Journal of Clinical Trials
Open Access

Orodispersible films of a polymorphic poorly soluble drug: Effect of casting solvent, film forming agent and solubilizer

Joint Event on Global Pharmacovigilance and Advanced Pharmacy

July 16-17, 2018 Sydney, Australia

Ibrahim Al Sharabi and Ahmed Abd El-Bary

Cairo University, Egypt

Posters & Accepted Abstracts: J Clin Trials

Abstract :

In the current work, a full factorial experimental design was utilized to formulate piroxicam into orodispersible films while investigating the effects of some formulation factors on the properties of the resulting films. These factors were: (1) The casting solvent: Water and acetone/water mixture, (2) the film forming agent: HPMC K4M and Na-alginate and (3) the solubilization system: No solubilizer, L-arginine, poloxamer and L-arginine/poloxamer mixture. 16 formulation runs were prepared by solvent casting method to obtain 10 mg piroxicam dosage units. Drug particle size in the prepared formulations and dissolution efficiency at 30 minutes were selected as responses variables. Additionally, the prepared films from each formulation were evaluated for other characters as drug content, thickness, residual water, etc. A selected formulation was then evaluated for its in vivo disintegration, palatability and stability. Utilizing acetone in the casting solution, Na-alginate as film forming agent or both of them resulted in formation films with larger drug particles and slower dissolution. Combined use of L-arginine and poloxamer showed better drug dissolution than using each alone. HPMC was more favorable than Na-alginate regarding mechanical properties and moisture absorption. Films from the selected formulation showed fast in vivo disintegration and acceptable palatability. These films were stable for six months under accelerated storage conditions.