Development of qulity control methods for cream based on clotrimazole and urea

Foot mycosis is varied in the population between 5% up to 20% and in some causes could reach 50% within the patients with chronic disease. There are some difficulties with treatments of mycosis with conducting by hyperkeratosis. Hence, development of medicines with target action with consideration of etiology of skin disease is actual. There is on going development of soft medicines base on clotrimazole and urea for fungous skin disease treatment which conducting by hyperkeratosis is taken place on pharmaceutical technology and biopharmacy department of Shupyk National Medical Academy of Post-graduate Education. Development of quality control methods of soft medicine based on clotrimazole and urea is the main target of current work. The object of study is cream base on oil/water emulsion type with consistent of clotrimazole (1%) an urea (5%). Quality control of medicine (description, homogeneity, pH) was conducted in compliance with State Pharmacopeia of Ukraine. Identification and quantity of clotrimazole was conducted by HELC (high-efficiency liquid chromatography); urea was detected by coloration and titration analysis accordingly. Estimation of general appearance, organoleptic qualities and homogeneity of cream samples was homogeneity, good consistence, white color, odorless. Value of pH is 6,6–6,7. It was found that quantity of active pharmaceutical ingredients in the medicine is within normal ranges, particular concentrations. Total number of aerobic microbial count (TAMC) is not more than 50 CFU/g; Total number of combined yeasts/moulds count (TYMC) is not more than 10 CFU/g; Staphylococcus aureus and Pseudomonas aeruginosa in 1g have not been found were found by microbiological study which is in compliance with State Pharmacopeia of Ukraine. Specified characteristics for cream based on clotrimazole and urea was found by complex study.