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Evaluation of emulgel formulations contain diclofenac sodium via quality by design approach

Year 2022, Volume: 26 Issue: 3, 460 - 468, 28.06.2025

Abstract

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.

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There are 21 citations in total.

Details

Primary Language English
Subjects Pharmaceutical Delivery Technologies
Journal Section Articles
Authors

Mehmet Kalayı 0000-0002-2288-309X

Gizem Yeğen

Neslihan Üstündağ 0000-0002-3210-3747

Buket Aksu

Publication Date June 28, 2025
Published in Issue Year 2022 Volume: 26 Issue: 3

Cite

APA Kalayı, M., Yeğen, G., Üstündağ, N., Aksu, B. (2025). Evaluation of emulgel formulations contain diclofenac sodium via quality by design approach. Journal of Research in Pharmacy, 26(3), 460-468.
AMA Kalayı M, Yeğen G, Üstündağ N, Aksu B. Evaluation of emulgel formulations contain diclofenac sodium via quality by design approach. J. Res. Pharm. June 2025;26(3):460-468.
Chicago Kalayı, Mehmet, Gizem Yeğen, Neslihan Üstündağ, and Buket Aksu. “Evaluation of Emulgel Formulations Contain Diclofenac Sodium via Quality by Design Approach”. Journal of Research in Pharmacy 26, no. 3 (June 2025): 460-68.
EndNote Kalayı M, Yeğen G, Üstündağ N, Aksu B (June 1, 2025) Evaluation of emulgel formulations contain diclofenac sodium via quality by design approach. Journal of Research in Pharmacy 26 3 460–468.
IEEE M. Kalayı, G. Yeğen, N. Üstündağ, and B. Aksu, “Evaluation of emulgel formulations contain diclofenac sodium via quality by design approach”, J. Res. Pharm., vol. 26, no. 3, pp. 460–468, 2025.
ISNAD Kalayı, Mehmet et al. “Evaluation of Emulgel Formulations Contain Diclofenac Sodium via Quality by Design Approach”. Journal of Research in Pharmacy 26/3 (June 2025), 460-468.
JAMA Kalayı M, Yeğen G, Üstündağ N, Aksu B. Evaluation of emulgel formulations contain diclofenac sodium via quality by design approach. J. Res. Pharm. 2025;26:460–468.
MLA Kalayı, Mehmet et al. “Evaluation of Emulgel Formulations Contain Diclofenac Sodium via Quality by Design Approach”. Journal of Research in Pharmacy, vol. 26, no. 3, 2025, pp. 460-8.
Vancouver Kalayı M, Yeğen G, Üstündağ N, Aksu B. Evaluation of emulgel formulations contain diclofenac sodium via quality by design approach. J. Res. Pharm. 2025;26(3):460-8.