Abstract

DEVELOPMENT, OPTIMIZATION AND EVALUATION OF ORAL STRIP OF AMLODIPINE BESYLATE

S. A. Polshettiwar*, P. V. Kesralikar, A. A. Battuwar and B. S. Kuchekar

ABSTRACT

Fast dissolving oral films (FDOFs) are the most advanced form of oral solid dosage form due to more flexibility and comfort. It improve the efficacy of APIs by dissolving within minute in oral cavity after the contact with less saliva as compared to fast dissolving tablets, without chewing and no need of water for administration. The films were prepared by solvent casting method using HPMC E3 LV as film former and PEG 400 as plasticizer The films were evaluated for drug content, thickness, tensile strength, % elongation and elastic modulus, in-vitro and in-vivo disintegration studies, in-vitro dissolution Studies and surface morphology. The films were also tested for complex formation using Differential scanning calorimetry. A 32 full factorial design was utilized to study the effect of 2 independent variables i.e. amount of HPMC E3 LV (X1) and amount of PEG 400 (X2) on responses in-vitro disintegration time and mechanical properties. Optimized batch F1 possessed in-vitro disintegration time 67.5 s, 17.7 N/mm2 tensile strength, 50.2% elongation and 274.2 N/mm2 elastic modulus. From in vitro release studies from all batches, F1 was found best, showing in vitro release of 93.9% in 30 minutes. The optimized formulation was compared with conventional tablet which shows 90.21% release of Amlodipine besylate in 60 mins. These results concludes that optimized formulation of oral fast dissolving film is superior over conventional tablet in achieving better release pattern.

Keywords: Fast dissolving oral films, Oral mucosa Permeability, Solvent casting and disintegration.