کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
2487552 | 1114422 | 2007 | 9 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Impact of critical process and formulation parameters affecting inâprocess stability of lactate dehydrogenase during the secondary drying stage of lyophilization: A mini freeze dryer study
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کلمات کلیدی
موضوعات مرتبط
علوم پزشکی و سلامت
داروسازی، سم شناسی و علوم دارویی
اکتشاف دارویی
پیش نمایش صفحه اول مقاله
![عکس صفحه اول مقاله: Impact of critical process and formulation parameters affecting inâprocess stability of lactate dehydrogenase during the secondary drying stage of lyophilization: A mini freeze dryer study Impact of critical process and formulation parameters affecting inâprocess stability of lactate dehydrogenase during the secondary drying stage of lyophilization: A mini freeze dryer study](/preview/png/2487552.png)
چکیده انگلیسی
The stresses during the secondaryâdrying stage of lyophilization were investigated using a controlled humidity miniâfreezeâdryer [Luthra S, Obert JâP, Kalonia DS, Pikal MJ. 2007. Investigation of drying stresses on proteins during lyophilization: Differentiation between primary and secondaryâdrying stresses on lactate dehydrogenase using a humidity controlled mini freezeâdryer. J Pharm Sci 96: 61-70.]. Lactate dehydrogenase (LDH), was formulated in: (1) Tween 80, (2) citrate buffer, and (3) both Tween 80 and citrate buffer. Protein activity recovery was measured as a function of relative humidity (RH), product temperature, and drying duration. Studies were also conducted with different concentrations of sucrose, sorbitol, and poly (vinyl pyrrolidone) (PVP). LDH stability was affected to a small extent by RH and significantly by drying temperature and duration. Complete stabilization of LDH was observed when lyophilized with sucrose and PVP but only a partial stabilization was observed with sorbitol. The miniâfreezeâdryer enabled studying the process parameters independently, unlike a conventional study where these effects are generally convoluted. The results suggest that the stability of the protein is a function of the dynamics of the system during lyophilization. The origin of the stabilization effect of sucrose, which could, in principle, be attributed both to direct interaction with the protein or vitrification of the protein was elucidated using lyoprotectants that can either hydrogen bond well with the protein (sorbitol) or form a good glass (PVP). It appears both effects are required for complete stabilization of the protein. © 2007 WileyâLiss, Inc. and the American Pharmacists Association J Pharm Sci 96: 2242-2250, 2007
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical Sciences - Volume 96, Issue 9, September 2007, Pages 2242-2250
Journal: Journal of Pharmaceutical Sciences - Volume 96, Issue 9, September 2007, Pages 2242-2250
نویسندگان
Sumit Luthra, JeanâPhilippe Obert, Devendra S. Kalonia, Michael J. Pikal,