On shelf stability of freeze-dried poly(methylidene malonate 2.1.2) nanoparticles

被引:20
作者
Roy, D
Guillon, X
Lescure, F
Couvreur, P
Bru, N
Breton, P
机构
[1] LABS UPSA,LAB RECH GALEN & PREFORMULAT,F-92506 RUEIL MALMAISON,FRANCE
[2] UNIV PARIS 11,LAB PHARMACOTECH & BIOPHARM,CNRS,URA 1218,F-92296 CHATENAY MALABR,FRANCE
[3] VIRSOL,F-75016 PARIS,FRANCE
关键词
nanoparticles; polymeric colloids; methylidene malonate; freeze-dried colloid stability; colloid physico-chemical characterization;
D O I
10.1016/S0378-5173(96)04842-9
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
Freeze-dried poly(methylidene malonate 2.1.2) (PMM 2.1.2)-made nanoparticles were evaluated for their 12-month stability under various storage conditions of temperature and illumination. At different period of time after their preparation, nanoparticles were resuspended and tested for their size, and the molecular weight and reversed-phase HPLC profiles of their components. The suspension pH, its turbidity at 400 nm as well as its in vitro cytotoxicity on CEM T cell line were also measured. Generally, nanoparticles maintained at 40 degrees C underwent significant alterations revealed by the suspension pH decrease, the progressive modification of the HPLC chromatogram and the decreased cytotoxicity. Degradation of the polymer side chains and generation of carboxyl moieties could account for these observations. From the 1 year measurements here reported, lyophilized PMM 2.1.2 colloidal nanoparticles conserved at room temperature or below, either in darkness or in daylight, may be assumed to have a satisfactory shelf-life. (C) 1997 Elsevier Science B.V.
引用
收藏
页码:165 / 175
页数:11
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