The impact of manufacturing variables on in vitro release of clobetasol 17-propionate from pilot scale cream formulations. (December 2014)

• Record Type: Journal Article
• Authors: Fauzee, Ayeshah Fateemah Beebee; Khamanga, Sandile Maswazi; Walker, Roderick Bryan
• Is Part Of: Drug development and industrial pharmacy. Volume 40:Number 12(2014:Dec.)
• Page Start: 1683
• Page End: 1692
• Publication Date: 2014-12
• Subjects: Pharmaceutical chemistry -- Periodicals; Pharmaceutical industry -- Periodicals; Drug Industry -- Periodicals; Technology, Pharmaceutical -- Periodicals; 615.05
• DOI: 10.3109/03639045.2013.842579
• Languages: English
• ISSNs: 0363-9045

Abstract

<abstract> <title>Abstract</title> <p> <italic>Objectives</italic>: The purpose of the study was to evaluate the effect of different homogenization speeds and times, anchor speeds and cooling times on the viscosity and cumulative % clobetasol 17-propionate released per unit area at 72 h from pilot scale cream formulations. A 2<sup>4</sup> full factorial central composite design for four independent variables were investigated.</p> <p> <italic>Materials and methods</italic>: Thirty pilot scale batches of cream formulations were manufactured using a Wintech® cream/ointment plant. The viscosity and <italic>in vitro</italic> release of CP were monitored and compared to an innovator product that is commercially available on the South African market, namely, Dermovate® cream.</p> <p> <italic>Results and discussion</italic>: Contour and three-dimensional response surface plots were produced and the viscosity and cumulative % CP released per unit area at 72 h were found to be primarily dependent on the homogenization and anchor speeds. An increase in the homogenization and anchor speeds appeared to exhibit a synergistic effect on the resultant viscosity of the cream whereas an antagonistic effect was observed for the <italic>in vitro</italic> release of CP from the experimental cream formulations. The <italic>in vitro</italic> release profiles were best fitted to a Higuchi model and diffusion proved to be the dominant mechanism of drug release that was confirmed by use of the Korsmeyer–Peppas model.</p> <p> <italic>Conclusion</italic>: The research was further validated and confirmed by the high prognostic ability of response surface methodology (RSM) with a resultant mean percentage error of (±SD) 0.17 ± 0.093 suggesting that RSM may be an efficient tool for the development and optimization of topical formulations.</p> </abstract>