Tropical Journal of Pharmaceutical Research

Original Research Article | OPEN ACCESS

Formulation of Fast-Dissolving Tablets of Promethazine Theoclate

Shailesh Sharma , Neelam Sharma, Ghanshyam Das Gupta

Dosage Form Design Laboratory, Pharmaceutics Research Division, Department of Pharmaceutics, ASBASJSM College of Pharmacy, BELA (Ropar) Punjab 140111, India;

For correspondence:- Shailesh Sharma Email: shailesh.bela@gmail.com Tel:+919888775589

Received: 24 February 2010 Accepted: 30 August 2010 Published: 17 October 2010

Citation: Sharma S, Sharma N, Gupta GD. Formulation of Fast-Dissolving Tablets of Promethazine Theoclate. Trop J Pharm Res 2010; 9(5):489-497 doi: 10.4314/tjpr.v9i5.10

© 2010 The authors.
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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