کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
620963 | 882524 | 2014 | 38 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Thermodynamically stable amorphous drug dispersions in amorphous hydrophilic polymers engineered by hot melt extrusion
ترجمه فارسی عنوان
پراکندگی مواد مخدر مقاوم در معرض ترمودینامیکی در پلیمرهای هیدرولیکی غیر آلی که توسط اکستروژن ذوب داغ
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کلمات کلیدی
اکستروژن داغ ذوب، پراکندگی جامد، ماتریکس پلیمر، دمای انتقال شیشه، آمورف کریستالی
موضوعات مرتبط
مهندسی و علوم پایه
مهندسی شیمی
تصفیه و جداسازی
چکیده انگلیسی
In this study thermodynamically stable dispersions of amorphous quinine, a model BCS class 2 therapeutic agent, within an amorphous polymeric platform (HPC), termed a solid-in-solid dispersion, were produced using hot melt extrusion. Characterisation of the pre-extrudates and extrudates was performed using hyper-differential scanning calorimetry (DSC), powder X-ray diffraction (PXRD) and Raman spectroscopy. Water uptake by the raw materials was determined using dynamic vapour sorption (DVS) analysis. Furthermore, the presence or absence of crystalline drug following storage at 25 °C/60% relative humidity and 40 °C/75% relative humidity in a sealed glass jar, and at 40 °C/75% relative humidity in an open glass jar for 3 months was determined using PXRD. Amorphous quinine was generated in situ during extrusion from both quinine base (5%, 10%, 20% w/w drug loading) and from quinine hydrochloride (5%, 10% w/w drug loading) and remained thermodynamically stable as a solid-in-solid dispersion within the HPC extrudates. When processed with HPC, quinine hydrochloride (20% w/w) was converted to amorphous quinine hydrochloride. Whilst stable for up to 3 months when stored under sealed conditions, this amorphous form was unstable, resulting in recrystallisation of the hydrochloride salt following storage for 1 month at 40 °C/75% relative humidity in an open glass jar. The behaviour of the amorphous quinine hydrochloride (20% w/w) HPC extrudate was related, at least in part, to the lower stability and the hygroscopic properties of this amorphous form.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Chemical Engineering Research and Design - Volume 92, Issue 12, December 2014, Pages 3046-3054
Journal: Chemical Engineering Research and Design - Volume 92, Issue 12, December 2014, Pages 3046-3054
نویسندگان
David S. Jones, Daniel N. Margetson, Mark S. McAllister, Tao Yu, Li Shu, Colin P. McCoy, Gavin P. Andrews,