Abstract

EFFECT OF HYDROPHILIC AND HYDROPHOBIC POLYMER COMBINATIONS IN DONEPEZIL HCL SUSTAINED RELEASE TABLETS

Vithu V. C.*, Natarajan R. and Murugananthan G.

ABSTRACT

The objective of the present study was to develop Donepezil Hcl sustained-release tablets, in order to overcome the problem of dose dumping and increase the compliance of patients. An attempt has been made to extend the release up to 14 hour using hydrophilic and hydrophobic polymer combinations such as HPMC and EC at different ratios were used. The FTIR study indicated no interaction between the drug and polymers. The wet granulation technique was employed for the preparation of tablets. The prepared tablets were characterized for pre and post compression parameters. The in-vitro drug release kinetic data confirmed that all the formulations best fit in to Higuchi model, which shows a R2 value of 0.914 to 0.968. And the in-vitro drug release kinetic data were fitted to the korsemeyer peppa‟s equation to analyze the release pattern of the drug from the polymeric system and the slope („n‟) value was found to be > 1, indicating that the drug release follows case II transport mechanism. The drug release of the best formulation (F6) having 40% of HPMC and 10% of EC compared with that of the innovator product and it was found to be similar(f2).

Keywords: Donepezil HCL, Alzheimer's disease, Combination polymer, Higuchi Model, Similarity factor.