The impact of formulation variables on the optimization of pilot scale clobetasol 17-propionate creams
- Authors: Fauzee, Ayesha F B , Walker, Roderick B
- Date: 2020
- Subjects: To be catalogued
- Language: English
- Type: text , article
- Identifier: http://hdl.handle.net/10962/183275 , vital:43937 , xlink:href="https://doi.org/10.1080/23311916.2020.1804713"
- Description: The impact of formulation variables on the optimization of pilot scale clobetasol 17-propionate (CP) cream formulations was investigated using a Central Composite Design of Experiments. Thirty batches of cream were manufactured and the formulation variables assessed were % v/v propylene glycol, % w/w Gelot® 64, cetostearyl alcohol and glyceryl monostearate content. The responses monitored included viscosity, spreadability, pH, CP content, extrudability, electrical conductivity, and % CP released at 72 hours. The responses were compared to those of a reference product, Dermovate® cream. ANOVA analysis revealed that viscosity, spreadability, and % CP released at 72 hours were significant formulation responses (p more than 0.05). Cetostearyl alcohol had the greatest impact on quality of pilot scale products. An increase in cetostearyl alcohol resulted in an increase in viscosity, a decrease in spreadability, and a decrease in % CP released at 72 hours. The optimized pilot scale CP formulation contained 46% v/v propylene glycol, 8.6% w/w cetostearyl alcohol, 10.5% w/w glyceryl monostearate, and 3.8% w/w Gelot® 64. The resultant viscosity, spreadability, pH, CP content, extrudability, electrical conductivity, and % CP released were 44633cP, 24.91cm2, 101.23 %, 76.98 g/cm2, 198.23 µS/cm, and 50.23%. The addition of cetostearyl alcohol and Gelot® 64 is critical for establishing a soft formulation that leads to the formation of a mixed crystal bilayer network of high viscosity. The formation of a separate crystalline lipophilic network usually occurs in semi-solid formulations that contain high concentrations of emulsifier, leading to an increase in shear stress and greater physicochemical stability of the formulation. The use of experimental design approaches to formulation development activities, permit evaluation of multiple factors simultaneously, reducing the time and costs associated with product development activities, whilst identifying a composition design space and ensuring stable and effective dosage forms are produced.
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- Date Issued: 2020
The impact of manufacturing variables on in vitro release of clobetasol 17-propionate from pilot scale cream formulations
- Authors: Fauzee, Ayesha F B , Khamanga, Sandile M , Walker, Roderick B
- Date: 2014
- Subjects: To be catalogued
- Language: English
- Type: text , article
- Identifier: http://hdl.handle.net/10962/183872 , vital:44077 , xlink:href="https://doi.org/10.3109/03639045.2013.842579"
- Description: 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 24 full factorial central composite design for four independent variables were investigated. Thirty pilot scale batches of cream formulations were manufactured using a Wintech® cream/ointment plant. The viscosity and in vitro release of CP were monitored and compared to an innovator product that is commercially available on the South African market, namely, Dermovate® cream. 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 in vitro release of CP from the experimental cream formulations. The in vitro 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. 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.
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- Date Issued: 2014