Dextromethorphan hydrobromide orally disintegrating tablets: Development and optimization using different formulation variables

Haitham Fady Mostafa, Mohamed Abbas Ibrahim, Adel Sakr

Research output: Contribution to journalJournal articlepeer-review

1 Scopus citations

Abstract

The objective of this work is to develop a simple inexpensive method for manufacturing dextromethorphan hydrobromide oral disintegrating tablets (ODTs) and to study the effect of some formulation variables. Two factors, three levels (32) full factorial design was used to optimize the diluent, dextrates, NF (X1) and superdisintegrant, croscarmellose sodium (X2) concentrations. Disintegration time (Y1), hardness (Y2) and time required for™ 50% release of the drug, T50 (Y3) values for all the formulations varied from 17.33 to 279.5 s, 3.58 to 4.97 kp and 1.2 to 5 min, respectively. The results indicated that the selected variables have a strong influence on the selected responses "disintegration time, hardness and T50" of the ODTs. The manufactured ODTs formula composed of 30.6% dextrates in combination with 4.2% croscarmellose sodium was chosen as optimized formula using multiple response optimization. The predicted and observed values for the optimized formula showed no significant difference which indicates the validity of the experimental design. The optimized formula showed a very significant lower disintegration time and T50 when compared to marketed conventional tablets. Also, it was compared to pharmburst™ based formula and it showed a significant higher disintegration time and lower hardness.

Original languageEnglish
Pages (from-to)1300-1310
Number of pages11
JournalPharmazeutische Industrie
Volume76
Issue number8
StatePublished - 1 Aug 2014
Externally publishedYes

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