Application of a quality-by-design approach for utilizing sodium stearyl fumarate as a taste-masking agent in dextromethorphan hydrobromide orally disintegrating tablets

Abstract

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 3² 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 3.0–3.7 kp, and the % loss in friability test was less than 1.1%. The in-vitro disintegration time ranged between 9 and 25 s. An in-vitro drug release study of the prepared ODTs showed that more than 90% of the drug was released within 30 min. A palatability test of the optimized formula conducted in human volunteers showed acceptable taste and mouthfeel with in-vivo disintegration time of 17 s. 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.

Keywords:

• Orally disintegrating tablets
• taste-masking
• dextromethorphan HBr
• sodium stearyl fumarate
• quality by design

Disclosure statement

No potential conflict of interest was reported by the authors.

Additional information

Funding

The authors would like to extend their sincere appreciation to the Deanship of Scientific Research at King Saud University for funding this research group [no. RG-1435–80].