DOI: https://doi.org/10.24959/nphj.14.1988

Development of the formulation of “Artproment®” combined gel for application in sports medicine

O. S. Shpychak, O. I. Tikhonov

Abstract


Based on the data of pharmaco-technological and physico-chemical studies conducted the formulation of the gel with the anti-inflammatory and local anesthetic action under the conditional name “Arthroment ®” has been theoretically and experimentally substantiated in the pharmacy and industrial conditions. It is intended for application in a complex treatment of mechanical injuries and post-traumatic inflammations of extremities soft tissues, diseases of the locomotor apparatus (tendons, muscles and joints), musculoskeletal injuries that are characteristic for sports medicine and sports during the rehabilitation period such as bruises, dislocations, sprains, ruptures of ligaments, tendons, etc. The objects of research were model samples of “Artproment®” gel, which includes such active pharmaceutical ingredients (APhI) in its composition as propolis phenolic hydrophobic drug, articaine hydrochloride, menthol (levomenthol) and rosemary oil, as well as the following excipients: a gelation agent (Ultrez-10 NF carbomer), a neutralizer (trometamol), a preservative, nonaqueous solvent (propylene glycol), ethanol and purified water. The results of the experimental research were used when developing the technological process flowchart for preparing “Artproment®” gel in the conditions of pharmacy production and standard operating procedure on the drug studied. Taking into account the physicochemical properties and according to the research results on solubility of APhI in the composition of the drug the technological process flowchart for manufacturing the combined gel industrially and the project of manufacturing instructions have been developed; technological parameters of its manufacturing have been substantiated; the optimal amount of solvents required for performing each technological stage has been calculated taking into account the solubility of the gel components, consequence and phasing of their mixing, temperature and other parameters affecting the quality and stability of the drug; and the formulation of “Artproment®” combined gel has been tested in the pharmacy and industrial conditions.


Keywords


traumas of the locomotor system; combined gel; gel technology; sports medicine

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References


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