ABSTRACT

The objective of the present study was to develop solid dispersion of Tadalafil with HPMC E3 and formulate an oral dissolving film for the treatment of hypertension and erectile dysfunction with enhanced disintegration, morphological properties, and optimal mechanical strength. Hydroxy propyl methyl cellulose E50 was used as a hydrophilic film-forming polymer and propylene glycol as a plasticizer. The solvent casting technique was used for preparing the films. Parameters such as In- vitro disintegrating time, tensile strength, content uniformity, folding strength, swelling index, and in vitro drug release were evaluated. 32 factorial designs were used to optimize the amount of polymer and plasticizer. In vitro dissolution studies showed that 99% of Tadalafil was released within 10 minutes with a mean disintegration time of 20 seconds in the F9 formulation. Polynomial regression analyses were done to study the effect of plasticizer and polymer on disintegrating time, folding strength, and in vitro drug release. FTIR spectroscopy was used to determine drug-excipient interactions. SEM study showed a smooth surface of the optimized formulation. Keywords: Tadalafil, solid dispersion, hypertension, oral dissolving films, solvent casting technique
Publication date: 01/05/2023

https://ijbpas.com/pdf/2023/May/MS_IJBPAS_2023_7141.pdf

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https://doi.org/10.31032/IJBPAS/2023/12.5.7141