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.
Highlights
At present there is a considerable list of medicines of local application for treating the pathology mentioned above in the arsenal of a practicing doctor in sports medicine; most of them act only for a short period of time or exhibit undesirable side effects [21]
The aim of this work is the experimental development of the scientifically based formulation of the combined gel with the anti-inflammatory and local anesthetic action under the conditional name “Artproment®” for application in a complex treatment of mechanical injuries and post-traumatic inflammations of extremities soft tissues, diseases of the locomotor apparatus, musculoskeletal injuries that are characteristic for sports medicine and sports during the rehabilitation period such as bruises, dislocations, sprains, ruptures of ligaments, tendons, etc., in the pharmacy and industrial conditions
To solve the goal set at the first stage of the experimental research it was necessary to obtain a stable gel system, which was prepared by dispersion of a gelation agent – Ultrez-10 NF carbomer in 1/3 part of purified water at the room temperature and constant stirring for one hour with a previously dissolved preservative in it
Summary
At present there is a considerable list of medicines of local application for treating the pathology mentioned above in the arsenal of a practicing doctor in sports medicine; most of them act only for a short period of time or exhibit undesirable side effects [21]. Taking into consideration the advantage of medicines for local application, in particular in the form of gels, as well as the nature of inflammatory processes and diseases of the locomotor apparatus, the topical problem of medicine and pharmacy is creation of a new effective drug of domestic manufacture with the anti-inflammatory and local anesthetic action for treating the given pathology. Our efforts are under way to develop a new complex drug in the form of gel under the conditional name “Artproment®” on the basis of synthetic substances and compounds of the natural origin, in particular apiculture products, for treating traumas and diseases of the locomotor apparatus that mainly occur in sports medicine [5, 6]. The technological process of manufacture should consist of the optimally planned systemic approach to complex experimental research conducted at the stage of the pharmaceutical development of the drug studied, and it influences on the final result of its quality and stability during storage [14]
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