کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
2484967 1114342 2013 5 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Differentiation of Subvisible Silicone Oil Droplets from Irregular Standard Dust Particles
موضوعات مرتبط
علوم پزشکی و سلامت داروسازی، سم شناسی و علوم دارویی اکتشاف دارویی
پیش نمایش صفحه اول مقاله
Differentiation of Subvisible Silicone Oil Droplets from Irregular Standard Dust Particles
چکیده انگلیسی
New methods are being applied to distinguish silicone oil droplets from subvisible particles in therapeutic protein formulations. The need to standardize these methods and compare them to established methods is critical to increase the understanding of the risks from protein aggregation and other subvisible particulate matter. We present the use of medium test dust (MTD) as a stable subvisible particle standard that can be distinguished from silicone oil by flow imaging methodology and the combination of light obscuration and microscopic methods. We further present the use of binary classification techniques to characterize the ability of flow imaging to distinguish between particle types (i.e., silicone vs. protein, silicone vs. standard, etc.) as a function of particle size. For the differentiation of silicone oil and MTD, the aspect ratio attribute was as good as or better than any other characteristic or combination of two characteristics applied to distinguish this particle population. However, the value of the discrimination by flow imaging was limited to particles larger than 5 μm. © 2013 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 102:1696-1700, 2013
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical Sciences - Volume 102, Issue 6, June 2013, Pages 1696-1700
نویسندگان
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