Patent ID: 7695739
Filing Date: 2010-04-13
Classification: A61K

Abstract:
1. An in vitro method for evaluating a solid dosage form, comprising: (a) dispersing a dosage form in a biorelevant medium, wherein the dosage form comprises at least one poorly water-soluble active agent, and wherein prior to incorporation into the solid dosage form, the active agent has an effective average particle size of greater than 2 microns; (b) measuring the particle size of the dispersed poorly water-soluble active agent; and (c) determining if the level of dispersibility is sufficient for in vivo effectiveness of the dosage form, wherein the level of dispersibility is sufficient for in vivo effectiveness of the dosage form if the dosage form disperses such that the particle size of the dispersed active agent particles resembles the particle size of the active agent prior to incorporation into the solid dosage form.