Preformulation studies for atorvastatin calcium

An instrumental approach
  • Mihaela Cristea
  • Bianca Baul
  • Ionuţ LedeţiEmail author
  • Adriana Ledeţi
  • Gabriela Vlase
  • Titus Vlase
  • Bożena Karolewicz
  • Oana Ştefănescu
  • Anca Octavia Dragomirescu
  • Cezara Mureşan
  • Dan-Simion Cipu
  • Dana Velimirovici
  • Mircea Ştefănescu


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.


Atorvastatin Compatibility study Excipient FTIR PXRD Statin Thermal stability 



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Copyright information

© Akadémiai Kiadó, Budapest, Hungary 2019

Authors and Affiliations

  • Mihaela Cristea
    • 1
  • Bianca Baul
    • 2
  • Ionuţ Ledeţi
    • 2
    Email author
  • Adriana Ledeţi
    • 2
  • Gabriela Vlase
    • 3
  • Titus Vlase
    • 3
  • Bożena Karolewicz
    • 4
  • Oana Ştefănescu
    • 1
  • Anca Octavia Dragomirescu
    • 2
  • Cezara Mureşan
    • 5
  • Dan-Simion Cipu
    • 5
  • Dana Velimirovici
    • 5
  • Mircea Ştefănescu
    • 1
  1. 1.Faculty of Industrial Chemistry and Environmental EngineeringPolitehnica University of TimişoaraTimişoaraRomania
  2. 2.Faculty of PharmacyUniversity of Medicine and Pharmacy “Victor Babeş”TimişoaraRomania
  3. 3.Research Centre for Thermal Analysis in Environmental ProblemsWest University of TimisoaraTimişoaraRomania
  4. 4.Department of Drug Form TechnologyWroclaw Medical UniversityWroclawPoland
  5. 5.Faculty of MedicineUniversity of Medicine and Pharmacy “Victor Babeş”TimişoaraRomania

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