Fiese E F Gene
Pharmaceutical Research and Development, Pfizer Global Research and Development, Eastern Point Road, Groton, CT 06340, USA.
J Pharm Sci. 2003 Jul;92(7):1331-42. doi: 10.1002/jps.10366.
General Pharmaceutics is proposed as the broad study of the biopharmaceutical and physical chemical properties of each potential drug substance. When the first quality bulk lot is delivered, usually the first GMP bulk lot, an extensive profiling of the potential drug substance should commence. This profile should include solid-state characterization as well as thorough analyses of solubility, stability, and absorption properties of the drug substance that could affect the development of a viable medicine. As a result of these studies, a number of initial specifications could be developed: the preferred polymorphic or crystalline form identified, the preferred particle size to optimize absorption/development, and an initial biopharmaceutics classification with a dose limit to identify those cases in which the formulation can be expected to improve absorption and exposure. The broad topic of General Pharmaceutics is discussed in this Minireview including many advances in technology in this field as well as the rationale behind the proposed initial specifications.
普通药剂学被认为是对每种潜在药物的生物制药和物理化学性质进行广泛研究。当第一批符合质量标准的批量产品交付时，通常是第一批符合药品生产质量管理规范（GMP）的批量产品，就应该开始对潜在药物进行广泛的分析。这种分析应包括固态表征，以及对可能影响可行药物开发的药物溶解度、稳定性和吸收特性的全面分析。通过这些研究，可以制定一些初始规范：确定优选的多晶型或结晶形式，确定优化吸收/开发的优选粒径，以及进行初始生物药剂学分类并设定剂量限制，以识别那些有望通过制剂改善吸收和暴露的情况。本综述讨论了普通药剂学这一广泛主题，包括该领域的许多技术进展以及所提议的初始规范背后的基本原理。
