Approaches to pre-formulation R and D for phytopharmaceuticals emanating from herb based traditional Ayurvedic processes.

ABSTRACT

Botanicals constitute a large part of the drugs from the traditional medicine (TM) and ethno medicine (EM) known for their history of safe use (HOSU). Phytopharmaceuticals having a base of such origin offer high advantages as they come with safety profi les, and often allow extrapolation of the HOSU data, under certain circumstances. However, while current pharmaceutical technologies are being adopted by the industry to make phytopharmaceuticals with such origin, there is a need for preformulation research and development (R and D) during formulation. Some suggestions for R and D studies in case of aqueous extracts known in Ayurveda, converted on an industrial scale to obtain a phytopharmaceutical, and formulated as a solid dosage form (granules, tablets, or capsules) are discussed.