Published Paper Details:

The present study deals with the formulation and evaluation of rapid release oral film of Donepezil Hydrochloride which is a specific non-competitive reversible inhibitor of acetyl cholinesterase (AChE) used in the treatment of Alzhiemer's disease. The objective of preparing Donepezil HCl rapid release film was to dissolve or disintegrate the film in few seconds and release the drug in oral cavity for rapid therapeutic effect due to a well supplied vascular and lymphatic drainage. Donepezil HCl films were prepared by solvent casting technique using film forming polymer HPMC E-15, different types of disintegrants such as maize starch, pregelatinized starch and superdisintegrants such as sodium starch glycolate, croscarmellose sodium and crospovidone. Triacetin was incorporated as plasticizer to improve the flexibility of films, glycerin as emollient, mannitol as diluent to provide good mouth feel and aspartame as sweetener. The prepared films were evaluated for weight variation, thickness, surface pH, folding endurance, drug content, disintegration time and in vitro dissolution studies by Pharmaceutical standard methods. Formulation F5 is considered as the best formulation as it showed good tensile strength (39.52 N/cm2), percentage elongation (11.83%), maximum drug content (99.75%), rapid disintegration time (20 seconds) and maximum drug release (99.86%) at the end of 10 minutes. The study concludes that rapid release oral films of Donepezil Hydrochloride can be considered suitable for clinical use in the treatment of Alzhiemer's disease, where a quicker onset of action along with the convenience of administration with higher therapeutic efficacy and bioavailability was desirable.