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Inventi Impact - Pharmaceutical Process Development

Articles

  • Inventi:ppd/19606/16
    OPTIMIZATION OF GALANTAMINE ORALLY DISSOLVING TABLETS: QUALITY BY DESIGN APPROACH AT LABORATORY SCALE
    Abd El-Bary A, El-Nabarawi M A, Ibrahim E E*

    Galantamine hydrobromide is a reversible acetylcholinesterase (AChE) inhibitor, currently approved as the first-line pharmacological agent for the symptomatic treatment of Alzheimer disease (AD). It offers several benefits in AD treatment, such as improving cognition, ability to perform instrumental and basic activities of daily living and reducing caregiver burden. It has been shown that patient compliance to AD treatments is low; therefore alternative routes for effective and well-tolerated treatment are of clinical needs. Therefore, in this study; galantamine orally dissolving tablets (ODTs) BCS class I was prepared with the intention of overcoming such problem, providing faster release and absorption of the drug for more convenience and compliance for AD patients. Galantamine ODT was prepared by direct compression process using sugar based filler namely: Emedex® which showed superior flowability to other tested fillers, directly compressible, completely soluble and imparts sweet taste masking bitterness of different API, instead of traditionally used microcrystalline cellulose. Response surface methodology was then used to optimize critical factors and establish the design space based on the evaluation of the effect, interaction and quadratic term of the four design factors (disintegrant level (X1), lubricant level (X2), lubricant blending time (X3) and compression force (X4)) on the responses (disintegration time (Y1), hardness (Y2), friability (Y3) and dissolution rate (Y4)). A desirability function was applied on the responses to obtain the optimum excipient and process conditions for preparation of galantamine ODT that would provide desired quality target product profile (QTPP).

    How to Cite this Article
    Abd El-Bary A, El-Nabarawi M A, Ibrahim E E. Optimization of Galantamine Orally Dissolving Tablets: Quality by Design Approach at Laboratory Scale. Inventi Impact: Pharmaceutical Process Development, 2016(4):186-197, 2016.
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