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Insulin Mucoadhesive Liposomal Gel for Wound Healing: a Formulation with Sustained Release and Extended Stability
Marwa H S Dawoud1, Ghada E Yassin2,3, Dalia M Ghorab4
1Department of Pharmaceutics, Faculty of Pharmacy, October University for Modern Sciences and Arts, (MSA University), Giza, Egypt. mdawoud@msa.eun.eg.
AAPS Pharmscitech
|April 10, 2019
Summary
Topical insulin formulated in liposomal chitosan gel enhances wound healing significantly. This novel drug delivery system offers extended stability and sustained release, improving healing rates 16-fold without causing hypoglycemia.
Area of Science:
- Biomaterials Science
- Drug Delivery Systems
- Dermatology
Background:
- Topical insulin shows promise for wound healing but faces delivery challenges.
- Controlled and safe delivery of insulin to wounds is crucial for therapeutic efficacy.
- Existing formulations lack extended stability and sustained release properties.
Purpose of the Study:
- To formulate topical insulin with enhanced stability and sustained release for wound healing.
- To apply Quality by Design (QbD) principles for optimizing insulin-loaded vesicles in bio-adhesive hydrogels.
- To evaluate the stability, release kinetics, and clinical efficacy of the optimized formulation.
Main Methods:
- Quality by Design (QbD) approach including Ishikawa diagrams and factorial designs (fractional and Box-Behnken).
- Formulation of insulin-loaded liposomes within a mucoadhesive hydrogel (chitosan gel).
- Characterization of optimized formula (particle size, zeta potential, entrapment efficiency, release rate) and stability/clinical studies.
Main Results:
- Optimized formula achieved particle size of 257.751 nm, zeta potential of -20.548 mV, 87.379% entrapment efficiency, and release rate of 91.521 μg/cm²/h.
- Liposomal insulin demonstrated stability for 6 months at 4°C and sustained release up to 24 hours.
- Clinical studies showed a 16-fold improvement in wound healing rate compared to controls, with reduced erythema and no hypoglycemia.
Conclusions:
- Insulin-loaded liposomal chitosan gel is a promising topical drug delivery system for wound healing.
- The formulation provides high stability and sustained insulin release, leading to significantly enhanced therapeutic outcomes.
- The QbD approach successfully optimized the formulation for safe and effective wound treatment.
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