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Evaluation of solid-state thermal stability of donepezil in binary mixtures with excipients using instrumental techniques

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Abstract

Donepezil (Don) is one of the main compounds used in the therapy of Alzheimer’s disease. In this study, donepezil hydrochloride was investigated for solid-state compatibility with several pharmaceutical excipients like calcium lactate (CaL), mannitol (Man), magnesium stearate (MgSt), anhydrous lactose (LAnh), talc (T), magnesium citrate (MgC), sorbitol (Sb), silica (SiO2), polyvinylpyrrolidone K30 (PVP), sodium carboxymethylcellulose (NaCMC) and starch (St) under ambient conditions, by ATR–FTIR spectroscopy and PXRD data, and later by thermoanalytical techniques (TG/DTG/HF), in order to evaluate the thermal-induced interactions. The instrumental investigations carried at ambiental temperature revealed no interaction between Don and selected excipients, while thermal treatment induced interactions between components in eight binary mixtures, except the ones containing magnesium citrate, talc and polyvinylpyrrolidone.

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Acknowledgements

This work was supported by the PN-II-RU-TE-2014-4-0515 to Ionuţ Ledeţi, Gabriela Vlase, Lenuţa-Maria Şuta and Adriana Ledeţi.

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    Authors and Affiliations

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

      Ionut Ledeti, Gabriela Vlase, Denisa Circioban, Cristina Dehelean, Lenuta-Maria Suta, Angelica Caunii & Adriana Ledeti

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

      Sorin Bolintineanu & Marius Murariu

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

      Denisa Circioban & Titus Vlase

    Authors
    1. Ionut Ledeti
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    2. Sorin Bolintineanu
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    3. Gabriela Vlase
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    8. Adriana Ledeti
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    Correspondence to Adriana Ledeti.

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    Ionut Ledeti and Sorin Bolintineanu contributed equally to this work.

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    Ledeti, I., Bolintineanu, S., Vlase, G. et al. Evaluation of solid-state thermal stability of donepezil in binary mixtures with excipients using instrumental techniques. J Therm Anal Calorim 130, 425–431 (2017). https://doi.org/10.1007/s10973-017-6250-3

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    • DOI: https://doi.org/10.1007/s10973-017-6250-3

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