ArticleAAPS PharmSciTech2026
Dapagliflozin Loaded Bilosomes Gel for Transdermal Delivery: Formulation, Optimization, Physicochemical Characterization, and In Vivo Evaluation.
Article in AAPS PharmSciTech, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Diabetes mellitus (Type 2, DM) is a metabolic disorder characterized by elevated blood glucose levels. Dapagliflozin (DZ) is a recently developed antidiabetic drug, but its oral use is challenged by permeability-limited absorption and first-pass metabolism, primarily via glucuronidation. The present study aims to formulate DZ-loaded bilosomes (BLS) gel for transdermal delivery to increase drug permeation and therapeutic efficacy. The DZ-BLS was formulated using the thin-film hydration method and optimized using BBD. Optimized DZ-BLS (DZ-BLS13) showed 124.2 nm of vesicle size (VS), 0.389 of PDI, 40.9 (negative) of zeta potential, and 90.76% of drug entrapment efficiency (EE). The DZ-BLS13 formulation was incorporated into chitosan gel and evaluated for various in vitro and in vivo studies. The optimized DZ-BLS13 gel formulation (DZ-BLS13G2) demonstrated favorable physicochemical properties, including an appropriate viscosity (764 ± 20.00 cP), good spreadability (228.33 ± 2.88%), and compatibility with the physiological pH (6.03 ± 0.23) of the skin. Additionally, the formulation demonstrated a sustained drug-release profile (95.17 ± 5.23%) for up to 24 h. Moreover, DZ-BLS13G2 exhibits significantly higher ex vivo rat skin permeation (1.69 ± 0.62-fold higher flux) than DZ conventional gel (DZ-G). Histopathology on excised rat skin revealed no sign of irritation. The pharmacokinetic study of DZ-BLS13G2 revealed improved bioavailability (1.88-fold and 1.48-fold) and prolonged plasma drug levels compared with DZ conventional gel and oral DZ-dispersion. Additionally, DZ-BLS13G2 exhibited significantly higher antidiabetic activity than DZ conventional gel and oral DZ-dispersion. From the findings, it can be concluded that BLS gel is a novel carrier for transdermal drug delivery to enhance therapeutic efficacy.
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