Market analysis of medicinal products with nimesulide

Анотація

nimesulide-containing medicinal products are the most popular non-steroidal anti-in-flammatory drugs which have been widely used in practice for many years. This active substance belongs to selective cyclooxygenase 2 inhibitors is a powerful pain reliever characterized by a rapidtherapeutic effect compared to other pain relievers. Despite the contradictory literature data of the lastdecades regarding the use of nimesulide due to its hepatotoxic effect, nimesulide medicine remain a priority in the treatment of patients with pain syndrome of various genesis all over the world. Current-ly, nimesulide is produced in the world in various dosage forms. Some studies in recent years have proved its antitumor effect which has led to the appearance of new specific forms with nimesulidesuch as microgranules, microspheres, nanoparticles with targeted delivery. Therefore, the purpose ofthe investigation was to analyze Ukrainian pharmaceutical market of products with the nimesulideactive substance by dosage forms, manufacturers; to establish the quality composition of original andgeneric drugs. The objects of the study were medicinal products containing nimesulide registered in Ukraine. The study was performed by analyzing of register data, using methods of grouping, compar-ison, graphic analysis, and generalization. In the work an analysis of medicines with nimesulide by dosage form and manufacturers was carried out. The excipients composition of reference drugs fornimesulide granules for oral suspension was also investigated. It was established that 32 medicines with nimesulide are registered in Ukraine, including 28 mono-preparations. A significant part of me-dicinal products with nimesulide are solid dosage forms, namely tablets (47 %) or granules for oral suspension (22 %) which contain 100 mg of nimesulide. It was established that there are no nime-sulide in the form of prolonged-release tablets on the domestic market. Nimesulide drug products of foreign producers are dominant (59.38 %), India has a leading position (50 %). Granules are mainlyproduced by foreign manufacturers that confirms the feasibility of developing a domestic generic product. The original product is Aulin, granules for oral suspension, “Angelini Pharma”, Czech Re-public. Differences in the qualitative composition of excipients of the original and generic products which present on the Ukrainian market were observed. The composition of products more often includes sucrose as filler, сetomacrogol 1000, liquid glucose spray-dried, maltodextrin, sodium sac-charin, anhydrous citric acid, orange flavoring, corn starch, or Aerosil 200. As follows, the feasibility of development of domestic medicinal product in the form of prolonged-release tablets and granuleswas confirmed; the original product of nimesulide granules for oral suspension was determined andthe qualitative composition of the reference drugs was established.

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