Применение синтетической и биологической тест-систем при разработке трансдермальных терапевтических систем

Abstract

There are several approaches to modeling percutaneous diffusion of drugs and predicting its effectiveness in the development of new transdermal therapeutic systems (TTS): mathematical models, synthetic and biological test-systems. The aim of the work is to substantiate the need to combined use synthetic and biological test systems at the initial stages of the transdermal therapeutic systems development using the Galavit® immunomodulator TTS as an example. Six batches of laboratory samples of TTS were made with a different composition of excipients in emulsions. Transdermal therapeutic systems formulations were screened on the synthetic test-system represented by Strat-M membrane (Merck Millipore). Based on the results of the study, two formulations with the best data of the drugs amount passed into the receiving chamber of the Franz diffusion cell were selected. Amount of drugs in the form were amounted 30 %. The use of non-preserved rabbit skin was revealed significant differences in this indicator for TTS of these two compositions. The mass of drugs passing through the skin from the TTS Galavit® for 24 hours of application for the first emulsion was 58 – 71 % and was 39 – 50 % for the second. The biological test-system turned out to be more sensitive to the emulsion compositions. Thus, the combined use of synthetic and biological test-systems makes it possible to significantly reduce the complexity and costs of preclinical studies of new TTS.