Abstract

Objective: The present study was aimed to develop the formulation and in vitro evaluation of Orodispersible tablets by wet granulation method using Donepezil HCl as a model drug to enhance patient compliance.
 Methods: In the wet granulation method, a mixture of microcrystalline cellulose and hydroxypropyl methylcellulose were used along with superdisintegrants, i.e., croscarmellose sodium and crospovidone. The prepared granules were subjected to both pre and post-compression evaluation parameters including; FTIR spectroscopy, micromeritics properties, tablet weight variation, hardness, friability, drug content, disintegration time and in vitro drug release.
 Results: FTIR studies indicated that there was nointeraction between the drug and the excipients used. The formulation containing high concentration of crospovidone and mixture as the best formulation F2 based on in vitro drug release characteristics of tablet formulation.
 Conclusion: The results of this work suggested that orodispersible tablets of Donepezil hydrochloride with rapid disintegration time, fast drug release and good hardness can be efficiently and successfully formulated by wet granulation method.

Highlights

  • Novel drug delivery system (NDDS) aims to improve safety and efficacy of drug molecule by formulating a convenient dosage form for administration and to achieve better patient compliance; one such approach is orodispersible tablets [1,2,3,4]

  • The main object of the present study is to develop an orodispersible tablet of donepezil

  • From the Fourier transform infrared spectroscopy (FT-IR) spectra, the interference was verified and found that donepezil hydrochloride did not interfere with the excipients used

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Summary

Introduction

Novel drug delivery system (NDDS) aims to improve safety and efficacy of drug molecule by formulating a convenient dosage form for administration and to achieve better patient compliance; one such approach is orodispersible tablets [1,2,3,4]. Donepezil hydrochloride is a new anti-alzheimer drug. Donepezil hydrochloride is apiperidine type reversible based inhibitor of the enzyme acetylcholinesterase (AChE) and has been approved for the symptomatic treatment of mild to moderate alzheimer’s disease [5,6]. Donepezil hydrochloride is available in white crystalline powder which is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrile and practically insoluble in ethyl acetate and n-hexane [7]. The main object of the present study is to develop an orodispersible tablet of donepezil

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