کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
2484657 1114322 2014 10 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Advanced Kinetic Analysis as a Tool for Formulation Development and Prediction of Vaccine Stability
ترجمه فارسی عنوان
تجزیه و تحلیل پیشرفته جنبشی به عنوان ابزار برای توسعه فرمولاسیون و پیش بینی صحیح واکسن
کلمات کلیدی
موضوعات مرتبط
علوم پزشکی و سلامت داروسازی، سم شناسی و علوم دارویی اکتشاف دارویی
چکیده انگلیسی
We have used a protein‐based vaccine, a live virus vaccine, and an experimental adjuvant to evaluate the utility of an advanced kinetic modeling approach for stability prediction. The modeling approach uses a systematic and simple procedure for the selection of the most appropriate kinetic equation to describe the degradation rate of compounds subjected to accelerated conditions. One‐step and two‐step reactions with unlimited combinations of kinetic models were screened for the three products under evaluation. The most appropriate mathematical model for a given product was chosen based on the values of residual sum of squares and the weight parameter w. A relatively simple n‐th order kinetic model best fitted the degradation of an adjuvanted protein vaccine with a prediction error lower than 10%. A more complex two‐step model was required to describe inactivation of a live virus vaccine under normal and elevated storage temperatures. Finally, an autocatalytic‐type kinetic model best fitted the degradation of an oil‐in‐water adjuvant formulation. The modeling approach described here could be used for vaccine stability prediction, expiry date estimation, and formulation selection. To the best of our knowledge, this is the first report describing a global kinetic analysis of degradation of vaccine components with high prediction accuracy.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical Sciences - Volume 103, Issue 10, October 2014, Pages 3055-3064
نویسندگان
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