FORMULATION AND EVALUATION OF ORAL FILMS OF ATOMOXETINE HYDROCHLORIDE

Abstract

The objective of the present study was to develop fast releasing oral films of atomoxetine hydrochloride. Good mechanical properties, instant disintegration and an acceptable taste in the oral cavity are the desirable characters that was to be attained. Different groups of films with drug were prepared using different amalgamations of polymers such as HPMC LV grades, sodium alginate, guar gum, PVA and superdisintegrants like SSG, CCS, CP and KYRON 314. The formulations from preliminary trials were optimized using Taguchi OA experimental design. Evaluation test such as weight variation, content uniformity, drug content, folding endurance, thickness, in-vitro dissolution and in-vitro disintegration were done. The optimized films F1 (HPMC LV 50), F4 (HPMC LV 15+ Sodium alginate) and F7 (HPMC LV 15) has disintegration time of less than 30s, releasing 95-100% within 5 min. With a variation in the type of the polymer and concentration of the polymer percentage release and disintegration time varied. Stability studies were conducted for optimized formulations and found to be stable for 1 month.