کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
2486326 | 1114381 | 2011 | 12 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Formulation and Stabilization of Francisella tularensis Live Vaccine Strain
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کلمات کلیدی
موضوعات مرتبط
علوم پزشکی و سلامت
داروسازی، سم شناسی و علوم دارویی
اکتشاف دارویی
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چکیده انگلیسی
Francisella tularensis live vaccine strain (F. tularensis LVS), a promising vaccine candidate for protection against F. tularensis exposure, is a particularly thermolabile vaccine and difficult to stabilize sufficiently for storage under refrigerated conditions. Our preliminary data show that F. tularensis LVS can be stabilized in the dried state using foam drying, a modified freeze drying method, with sugarâbased formulations. The process was conducted under mild drying conditions, which resulted in a good titer retention following processing. The inclusion of osmolytes in the growth media resulted in an acceleration of growth kinetics, although no change in osmotolerance was observed. The optimized F. tularensis formulation, which contained trehalose, gelatin, and Pluronic F68 demonstrated stability for approximately 1.5âweeks at 37°C (i.e., time required for the vaccine to decrease in potency by 1âlog10 colony forming unit) and for 12âweeks at 25°C. At refrigerator storage condition (4°C), stabilized F. tularensis LVS vaccine exhibited no activity loss for at least 12âweeks. This stabilization method utilizes conventional freeze dryers and pharmaceutically approved stabilizers, and thus can be readily implemented at many manufacturing sites for largeâscale production of stabilized vaccines. The improved heat stability of the F. tularensis LVS could mitigate risks of vaccine potency loss during longâterm storage, shipping, and distribution. © 2011 WileyâLiss, Inc. and the American Pharmacists Association J Pharm Sci 100:3076-3087, 2011
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical Sciences - Volume 100, Issue 8, August 2011, Pages 3076-3087
Journal: Journal of Pharmaceutical Sciences - Volume 100, Issue 8, August 2011, Pages 3076-3087
نویسندگان
Satoshi Ohtake, Russell A. Martin, Atul Saxena, David Lechugaâballesteros, Araceli E Santiago, Eileen M. Barry, Vu TruongâLe,