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Details for Patent: 6,936,277

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Details for Patent: 6,936,277

Title: Pharmaceutical excipient having improved compressibility
Abstract:A method of preparing an excipient composition includes forming an aqueous slurry containing a mixture of microcrystalline cellulose in the form of a wet cake and a surfactant, said surfactant being present in an amount from about 0.1% to about 0.5% by weight of the wet-cake microcrystalline cellulose; and drying said slurry to obtain an excipient comprising a plurality of agglomerated particles of microcrystalline cellulose in intimate association with said surfactant. The excipient may be mixed with a therapeutically active agent to form a dosage form. The surfactant provides a hydrophobic boundary at cellulose surfaces, and improves absorptivity of the therapeutically active agent.
Inventor(s): Staniforth; John N. (Bath, GB), Hunter; Edward A. (Amenia, NY), Sherwood; Bob E. (Glenham, NY)
Assignee: J. Rettenmaier & Soehne GmbH & Co. KG (Rosenberg, DE)
Filing Date:May 14, 2002
Application Number:10/145,563
Claims:1. A method of preparing an excipient composition, comprising forming an aqueous slurry containing a mixture of microcrystalline cellulose in the form of a wet cake from about 0.1% to about 20% by weight silicon dioxide, based on the weight of the microcrystalline cellulose and a surfactant selected from the group consisting of sodium lauryl sulfate, and docusate sodium, and drying said slurry to obtain an excipient comprising a plurality of agglomerated particles of microcrystalline cellulose in intimate association with said surfactant, said surfactant being present in an amount from about 0.1% to about 0.5% by weight of the microcrystalline cellulose.

2. The method of claim 1, wherein said surfactant is included in an amount of from about 0.15% to about 0.4%, based on the weight of said microcrystalline cellulose.

3. The method of claim 1, wherein said surfactant is included in an amount of from about 0.2% to about 0.3%, based on the weight of said microcrystalline cellulose.

4. The method of claim 1, wherein said excipient composition comprises particles having an average particle size of from about 10 .mu.m to about 1,000 .mu.m.

5. The method of claim 1, wherein said excipient particles have an average particle size of from about 10 .mu.m to about 500 .mu.m.

6. The method of claim 1, wherein said excipient particles have an average particle size of from about 30 .mu.m to about 250 .mu.m.

7. The method of claim 1, wherein said excipient particles have an average particle size of from about 40 .mu.m to about 200 .mu.m.

8. The method of claim 1, wherein said excipient composition has a moisture content from about 0.5% to about 15%.

9. The method of claim 1, wherein said excipient composition futher comprises from about 0.5 to about 10% by weight silicon dioxide, based on the weight of the microcrystalline cellulose.

10. The method of claim 1, wherein said excipient composition further comprises from about 1.25 to about 5% by weight silicon dioxide,based on the weight of the microcrystalline cellulose.

11. The method of claim 9, wherein said silicon dioxide is derived from colloidal silicon dioxide.

12. The method of claim 1, wherein said excepient has a bulk density from about 0.2 g/ml to about 0.5 g/ml.

13. The method of claim 10, wherein said excepient has a bulk density from about 0.22 g/ml to about 0.35 g/ml.

14. The method of claim 1, wherein said excepient particles further comprise a member selected from the group consisting of non-silicon metal oxides, starches, starch derivatives, polyalkylene oxides, celluloses, cellulose ethers, cellulose esters and mixtures thereof.
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