PREPARATION AND EVALUATION OF MOUTH DISSOLVING FILMS FOR THE DELIVERY OF ALMOTRIPTAN

Abstract

The aim of the present investigation is to prepare and evaluate mouth dissolving films (MDFs) of Almotriptan (ALMO) and to find out the effect of various formulation variables like film thickness, plasticizers, polymer viscosities and solubilizing agents on physico-mechanical and drug release properties of ALMO. Hydroxyl propyl methyl cellulose (HPMC E3, E5, E15) of different viscosity grades were used as film forming agents, poly ethylene glycol (PEG-400) and glycerol as plasticizers. The developed MDFs were characterized for film thickness, disintegration time, FTIR, DSC, XRD and drug release behavior. The films were homogenous, elegant, transparent and smooth in texture. Photomicrographs, along with DSC and XRD studies confirm no recrystallization of ALMO with in MDFs. In-vitro dug release studies indicate that HPMC E15 films attributed to their higher viscosity showed slower ALMO release compared to other formulations. Addition of solubilizing agents (PVP K30 and SLS) to HPMC E3 formulations brought a significant increase in ALMO release rates compared to formulations without them. The formulation F5 showed quicker disintegration (within 8.66sec) and ALMO release rates (complete release was obtained in 80sec) along with good physico-mechanical properties. Accelerated stability studies revealed no significant change in appearance and ALMO content in MDFs indicating that ALMO was stable in MDFs.