Journal
PHARMACEUTICAL DEVELOPMENT AND TECHNOLOGY
Volume 24, Issue 6, Pages 711-719Publisher
TAYLOR & FRANCIS LTD
DOI: 10.1080/10837450.2019.1579228
Keywords
Orally disintegrating tablets; taste-masking; dextromethorphan HBr; sodium stearyl fumarate; quality by design
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Funding
- Deanship of Scientific Research at King Saud University [RG-1435-80]
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Orally dissolving tablets (ODTs) represent one of the recent advances in drug delivery. The foremost objective of this study was to optimize the utilization of lubricant sodium stearyl fumarate in the preparation of dextromethorphan hydrobromide ODTs with enhanced taste-masking properties. The simple blending of sodium stearyl fumarate with the powder bed would result in taste-masking through physical adsorption of the lubricant particles on the drug particles. A randomized 3(2) full factorial experimental design was used to characterize the relationship between lubricant ratio (X1), mixing time (X2), and the tablet properties. The tablets were assessed for friability, hardness, disintegration time, and in-vitro dissolution. All tablets showed hardness within the range of 3.0-3.7kp, and the % loss in friability test was less than 1.1%. The in-vitro disintegration time ranged between 9 and 25s. An in-vitro drug release study of the prepared ODTs showed that more than 90% of the drug was released within 30min. A palatability test of the optimized formula conducted in human volunteers showed acceptable taste and mouthfeel with in-vivo disintegration time of 17s. Thus, results obtained convincingly showed successful fast disintegration of the prepared tablets and acceptable palatability when using sodium stearyl fumarate as a taste masking agent.
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