Solid-state compatibility studies of a drug without melting point The case of omeprazole sodium

Veiga Andressa; Oliveira Paulo R.; Bernardi Larissa S.Mendes CassianaSilva Marcos A. S.Sangoi Maximiliano S.Janissek Paulo R.Murakami Fabio S.

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Solid-state compatibility studies of a drug without melting point The case of omeprazole sodium

机译：Solid-state compatibility studies of a drug without melting point The case of omeprazole sodium

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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.

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来源
《Journal of thermal analysis and calorimetry》 |2018年第3期|3201-3209|共9页
作者
Veiga Andressa; Oliveira Paulo R.; Bernardi Larissa S.Mendes CassianaSilva Marcos A. S.Sangoi Maximiliano S.Janissek Paulo R.Murakami Fabio S.;
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作者单位

Univ Fed Parana, Dept Pharm, Ave Pref Lothario Meissner 632, BR-80210170 Curitiba, PR, Brazil;

Univ Estadual Ctr Oeste UNICENTRO, Post Grad Program Pharmaceut Sci, BR-85040080 Guarapuava, PR, Brazil;

Univ Fed Santa Catarina, Qual Control Lab, BR-88040900 Florianopolis, SC, BrazilUniv Fed Rio de Janeiro, Lab Qual Control & Pharmaceut Anal, Fac Pharm, BR-27930560 Macae, RJ, BrazilUP, Pedro R Prof Viriato Parigot de Souza 5300, BR-81280330 Curitiba, PR, Brazil;

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正文语种英语
中图分类物理化学（理论化学）、化学物理学;
关键词
Drug without melting point; Omeprazole sodium; Pharmaceutical excipients; Solid-state interactions; Compatibility studies;

Solid-state compatibility studies of a drug without melting point The case of omeprazole sodium

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