کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
10162363 | 1114327 | 2014 | 9 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Functional Evaluation and Characterization of a Newly Developed Silicone Oil-Free Prefillable Syringe System
ترجمه فارسی عنوان
ارزیابی عملکردی و مشخصه یک سیستم سرنگ قابل انعطاف بدون سیلیکون تازه تولید شده
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کلمات کلیدی
تجمع پروتئین، شیمی در سطح، اندازه ذرات، ثبات، تجزیه و تحلیل تصویری، سرنگ تزریقی ثبات فیزیکی، روغن سیلیکون، نیروی قایقرانی، یکپارچگی بسته بندی ظرف،
موضوعات مرتبط
علوم پزشکی و سلامت
داروسازی، سم شناسی و علوم دارویی
اکتشاف دارویی
چکیده انگلیسی
The functionality of a newly developed silicone oil-free (SOF) syringe system, of which the plunger stopper is coated by a novel coating technology (i-coatingâ¢), was assessed. By scanning electron microscopy observations and other analysis, it was confirmed that the plunger stopper surface was uniformly covered with the designed chemical composition. A microflow imaging analysis showed that the SOF system drastically reduced both silicone oil (SO) doplets and oil-induced aggregations in a model protein formulation, whereas a large number of subvisible particles and protein aggregations were formed when a SO system was used. Satisfactory container closure integrity (CCI) was confirmed by means of dye and microorganism penetration studies. Furthermore, no significant difference between the break loose and gliding forces was observed in the former, and stability studies revealed that the SOF system could perfectly show the aging independence in break loose force observed in the SO system. The results suggest that the introduced novel SOF system has a great potential and represents an alternative that can achieve very low subvisible particles, secure CCI, and the absence of a break loose force. In particular, no risk of SO-induced aggregation can bring additional value in the highly sensitive biotech drug market. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical Sciences - Volume 103, Issue 5, May 2014, Pages 1520-1528
Journal: Journal of Pharmaceutical Sciences - Volume 103, Issue 5, May 2014, Pages 1520-1528
نویسندگان
Keisuke Yoshino, Koji Nakamura, Arisa Yamashita, Yoshihiko Abe, Kazuhiro Iwasaki, Yukie Kanazawa, Kaori Funatsu, Tsuyoshi Yoshimoto, Shigeru Suzuki,