The impact of formulation variables on the optimization of pilot scale clobetasol 17-propionate creams
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/...
| Main Authors: | , |
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2020-01-01
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| Series: | Cogent Engineering |
| Subjects: | |
| Online Access: | http://dx.doi.org/10.1080/23311916.2020.1804713 |
| _version_ | 1797764915336839168 |
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| author | Ayeshah Fateemah Beebee Fauzee Roderick Bryan Walker |
| author_facet | Ayeshah Fateemah Beebee Fauzee Roderick Bryan Walker |
| author_sort | Ayeshah Fateemah Beebee Fauzee |
| collection | DOAJ |
| 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 < 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 asscoiated with product development activities, whilst identifying a composition design space and ensuring stable and effective dosage forms are produced. |
| first_indexed | 2024-03-12T20:03:35Z |
| format | Article |
| id | doaj.art-3479a2b20a9543d683dce1c72c1eab6e |
| institution | Directory Open Access Journal |
| issn | 2331-1916 |
| language | English |
| last_indexed | 2024-03-12T20:03:35Z |
| publishDate | 2020-01-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Cogent Engineering |
| spelling | doaj.art-3479a2b20a9543d683dce1c72c1eab6e2023-08-02T02:16:34ZengTaylor & Francis GroupCogent Engineering2331-19162020-01-017110.1080/23311916.2020.18047131804713The impact of formulation variables on the optimization of pilot scale clobetasol 17-propionate creamsAyeshah Fateemah Beebee Fauzee0Roderick Bryan Walker1Rhodes UniversityRhodes UniversityThe 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 < 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 asscoiated with product development activities, whilst identifying a composition design space and ensuring stable and effective dosage forms are produced.http://dx.doi.org/10.1080/23311916.2020.1804713glyceryl monostearatecetostearyl alcoholgelot® 64propylene glycolresponse surface methodologypilot scale topical formulationsproduct performanceclobetasol 17-propionatedesign of experiments |
| spellingShingle | Ayeshah Fateemah Beebee Fauzee Roderick Bryan Walker The impact of formulation variables on the optimization of pilot scale clobetasol 17-propionate creams Cogent Engineering glyceryl monostearate cetostearyl alcohol gelot® 64 propylene glycol response surface methodology pilot scale topical formulations product performance clobetasol 17-propionate design of experiments |
| title | The impact of formulation variables on the optimization of pilot scale clobetasol 17-propionate creams |
| title_full | The impact of formulation variables on the optimization of pilot scale clobetasol 17-propionate creams |
| title_fullStr | The impact of formulation variables on the optimization of pilot scale clobetasol 17-propionate creams |
| title_full_unstemmed | The impact of formulation variables on the optimization of pilot scale clobetasol 17-propionate creams |
| title_short | The impact of formulation variables on the optimization of pilot scale clobetasol 17-propionate creams |
| title_sort | impact of formulation variables on the optimization of pilot scale clobetasol 17 propionate creams |
| topic | glyceryl monostearate cetostearyl alcohol gelot® 64 propylene glycol response surface methodology pilot scale topical formulations product performance clobetasol 17-propionate design of experiments |
| url | http://dx.doi.org/10.1080/23311916.2020.1804713 |
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