Development and optimization of fast-dissolving tablets of Promethazine Theoclate using vacuum drying technology by 3-factor, 3-level response surface full factorial design 

By Shailesh Sharma and Ghanshyam Das Gupta 


The purpose of the research work was to optimize and formulate promethazine theoclate fast dissolving tablets that offer a suitable approach for the treatment and management of nausea and vomiting. The solubility of promethazine theoclate was increased by preparing its fast dissolving tablets containing ß-cyclodextrin, crospovidone, and thymol using direct compression method. A 3-3 full factorial design was used to investigate the combined influence of three independent variables - amount of thymol, crospovidone and ß-cyclodextrin on disintegration time, percentage friability and percent drug release after 5 min. The optimization study, involving multiple regression analysis, reveals that optimum amounts of thymol, crospovidone and ß-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 ß-cyclodextrin (19.20 mg), thymol (12.26 mg) and crospovidone (2.44 mg) which disintegrated in the 30 seconds, with a friability of 0.60 % and 81 % of drug release in 5 min. 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 formulation.  

Keywords: Fast dissolving tablet; Factorial design; Promethazine theoclate; Optimization studies.  

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