Narayan Padma
The Dow Chemical Company, Engineering Sciences, Solids Processing, Midland, Michigan, USA.
Curr Protoc Pharmacol. 2011 Dec;Chapter 7:Unit 7.3.1-29. doi: 10.1002/0471141755.ph0703s55.
The process for developing drug delivery systems has evolved over the past two decades with more scientific rigor, involving a collaboration of various fields, i.e., biology, chemistry, engineering, and pharmaceutics. Drug products, also commonly known in the pharmaceutical industry as formulations or "dosage forms," are used for administering the active pharmaceutical ingredient (API) for purposes of assessing safety in preclinical models, early- to late-phase human clinical trials, and for routine clinical/commercial use. This overview discusses approaches for creating small-molecule API dosage forms, from preformulation to commercial manufacturing.
在过去二十年中，药物递送系统的研发过程变得更加科学严谨，涉及生物学、化学、工程学和药剂学等多个领域的合作。药品在制药行业中也通常被称为制剂或“剂型”，用于施用活性药物成分（API），以评估临床前模型中的安全性、早期至晚期人体临床试验以及常规临床/商业用途。本概述讨论了从小分子API剂型的处方前研究到商业化生产的方法。
