Study of paracetamol-containing pastilles produced by melt technology

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• 作者：Gábor Katona ; Péter Sipos ; Patrick Frohberg…
• 关键词：Eutectic mixture ; Sugar alcohols ; Melt technology ; Paracetamol ; Pastilles
• 刊名：Journal of Thermal Analysis and Calorimetry
• 出版年：2016
• 出版时间：March 2016
• 年：2016
• 卷：123
• 期：3
• 页码：2549-2559
• 全文大小：1,673 KB
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• 作者单位：Gábor Katona (1) (3)
  Péter Sipos (1)
  Patrick Frohberg (2)
  Joachim Ulrich (2)
  Piroska Szabó-Révész (1)
  Orsolya Jójárt-Laczkovich (1)
  
  1. Department of Pharmaceutical Technology, University of Szeged, Eötvös 6, Szeged, 6720, Hungary
  3. Richter Gedeon Plc., Budapest, Gyömrői 19-21, Budapest, 1103, Hungary
  2. Centre of Engineering Science, Thermal Process Engineering, Martin Luther University Halle-Wittenberg, 06099, Halle, Germany
  
• 刊物类别：Chemistry and Materials Science
• 刊物主题：Chemistry
  Sciences
  Polymer Sciences
  Physical Chemistry
  Inorganic Chemistry
  Measurement Science and Instrumentation
  
• 出版者：Akad茅miai Kiad贸, co-published with Springer Science+Business Media B.V., Formerly Kluwer Academic
• ISSN：1572-8943

文摘

The focus of this work was to apply melt technology for the formulation of a pastille containing paracetamol (PCT) in a solid dispersion with two sugar alcohols (xylitol and mannitol) and polyethylene glycol 6000 (PEG) as the carrier system components. Optimization of the pastillization was performed both statistically by using the Box–Behnken design and experimentally by determining the phase diagrams. For the latter and recrystallization of the components, differential scanning calorimetry detection was utilized. The developed pastilles consisted of a eutectic mixture of xylitol (61.25 %) and mannitol (15.31 %) with PEG (7.81 %) as carrier system together with PCT (15.63 %). The components of the pastilles underwent recrystallization at different rates for 5 days. Transmission Raman spectroscopy revealed the homogeneous distribution of the PCT in the pastille. X-ray powder diffractometry showed that the recrystallization of the PCT resulted in its monoclinic form I, while dispersive Raman spectroscopy detected both the monoclinic and orthorhombic forms. The drop-melted pastilles displayed relatively high hardness, and the PCT dissolved within 15 min. It is concluded that pastillization can be achieved through melt technology and the structure and the technological parameters of the pastille are suitable for the development of lozenges as a solid dosage form for children therapy.