Formulation and Evaluation of Patient Centric Paper Dosage Form of Donepezil Hydrochloride

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Arun Radhakrishnan
Gowthamarajan Kuppusamy
Soni Abishek

Abstract

The aim of this study was to develop a dose flexible paper dosage containing donepezil hydrochloride, with fast disintegration time and suitable mechanical strength, for the treatment of Alzheimer’s disease. Hydroxypropylmethylcellulose and pectin served as the hydrophilic polymeric bases of the ODF. The uniformity, in vitro disintegration time, drug release and the folding endurance of the ODF were examined. The in vitro results showed that 90% of donepezil hydrochloride was released within 20 minutes with mean disintegration time of 32 seconds. The result of the film flexibility test showed that the number of folding time to crack the film was average 200 times, an indication of sufficient mechanical property for patient use. All the required evaluations were recorded. ODF containing 30 mg of sucralose were more superior to saccharin and aspartame in terms of taste, aftertaste, mouthfeel, and acceptance. Furthermore, the film forming capacity of the polymers was evaluated and resulted better than single polymers. The drug and polymers showed no major interactions which were displayed by the DSC studies. As per the required results for paper dosage form, all parameters were showing satisfactory results. Formulation F3 was selected as the ideal formulation for the development of paper dosage form. F3 showed a disintegration time less than 35 sec, which shows that the drug will start releasing in less than a minute and more than 60% drug was released in 5 mins which were required for the quick onset of action.

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Research Article