Method and preparations for stabilizing biological materials...

A - Human Necessities – 61 – K

Patent

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Details

A61K 47/26 (2006.01) A61K 9/14 (2006.01) A61K 38/18 (2006.01) A61K 38/19 (2006.01) A61K 38/44 (2006.01) A61K 47/18 (2006.01) A61K 49/00 (2006.01) A61K 51/00 (2006.01) F26B 5/04 (2006.01)

Patent

CA 2235243

The invention concerns a method of producing dry partially amorphous products containing biological, in particular therapeutically active, material, the products comprising macroscopically homogeneous substance mixtures. The substance mixtures are selected from at least one substance of the group comprising: (i) carbohydrate or zwitterion with a polar residue and its derivatives; and (ii) zwitterion with an apolar residue and its derivatives. The method is characterized in that a solution of the biologically or therapeutically active material and substances (i) and (ii) is produced and dried at a product temperature above the freezing point of the solution. The invention further concerns novel substance mixtures obtained by the above method and their use in diagnostic or therapeutic processes.

L'invention concerne un procédé de préparation de produits secs partiellement amorphes contenant un matériau biologique ayant notamment une action thérapeutique, qui présentent des mélanges de substances homogènes sur le plan macroscopique. Les mélanges de substances sont sélectionnés parmi au moins une des substances du groupe (i) hydrate de carbone ou zwitterion à reste polaire et ses dérivés, et (ii) zwitterion à reste apolaire et ses dérivés. Ce procédé se caractérise en ce qu'une solution comprenant le matériau biologique ou à action thérapeutique et les substances (i) et (ii) est préparée, puis est desséchée à une température du produit supérieure au point de congélation de ladite solution. L'invention concerne en outre de nouveaux mélanges de substances obtenus à l'aide dudit procédé, ainsi que leur utilisation dans des méthodes diagnostiques ou thérapeutiques.

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