500 .mu.m.

11. The pharmaceutical composition of claim 4, wherein said excipient particles have an average particle size of from about 30 .mu.m to about 250 .mu.m.

12. The pharmaceutical composition of claim 4, wherein said excipient particles have a moisture content from about 0.5% to about 15%.

13. The pharmaceutical composition of claim 4, wherein said excipient particles further comprise a member of the group consisting of non-silicon metal oxides, starches, starch derivatives, surfactants, polyalkylene oxides, celluloses, cellulose ethers, cellulose esters and mixtures thereof.

14. The pharmaceutical composition of claim 4, wherein said silicon dioxide is derived from a silicon dioxide having a surface area from about 10 m.sup.2 /g to about 500 m.sup.2 /g.

15. The pharmaceutical composition of claim 4, wherein said silicon dioxide is derived from a silicon dioxide having a surface area from about 175 m.sup.2 /g to about 350 m.sup.2 /g.

16. The pharmaceutical composition of claim 4, wherein said excipient has a bulk density from about 0.35 g/ml to about 0.55 g/ml.

17. The pharmaceutical composition of claim 9, wherein said silicon dioxide is derived from a silicon dioxide having an average primary particle size from about 5 nm to about 40 .mu.m.

18. The pharmaceutical composition of claim 9, wherein said silicon dioxide is derived from colloidal silicon dioxide.

19. The pharmaceutical composition of claim 1, wherein said silicon dioxide is integrated with or partially coats said microcystalline cellulose.
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