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Preformulation studies for atorvastatin calcium |
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| Authors: | Cristea Mihaela Baul Bianca Ledeţi Ionuţ Ledeţi Adriana Vlase Gabriela Vlase Titus Karolewicz Bożena Ştefănescu Oana Dragomirescu Anca Octavia Mureşan Cezara Cipu Dan-Simion Velimirovici Dana Ştefănescu Mircea |
| Affiliation: | 1.Faculty of Industrial Chemistry and Environmental Engineering, Politehnica University of Timi?oara, Vasile Parvan Street 6, 300223, Timi?oara, Romania ;2.Faculty of Pharmacy, University of Medicine and Pharmacy “Victor Babe?”, Eftimie Murgu Square 2, 300041, Timi?oara, Romania ;3.Research Centre for Thermal Analysis in Environmental Problems, West University of Timisoara, Pestalozzi Street 16, 300115, Timi?oara, Romania ;4.Department of Drug Form Technology, Wroclaw Medical University, Borowska 211A, 50-556, Wroclaw, Poland ;5.Faculty of Medicine, University of Medicine and Pharmacy “Victor Babe?”, Eftimie Murgu Square 2, 300041, Timi?oara, Romania ; |
| 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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