کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
620580 | 882491 | 2014 | 9 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
The influence of spiral jet-milling on the physicochemical properties of carbamazepine form III crystals: Quality by design approach
ترجمه فارسی عنوان
تأثیر جت میلز مارپیچ روی خواص فیزیکوشیمیایی کریستالهای فرم 450 کاربامازپین: کیفیت طراحی با رویکرد
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کلمات کلیدی
جت فرز، کاربامازپین، طرح غربالگری فاکتوریل، اندازه ذرات، پلی مورفیسم، کیفیت طراحی
موضوعات مرتبط
مهندسی و علوم پایه
مهندسی شیمی
تصفیه و جداسازی
چکیده انگلیسی
The purpose of this study was to investigate the influence of spiral jet-milling process on the physicochemical characteristics of α polymorphic active pharmaceutical ingredient, using Carbamazepine form III as a model drug, and taking into consideration Quality by Design (QbD) approach to pharmaceutical development. A 2(4-1) factorial screening design was implemented to identify the spiral jet-milling process variables that significantly affect the particle size distribution of milled samples. Diameter of injector nozzles, diameter of ring nozzles and air pressure were selected for further analysis using a 2(3-1) factorial experimental design. Particle size distribution of additional samples was determined, while physicochemical properties were examined by differential scanning calorimetry (DSC), hot-stage polarized microscopy (HSPM), attenuated total reflectance Fourier transform infrared spectroscopy (ATR-FTIR), and compared to those of un-milled drug. The gathered results shown that applied experimental design approach is capable to predict material behavior and could help in better understanding of material behavior during jet-milling process. Created design space (DS) provides assurance of product quality, expressed as the powder particle sizes lower than 5 μm, as well as, in initial polymorph form existence after jet-milling through combination and interaction of input variables.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Chemical Engineering Research and Design - Volume 92, Issue 3, March 2014, Pages 500-508
Journal: Chemical Engineering Research and Design - Volume 92, Issue 3, March 2014, Pages 500-508
نویسندگان
Marija DjokiÄ, Jelena DjuriÅ¡, Ljiljana Solomun, Kyriakos Kachrimanis, Zorica DjuriÄ, Svetlana IbriÄ,