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- Title
Formulation of Fast-Dissolving Tablets of Promethazine Theoclate.
- Authors
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.
- Subjects
DRUG tablets; PROMETHAZINE; NAUSEA treatment; VOMITING treatment; DOSAGE forms of drugs; CYCLODEXTRINS; CAMPHOR; MULTIPLE regression analysis; MATHEMATICAL models
- Publication
Tropical Journal of Pharmaceutical Research, 2010, Vol 9, Issue 5, p489
- ISSN
1596-5996
- Publication type
Article
- DOI
10.4314/tjpr.v9i5.61063