Abstract
Aim: To develop and characterize the topical insulin-loaded organogel formulation for the management of diabetic wounds.
Objectives: To formulate and evaluate organogel of insulin that can serve as a topical administration for promoting enhanced wound healing in diabetic patients by providing sustained and localized delivery of drug to the wound site.
Methodology: The insulin organogel formulated by the micro-emulsion method involves mixing the “aqueous and oil phases” at high shear. Physical and chemical properties, as well as an in vitro study with a Franz diffusion chamber, were used to evaluate the prepared organogel.
Results: All formulations proved to be off-white, homogeneous, washable, and had a pH between 6 and 6.5; moreover, they were non-irritating and skin-compatible. Formulations F1–F6 had viscosity ranging from 2058 to 3168 cps, spreadability ranges of 0.35 to 0.52 g*cm/s, and gel transition ranges of 28.33 to 35.33 °C. In formulations F1–F3, the concentration of lecithin was gradually increased, and in formulations F4–F6, the concentration of PF-127 was increased, resulting in a decrease in gel transition temperature, an increase in viscosity, and a gradual change in spreadability. The higher-viscosity formulations were much more stable and had better drug release. All formulations were fitted to a kinetic model belonging to first-order kinetics. However, after examining the parameter evaluation, it was found that the formulations F2 and F6 were better suited to the kinetic model and were consistent with the first-order and Higuchi models in Korsmeyer-Peppas F2 (r2 = 0.9544 and n = 1.0412); F6 (r2 = 0.9019 and n = 1.0822), which was a confirmation of the sustainability of the release system with matrix diffusion and drug delivery mechanisms that were based on the Super-Case II transport.
Conclusion: Further research and clinical trials are needed to validate its efficacy, optimize the formulation, and establish its long-term safety. Topical insulin organogel has the potential to revolutionize diabetic wound management by improving healing outcomes, reducing complications, and raising the standard of living for those who have diabetes.
Keywords: Diabetic wound, insulin, organogels, topical delivery, epidermis and first-order kinetics.
[http://dx.doi.org/10.1089/wound.2013.0518] [PMID: 27134763]
[http://dx.doi.org/10.1016/j.medengphy.2019.08.010] [PMID: 31554571]
[http://dx.doi.org/10.1007/978-1-4939-2671-8_46]
[http://dx.doi.org/10.7759/cureus.27180] [PMID: 36035037]
[http://dx.doi.org/10.3390/ijms22126403] [PMID: 34203830]
[PMID: 29118927]
[http://dx.doi.org/10.3390/molecules23030681] [PMID: 29562618]
[http://dx.doi.org/10.3390/pharmaceutics13010100] [PMID: 33466845]
[http://dx.doi.org/10.2147/DMSO.S237294] [PMID: 32214835]
[http://dx.doi.org/10.22270/ajprd.v10i1.1088 ]
[http://dx.doi.org/10.1080/10837450701247400] [PMID: 18161637]
[http://dx.doi.org/10.1080/10717544.2016.1212439] [PMID: 27494650]
[http://dx.doi.org/10.3390/gels7020065] [PMID: 34205955]
[http://dx.doi.org/10.1163/138577211X555721]
[http://dx.doi.org/10.3109/10717544.2016.1155243] [PMID: 27187718]
[http://dx.doi.org/10.1002/jps.22673] [PMID: 21702052]
[http://dx.doi.org/10.5958/0974-360X.2020.00247.4]
[http://dx.doi.org/10.1016/j.jsps.2020.10.016] [PMID: 33424262]
[http://dx.doi.org/10.3109/10717544.2013.847032] [PMID: 24295500]
[PMID: 25092976]
[http://dx.doi.org/10.2147/DDDT.S111351] [PMID: 27660416]
[http://dx.doi.org/10.2174/156720106778559010] [PMID: 17076644]
[http://dx.doi.org/10.22270/jddt.v12i5.5614]
[http://dx.doi.org/10.3390/app10155341]