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Thermal characterization of antimicrobial drug ornidazole and its compatibility in a solid pharmaceutical product

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Abstract

The ornidazole drug substance presents melt at approximately 90 °C (∆T = 85–98 °C), which is critical for its use on pharmaceutical manufacturing process. This work aimed the thermal characterization of ornidazole raw-material synthesized by three different manufacturers from India, China, and Italy, using the thermoanalytical techniques of DTA, DSC, and TG, besides the verification of its stability and compatibility as a solid pharmaceutical product by the analysis of its binary mixtures (BM) with excipients and a tablet formulation. The characterization includes the thermal decomposition kinetic investigation by Ozawa model using Arrhenius equation and drug purity determination by Van’t Hoff equation. The DSC purity determination and precision were compared with results from UV–Vis spectrophotometric and liquid chromatography, showing an adequate correlation before being recommended as a general method for purity assay. The drug raw-materials presented similar quality and zero-order kinetic behavior, besides showing differences on thermal stability. The drug presented compatibility with the tested excipients since the BM studied presented melting at the same temperature range as the drug and a decomposition temperature similar to the drug for two of the BM, and at a higher temperature for the others three of the BM evaluated, which presented excipients with higher molecular structure, capable of spatial coating on the small drug molecule promoting a physical interaction pharmaceutical acceptable. The tablet was processed by wet granulation and compressed under normal conditions of pressure and temperature, maintaining the physical properties of solid drug approving the manufacturing process used. In this study, the thermal analysis was used with success as an alternative method to characterize, quantify, and perform a preformulation study.

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Authors and Affiliations

  1. Department of Pharmaceutical Sciences, Federal University of Pernambuco, Arthur de Sá, s/n, Recife, PE, 50740-521, Brazil

    Monica Felts de La Roca Soares, José Lamartine Soares-Sobrinho, Keyla Emanuelle Ramos da Silva, Lariza Darlene Santos Alves & Pedro José Rolim-Neto

  2. Core of Pharmaceutical Technology, Federal University of Piauí, Campus Universitário Ministro Petrônio Portella. s/n, Teresina, PI, 64049-550, Brazil

    Monica Felts de La Roca Soares & José Lamartine Soares-Sobrinho

  3. Pharmaceutical Sciences Department, Federal University of Paraíba, João Pessoa, PB, Brazil

    Pablo Queiroz Lopes, Lidiane Pinto Correia, Fábio Santos de Souza & Rui Oliveira Macêdo

Authors
  1. Monica Felts de La Roca Soares
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  2. José Lamartine Soares-Sobrinho
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  3. Keyla Emanuelle Ramos da Silva
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  4. Lariza Darlene Santos Alves
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  5. Pablo Queiroz Lopes
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  6. Lidiane Pinto Correia
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  7. Fábio Santos de Souza
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  8. Rui Oliveira Macêdo
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  9. Pedro José Rolim-Neto
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Correspondence to Pedro José Rolim-Neto.

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Soares, M.F.d.L.R., Soares-Sobrinho, J.L., da Silva, K.E.R. et al. Thermal characterization of antimicrobial drug ornidazole and its compatibility in a solid pharmaceutical product. J Therm Anal Calorim 104, 307–313 (2011). https://doi.org/10.1007/s10973-010-1185-y

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  • DOI: https://doi.org/10.1007/s10973-010-1185-y

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