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5346625 
Journal Article 
Solid-state compatibility studies of a drug without melting point The case of omeprazole sodium 
Veiga, A; Oliveira, PR; Bernardi, LS; Mendes, C; Silva, MAS; Sangoi, MS; Janissek, PR; Murakami, FS 
2018 
1 
Journal of Thermal Analysis and Calorimetry
ISSN: 1388-6150
EISSN: 1588-2926 
131 
3 
3201-3209 
WOS:000425965400106 
In preliminary pre-formulation studies, the evaluation of solid-state interactions between an active pharmaceutical ingredient and different excipients is essential to guarantee the quality of the final product. Studies of drug-excipient compatibility represent an important phase in the development of all dosage forms. In this study, to evaluate the possible solid-state interaction from thermal events other than the usual melting point, physical mixtures (1:1, w/w) of a model drug without melting point (omeprazole sodium) and a number of pharmaceutical excipients were investigated. Differential scanning calorimetry (DSC), differential diffuse reflectance infrared Fourier transform (DRIFT) and high-performance liquid chromatography (HPLC) methods were used. The properties of the pure drug were compared with those of a binary drug-excipient mixture (1:1; w/w). Evidence of solid-solid incompatibility of omeprazole sodium and Acryl-Eze((R)), stearic acid and citric acid was observed from the first decomposition step in the DSC curve and subsequently confirmed by DRIFT and HPLC analyses. 
Drug without melting point; Omeprazole sodium; Pharmaceutical excipients; Solid-state interactions; Compatibility studies