Reverse Engineering of Medicinal and Nutritional Products - Approaches Available for Generic Product Development

Abstract: Pharmaceutical preparations contain at least one active pharmaceutical ingredient and a wide range of excipients, each with a defined pharmaceutical purpose. India is known as the pharmacy of the world [manufacturing of generic drug products]. The market demand of the generic products is increasing exponentially throughout the Asian and African regions. To satisfy the general population needs and competition in the market specific tools need to be there in the generic manufacturing unit that can fulfil the need of generic manufactures in cracking the branded medicinal and nutritional products. The aim of this review is to present reverse engineering techniques which have been found beneficial in the qualitative and quantitative analysis. The diversity of techniques and their uses in generic product development have been reviewed here. This was a supposed idea to provide the generic manufacturers an analytical tool set which can make generic product development easier and provides several examples of excipients which have been identified to crack the drug composition.