Romanian Society of Pharmaceutical Sciences

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COMPATIBILITY STUDY BETWEEN MAGNESIUM OROTATE AND VARIOUS EXCIPIENTS IN THEIR PHYSICAL MIXTURES

CORINA MOISA 1, OANA CADAR 2, ERIKA ANDREA LEVEI 2, LAURA MUREȘAN 3, MARIANA GANEA 1, SEBASTIAN NEMETH 1, SIMONA CAVALU 4, LUCIANA DOBJANSCHI 4, MIHAELA ZDRINCA 4*, REKA BARABAS 5, FLORIN BĂNICĂ 1

1University of Oradea, Medicine and Pharmacy Faculty, Department of Pharmacy, 29 Nicolae Jiga Street, 410028 Oradea, Romania
2INCDO-INOE 2000, Research Institute for Analytical Instrumentation, 67 Donath Street, 400293 Cluj-Napoca, Romania 3Babes-Bolyai University, “Raluca Ripan” Institute for Research in Chemistry, Fântânele Street 30, 400294 Cluj-Napoca,
Romania
4University of Oradea, Medicine and Pharmacy Faculty, Department of Medical Disciplines, 1 Decembrie Street, 410028 Oradea, Romania
5Babeş-Bolyai University, Faculty of Chemistry and Chemical Engineering, 11 Arany Janos Street, 400028 Cluj-Napoca, Romania

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The assessment of magnesium orotate compatibility with various excipients is an important step in the development of drug formulation and development. A good physicochemical compatibility between magnesium orotate and different excipients allows obtaining novel combinations with a complex composition that enhances the therapeutic effect of magnesium orotate. The purpose of this research was to assess the compatibility of magnesium orotate with various excipients presently used in pharmaceutical formulations in a 1:1 mass ratio, which was higher than what was currently used in drug formulation, with the possibility of influencing the expected therapeutic benefit by delaying magnesium orotate release. The compatibility of the most used excipients (croscarmellose, corn starch, lactate, magnesium stearate, microcrystalline cellulose, polyvinylpyrrolidone and talcum) with magnesium orotate was assessed by investigating the TG–DTA-DTG curves, FTIR spectra and XRD pattern of the excipients and their physical mixture with magnesium orotate. A partial compatibility of magnesium orotate with corn starch, cellulose and croscarmellose was noticed based on thermal analysis. The FTIR spectra and TG-DTG results indicated the best stability of magnesium orotate in combination with polyvinyl-pyrrolidone, while a possible incompatibility between magnesium orotate and talcum was evidenced based upon FTIR spectra. No modifications in XRD pattern of magnesium orotate was noticed in the spectra corresponding to binary combinations. By corroborating the results, one can conclude that polyvinyl-pyrrolidone is the best choice as excipient for magnesium orotate.