Analysis of combined cream with antifungal activity in terms of «microbiological purity»

  • С. V. Birukova Kharkiv Medical Academi of Post-graduate Education
  • Aram Dullah Shupyk National Medical Academy of Post-graduate Education, Куiv
  • I. A. Vlasenko Shupyk National Medical Academy of Post-graduate Education, Куiv
  • L. L. Davtyan Shupyk National Medical Academy of Post-graduate Education, Куiv
  • Y. V. Voyda Kharkiv Medical Academi of Post-graduate Education
Keywords: microbiological purity, antifungal cream, storage, stability

Abstract

According to GMP requirements, quality control of medicinal products justifies their safety and effectiveness from the development and production to the consumer. One of the important parameters in the development of a new pharmaceutical drug is its microbiological purity. Therefore, the development and validation of methods of determining the indicator «microbiological purity» as a component of stability of developed drug is obligatory.

The aim of the study was to evaluate the microbiological purity of the developed combination soft drug for the treatment of dermatomycosis in different conditions of storage and packaging.

The objects of the analysis were samples of the developed cream containing clotrimazole, metronidazole, betamethasone dipropionate and urea. The study of the microbiological purity was conducted according to the requirements of the State Pharmacopoeia of Ukraine.

The analysis of the developed cream in terms of «microbiological purity» using deep-sowing method has showed the total aerobic microbial count (TAMC) for each sample: not more than 102 CFU/g; the total combined yeasts/moulds count (TYMC): not more than 10 CFU/g; Staphylococcus aureus and Pseudomonas aeruginosa in 1g have not been found. During the shelf time at 2–25 °C condition cream meets the requirements of the State Pharmacopoeia of Ukraine.

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Published
2019-02-12
How to Cite
BirukovaС. V., Dullah, A., Vlasenko, I. A., Davtyan, L. L., & Voyda, Y. V. (2019). Analysis of combined cream with antifungal activity in terms of «microbiological purity». Farmatsevtychnyi Zhurnal, (1), 27-37. Retrieved from https://pharmj.org.ua/index.php/journal/article/view/257
Issue
No. 1 (2015): Farmatsevtychnyi zhurnal
Section
Pharmaceutical technology
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