Application of Quality by Design: Development to Manufacturing of Diclofenac Sodium Topical Gel
| Autor: | Preeti Raut, Aruna Khanolkar, Viraj Thorat, Gautam Samanta |
|---|---|
| Rok vydání: | 2016 |
| Předmět: |
Diclofenac
Central composite design Administration Topical Chemistry Pharmaceutical Monte Carlo method Pharmaceutical Science 02 engineering and technology Aquatic Science 030226 pharmacology & pharmacy Quality by Design 03 medical and health sciences Viscosity 0302 clinical medicine Drug Discovery Ecology Evolution Behavior and Systematics Mathematics Ecology Design of experiments General Medicine Diclofenac Sodium 021001 nanoscience & nanotechnology Process capability index 0210 nano-technology Biological system Critical quality attributes Agronomy and Crop Science Gels Monte Carlo Method |
| Zdroj: | AAPS PharmSciTech. 18(7) |
| ISSN: | 1530-9932 |
| Popis: | The objective of the present study was to develop and optimize generic topical gel formulation of diclofenac sodium through quality by design approaches. The quality target product profile was set for the critical quality attributes of the gel. The key material variables like hydrophilic gelling agent carbopol and penetration enhancer kolliphor were optimized using design of experiments. A central composite design was used considering viscosity and cumulative percent diffusion of the drug after 0.5, 1, 2, 4 and 6 h as responses. The p values for all models generated for different responses were statistically significant ( |
| Databáze: | OpenAIRE |
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