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Preformulation studies for atorvastatin calcium

An instrumental approach

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Abstract

This paper deals with the study of compatibility between antihyperlipidemic agent atorvastatin calcium trihydrate (ATV) and eight pharmaceutical excipients used in the development of solid dosage forms, namely citric acid, anhydrous lactose, magnesium citrate, magnesium carbonate, sodium carboxymethyl cellulose, polyvinylpyrrolidone K30, colloidal silica and sorbitol. As investigational tools, universal attenuated total reflectance Fourier transform infrared spectroscopy and powder X-ray diffractogram patterns were used for binary mixtures of ATV with each excipient at ambient condition and then completed by subjecting the samples to thermal stress using thermal analysis (TG/DTG/HF), in non-isothermal conditions and in oxidative medium. It was shown the binary mixtures do not present interactions between ATV and excipients when stored under ambient conditions for 2 months, while under thermal stress, ATV presents interactions with sorbitol.

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Authors and Affiliations

  1. Faculty of Industrial Chemistry and Environmental Engineering, Politehnica University of Timişoara, Vasile Parvan Street 6, 300223, Timişoara, Romania

    Mihaela Cristea, Oana Ştefănescu & Mircea Ştefănescu

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

    Bianca Baul, Ionuţ Ledeţi, Adriana Ledeţi & Anca Octavia Dragomirescu

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

    Gabriela Vlase & Titus Vlase

  4. Department of Drug Form Technology, Wroclaw Medical University, Borowska 211A, 50-556, Wroclaw, Poland

    Bożena Karolewicz

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

    Cezara Mureşan, Dan-Simion Cipu & Dana Velimirovici

Authors
  1. Mihaela Cristea
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  2. Bianca Baul
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  3. Ionuţ Ledeţi
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  4. Adriana Ledeţi
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  5. Gabriela Vlase
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  8. Oana Ştefănescu
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Correspondence to Ionuţ Ledeţi.

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Cristea, M., Baul, B., Ledeţi, I. et al. Preformulation studies for atorvastatin calcium. J Therm Anal Calorim 138, 2799–2806 (2019). https://doi.org/10.1007/s10973-019-08798-1

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  • DOI: https://doi.org/10.1007/s10973-019-08798-1

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