Formulation and Evaluation of Topical Gel Containing Clindamycin Phosphate and Vitamin E for Acne Treatment

Abstract

Background: Clindamycin phosphate is widely used in topical anti-acne preparations because of its antibacterial activity against Cutibacterium acnes. Vitamin E possesses antioxidant and skin-protective properties that may improve skin tolerability and formulation stability. Objective: The objective of the present investigation was to formulate and evaluate a stable topical gel containing clindamycin phosphate and vitamin E for enhanced anti-acne activity and improved patient compliance. Methods: Four gel formulations (F1–F4) were prepared using Carbopol 940 at varying concentrations. Prepared gels were evaluated for physical appearance, pH, viscosity, spreadability, extrudability, drug content, in vitro diffusion, antimicrobial activity, skin irritation, and accelerated stability studies. Results: The optimized formulation F3 showed satisfactory homogeneity, pH (6.2 ± 0.1), viscosity (5810 ± 32 cPs), spreadability (7.4 ± 0.2 g•cm/sec), and drug content (98.7 ± 0.4%). In vitro drug diffusion studies demonstrated sustained drug release of 94.2 ± 0.5% within 8 h. Conclusion: The developed topical gel exhibited acceptable pharmaceutical characteristics and may serve as a promising topical delivery system for acne management.

Introduction

The study focuses on the formulation and evaluation of a topical gel for acne vulgaris using Clindamycin phosphate as the active antibacterial agent and Vitamin E acetate as an antioxidant to enhance skin protection and reduce irritation. Acne is a common skin disorder caused by factors such as excess sebum production, bacterial growth, and inflammation. Topical gel formulations are preferred due to their localized action, ease of application, and minimal systemic side effects.

The gel was prepared using Carbopol 940 as a gelling agent along with excipients like propylene glycol, preservatives, and triethanolamine to achieve desired consistency and stability. Four formulations (F1–F4) were developed with varying polymer concentrations.

Evaluation of the formulations included tests for pH, viscosity, spreadability, drug content, drug release, antimicrobial activity, stability, and skin irritation. Among all formulations, F3 was identified as the optimized formulation, showing balanced pH, suitable viscosity, excellent spreadability, high drug content (98.7%), sustained drug release, strong antimicrobial activity against Cutibacterium acnes, good extrudability, and no skin irritation.

In vitro studies using a Franz diffusion cell showed controlled drug release over 8 hours, and kinetic analysis indicated that drug release followed the Higuchi model, suggesting diffusion-controlled release. Stability and FTIR studies confirmed formulation stability and compatibility of ingredients.

Conclusion

The present investigation successfully developed and evaluated a topical gel containing clindamycin phosphate and vitamin E using Carbopol 940 as a gelling agent. Among all formulations, F3 demonstrated optimum physicochemical properties, satisfactory drug content, controlled drug release, and excellent antimicrobial activity. Incorporation of vitamin E improved skin compatibility and formulation stability. Therefore, the developed gel may serve as an effective topical therapy for acne vulgaris.

References

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Copyright

Copyright © 2026 Om Prakash, Vishal Baliyan. 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.