Experimental Investigation of Immunomodulator Galavit^® Diffusion in a Model System

Introduction. The widespread use of immunomodulators in medical practice contributes to the development of their new dosage forms.

Aim. The aim of this work is to develop a transdermal therapeutic system (TTS) Galavit^® and to study a diffusion of the drug from it through the Strat-M membrane in vitro.

Materials and methods. The medicinal substance was Galavit^® in the form of a powder for the preparation of a solution for intramuscular administration («SELVIM», Russia). Saline solution, sodium dodecyl sulfate, apricot kernel oil, Decaglyn PR-20 and others were used as excipients. Heidolph DIAX900 dispersant (Germany) and ultrasonic homogenizer Heilscher UIS250V (Germany) were used to make the emulsion compositions. The delamination time and particle size of emulsion compositions were determined using the LUMiSizer dispersion analyzer (LUM, Germany). Diffusion studies of Galavit^® from TTS through the Strat-M membrane (25 mm in diameter, Merck Millipore) were carried out on the Copley diffusion analyzer (UK). Quantitative determination of Galavit^® was performed by spectrophotometry (UV-2600 Shimadzu, Japan) in the wavelength range 294–298 nm in model media.

Results and discussion. The characteristic parameters of emulsion compositions were determined during the study: the particle size varied from 0.1 to 2 µm, the delamination time – from 9 to 95 min depending on the composition. The maximum yield of the drug from the TTS was 30 % through the membrane.

Conclusion. The possibility of transdermal transfer of Galavit^® from TTS is shown in model experiments.

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