Ann Newman - "Solid-state Analysis of the Active Pharmaceutical Ingredient in Drug Products", A. W. Newman, S. R. Byrn

Version 1

      Publication Details (including relevant citation   information):

      Drug Discovery Today2003,   8, 898-905

      Abstract:

      The solid form of a drug substance is important when developing a   new chemical entity. The crystalline form used in development is   significant based on possible manufacturability, solubility,   bioavailability and stability differences between the solid   forms. Regulatory issues require that the form present in a solid   dosage form or liquids containing undissolved drug substance be   identified. Drug product samples can be analyzed by a variety of   techniques to determine the crystal form present or changes that   occur during the manufacture of a drug product. The form present   will affect development, regulatory and intellectual property   issues.

      Address (URL): http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6T64-49NHHS3-F&_user=1 0&_coverDate=10%2F01%2F2003&_alid=986126754&_rdoc=1&_fmt=high&_orig=search&_cdi= 5020&_sort=r&_docanchor=&view=c&_ct=1&_acct=C000050221&_version=1&_urlVersion=0& _userid=10&md5=528c8745ead79432cbe6a9f312e7c686