Lubricant-Induced Crystallization of Itraconazole From Tablets Made of Electrospun Amorphous Solid Dispersion.

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ID: 58029
2016
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Abstract
Investigation of downstream processing of nanofibrous amorphous solid dispersions to generate tablet formulation is in a quite early phase. Development of high speed electrospinning opened up the possibility to study tableting of electrospun solid dispersions (containing polyvinylpyrrolidone-vinyl acetate and itraconazole [ITR] in this case). This work was conducted to investigate the influence of excipients on dissolution properties and the feasibility of scaled-up rotary press tableting. The dissolution rates from tablets proved to be mainly composition dependent. Magnesium stearate acted as a nucleation promoting agent (providing an active hydrophobic environment for crystallization of ITR) hindering the total dissolution of ITR. This crystallization process proved to be temperature dependent as well. However, the extent of dissolution of more than 95% was realizable when a less hydrophobic lubricant, sodium stearyl fumarate (soluble in the medium), was applied. Magnesium stearate induced crystallization even if it was put in the dissolution medium next to proper tablets. After optimization of the composition, scaled-up tableting on a rotary press was carried out. Appropriate dissolution of ITR from tablets was maintained for 3 months at 25°C/60% relative humidity. HPLC measurements confirmed that ITR was chemically stable both in the course of downstream processing and storage.
Reference Key
dmuth2016lubricantinducedjournal Use this key to autocite in the manuscript while using SciMatic Manuscript Manager or Thesis Manager
Authors Démuth, Balázs;Farkas, Attila;Balogh, Attila;Bartosiewicz, Karolina;Kállai-Szabó, Barnabás;Bertels, Johny;Vigh, Tamás;Mensch, Jurgen;Verreck, Geert;Van Assche, Ivo;Marosi, György;Nagy, Zsombor K;
Journal journal of pharmaceutical sciences
Year 2016
DOI
S0022-3549(16)41406-1
URL
Keywords
Crystallization Raman Spectroscopy nanotechnology chemical stability solid dispersion dissolution amorphous oral drug delivery tableting

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