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Tropical Journal of Pharmaceutical Research
Pharmacotherapy Group, Faculty of Pharmacy, University of Benin, Benin City, Nigeria
ISSN: 1596-5996
EISSN: 1596-9827
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

 en Formulation of Fast-Dissolving Tablets of Promethazine Theoclate
Sharma, Shailesh; Sharma, Neelam & Gupta, Ghanshyam Das

Abstract

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 formulation.

Keywords
Fast-dissolving tablet, 33 Factorial design, Promethazine theoclate, Optmization studies.

 
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