1Department of Pharmacology, KLE College of Pharmacy, Rajajinagar, Bengaluru, KLE Academy of Higher Education and Research, Belagavi, 590010, Karnataka, India.
2Pharmacognosy and Phytochemistry, Shri Rawatpura Sarkar Institute of Pharmacy, Kumhari, Dist. Durg, C.G. 490042.
3,6Department of Pharmaceutical Chemistry, Bharati Vidyapeeth College of Pharmacy, Kolhapur, Pin code – 416013. Email: rohankumar3102@gmail.com
4Department of Applied Science & Humanities, Parul Institute of Engineering & Technology - Diploma Studies, Parul University, Post Limda, Taluka Waghodia, Vadodara, Gujarat 391760.
5Department of Pharmacology, Bharati Vidyapeeth's College of Pharmacy, Navi Mumbai – 400614.
7Department of Pharmacognosy, Nagpur College of Pharmacy, Wanadongri, Hingna Road, Nagpur, 441110.
8Faculty of Pharmaceutical Science, Assam down town University, Panikhaiti, Guwahati, Assam, India. Pin: 781026.
Background: Conventional terbinafine topical formulations are limited by poor skin penetration and low dermal drug deposition, leading to prolonged treatment durations in superficial fungal infections. This study aimed to develop a carboxymethyl chitosan (CMCS)-based transfersomal gel of terbinafine using a Quality by Design (QbD) approach to enhance dermal delivery.
Methods: Transfersomes were prepared by thin-film hydration and optimized using a Box–Behnken Design with Tween 80 concentration, hydration volume, and sonication time as independent variables. Critical responses included vesicle size, entrapment efficiency (EE), and skin drug deposition. The optimized transfersomal dispersion was incorporated into a Carbopol gel and evaluated for physicochemical characteristics, ex vivo skin permeation, confocal laser scanning microscopy (CLSM), and stability under ICH conditions.
Results: The optimized formulation (F9) exhibited vesicle size of 164.2 ± 4.3 nm, PDI of 0.182, and EE of 84.9 ± 1.9%. Ex vivo studies showed significantly higher permeation flux (42.6 ± 2.1 µg/cm²/h) and drug deposition (27.8 ± 1.2 µg/cm²) compared to conventional gel. CLSM confirmed deeper penetration up to 120 µm. Stability studies indicated minimal changes in vesicle characteristics over 3 months.
Conclusion: The QbD-optimized CMCS transfersomal gel demonstrated superior dermal delivery of terbinafine and holds strong potential for improved antifungal therapy.
Keywords: Terbinafine, transfersomes, carboxymethyl chitosan, Quality by Design, dermal delivery, antifungal therapy.
How to cite this article: Ullagaddi M, Muley B, Chavan RR, Joshi PN, Patil P, Takade RS, Mishra KA, Sarma KN. Design, Optimization, and Evaluation of Carboxymethyl Chitosan-Based Terbinafine-Loaded Transfersomal Gel for Enhanced Dermal Delivery in Superficial Fungal Infections. Int J Drug Deliv Technol. 2026;16(10s): 523-532; DOI: 10.25258/ijddt.16.10s.65
Source of support: Nil.
Conflict of interest: None