Development and standardization of lozenges containing furosemide


I.N. Zilfikarov(1–3), A.K. Arutyunov(1), A.S. Lebedeva(2), I.I. Bochkareva(1), V.A. Artemyeva(1)
1-Maikop State Technological University of the Ministry of Science and Higher Education of the Russian Federation, st. Pervomaiskaya, 191, Maykop, Republic of Adygea, 385000, Russian Federation;
2-ZAO “VIFITEH”, State Scientific Center for Medical and Biology, room 84, Obolensk village, Serpukhov district, Moscow region, 142279, Russian Federation;
3-All-Russian Scientific Research Institute of Medicinal and Aromatic Plants (VILAR) of the Ministry of Science and Higher Education of the Russian Federation, st. Grina, 7, building 1, Moscow, 117216, Russian Federation

Introduction. Increasing the bioavailability and speed of onset of the diuretic effect of furosemide are necessary for accelerated elimination of toxins in acute and chronic diseases associated with swelling, as well as in acute and chronic poisoning. In conditions where oral or parenteral administration of furosemide is difficult or impossible due to the presence of restrictions in a number of diseases, the use of dosage forms of furosemide with local resorptive action, in particular lozenges, is relevant. Purpose of the study: Experimental substantiation of quality standards and methods of analysis of lozenges containing furosemide. Material and methods. The objects of the study are furosemide and lozenges manufactured at the production site of a pharmaceutical company. Research methods: spectrophotometric, chromatographic (HPLC). Results. The basic physicochemical and technological properties of furosemide have been studied. It has been established that furosemide, as a practically insoluble substance in water, is advisable to introduce into the composition of a drug with local resorptive action in the form of a water-soluble derivative. Methods have been developed for the determination of furosemide in lozenges using two methods, spectrophotometry and HPLC, which meet the main validation criteria, are characterized by accuracy, reproducibility, relative ease of execution, and allow for quality control of the drug at all stages of production. Conclusion. The physicochemical properties of furosemide make it possible to obtain water-soluble derivatives that can be included in dosage forms with local resorptive action. We have obtained furosemide in the form of a potassium salt, which is the active ingredient of lozenges, the composition of the tablets has been selected and tested, and pilot series have been developed. Methods for the detection and quantitative determination of furosemide have been developed, tested and certified.

high-performance liquid chromatography.

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