Editor-in-Chief Hatice Kübra Elçioğlu Vice Editors Levent Kabasakal Esra Tatar Online ISSN 2630-6344 Publisher Marmara University Frequency Bimonthly (Six issues / year) Abbreviation J.Res.Pharm. Former Name Marmara Pharmaceutical Journal
Journal of Research in Pharmacy 2022 , Vol 26 , Issue 3
Evaluation of emulgel formulations contain diclofenac sodium via quality by design approach
Mohammed KALAYI1,Gizem YEĞEN1,Neslihan ÜSTÜNDAĞ OKUR2,Buket AKSU1
1Department of Pharmaceutical Technology, Faculty of Pharmacy, Altınbaş University, Bakırköy 34147 İstanbul, Turkey
2Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Health Sciences, Üsküdar 34668 İstanbul, Turkey
DOI : 10.29228/jrp.143 Emulgel is considered as emulsions, either oil-in-water or water-in-oil type, that is formed via blending with a gelling agent. Their common usage as pharmaceutical dosage form results from the broad utilization of emulsion systems, particularly for dermatological formulations. Quality by Design (QbD) is a scientific, holistic, risk-based, systematic, and proactive approach that starts with predefined objectives and assertiveness on product quality, procedure understanding, and process control. In this study, the QbD approach was implemented in the production of emulgel containing diclofenac sodium and the goal was to build quality into the product from the inception of formulation development. The hydrogel phase and oil phase of emulgel were prepared separately, then mixed. Emulgels were evaluated for their macroscopic, and microscopic examination, pH, electrical conductivity measurements, and viscosity. The optimum formulation was found by using the ANN Modelling program. According to macroscopic evaluation the optimum emulgel was an opaque white color, and homogeneous with no phase separation or grittiness. The viscosity of the optimum formula is 4600, pH value is 6.7, electrical conductivity is 120 μS-1, and particle diameter was also 0,989 μm. Results showed the optimized formula has the required properties. ANN modeling technique has been used to develop a pharmaceutical formulation via determining multivariate relations between independent parameters and quality properties affected by these parameters. Although artificial intelligence programs are not enough to build and develop formulations by itself, they play a significant role in formulation development. Keywords : Emulgel; quality by design; artificial neural network; diclofenac sodium; carbopol 940; optimization
Marmara University