Article: ROLE OF PHARMACOVIGILANCE IN ENSURING SAFETY AND EFFICACY OF AYURVEDIC NOVEL DOSAGE FORMS: A REVIEW

Article Category: Review articles

DOI: 10.7897/2277-4343.17126

Pages: 153-157

Author: Shubhashree MN, Arsha KS *, Sulochana Bhat

Abstract: The unprecedented global expansion of Ayurveda has led to medicines produced as international commodities, yet they are valued for their perceived 'traditional virtues. Ayurvedic dosage forms were designed by ancient scholars of Ayurveda focusing on disease condition, strength of the patient, tolerance, digestive capacity, bowel habits, diet patterns, pathology of the disease and so on. However, in the modern era, the focus is on effective and palatable drug dosage form to enhance the solubility, bioavailability, pharmacological activity, stability, and increase the compliance. Hence, unique challenges are posed by novel dosage forms in pharmacovigilance. This study aims to (1) understand the safety and efficacy of novel dosage forms in comparison with traditional Ayurvedic formulations, dosage and to be aware of side effects if any from new dosage forms (2) to expand the horizons of pharmacovigilance to accommodate future innovations and the role of regulatory agencies in ensuring safety and efficacy. An in-depth review was conducted on various Novel oral dosage forms which includes granules (effervescent and rapid release granules), tablets (fast dissolving, Oral disintegrating, multilayered tablet), gummies, capsule in capsule, chews, latte and topical dosage form like toothpaste, hair dye, sprays, emulsions, patches etc. for any possible side effects. The review discusses how the bioavailability of novel dosage forms like orally disintegrating tablets, may differ from conventional oral formulations and explores how Ayurvedic medicine is adapting to these innovations, emphasizing the critical role of pharmacovigilance in ensuring their continued safety and therapeutic efficacy.

Keyword: Pharmacovigilance, novel drug dosage forms, Ayurveda, bioavailability