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- Title
NONINVASIVE TRANSDERMAL ADMINISTRATION OF INSULIN AT A THERAPEUTIC LEVEL: PRELIMINARY STUDIES.
- Authors
BIERNAT, PAWEŁ; BALWIERZ, RADOSŁAW; POGORZELEC, ŁUKASZ; MICEWICZ, EWA; BURSY, DAWID; DYLIŃSKI, MIESZKO
- Abstract
Introduction: Transporting molecules, especially large proteins, through the skin is a challenging task due to the skin's efficient barrier function. Insulin in turn is highly susceptible to chemical and physical denaturation. Despite these challenges, it is worth noting that insulin remains a crucial component in the treatment of diabetes, and ongoing research is focused on developing more stable formulations. It should be mentioned that the effective administration of insulin in a transdermal patch is a novelty never seen before in the scientific literature. Aim: The study aimed to assess the feasibility of transdermal insulin delivery using the Biotts MTC transdermal carrier and to determine the therapeutic concentration in an animal model.. Material and methods: In accordance with OECD guidelines, porcine skins were prepared and suitable skin samples were chosen for analysis. The insulin release study from the MTC transdermal carrier was conducted using a pharmacopoeial paddle dissolution apparatus wiThenhancer cell vessels and autosampler. This method enabled a comprehensive evaluation of the formulation's performance. Additionally, in vivo studies were conducted using male Wistar rats as the animal model. The LC-MS/MS method was employed to determine insulin concentrations in the acceptor medium and rat plasma in vivo. Results: The concentration of insulin reached nearly 60 ng/ml after 72 hours. Following subcutaneous insulin administration, the Cmax reaches approximately 3.8 ng/ml and decreases to zero after approximately 32 hours. However, when insulin is administered transdermally using a modified MTC transdermal carrier, the Cmax level reaches an impressive 8.5 ng/ml. Additionally, the measured concentration remaining stable after 48 hours. Conclusions: The MTC transdermal carrier has been found to be an effective method of transporting insulin into the bloodstream via the transdermal route. Studies have shown that API concentrations achieved through this method are comparable to those achieved through subcutaneous administration.
- Subjects
INSULIN therapy; TRANSDERMAL medication; SCIENTIFIC literature; LABORATORY rats
- Publication
Medical Science Pulse, 2024, Vol 18, p45
- ISSN
2544-1558
- Publication type
Abstract