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Solid-state preformulation studies of amiodarone hydrochloride

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Abstract

This paper deals with the application of fast screening tools such as FTIR, thermal analysis and DSC in the evaluation of compatibility between the active pharmaceutical ingredient amiodarone hydrochloride and different pharmaceutical excipients used in tablet formulations, such as polyvinylpyrrolidone, microcrystalline cellulose, starch, talc and anhydrous lactose. Samples were investigated initially immediately after preparation by FTIR analysis and later by TG/DTG/HF technique. It was found that under ambient condition, amiodarone hydrochloride was compatible with all selected excipients. During the non-isothermal thermal treatment in oxidative atmosphere, amiodarone showed incompatibility with lactose. The final investigations consisted of maintaining the samples under moderate thermal stress (48 h at 40 °C), when DSC investigations revealed that thermal-induced interactions occurred with all selected excipients except talc.

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Acknowledgements

This work was partly supported by the strategic grant POSDRU/159/1.5/S/137750, Project “Doctoral and Postdoctoral programs support for increased competitiveness in Exact Sciences research” cofinanced by the European Social Fund within the Sectoral Operational Programme Human Resources Development 2007–2013 to Ionuţ Ledeţi.

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Authors and Affiliations

  1. Faculty of Pharmacy, University of Medicine and Pharmacy “Victor Babeş”, Eftimie Murgu Square 2, 300041, Timisoara, Romania

    Adriana Ledeţi, Ionuţ Ledeţi & Lenuţa-Maria Şuta

  2. Research Center for Thermal Analysis in Environmental Problems, West University of Timisoara, Pestalozzi Street 16, 300115, Timisoara, Romania

    Gabriela Vlase & Titus Vlase

  3. Faculty of Industrial Chemistry and Environmental Engineering, Politehnica University Timişoara, 6 Carol Telbisz, 300001, Timisoara, Romania

    Vasile Bercean

  4. Faculty of Medicine, Department of Surgery II, First Surgical Clinic, University of Medicine and Pharmacy “Victor Babeş”, Eftimie Murgu Square 2, 300041, Timisoara, Romania

    Marius Sorin Murariu

Authors
  1. Adriana Ledeţi
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  2. Gabriela Vlase
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  3. Titus Vlase
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  4. Vasile Bercean
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  6. Ionuţ Ledeţi
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  7. Lenuţa-Maria Şuta
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Correspondence to Ionuţ Ledeţi.

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Ledeţi, A., Vlase, G., Vlase, T. et al. Solid-state preformulation studies of amiodarone hydrochloride. J Therm Anal Calorim 126, 181–187 (2016). https://doi.org/10.1007/s10973-016-5256-6

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  • DOI: https://doi.org/10.1007/s10973-016-5256-6

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