EP 1843753 A2 20071017 - COMPOSITIONS FOR FREEZE-DRYING PROTEINS
Title (en)
COMPOSITIONS FOR FREEZE-DRYING PROTEINS
Title (de)
ZUSAMMENSETZUNGEN FÜR GEFRIERGETROCKNETE PROTEINE
Title (fr)
COMPOSITIONS POUR LA LYOPHILISATION DE PROTEINES
Publication
Application
Priority
- FR 2006000177 W 20060126
- FR 0500791 A 20050126
Abstract (en)
[origin: FR2881139A1] A liquid composition (A) for lyophilization of proteins (I), previously diluted in (A), so as to stabilize (I) in the dry, lyophilized state and optionally also in the liquid state after rehydration of the lyophilizate, where (A) has a predominantly crystalline or amorphous structure when lyophilized, comprises a filler, stabilizer, buffer and optionally nonionic surfactant. A liquid composition (A) for lyophilization of proteins (I), previously diluted in (A), so as to stabilize (I) in the dry, lyophilized state and optionally also in the liquid state after rehydration of the lyophilizate, where (A) has a predominantly crystalline or amorphous structure when lyophilized, comprises about 40-60 g/l filler (II) with temperature of collapse (Tc) -18 to 0[deg]C; 10-20 g/l of a stabilizer (III); 10-20 mM buffer solution (IV) that does not crystallize when the composition is frozen and optionally 0.1-0.4 g/l of nonionic surfactant (V). In (A) the weight ratio (II):(III) is over 3:1 when the composition has a mainly crystalline structure when frozen; the weight ratio (III):(I) is over 1:1; (A) contains no excipients of animal origin, and Tc is -16 to -10[deg]C. Independent claims are also included for: (1) lyophilizing selected proteins (I) that includes dissolving them in (A); (2) preparing (I) stabilized in solution by rehydrating lyophilized products of method (1); (3) screening (A) for use in lyophilization of particular proteins; and (4) liquid compositions (A).
IPC 8 full level
A61K 9/19 (2006.01); A61K 38/00 (2006.01); A61K 47/02 (2006.01); A61K 47/10 (2006.01); A61K 47/18 (2006.01); A61K 47/26 (2006.01); A61K 47/32 (2006.01); A61K 47/36 (2006.01); C12N 1/04 (2006.01)
CPC (source: EP US)
A61K 9/19 (2013.01 - EP US); A61K 47/02 (2013.01 - EP); A61K 47/10 (2013.01 - EP); A61K 47/183 (2013.01 - EP US); A61K 47/26 (2013.01 - EP US); A61K 47/32 (2013.01 - EP); A61K 47/36 (2013.01 - EP)
Citation (search report)
See references of WO 2006079722A2
Designated contracting state (EPC)
AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HU IE IS IT LI LT LU LV MC NL PL PT RO SE SI SK TR
DOCDB simple family (publication)
FR 2881139 A1 20060728; EP 1843753 A2 20071017; WO 2006079722 A2 20060803; WO 2006079722 A3 20061019
DOCDB simple family (application)
FR 0500791 A 20050126; EP 06709174 A 20060126; FR 2006000177 W 20060126