Projection of Target Drug Particle Size in Oral Formulations Using the Refined Developability Classification System (rDCS).

ABSTRACT: Dissolution limitations to oral absorption can occur if the time required for dissolution is longer than the transit time across the small intestine and/or if dissolution is slower than the drug's permeation through the gut wall. These limitations most often occur for poorly soluble drugs. A standard method for overcoming dissolution issues is to reduce the particle size of the (solid) drug. Building on the refined Developability Classification System (rDCS), this work establishes a novel set of equations with which the appropriate degree of particle size reduction needed to mitigate dissolution limitations to absorption can be calculated. According to the type of data available, the appropriate equation(s) for each situation can be applied. Three case examples are used to illustrate imple

SUBMITTER: Beran K 

PROVIDER: S-EPMC10385664 | biostudies-literature | 2023 Jul

REPOSITORIES: biostudies-literature