Clinical and regulatory requirement
To indicate bioequivalency of a product to that of existing oral drug, an abbreviated new drug application is required. In-vitro dissolution studies and therapeutic equivalence are considered. Comparative bioequivalence between an orally disintegrating
tablet and an ODF can be evaluated. If the ODF exhibits a different target pharmacokinetic profile compared with the existing
marketed product, the ODF is considered a new dosage form. For a new dosage form, a new clinical study is required. A new
clinical study offers the advantage of three years of marketing exclusivity to the product. Preclinical toxicity studies are
not required if the molecule is the same as that of the approved product. Safety, tolerability, and efficacy features are
to be demonstrated in such trials. Oral mucosa-irritation testing is carried out in both animal models and humans. The hamster-cheek
pouch is the most appropriate model for predicting irritation criteria before testing in humans (12).
ODFs are a possible alternative dosage form to orally disintegrating tablets. These films offer the benefits of pleasant mouthfeel
and rapid disintegration in the mouth. Solvent casting, hot-melt extrusion, semisolid casting, solid-dispersion extrusion,
and rolling are important manufacturing methods to produce these films.
Renuka Mishra* is an assistant professor, and Avani Amin is a professor in the Department of Pharmaceutics and Pharmaceutical Technology, the Institute of Pharmacy, Nirma University,
Ahmedabad, Gujarat, India, Sarkhej-Gandhinagar Highway, Ahmedabad, Gujarat, India, email@example.com
*To whom all correspondence should be addressed.
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