Advances in Pharmacology and Pharmacy Vol. 12(1), pp. 71 - 84
DOI: 10.13189/app.2024.120109
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Prashant Gajananrao Karamkar 1, Ashish Agrawal 1, Vivekanand Kisan Chatap 2,*
1 Department of Pharmaceutics, B. R. Nahata College of Pharmacy, Mandsaur University, India
2 Department of Pharmaceutics, H. R. Patel Institute of Pharmaceutical Education & Research, India

ABSTRACT

The present study work was undertaken with the intent to develop a topical emulgel formulation of dapsone 7.5% which would attenuate the first-pass metabolism associated with an oral administration. Dapsone has low solubility and low permeability and is designated as Biopharmaceutical Classification System (BCS) class-II drug as per the biopharmaceutics classification system. The dapsone is formulated as an emulgel which is premeditated to the application by topical route for the management of the skin disease acne vulgaris. The quality target product profile (QTPP) was defined considering product superiority and efficacy. Critical quality attributes (CQAs) are finished product quality metrics and are identified for process validation. The emulgel formulation containing dapsone was optimized by using a 3-factor, 2-level central composed design (CCD). The concentration of polymer, oil, and surfactant were identified as independent variables and drug release and viscosity were dependent variables, Ultrez 10 with a concentration of 1.25 – 4.5 %, Olive Oil with 7.5 – 20 % as oil phase and tween 80 with 12.5 – 37.5 % as surfactant. The optimization study confirms 20 runs which designate a high level of prognostic skill in response surface methodology. The formulations are characterized by drug content, spreadability, pH, residence time, drug release, and viscosity. From the obtained results of drug release, it was concluded that an optimized formulation shows a complete drug release. An accelerated stability study analysis showed acceptable results for an optimized trial formulation.

KEYWORDS
Emulgel, CCD, Dapsone, Ultrez 10

Cite This Paper in IEEE or APA Citation Styles
(a). IEEE Format:
[1] Prashant Gajananrao Karamkar , Ashish Agrawal , Vivekanand Kisan Chatap , "Preparation and Characterization of Dapsone Emulgel 7.5% Using Quality by Design," Advances in Pharmacology and Pharmacy, Vol. 12, No. 1, pp. 71 - 84, 2024. DOI: 10.13189/app.2024.120109.

(b). APA Format:
Prashant Gajananrao Karamkar , Ashish Agrawal , Vivekanand Kisan Chatap (2024). Preparation and Characterization of Dapsone Emulgel 7.5% Using Quality by Design. Advances in Pharmacology and Pharmacy, 12(1), 71 - 84. DOI: 10.13189/app.2024.120109.