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

Mehmet Kalayı; Gizem Yeğen; Neslihan Üstündağ; Buket Aksu

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

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.

Keywords

References

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Details

Primary Language

English

Subjects

Pharmaceutical Delivery Technologies

Journal Section

Research Article

Authors

Mehmet Kalayı ^*
0000-0002-2288-309X
Türkiye

Gizem Yeğen
Türkiye

Neslihan Üstündağ
0000-0002-3210-3747
Türkiye

Buket Aksu
Türkiye

Publication Date

June 28, 2025

Submission Date

September 20, 2021

Acceptance Date

February 15, 2022

Published in Issue

Year 2022 Volume: 26 Number: 3

IZ

https://izlik.org/JA86CE49ZN

Cite

RIS / Bibtex

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. https://izlik.org/JA86CE49ZN

AMA

1.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):460-468. https://izlik.org/JA86CE49ZN

Chicago

Kalayı, Mehmet, Gizem Yeğen, Neslihan Üstündağ, and Buket Aksu. 2025. “Evaluation of Emulgel Formulations Contain Diclofenac Sodium via Quality by Design Approach”. Journal of Research in Pharmacy 26 (3): 460-68. https://izlik.org/JA86CE49ZN.

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

[1]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, June 2025, [Online]. Available: https://izlik.org/JA86CE49ZN

ISNAD

Kalayı, Mehmet - Yeğen, Gizem - Üstündağ, Neslihan - Aksu, Buket. “Evaluation of Emulgel Formulations Contain Diclofenac Sodium via Quality by Design Approach”. Journal of Research in Pharmacy 26/3 (June 1, 2025): 460-468. https://izlik.org/JA86CE49ZN.

JAMA

1.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, June 2025, pp. 460-8, https://izlik.org/JA86CE49ZN.

Vancouver

1.Mehmet Kalayı, Gizem Yeğen, Neslihan Üstündağ, Buket Aksu. Evaluation of emulgel formulations contain diclofenac sodium via quality by design approach. J. Res. Pharm. [Internet]. 2025 Jun. 1;26(3):460-8. Available from: https://izlik.org/JA86CE49ZN