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