Formulation And Invitro Evaluation Of Orodispersible Films Of Donepezil Hydrochloride And Determination Of Percentage Purity By Orthogonal Polynomials

The current project aims to increase the bioavailab ility of Donepezil Hydrochloride (an anti Alzheimer drug which is extensively metabolized by hepatic first pass). Although the drug is known to be majorly eliminated by the renal route in humans, the drug also is known to un dergo hepatic first pass considerably.The drug has been successfully formulated into a novel drug delivery system “Mouth Dissolving Films”. Almost all of the drug is dissoluted out in the mouth and is absorbed by the mucosal membrane itself. The films have been formulated by the incorporation of superdisintegrants Sodium Star ch Glycollate and Doshion P-544 for the instant rel ease of the drug.The films have been formulated also by incorpo rating suitable plasticizers and flavourants for th e patient compliance. The rate of drug release from the formu lations has been compared with that of a convention al dosage form ARICEP. (A market tablet of 5 mg from Eisai Pharma) and was found to be almost superior with that of the tablet. Also owing to the change in the site of abs orption an increase in the bioavailability of the d rug is anticipated. The amount of drug release has been es timated by conducting comparative dissolution studi es. The two dosage forms of the drug, the tablet and the fi lm were subjected to the dissolution test and the r ate and amount of drug release was calculated and found to be comp arable. The assay of the drug has also been counter checked and calculated by the implementation of a mathemati cal tool “The Orthogonial Polynomials” establishing its significance of applicability in drug content calcu lation.