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Thermal analysis and compatibility studies of prednicarbate with excipients used in semi solid pharmaceutical form

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Abstract

Differential Scanning Calorimetry (DSC), thermogravimetry/derivative thermogravimetry (TG/DTG) and infrared spectroscopy (IR) techniques were used to investigate the compatibility between prednicarbate and several excipients commonly used in semi solid pharmaceutical form. The thermoanalytical studies of 1:1 (m/m) drug/excipient physical mixtures showed that the beginning of the first thermal decomposition stage of the prednicarbate (T onset value) was decreased in the presence of stearyl alcohol and glyceryl stearate compared to the drug alone. For the binary mixture of drug/sodium pirrolidone carboxilate the first thermal decomposition stage was not changed, however the DTG peak temperature (T peak DTG) decreased. The comparison of the IR spectra of the drug, the physical mixtures and of the thermally treated samples confirmed the thermal decomposition of prednicarbate. By the comparison of the thermal profiles of 1:1 prednicarbate:excipients mixtures (methylparaben, propylparaben, carbomer 940, acrylate crosspolymer, lactic acid, light liquid paraffin, isopropyl palmitate, myristyl lactate and cetyl alcohol) no interaction was observed.

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Acknowledgements

The authors acknowledge to Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq), Coordenação de Aperfeiçoamento de Pessoal de Nível Superio (CAPES), Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP) and Stiefel Laboratories for the financial support.

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Authors and Affiliations

  1. Faculdade de Ciências Farmacêuticas, Universidade de São Paulo, Av. Prof. Lineu Prestes, 580, São Paulo, Brazil

    H. Salvio Neto

  2. Research Group of Technical Analytical Chemistry, Hungarian Academy of Sciences, Budapest University of Technology and Economics, Szt. Gellert ter 4, 1111, Budapest, Hungary

    Cs. Novák

  3. Departamento de Química Fundamental, Instituto de Química, Universidade de São Paulo-USP, Av. Prof. Lineu Prestes, 748, Cidade Universitária, São Paulo, Brazil

    J. R. Matos

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  1. H. Salvio Neto
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  2. Cs. Novák
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  3. J. R. Matos
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Correspondence to H. Salvio Neto or J. R. Matos.

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Neto, H.S., Novák, C. & Matos, J.R. Thermal analysis and compatibility studies of prednicarbate with excipients used in semi solid pharmaceutical form. J Therm Anal Calorim 97, 367 (2009). https://doi.org/10.1007/s10973-009-0234-x

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  • DOI: https://doi.org/10.1007/s10973-009-0234-x

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