DEVELOPMENT OF MELOXICAM ORAL LYOPHILISATES: ROLE
OF THERMAL ANALYSIS AND COMPLEMENTARY TECHNIQUES
LUCIA MARIA RUS 1#, SONIA IURIAN 2#, IRINA KACSO 3, GHEORGHE BORODI 3, SEBASTIAN PORAV 3, SIMONA CODRUŢA HEGHEŞ 1, CRISTINA ADELA IUGA 1,4*, IOAN TOMUŢĂ 2
1“Iuliu Hațieganu” University of Medicine and Pharmacy Cluj-Napoca, Faculty of Pharmacy, Department of Drug Analysis, 6
Louis Pasteur Street, 400349 Cluj-Napoca, Romania
2“Iuliu Hațieganu” University of Medicine and Pharmacy Cluj-Napoca, Faculty of Pharmacy, Department of Pharmaceutical
Technology and Biopharmaceutics, 41 Victor Babeș Street, 400012 Cluj-Napoca, Romania
3National Institute of Research and Development for Isotopic and Molecular Technologies, 67-103 Donat Street, 400293 Cluj-
Napoca, Romania
4“Iuliu Hațieganu” University of Medicine and Pharmacy, Department of Proteomics and Metabolomics, MedFuture - Research
Centre for Advanced Medicine, 8 Victor Babeș Street, 400000 Cluj-Napoca, Romania
*corresponding author: iugac@umfcluj.ro
#Authors with equal contribution
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Abstract:
The purpose of this study was to highlight the way in which thermoanalytical and complementary techniques can guide the
development of meloxicam oral lyophilisates both in the preformulation and formulation stages, as well as for the final
products characterization. Thermoanalytical methods (differential scanning calorimetry – DSC, thermogravimetry – TGA)
and complementary methods (Fourier transform infrared – FTIR, X-Ray powder diffraction – XRPD, scanning electron
microscopy – SEM) were applied in order to obtain a complete set of data. In the preformulation stage, the compatibility
between meloxicam and excipients was assessed. DSC results showed the compatibility between meloxicam and excipients.
Tg’ measurement in the frozen state led to the addition of an annealing step at -25°C into the freezing stage, to facilitate
complete crystallization and end-product integrity. The designed lyophilization cycle yielded good cake appearance. The
DSC, XRPD analysis as well as SEM morphology studies, performed in the final stage, evidenced that the meloxicam freezedried
products were partially crystalline. By the TGA analysis the moisture content was evaluated in accordance or close to
the recommended limits. In conclusion, thermoanalytical techniques are well suited for the design of freeze-drying process,
in order to obtain good quality oral lyophilisates.






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