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    Comparative study of different methods for the prediction of drug-polymer solubility

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    Paluch_Molecular_Pharmaceutics.pdf (1.071Mb)
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    Publication date
    2015-07
    Author
    Knopp, M.M.
    Tajber, L.
    Tian, Y.
    Olesen, N.E.
    Jones, D.S.
    Kozyra, A.
    Lobmann, K.
    Paluch, Krzysztof J.
    Brennan, C.M.
    Holm, R.
    Healy, A.M.
    Andrews, G.P.
    Rades, T.
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    Keyword
    Solubility; Polymers; Solid dispersion; Thermal analysis; Thermodynamics; Calorimetry (DSC); Amorphous; Flory−Huggins; Melting point depression; Recrystallization
    Rights
    This document is the Accepted Manuscript version of a Published Work that appeared in final form in Molecular Pharmaceutics, copyright © 2015 American Chemical Society after peer review and technical editing by the publisher. To access the final edited and published work see http://dx.doi.org/10.1021/acs.molpharmaceut.5b00423
    Peer-Reviewed
    Yes
    
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    Abstract
    In this study, a comparison of different methods to predict drug−polymer solubility was carried out on binary systems consisting of five model drugs (paracetamol, chloramphenicol, celecoxib, indomethacin, and felodipine) and polyvinylpyrrolidone/vinyl acetate copolymers (PVP/VA) of different monomer weight ratios. The drug−polymer solubility at 25 °C was predicted using the Flory−Huggins model, from data obtained at elevated temperature using thermal analysis methods based on the recrystallization of a supersaturated amorphous solid dispersion and two variations of the melting point depression method. These predictions were compared with the solubility in the low molecular weight liquid analogues of the PVP/VA copolymer (N-vinylpyrrolidone and vinyl acetate). The predicted solubilities at 25 °C varied considerably depending on the method used. However, the three thermal analysis methods ranked the predicted solubilities in the same order, except for the felodipine−PVP system. Furthermore, the magnitude of the predicted solubilities from the recrystallization method and melting point depression method correlated well with the estimates based on the solubility in the liquid analogues, which suggests that this method can be used as an initial screening tool if a liquid analogue is available. The learnings of this important comparative study provided general guidance for the selection of the most suitable method(s) for the screening of drug−polymer solubility.
    URI
    http://hdl.handle.net/10454/14340
    Version
    Accepted Manuscript
    Citation
    Knopp MM, Tajber L, Tian Y et al (2015) Comparative study of different methods for the prediction of drug-polymer solubility. Molecular Pharmaceutics. 12(9): 3408-3419.
    Link to publisher’s version
    http://dx.doi.org/10.1021/acs.molpharmaceut.5b00423
    Type
    Article
    Collections
    Life Sciences Publications

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