Department of Pharmaceutics and Drug Delivery, The University of Mississippi, University, MS, 38677, United States.
Institute for Drug Delivery and Biomedical Research, Bangalore, India.
AAPS PharmSciTech. 2018 Jan;19(1):12-26. doi: 10.1208/s12249-017-0864-4. Epub 2017 Sep 11.
The choice of excipients constitutes a major part of preformulation and formulation studies during the preparation of pharmaceutical dosage forms. The physical, mechanical, and chemical properties of excipients affect various formulation parameters, such as disintegration, dissolution, and shelf life, and significantly influence the final product. Therefore, several studies have been performed to evaluate the effect of drug-excipient interactions on the overall formulation. This article reviews the information available on the physical and chemical instabilities of excipients and their incompatibilities with the active pharmaceutical ingredient in solid oral dosage forms, during various drug-manufacturing processes. The impact of these interactions on the drug formulation process has been discussed in detail. Examples of various excipients used in solid oral dosage forms have been included to elaborate on different drug-excipient interactions.
辅料的选择是药物剂型制备前体和制剂研究的主要部分。辅料的物理、机械和化学性质会影响各种制剂参数，如崩解、溶解和保质期，并对最终产品产生重大影响。因此，已经进行了多项研究来评估药物-辅料相互作用对整体配方的影响。本文综述了有关辅料的物理和化学不稳定性及其在固体制剂中与活性药物成分的不相容性的信息，涉及各种药物制造过程。详细讨论了这些相互作用对药物制剂过程的影响。还包括了固体制剂中使用的各种辅料的实例，以详细说明不同的药物-辅料相互作用。
