US Patent:
20050181043, Aug 18, 2005
Inventors:
Indranil Nandi - Plainsboro NJ, US
Pablo Davila - East Windsor NJ, US
Theodore Burnell - Superior CO, US
International Classification:
A61K031/66
A61K009/20
Abstract:
A tablet composition comprising an alendronate salt and optionally one or more excipients, wherein the cumulative total of the alendronate salt particles in the composition have a particle size distribution as follows: (a) about 19% to about 25% of the particles have a particle size of 250 microns as determined by a U.S. Sieve No. 60; (b) about 14% to about 17% of the particles have a particle size of 180 microns as determined by a U.S. Sieve No. 80; (c) about 10% to about 13% of the particles have a particle size of about 150 microns as determined by a U.S. Sieve No. 100; (d) about 16% to about 23% of the particles have a particle size of 90 microns as determined by a U.S. Sieve No. 170; (e) about 9% to about 17% of the particles have a particle size of 75 microns as determined by a U.S. Sieve No. 250; (f) about 13% to about 16% of the particles have a particle size of 45 microns as determined by a U.S. Sieve No. 325; and (g) about 1% to about 10% of the particles have a particle size of less than 45 microns, wherein the weight percents are based on the total weight of the alendronate salt. The tablets do not require lactose or polyvinylpyrrolidone in order to achieve blend uniformity.