Quality by design: discussing and assessing the solid dispersions risk.

摘要: The poor water solubility tops the list of undesirable physicochemical properties in drug discovery and Solid Dispersions (SDs) has been frequently used to enhance dissolution such compounds. Although, some challenges limit studies SD commercial application. During recent years, Quality by Design (QbD) approach begun to change development, and focus on pharmaceutical production, which shifted from an univariate empirical understanding for a systematic multivariate process. In this review, possible variables during development process, formulation production SDs were defined, introducing applying QbD concept. proposed work presented important definitions as well its application product process design, especially the challenges encountered formulations poorly soluble drugs. aspect, technique was deeply discussed, important parameters design mentioned method of polymers commonly used, methods for characterization stability evaluation, addition biopharmaceutical considerations. Finally, specific risk assessment critical points were discussed, was positive evolution may lead better understanding rational formulation.