Lyophilization process and products obtained thereby

A - Human Necessities – 61 – K

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A61K 9/14 (2006.01)

Patent

CA 2628178

A lyophilization process which comprises dissolving a material in one or more solvents for said material to form a solution; forcing said material at least partially out of solution by combining the solution and a non-solvent for the material, which non-solvent is miscible with the solvent or solvents used and wherein said non-solvent is volatilizable under freeze-drying conditions. In addition, for hydrophobic and/or lipophilic materials, the anti-solvent can be omitted, and the solution of the material in the solvent can be subjected directly to freeze drying. The lyophilizates can then be reconstituted with typical aqueous diluent in the case of hydrophilic materials. Hydrophobic and or lipophilic materials can be initially reconstituted with propylene glycol and/or polyethyleneglycol to form a high concentration solution therein and this is further diluted for use with a diluent of Intralipid, plasma, serum, or even whole blood.

L'invention porte sur un procédé de lyophilisation qui consiste à dissoudre un matériau dans au moins un solvant afin de former une solution dudit matériau; à extraire au moins en partie ledit matériau de la solution en combinant la solution et un non solvant pour ledit matériau, lequel non solvant est miscible avec le ou les solvants utilisés et lequel non solvant est volatilisable dans des conditions de lyophilisation. Pour les matériaux hydrophobes ou hydrophiles, on peut en outre omettre l'antisolvant et soumettre directement à la lyophilisation la solution de matériau dans le solvant. Dans le cas de matériaux hydrophiles, on peut ensuite reconstituer les lyophilisats avec un diluant aqueux ordinaire. On reconstitue les matériaux hydrophobes ou lipophiles avec du propylène glycol et/ou du polyéthylène glycol afin de former une solution à haute concentration que l'on dilue encore avec un diluant Intralipide, du plasma, du sérum ou même du sang total.

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