AAPS PharmSciTech

, Volume 13, Issue 1, pp 134–142 | Cite as

Characterization of Oral Disintegrating Film Containing Donepezil for Alzheimer Disease

  • Kai Bin Liew
  • Yvonne Tze Fung Tan
  • Kok Khiang Peh
Research Article Theme: Advanced Technologies for Oral Controlled Release

Abstract

The aim of this study was to develop a taste-masked oral disintegrating film (ODF) containing donepezil, with fast disintegration time and suitable mechanical strength, for the treatment of Alzheimer’s disease. Hydroxypropyl methylcellulose, corn starch, polyethylene glycol, lactose monohydrate and crosspovidone 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 80% of donepezil hydrochloride was released within 5 minutes with mean disintegration time of 44 seconds. The result of the film flexibility test showed that the number of folding time to crack the film was 40 times, an indication of sufficient mechanical property for patient use. A single-dose, fasting, four-period, eight-treatment, double-blind study involving 16 healthy adult volunteers was performed to evaluate the in situ disintegration time and palatability of ODF. Five parameters, namely taste, aftertaste, mouthfeel, ease of handling and acceptance were evaluated. The mean in situ disintegration time of ODF was 49 seconds. ODF containing 7 mg of sucralose were more superior than saccharin and aspartame in terms of taste, aftertaste, mouthfeel and acceptance. Furthermore, the ODF was stable for at least 6 months when stored at 40°C and 75% relative humidity.

KEY WORDS

Alzheimer disease donepezil HCl oral disintegrating film palatability 

Notes

ACKNOWLEDGEMENT

This author would like to thank Institute of Postgraduate Studies, Universiti Sains Malaysia for providing Fellowship.

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Copyright information

© American Association of Pharmaceutical Scientists 2011

Authors and Affiliations

  • Kai Bin Liew
    • 1
  • Yvonne Tze Fung Tan
    • 1
  • Kok Khiang Peh
    • 1
  1. 1.Department of Pharmaceutical Technology, School of Pharmaceutical SciencesUniversiti Sains MalaysiaMindenMalaysia

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