Formulation and Characterization of Fast Dissolving Tablet Containing Promethazine Theoclate Solid Dispersion with PEG 4000

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Submitted by SHAILESH SHARMA on Mon, 09/01/2008 - 13:18.

Publication Type:

Journal Article

Authors:

Shailesh Sharma; G. D. Gupta

Source:

Pharma Review, Kongposh Publication (2008)

URL:

http://kppub.com/articles/august2008/formulation_and_characterization.html

Keywords:

FDT; Promethazine; Solid Dispersion

Abstract:

This article investigates enhancement of the dissolution profile of promethazine Theoclate using solid dispersion with PEG 4000. The article also describes the preparation of fast-dissolving tablets of promethazine Theoclate by using a optimized amount of superdisintegrants. A phase solubility method was used to evaluate the effect of various water-soluble polymers on aqueous solubility of promethazine Theoclate. Polyvinyl pyrrolidone (PEG 4000) was selected and solid dispersions were prepared by the method of fusing. Dissolution studies using the USP paddle method were performed for solid dispersions of promethazine Theoclate. Infrared (IR) spectroscopy, differential scanning calorimetry (DSC), and x-ray diffractometry (XRD) were performed to identify the physicochemical interaction between drug and carrier, hence its effect on dissolution. Tablets were formulated containing solid dispersion products and compared with commercial products. IR spectroscopy, XRD, and DSC showed no change in the crystal structure of promethazine Theoclate. Dissolution of promethazine Theoclate improved significantly in solid dispersion products (< 85% in 5 minutes). Tablets containing solid dispersion exhibited better dissolution profile than commercial tablets. Thus, the solid dispersion technique can be successfully used for improvement of dissolution of promethazine Theoclate.