Tropical Journal of Pharmaceutical Research
Pharmacotherapy Group, Faculty of Pharmacy, University of Benin, Benin City, Nigeria
Vol. 9, No. 5, 2010, pp. 489-497
Bioline Code: pr10059
Full paper language: English
Document type: Research Article
Document available free of charge
Tropical Journal of Pharmaceutical Research, Vol. 9, No. 5, 2010, pp. 489-497
© Copyright 2010 Tropical Journal of Pharmaceutical Research.
Formulation of Fast-Dissolving Tablets of Promethazine Theoclate|
Sharma, Shailesh; Sharma, Neelam & Gupta, Ghanshyam Das
Purpose: To optimize and formulate promethazine theoclate fast-dissolving tablets that offer a suitable
approach to the treatment of nausea and vomiting.
Method: The solubility of promethazine theoclate was increased by formulating it as a fast-dissolving
tablet containing β-cyclodextrin, crospovidone, and camphor, using direct compression method. A 33 full
factorial design was used to investigate the combined influence of three independent variables -
amounts of camphor, crospovidone and β-cyclodextrin - on disintegration time, friability and drug
release after 5 min.
Result: The optimization study, involving multiple regression analysis, revealed that optimum amounts
of camphor, crospovidone and β-cyclodextrin gave a rapidly disintegrating/dissolving tablet. A
checkpoint batch was also prepared to verify the validity of the evolved mathematical model. The
optimized tablet should be prepared with an optimum amount of β-cyclodextrin (3.0 mg), camphor (3.29
mg) and crospovidone (2.61 mg) which disintegrated in 30 s, with a friability of 0.60 % and drug release
of 89 % in 5 min.
Conclusion: The optimized approach aided both the formulation of fast-dissolving theoclate tablets and
the understanding of the effect of formulation processing variables on the development of the
Fast-dissolving tablet, 33 Factorial design, Promethazine theoclate, Optmization studies.
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