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Current Analytical Chemistry

Author(s): Simran Kaur, Junaid Ul Hamid and Sunil Gupta*

DOI: 10.2174/1573411018666220810124544

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

Page: [130 - 146] Pages: 17

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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 generic drug products). The market demand of 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 fulfill the need of generic manufactures in cracking the branded medicinal and nutritional products. This review aims to present reverse engineering techniques that have been found beneficial in 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 with an analytical tool set that can make generic product development easier and provides several examples of excipients that have been identified to crack the drug composition.

Keywords: Reverse engineering, Deformulation, Analytical techniques, Generic Product development, Forensic evaluation.

Graphical Abstract

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