Development and comparative analysis of transdermal patches with humic derivatives

Introduction. Fulvic acid as a fraction of humic substances is a hydrophilic molecule that can form aggregated particles in solutions. This can cause problems in the development of topical formulations such as ointments, gels and transdermal patches. In such cases, the development of formulations improving the penetration of small polar molecules through the lipophilic stratum corneum are required.

Aim of the report – the development of compositions of transdermal therapeutic system and study of release of humic derivatives from them.

Material and methods. Objects of the study: Transdermal patch is a dosage form for external use intended for controlled delivery of a medicinal substance (substances) into the systemic circulation by passive diffusion through intact skin. Fulvic acid (FA) was studied as humic derivatives. Determination of the release rate of the active substance from the base and modified formulations was carried out according the pharmaceutical article Dissolution for transdermal patches. Determination of the concentration of fulvic acid in the aqueous extracts is carried out using spectrofluorimetry (spectrofluorimeter SolarCM 2203).

Results. Emulsion transdermal patches have been developed and investigated. Based on the dissolution test for transdermal patches, the following results were obtained. The amount of FA released from the transdermal patches, with an initial content of 0.016 g, was equal to: (0.0081±0.0002) g (composition 1, Kolliphop p237) in 8.25 hours (495 minutes); (0.0046±0.0003) g (composition 2, Kolliphor p338), for 8.5 hours (510 min); (0.0048±0.0002) g (basic composition), for 6.5 hours (390 min).

Conclusions. From the results of the experiment, it can be concluded that the modified composition 1 (Kolliphor p237) showed the best result in the release of fulvic acid in comparison with other compositions.