Volume 7

July-September 2015

Development and characterization of oral dissolving films of tadalafil based on pregelatinized hydroxypropyl pea starch

Hitendra S Mahajan, Vinayak B Kokate

Abstract: 
The aim of the present work was to develop and characterize oral dissolving film of pregelatinized hydroxypropyl pea starch (Lycot RS720®) polymers for oral delivery of tadalafil. ODFs films were prepared by solvent casting technique. Formulations were prepared based on Box-Behnken statistical design with concentrations of Lycot RS720® and glycerin (plasticizer) as independent variables. Two dependent variables considered were tensile strength and drug release. Results revealed that film containing 25% (w/v) of Lycot RS720® and 3% (w/v) glycerin demonstrated more than 90% drug release within 5min. SEM images demonstrated smooth and uniform surface of film suitable for oral mucosa. Thus, this study suggests that pregelatinized hydroxypropyl pea starch can act as a rapid dissolving film forming polymer for oral delivery of a tadalafil.

Keywords: Pregelatinized Hydroxypropyl Pea Starch, Oral Dissolving Films, Polymer, Tadalafil.