Volume 8

July-September 2016

Design and development of fast dissolving sublingual film of an aminophylline

Mohd Nazish, K Mahalingan

Abstract:
The present study was planned to formulate fast dissolving sublingual film of Aminophylline by solvent casting method using a polymer HPMC E50 as film forming agent. The FT-IR study revealed no interaction between the drug and excipients. Sucrose was added to mask the bitter taste of the drug. FDS Films were prepared by using the drug polymer ratio 1:1 to 1:9. The prepared films were evaluated for physicochemical parameters such as weight variation, thickness, folding endurance, drug content, tensile strength, % elongation, % moisture absorption and in vitro dissolution test. Formulations (F2 & F3) showed better drug release (99.05% and 99.43%) within 210 sec. and also showed less disintegration time (33.33±0.57 and 37±0.57sec.). The appearance and surface smoothness of formulation (F2) was not good. Therefore, Formulation F3 was selected as the best formulation based on the physicochemical parameter and in vitro dissolution studies. Stability study was conducted for the best formulation (F3) as per ICH guidelines and showed no significant changes in physical appearance, weight uniformity, folding endurance, % drug content, % moisture absorption and in vitro drug release during study period. Therefore, it can be concluded that the prepared fast dissolving Aminophylline sublingual films might be a potential formulation for the treatment of patient having asthma.

Keywords: Aminophylline, Fast dissolving Sublingual Films, Solvent Casting Method, Film Forming Polymer HPMC E50, In Vitro Drug Release.