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Compatibility study between indomethacin and excipients in their physical mixtures

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Abstract

Thermal analysis is a routine method for analysis of drugs and substances of pharmaceutical interest. Thermogravimetry/derivative thermogravimetry (TG/DTG) and differential scanning calorimetry (DSC) are thermoanalytical methods which offer important information about the physical and chemical properties of drugs (purity, stability, phase transition, polymorphism, compatibility, kinetic analysis, etc.). This work exemplifies a general method of studying the drug-excipient interactions with the aim of predicting rapidly and inexpensively the long thermal stability of their mixtures. The TG/DTG and DSC were used as screening techniques for assessing the compatibility between indomethacin (IND) and its physical associations as binary mixtures with some common excipients. Based on their frequent use in preformulations eleven different excipients: corn starch, microcrystalline cellulose (PH 101; PH 102), colloidal silicon dioxide, lactose (monohydrate and anhydre), polyvinilpyrrolidone K30, magnesium stearate, talc, stearic acid, and manitol were blended with IND. The samples were prepared by mixing the analyte and excipients in a proportion of 1:1 (w:w). In order to investigate the possible interactions between the components, the thermal curves of IND and each selected excipient were compared with those of their 1:1 (w/w) physical mixtures. FT-IR spectroscopy and X-ray powder diffraction were used as complementary techniques to adequately implement and assist in interpretation of thermal results. On the basis of thermal results, confirmed by FT-IR and X-ray analyses, a possible interaction was found between IND with polyvinylpyrrolidone K30, magnesium stearate, and stearic acid.

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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

    Bogdan Tita, Ionut Ledeti & Dumitru Tita

  2. Industrial Chemistry and Environmental Engineering Faculty, Politehnica University of Timişoara, Victoriei Square 2, 300006, Timisoara, Romania

    Geza Bandur

Authors
  1. Bogdan Tita
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  2. Ionut Ledeti
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  3. Geza Bandur
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  4. Dumitru Tita
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Correspondence to Bogdan Tita.

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Tita, B., Ledeti, I., Bandur, G. et al. Compatibility study between indomethacin and excipients in their physical mixtures. J Therm Anal Calorim 118, 1293–1304 (2014). https://doi.org/10.1007/s10973-014-3986-x

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  • DOI: https://doi.org/10.1007/s10973-014-3986-x

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