کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
8513241 | 1556492 | 2018 | 40 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Development of Stabilizing Formulations of a Trivalent Inactivated Poliovirus Vaccine in a Dried State for Delivery in the Nanopatch⢠Microprojection Array
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کلمات کلیدی
LCPbOPVtOPVwpvVAPPcVDPVPS80IPVDPBSDTTBSA - BSAbovine serum albumin - آلبومین سرم گاوphosphate buffer - بافر فسفاتELISA - تست الیزاEnzyme-linked immunosorbent assay - تست الیزاStability - ثباتdithiothreitol - دیتیوتریتولDelivery - زایمانVaccine-associated paralytic poliomyelitis - سندرم تخمدان پلی کیستیFormulation - فرمولاسیونDulbecco's phosphate buffered saline - فسفات باسیل نمک DulbeccoVaccine - واکسنinactivated polio vaccine - واکسن فلج اطفال غیر فعال شدهWild poliovirus - ویروس ویولون وحشیPolysorbate 80 - پلی ساکارید 80Liquid crystal polymer - پلیمر کریستال مایعPoliovirus - پلیو ویروس
موضوعات مرتبط
علوم پزشکی و سلامت
داروسازی، سم شناسی و علوم دارویی
اکتشاف دارویی
پیش نمایش صفحه اول مقاله
چکیده انگلیسی
The worldwide switch to inactivated polio vaccines (IPVs) is a key component of the overall strategy to achieve and maintain global polio eradication. To this end, new IPV vaccine delivery systems may enhance patient convenience and compliance. In this work, we examine Nanopatch⢠(a solid, polymer microprojection array) which offers potential advantages over standard needle/syringe administration including intradermal delivery and reduced antigen doses. Using trivalent IPV (tIPV) and a purpose-built evaporative dry-down system, candidate tIPV formulations were developed to stabilize tIPV during the drying process and on storage. Identifying conditions to minimize tIPV potency losses during rehydration and potency testing was a critical first step. Various classes and types of pharmaceutical excipients (â¼50 total) were then evaluated to mitigate potency losses (measured through D-antigen ELISAs for IPV1, IPV2, and IPV3) during drying and storage. Various concentrations and combinations of stabilizing additives were optimized in terms of tIPV potency retention, and 2 candidate tIPV formulations containing cyclodextrin and a reducing agent (e.g., glutathione), maintained â¥80% D-antigen potency during drying and subsequent storage for 4 weeks at 4°C, and â¥60% potency for 3 weeks at room temperature with the majority of losses occurring within the first day of storage.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical Sciences - Volume 107, Issue 6, June 2018, Pages 1540-1551
Journal: Journal of Pharmaceutical Sciences - Volume 107, Issue 6, June 2018, Pages 1540-1551
نویسندگان
Ying Wan, John M. Hickey, Christopher Bird, Katey Witham, Paul Fahey, Angus Forster, Sangeeta B. Joshi, David B. Volkin,