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Thermoanalytical investigation of olanzapine compatibility with excipients used in solid oral dosage forms

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Abstract

During preformulation studies of pharmaceutical solid dosage forms, thermal analysis techniques are very useful to detect physical or chemical incompatibilities between the drug and adjuvants of interest that might interfere with efficacy and safety of the final drug product. Differential scanning calorimetry (DSC) and thermogravimetry (TG) are useful tools for this purpose. The aim of this study was to investigate the thermoanalytical behavior of olanzapine (OLZ) when mixed with several excipients commonly used in solid dosage forms such as microcrystalline cellulose, croscarmellose, dicalcium phosphate dihydrate (DCPD), lactose, magnesium stearate, and povidone. Following DSC and TG analyses, powder X-ray diffraction tests were carried out. Thermoanalytical methods showed evidence of interaction between OLZ and magnesium stearate, lactose, and povidone. These results can be useful during the selection of excipients for pharmaceutical formulation development.

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Acknowledgements

The authors thank CAPES, CNPq, and FINEP for financial support, and Laboratório Teuto Brasileiro S/A.

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Authors and Affiliations

  1. Lab. Tecnologia Farmacêutica e Sistemas de Liberação de Fármacos, Faculdade de Farmácia, Universidade Federal de Goiás, Praça Universitária c/1ª, Avenida, Qd. 62, Goiânia, GO, 74605-220, Brazil

    Marco Júnio Peres-Filho, Marilisa Pedroso Nogueira Gaeti, Stela Ramirez de Oliveira, Ricardo Neves Marreto & Eliana Martins Lima

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  1. Marco Júnio Peres-Filho
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  2. Marilisa Pedroso Nogueira Gaeti
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  3. Stela Ramirez de Oliveira
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  4. Ricardo Neves Marreto
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  5. Eliana Martins Lima
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Correspondence to Eliana Martins Lima.

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Peres-Filho, M.J., Gaeti, M.P.N., de Oliveira, S.R. et al. Thermoanalytical investigation of olanzapine compatibility with excipients used in solid oral dosage forms. J Therm Anal Calorim 104, 255–260 (2011). https://doi.org/10.1007/s10973-010-1245-3

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  • DOI: https://doi.org/10.1007/s10973-010-1245-3

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