Reverse Engineering in Pharmaceutical Product Development

Reverse engineering or deformulation is a known process for generic product development and is widely used by the pharmaceutical industry for regulatory purpose. In order to achieve a generic product having all the essential features described in Q1/Q2/Q3 ICH guidelines, a systematic, well-planned and skilled process is applied to identify the API, excipients and physicochemical characteristics of the innovator product. Apart from this, reverse engineering is applied on stability testing and identification of manufacturing defects. Here, we summarised to answer few questions like why it is required, how it is performed, what are common analytical techniques and method involved in the reverse engineering of tablet, capsule, ophthalmic preparation, depot and herbal formulations. This chapter deals with the review of the literature on this demanding topic with a comprehensive discussion on case studies.