کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
2485839 1114368 2012 7 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Nondestructive Detection of Glass Vial Inner Surface Morphology with Differential Interference Contrast Microscopy
موضوعات مرتبط
علوم پزشکی و سلامت داروسازی، سم شناسی و علوم دارویی اکتشاف دارویی
پیش نمایش صفحه اول مقاله
Nondestructive Detection of Glass Vial Inner Surface Morphology with Differential Interference Contrast Microscopy
چکیده انگلیسی
Glass particles generated by glass dissolution and delamination of the glass container for pharmaceutical products have become a major issue in the pharmaceutical industry. The observation of glass particles in certain injectable drugs, including several protein therapeutics, has recently resulted in a number of product recalls. Glass vial surface properties have been suggested to play a critical role in glass dissolution and delamination. Surface characterization of glass container, therefore, is important to evaluate the quality of the glass container. In this work, we demonstrate that differential interference contrast (DIC) microscopy is a powerful, effective, and convenient technique to examine the inner surface morphology of glass vials nondestructively. DIC microscopy does not require the cutting of the glass vial for scanning the inner surface and has sufficient spatial resolution to reveal glass pitting, phase separation, delamination scars, and other defects. Typical surface morphology of pharmaceutical glass vials with different alkalinity are compared and discussed.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical Sciences - Volume 101, Issue 4, April 2012, Pages 1378-1384
نویسندگان
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