Formulation,Licensing,Chemical Characterization, and Validation of Ayurvedic Medicine

This chapter, besides sharing the story behind the formulation and development of Ayurvedic medications acceptable in modern medicine, provides a detailed standard operating procedure for developing Ayurvedic drugs. To fight the COVID-19 infection, caused by the SARS-CoV-2 coronavirus, Patanjali Research Institute (PRI), Haridwar, developed the Divya Swasari Coronil kit. It contains Coronil Tablet, Divya Swasari Vati, and Divya Anu Taila. Divya Pharmacy, Haridwar, India, has obtained a manufacturing license from the Ayurvedic & Unani Department of Uttarakhand, Dehradun (License No.: 13-71-72/D-431/2020-2021) for Coronil and Swasari Vati tablets. Divya Coronil tablet has been formulated from a blend of Giloy, Ashwagandha, and Tulsi, whereas Divya Swasari Vati and Divya Anu Taila were prepared according to the classical recipe mentioned in traditional Ayurvedic texts. Analytical methods have been developed to identify and quantify the active phytoconstituents present in these blends and tablets. Sophisticated techniques are used in the manufacturing of these tablets, like liquid chromatography, equipped with single quadrupole, colloisan cell and time of light (UPLC/QToF MS), high-performance liquid chromatography (HPLC) equipped with PDA detector and high-performance thin layer chromatography (HPTLC) with automatic spotting, in which developing and scanning chambers are used for the identification and quantification of herbs. The methods have been validated in-house using ICH-Q2 (R1) and pharmacopoeia guidelines to demonstrate the repeatability, reproducibility, and reliability of the data generated. There are stringent quality checks for the authentication of raw material used in the manufacturing of the tablet, along with in-process checks and the final release of the batch. The herbs used during the manufacturing of these products have been authenticated, and voucher specimens have been stored in a government-approved depositary. The synergistic effect of these tablets has been studied by Patanjali Research Institute (PRI) for their immunity-boosting properties and the restoration of health of SARS-CoV-2 infected patients.

Keywords: CoP, HPTLC, Manufacturing license, Pharmacopoeia guidelines, Raw material selection and sampling, UPLC/QToF MS.