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SM ISO690:2012 RUS, Lucia Maria, IURIAN, Sonia, KACSO, Irina E., BORODI, Gheorghe, HEGHES, Simona Codruta, IUGA, Cristina Adela, TOMUTA, Ioan. Physical characterisation used for the development of a stable freeze-dried meloxicam formulation. In: Central and Eastern European Conference on Thermal Analysis and Calorimetry, Ed. 4, 28-31 august 2017, Chişinău. Germany: Academica Greifswald, 2017, Editia 4, p. 241. ISBN 978-3-940237-47-7. |
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Central and Eastern European Conference on Thermal Analysis and Calorimetry Editia 4, 2017 |
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Conferința "Central and Eastern European Conference" 4, Chişinău, Moldova, 28-31 august 2017 | |
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Pag. 241-241 | |
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Meloxicam is a non steroidal anti-inflammatory used in the form of tablets for the symptomatic treatment of inflammatory conditions in the elderly. The objective of this study was the characterization by physical methods of the formulations developed to obtain meloxicam oral lyophilisates. In the first stage of the study, meloxicam-excipient compatibility studies were realized, using Differential Scanning Calorimetry DSC, X-ray Powder Diffraction XRPD and Infrared Spectroscopy FTIR methods [1]. In the second stage, the glass transition temperature (Tg') of formulations containing meloxicam and excipients compatible with the drug chosen from the first stage, was determined using a DSC method. The same formulations were also subjected to an annealing program by DSC, in order to obtain a complete crystallization. In the third stage, the lyophilized formulations were analyzed by DSC and XRPD to determine the crystallinity and by Thermogravimetric Analysis TGA for the residual water content [2, 3]. Following studies in the preformulation stage, excipients compatible with the drug substance (gelatin, sodium alginate, mannitol, croscarmellose, polyvinylpyrrolidone K30, poloxamer 188, polyethylene glycol 4000) were chosen. The formulations were the freeze-dried according to the results in the second stage. It has been determined the degree of crystallinity of the meloxicam oral lyophilizated and their residual water content. Thus, it was elaborated an optimal lyophilization cycle for the achievement of meloxicam oral lyophilizates. |
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