Formulation Development and Evaluation of Halcinonide Topical Gel

Abstract

Halcinonide is a potent topical corticosteroid widely used for the treatment of inflammatory skin disorders such as psoriasis, eczema, dermatitis, and allergic skin conditions. The present study was undertaken to formulate, optimize, and evaluate a topical gel of Halcinonide with improved physicochemical characteristics, patient acceptability, and drug release properties. Preformulation studies, including melting point determination, Fourier Transform Infrared (FTIR) spectroscopy, Differential Scanning Calorimetry (DSC), and solubility studies, confirmed the purity of the drug and its compatibility with selected excipients. Carbopol 934 was employed as the gelling polymer, while propylene glycol, glycerin, and triethanolamine were incorporated to obtain a stable and homogeneous gel formulation. A Design of Experiments (DOE) approach was utilized to optimize the formulation variables affecting viscosity and in-vitro drug release. Nine formulation batches (F1–F9) were prepared and evaluated for appearance, pH, homogeneity, spreadability, viscosity, drug content, and in-vitro diffusion. Among all formulations, batch F7 exhibited the most desirable characteristics, including good homogeneity, smooth texture, acceptable viscosity, pH (6.7 ± 0.25), spreadability (4.3 ± 0.15 cm), drug content (97.32 ± 0.54%), and maximum cumulative drug diffusion of 93.14% within 3 hours. Stability studies demonstrated that the optimized formulation remained physically stable without significant changes in appearance, pH, viscosity, or drug content.The results indicate that the optimized Halcinonide topical gel provides excellent physicochemical properties and efficient drug release, making it a promising topical dosage form for the effective management of inflammatory skin disorders. Further clinical evaluation is recommended to establish its therapeutic efficacy and safety in human subjects.

Introduction

Topical dosage forms are pharmaceutical preparations applied directly to the skin or mucous membranes, including the eyes, ears, nose, throat, vagina, and rectum, to produce either local or systemic therapeutic effects. Topical drug delivery has gained significant attention because it improves patient compliance, enhances drug bioavailability, avoids first-pass metabolism, minimizes gastrointestinal irritation, and provides targeted drug delivery. Topical formulations are classified into external topical preparations, which are applied to the skin, and internal topical preparations, which are administered to mucosal tissues. Despite these advantages, topical delivery also has limitations such as poor skin permeability for certain drugs, difficulty in absorbing large molecules, risk of allergic reactions, and suitability only for drugs requiring low plasma concentrations.

This study focuses on the formulation and evaluation of a 0.1% Halcinonide topical gel using Carbopol 934 as the gelling agent, propylene glycol and glycerine as penetration enhancers and humectants, triethanolamine as a neutralizing agent, methanol as a solvent, and purified water. Nine different formulations (F1–F9) were prepared by varying the concentrations of Carbopol 934, propylene glycol, and glycerine to identify the optimized gel formulation.

Preformulation studies were conducted to confirm the identity and physicochemical properties of Halcinonide before formulation. The melting point determined by both the glass capillary method and Differential Scanning Calorimetry (DSC) matched the reported standard values, confirming the purity of the drug. DSC analysis showed a sharp endothermic melting peak around 279°C, indicating the crystalline nature and thermal stability of Halcinonide.

The drug was further characterized using Infrared (IR) spectroscopy, where the observed characteristic absorption peaks corresponded with the reported IR spectrum of Halcinonide, confirming its chemical identity without structural changes. Solubility studies demonstrated that Halcinonide is insoluble in distilled water, moderately soluble in methanol (0.59 mg/ml), and only slightly soluble in phosphate buffer (0.027 mg/ml), indicating the need for suitable formulation strategies to enhance drug release.

UV spectrophotometric analysis established the maximum absorbance (λmax) of Halcinonide at 239 nm in methanol. A standard calibration curve prepared over a concentration range of 3–21 μg/ml showed excellent linearity, confirming compliance with Beer–Lambert's law and validating the method for quantitative drug estimation.

To optimize the formulation, a 3² full factorial experimental design was employed. This statistical optimization method evaluated the effects of key formulation variables, particularly the concentrations of Carbopol 934 and propylene glycol, on important response parameters such as gel viscosity and percentage drug release. The factorial design reduced the number of experimental trials while identifying the optimum formulation with desirable physical characteristics and drug release performance.

Conclusion

The present study successfully formulated and optimized a Halcinonide topical gel using Carbopol 934 as the gelling agent. Preformulation studies confirmed the compatibility of the drug with the selected excipients. The prepared formulations exhibited satisfactory physicochemical properties, including acceptable pH, good homogeneity, suitable viscosity, excellent spreadability, and uniform drug content. Using the Design of Experiments (DOE) approach, batch F7 was identified as the optimized formulation, exhibiting 97.32 ± 0.54% drug content, pH 6.7 ± 0.25, spreadability of 4.3 ± 0.15 cm, viscosity of 5485 cP, and 93.14% cumulative drug release within 180 minutes. Stability studies confirmed that the optimized formulation remained stable over 3 months without significant changes in its physicochemical properties or drug release. Overall, the developed Halcinonide gel demonstrated satisfactory quality, stability, and in-vitro performance, indicating its potential as an effective topical formulation for the treatment of inflammatory skin disorders. Further in-vivo and clinical studies are required to confirm its therapeutic efficacy and safety

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Copyright

Copyright © 2026 Mayur Prakash Narode, Dr. Vinayak Sahebrao Mundhe. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.