Investigation of the Effect of Ethylcellulose Viscosity Variation on Slightly Soluble and Freely Soluble Drugs from Extended Release Multiparticulates

摘要

Ethylcellulose is a commonly used polymer for extended release (ER) multiparticulate formulations due to its excellent barrier properties, safety, and global acceptance. The critical material attributes of ethylcellulose which may influence drug release are viscosity and ethoxyl substitution. These attributes must be evaluated to aide in developing robust ER multiparticulate formulations and fulfill the Quality by Design (QbD) precedence being set forth by the FDA. The current study investigated the effect of viscosity variation for ETHOCELTM Std 10 cP, 20 cP, 100 cP Premium product grades on the extended drug release from multiparticulates containing slightly soluble (acetaminophen, APAP) or freely soluble (metoprolol tartrate, MT) drug compounds.