Stable freeze-dried pharmaceutical formulation
AssigneeSanofi-Synthelabo
InventorsColette Bouloumie, Thierry Breul, Laurence Colliere, Philippe Faure
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Abstract
The subject of the invention is a freeze-dried formulation consisting of an amorphous phase and a crystalline phase, which is pharmaceutically acceptable, comprising at least one nonprotein active ingredient, characterized in that it contains mannitol and alanine in a ratio R of between 0.1 and 1, R representing the mass of mannitol to the mass of alanine.
Claims13
Freeze-dried formulation consisting of an amorphous phase and a crystalline phase, which is pharmaceuticlly acceptable, comprising at least one nonprotein active ingredient, characterized in that it contains mannitol and alanine in a ratio R of between 0.1 and 1, R representing the mass of mannitol to the mass of alanine, it being understood that formulations further comprising one or more matrix forming agent selected from the group consisting of pectins, gelatins, soy fiber proteins and mixtures thereof are excluded.
Process for the stabilization of a nonprotein active ingredient contained in a freeze-dried pharmaceutically acceptable formulation, wherein the freeze-dried formulation is obtained starting from an aqueous solution comprising said active ingredient, mannitol and alanine in a ratio R of between 0.1 and 1, R representing the mass of mannitol to the mass of alanine.
Dependencies are inferred from the claim text.