کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
2486284 | 1114379 | 2010 | 8 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
A PAT Approach to Improve Process Understanding of High Shear Wet Granulation Through In-Line Particle Measurement Using FBRM C35
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کلمات کلیدی
Focused beam reflectance measurement (FBRM)Particle size - اندازه ذراتParticle size distribution (PSD) - توزیع اندازه ذرات (PSD)Design of Experiments (DOE) - طراحی آزمایش (DOE)Process analytical technology (PAT) - فن آوری تحلیلی فرآیند (PAT)Quality by design (QbD) - کیفیت با طراحی (QbD)High shear wet granulation - گرانوله مرطوب برشی بالا
موضوعات مرتبط
علوم پزشکی و سلامت
داروسازی، سم شناسی و علوم دارویی
اکتشاف دارویی
پیش نمایش صفحه اول مقاله
![عکس صفحه اول مقاله: A PAT Approach to Improve Process Understanding of High Shear Wet Granulation Through In-Line Particle Measurement Using FBRM C35 A PAT Approach to Improve Process Understanding of High Shear Wet Granulation Through In-Line Particle Measurement Using FBRM C35](/preview/png/2486284.png)
چکیده انگلیسی
This article summarizes the investigation of in-line particle characterization during high shear wet granulation (HSWG) using focused beam reflectance measurement (FBRM) for enhanced process understanding, which is part of an effort to develop this drug product within the framework of quality by design (QbD) and process analytical technology (PAT). Traditionally, the effectiveness of in-line monitoring of HSWG processes is hindered by wet and sticky material fouling the probe resulting in inconsistent and erroneous data collection. For this study, a FBRM C35 probe was used which incorporates a scraping mechanism to maintain a clean probe window ensuring consistent measurements throughout each batch. The evaluations were conducted on nine scale-up DOE development batches and eight clinical sub-lots. In the DOE campaign, the purpose of FBRM was used to study the impact of varying water amount and wet massing time on granule dimension and count during granulation, while batch-to-batch variation or batch reproducibility was evaluated under the same process conditions for the clinical batches. In addition, a preliminary investigation of the most optimal probe position was conducted. The results indicate that FBRM is capable of monitoring the rate and degree of change to granule dimension/count during HSWG, and could be a potential technique for granulation endpoint determination.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical Sciences - Volume 99, Issue 7, July 2010, Pages 3205-3212
Journal: Journal of Pharmaceutical Sciences - Volume 99, Issue 7, July 2010, Pages 3205-3212
نویسندگان
Jun Huang, Goldi Kaul, Julia Utz, Pedro Hernandez, Victor Wong, Daragh Bradley, Arwinder Nagi, Des O'Grady,