Development of the technology for «Propolis-AK» gel for treating acne

In modern conditions of industrial production of drugs pharmaceutical development, which affects the quality and efficiency of the obtained drugs, primarily depends on carefully predicted realization of the technological process taking into account given control parameters (conditions of preparation, consistency, components mixing, temperature regime, etc.) and evaluation criteria that are shown in the relevant regulations. Aim. To develop an experimental gel technology under conditional name “Propolis-AK” for acne treatment. Materials and methods. The objects of study were model examples of gel “Propolis-AK”, which containe the following active pharmaceutical ingredients: phenolic hydrophobic propolis product and azelaic acid, and excipients: gel former (Carbomer Ultrez-10 NF), neutralizer (trometamol), nonaqueous hydrophilic solvents (propylene glycol and glycerin) and purified water. Results. Based on the results of pharmaco-technological and physico-chemical studies, technology of pharmaceutical compounding and industrial production of gel “Propolis-AK” for the treatment of acne was theoretically grounded and experimentally proved. Conclusions. The results of experimental studies were used to develop flow charts of the manufacturing process of gel “Propolis-AK” in pharmaceutical conditions and technological instructions for the studied drug. Taking into consideration the physical and chemical properties and the results of the study of solubility of active pharmaceutical ingredients, which are included in the drug, flowchart of the production process of the gel in industrial conditions and the project of technological regulation were developed, technological parameters of the production were grounded, the optimal quantity of solvents was calculated, required for each technological stage in view of solubility of gel components, consistency and the gradual implementation of the mixing rate and other parameters that affect the quality and stability of the product, and gel technology “Propolis-AK” was tested in pharmaceutical and industrial environments.