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    Amorphous solid dispersions of sulfonamide/soluplus® and sulfonamide/pvp prepared by ball milling

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    Date
    2013-02-07
    Author
    Caron, Vincent
    Hu, Yun
    Tajber, Lidia
    Erxleben, Andrea
    Corrigan, Owen I.
    McArdle, Patrick
    Healy, Anne Marie
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    Recommended Citation
    Caron, Vincent; Hu, Yun; Tajber, Lidia; Erxleben, Andrea; Corrigan, Owen I. McArdle, Patrick; Healy, Anne Marie (2013). Amorphous solid dispersions of sulfonamide/soluplus® and sulfonamide/pvp prepared by ball milling. AAPS PharmSciTech 14 (1), 464-474
    Published Version
    http://europepmc.org/articles/pmc3581644?pdf=render
    Abstract
    The aim of this paper is to investigate the physicochemical properties of binary amorphous dispersions of poorly soluble sulfonamide/polymeric excipient prepared by ball milling. The sulfonamides selected were sulfathiazole (STZ), sulfadimidine (SDM), sulfamerazine (SMZ) and sulfadiazine (SDZ). The excipients were polyvinylpyrrolidone (PVP) and polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft co-polymer, commercially known as Soluplus (R). Co-milled systems were characterised by powder X-ray diffraction and differential scanning calorimetry. PVP was shown to form amorphous dispersions over a wider composition range than Soluplus (R) for the four sulfonamides tested. Moreover, amorphous dispersions made with PVP were homogeneous [single glass transition (Tg)], while amorphous dispersions made from Soluplus (R) were heterogeneous (two Tgs). This behaviour is consistent with the fact that all the sulfonamides tested presented a lower solubility in Soluplus (R) than in PVP, as evidenced by Flory-Huggins parameters determined. Amorphous dispersions of SDM with Soluplus (R) could be produced even though SDM does not amorphise alone upon milling and Soluplus (R) presents Tg at a lower temperature than SDM. Amorphous dispersions of SMZ could be prepared with a lower excipient concentration compared to STZ, SDM and SDZ, which may reflect the one-dimensional H-bonding network in SMZ compared to the 2D or 3D H-bonding network found in the other sulfonamides. Stability tests (60% RH/25 degrees C) revealed that dispersions made with Soluplus (R) remained dry and powdery compared to those made with PVP that formed a sticky paste in less than 2 weeks, indicating a possible advantage of using Soluplus (R) in terms of increased physical stability under high humidity storage conditions.
    URI
    http://hdl.handle.net/10379/10706
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