Preparation and evaluation of orally disintegrating film containing donepezil for Alzheimer disease

The present study intended to prepare orally disintegrating film (ODF) containing donepezil (DP) for the treatment of mild to moderate alzheimer disease.

HPMC and HPC, glycerine were used as film forming agents, plasticizer, respectively. The ODFs were prepared by solvent casting method. The method was optimized with full factorial design considering the amount of film forming agents, the proportion of HPMC: HPC, amount of plasticizer as independent variables and tensile strength, elongation, folding endurance and disintegration time as dependent variables. Furthermore the study of mechanical, drug release and bioavailability of the optimized DP-loading ODF formulation were performed.

The results indicated the prepared film hold uniform, smooth film surface, non-sticky and disintegrated within 30 s, and over 85% of the drug dissolved in the first 5 min. And there was no significant difference between the optimized ODF formulation and the marketed one in cmax, tmax and AUC0-t.Current study suggested the optimized ODF formulation will be an effective alternative for commercially available dosage forms for the treatment of Alzheimer’s diseases. More on Donepezil ODF