کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
2485994 1114372 2012 13 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Influence of Formulation pH and Suspension State on Freezing-Induced Agglomeration of Aluminum Adjuvants
موضوعات مرتبط
علوم پزشکی و سلامت داروسازی، سم شناسی و علوم دارویی اکتشاف دارویی
پیش نمایش صفحه اول مقاله
Influence of Formulation pH and Suspension State on Freezing-Induced Agglomeration of Aluminum Adjuvants
چکیده انگلیسی
Freezing and thawing of vaccines containing aluminum adjuvants can lead to formation of aggregates and loss in vaccine potency. We sought to understand whether and to what extent the freeze-thaw damage to aluminum adjuvants would differ based on suspension state (flocculation and settlement) at the time of freezing. As flocculation and settlement characteristics of aluminum adjuvants are driven largely by the electrostatic charges on the adjuvant particles, which, in turn, are strongly influenced by the pH of the suspension, we conducted freeze-thaw studies on both Adjuphos and Alhydrogel™ samples at three pH levels (4, 6.5, and 7.2) in buffer solutions with 9% sucrose. Significantly less aggregation occurred in the buffered sucrose solutions at the pH furthest from the aluminum adjuvant point of zero charge during slow freezing at −20°C. The freezing-induced aggregation for the samples with 9% sucrose at each pH was minimal during fast freezing at −70°C and −115°C. Suspensions that were flocculated and settled to a greater extent experienced the most freeze-thaw aggregation, whereas suspensions that were frozen before significant flocculation and settlement occurred showed little or no aggregation. Because pH of formulation can affect flocculation and settling time, it indirectly affects the extent of freeze-thaw aggregation. © 2011 Wiley Periodicals, Inc. and the American Pharmacists Association
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical Sciences - Volume 101, Issue 3, March 2012, Pages 1050-1062
نویسندگان
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