Development of in vitro Release Testing for Topical Semi-Solid Products of Dapsone

Year 2025, Volume: 55 Issue: 3, 343 - 351, 14.01.2026

Seda Sari , Emine Kahraman , Sevgi Güngör

https://doi.org/10.26650/IstanbulJPharm.2025.1745307

https://izlik.org/JA65UG34TC

Abstract

Objective: This study aimed to develop and optimise a regulatory-compliant in vitro release testing (IVRT) method for topical semi-solid products of dapsone.

Methods: The IVRT method was designed based on the U.S. FDA and EMA guidelines. The analytical method for dapsone was developed using high performance liquid chromatography (HPLC) and validated according to ICH Q2(R1) guidelines. The IVRT parameters were optimised stepwise. Solubility studies were conducted to determine the most suitable receptor medium to ensure sink conditions. The membrane inertness was evaluated by assessing dapsone recovery in various synthetic membranes. In addition, equipment-related parameters such as sampling intervals and product dose amounts were optimised.

Results: Solubility studies confirmed that dapsone exhibited higher solubility in phosphate-buffered saline (PBS), pH 7.4 : ethanol (60:40, v/v), which was selected as the receptor medium. Membrane inertness testing revealed that regenerated cellulose (RC) membranes provided the highest drug recovery, indicating minimal interaction with dapsone. The optimum IVRT conditions were identified as a receptor medium temperature of 32.0 ± 0.5°C, stirring speed of 500 rpm, and sampling intervals up to 6 h using a six-station vertical diffusion system. The 300 mg product dose provided the most favourable release profile, with the highest cumulative release and linearity coefficients (R² > 0.97), meeting the U.S. FDA acceptance criteria.

Conclusion: This study proposed an IVRT method for the in vitro evaluation of semi-solid topical products of dapsone. The developed method may contribute to future quality control practices and support comparative studies of topical semi-solid products of dapsone.

Keywords

Dapsone , Gels , IVRT , Semi-solid dosage forms , Topical products

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