Evaluation of some technological parameters for active pharmaceutical ingredient and excipients in the preformulation process of combined powder
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MAZUR, Ecaterina, GANDACOV, Vladilena, VALICA, Vladimir, UNCU, Livia. Evaluation of some technological parameters for active pharmaceutical ingredient and excipients in the preformulation process of combined powder. In: Perspectives of the Balkan medicine in the post COVID-19 era: The 37th Balkan Medical Week. The 8th congress on urology, dialysis and kidney transplant from the Republic of Moldova “New Horizons in Urology”, Ed. 37, 7-9 iunie 2023, Chişinău. București: Balkan Medical Union, 2023, Ediția 37, p. 270. ISSN Print: ISSN 1584-9244 ISSN-L 1584-9244 Online: ISSN 2558-815X.
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Perspectives of the Balkan medicine in the post COVID-19 era
Ediția 37, 2023
Congresul "Perspectives of the Balkan medicine in the post COVID-19 era"
37, Chişinău, Moldova, 7-9 iunie 2023

Evaluation of some technological parameters for active pharmaceutical ingredient and excipients in the preformulation process of combined powder


Pag. 270-270

Mazur Ecaterina1, Gandacov Vladilena1, Valica Vladimir12, Uncu Livia12
 
1 Scientific Center of Drug Research,
2 ”Nicolae Testemițanu” State University of Medicine and Pharmacy
 
 
Disponibil în IBN: 5 ianuarie 2024


Rezumat

Introduction. Powder represents a solid pharmaceutical form, which according to its composition, can be simple (has only one active pharmaceutical ingredient (API)) and compound (has more than one API). To ensure optimal stability and pharmacokinetics of APIs, excipients (E) are added to the powders as the diluents, lubricants, glidants, sweeteners, stabilizers. The aim of the work. Evaluation of technological parameters for Es and their mixtures in combination with APIs at the stage of the powders preformulation. Material and methods. Individual Es such as: microcrystalline cellulose, lactose monohydrate, d-mannitol (Cel.; Lact.; Himedia), citric acid (Chem-Lab), saccharin (Zah.; SigmaAldrich) were used; model M1-M12 mixtures of E and combinations of E with APIs (potassium aspartate, magnesium aspartate and potassium orotate (Sigma-Aldrich) and spironolactone, (Acros Organic)) were prepared; RADWAG analytical electronic balance, ERWEKA tapped density tester, VP12A powder flow speed tester were employed. Results. Mechanical mixtures of Es without APIs and with them were prepared according to the technological rules of powder preparation and analyzed in terms of the basic technological parameters, the values of which should not exceed the established limits: Carr’s Index (<26%), Hausner’s Ratio (<1.35), Angle of repose (<350), Flow speed (<100g/25s). Following the conducted research, those combinations of model mixtures, corresponding to these established limits for the technological parameters: M3 (SA23.6%, Cel-50%, Lact-16.4%, Zah-10%), M5 (SA-23.6%, Cel-66.4%, Zah-10%), M8 (SA23.6%, Cel-50%, Lact-26.4%,) were analyzed. Conclusions. Following these studies, the technologically optimal Es for the formulation of the compound powders were selected and three formulations were chosen, which will be used for the next stages of analysis.