Development and Evaluation of Roflumilast-Loaded Hydrogel for the Treatment of Psoriasis
DOI:
https://doi.org/10.22270/ajprd.v14i5.1877Abstract
Background and Objective: Psoriasis is a chronic immune-mediated inflammatory skin disorder affecting approximately 1–3% of the global population. Conventional topical therapies including corticosteroids and vitamin D analogues are limited by adverse effects such as skin atrophy and tachyphylaxis. This study aimed to develop and evaluate a Roflumilast-loaded hydrogel as an effective, safe, and patient-compliant topical drug delivery system for the management of psoriasis.
Methods: Nine hydrogel formulations (F1–F9) were prepared using Carbopol 940 (0.5%, 0.75%, 1.0% w/w) as the gelling agent combined with Roflumilast (150 mg), PEG 400, ethanol (4, 6, 8 ml), glycerin, methyl paraben, propyl paraben, and triethanolamine (pH adjuster). Preformulation studies including UV spectrophotometry, FTIR, DSC, solubility, and melting point determination were conducted. Formulations were evaluated for physical appearance, pH, viscosity, spreadability, drug content uniformity, in vitro drug diffusion (dialysis membrane, phosphate buffer pH 7.4, 480 min), stability, grittiness, extrudability, homogeneity, and in vivo skin irritation on Wistar albino rats.
Results: The calibration curve of Roflumilast at λmax 248 nm showed excellent linearity (R² = 0.9996). FTIR and DSC studies confirmed drug–polymer compatibility. All formulations exhibited pH 6.2–6.7 (within the skin-compatible range). Viscosity ranged from 29,540–48,210 cps at 5 RPM, demonstrating pseudoplastic (shear-thinning) behaviour. Drug content uniformity was 91.24–99.84%. The optimised formulation F9 (Carbopol 940: 1.0%, Ethanol: 8 ml) achieved the highest cumulative drug release of 99.1 ± 0.40% at 480 min, spreadability of 21.7 g·cm/sec, drug content 99.84 ± 0.10%, pH 6.7, and viscosity of 48,210 cps. Stability studies showed no significant changes after 30 days. In vivo skin irritation testing showed no erythema, oedema, or redness, confirming excellent dermal safety.
Conclusion: Roflumilast-loaded hydrogel (F9) demonstrates superior physicochemical properties, controlled and sustained drug release, excellent stability, and dermal safety. This formulation represents a promising non-steroidal topical drug delivery system for effective psoriasis management, offering improved patient compliance and reduced systemic side effects.
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Copyright (c) 2026 Saurabh V. Bodke, Vikrant P. Wankhade, Abhishek D. Mankar, Ishika S. Bijore
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