Formulation and Evaluation of Novel Deflazacort and Tamsulosin Loaded Mouth Dissolving Films

Abstract

Mouth dissolving films (MDFs) is a newly emerging drug delivery system that contains a polymer to retain the dosage form which adhere to mucosa, and disintegrate quickly and releases the medication. Since Deflazacort and Tamsulosin belongs to BCS II classification, MDFs formulation was developed with the intention of obtaining better therapeutic efficiency with increase in bioavailability that can be beneficial to treat kidney stones. In this study, three MDFs with the combination of Deflazacort and Tamsulosin was formulated by solvent casting method using three different concentrations of polymer (PVA), and evaluated for various parameters such as thickness, folding endurance, surface pH, drug content, weight variation, in vitro disintegration and in vitro dissolution studies. Physical incompatibilities between API and the excipients in the films were tested using FTIR. Formulated MDFs complied with films parameters and physical incompatibilities. Among the 3 formulations, optimized formulation F2 exhibited more than 97% drug release within 10 min and disintegrated within 55 secs. Mouth dissolving films of Deflazacort and Tamsulosin were found to be suitable for eliciting better therapeutic effect for treating renal calculi.