Aram Dullah - Master of Pharmacy, Post-graduate Student, Shupik National Medical Academy of Postgraduate Education (Kiev, Ukraine) I.А.Vlasenko - Ph.D. (Pharm.), Associate Professor, Shupik National Medical Academy of Postgraduate Education (Kiev, Ukraine) L.L. Davtyan - Dr.Sc. (Pharm.), Professor, Shupik National Medical Academy of Postgraduate Education (Kiev, Ukraine) С.V Birukova - Dr.Sc. (Med.), Professor, Kharkiv Medical Academy of Postgraduate Education (Ukraine) Y.V. Voida - Ph.D. (Med.), Associate Professor, Kharkiv Medical Academy of Postgraduate Education (Ukraine)

One of the important stages of pharmaceutical development, affecting on the quality of the final product is the technology of its manufacturing. Therefore, the study of pharmaceutical factors affecting the pharmacokinetics of the drug, are an important phase in the development of a new drug. In order to determine the optimal technological method of adding the active pharmaceutical ingredients to the base, antimicrobial activity of samples prepared in various ways have been studied. Microbiological studies were carried out in accordance with the relevant recommendations and the State Pharmacopoeia of Ukraine - method of diffusion in agar gel by comparing the diameters of the zones of growth inhibition test cultures. To evaluate the activity of the samples reference test strains from the American Type Culture Collection were used. Determination of homogeneity of the samples and the thermal and colloidal stability was carried out according to the State Pharmacopoeia of Ukraine and State Standard 4765:2007 «Cosmetic cream. General specifications». Consider the different ways of adding - clotrimazole, urea, betamethasone dipropionate in solubilized form, study of samples antimicrobial activity depending on the method of API adding to the base is of interest. Furthermore, the antimicrobial activity of the samples by various methods of combining the oil and aqueous phases was investigated. Analysis of the results of antimicrobial activity of model samples showed that the model samples 2 and 4, in which metronidazole was suspended in vaseline oil, demonstrated a high antimicrobial activity against the investigated test cultures than sample 1, wherein metronidazole was added to the base as suspension with PEO-400 and sample 3 - with glycerin. During comparing the antimicrobial activity of Samples 2 and 4, was found that in the method 2 (the aqueous phase was added to the oil) antimicrobial activity was a little higher. Homogeneity studies of samples 2 and 4 as well as their thermal and colloidal stability demonstrated that the model sample 2 has thermal and colloidal stability not only during manufacturing, but also during the storage period. Samples were homogeneous. By experimental studies the influence of pharmaceutical factors on technology of developed soft drug has been determined. Based on the study of the antimicrobial activity optimal way of adding of metronidazole (paraffin oil suspension) to the base during adding aqueous phase into the oil phase was justified.

 

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