A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 33/26 (2006.01) A61K 45/06 (2006.01) A61K 47/12 (2006.01) A61K 47/26 (2006.01) B01D 15/08 (2006.01) G01N 30/86 (2006.01) G01N 33/15 (2006.01) G01N 30/02 (2006.01)
Patent
CA 2426799
A method for separating and purifying the active hematinic species present in iron-saccharidic complexes comprising sodium ferric gluconate complex in sucrose, ferric hydroxide-sucrose complex and ferric saccharate complex and others of similar form and function, based on separation of the iron- saccharidic complex from one or more excipients and, preferably, lyophilization. Separation of the iron-saccharidic complex permits its analytical quantification; further concentration or purification as a new and useful product; preparation of redesigned formulations for new and useful pharmaceuticals; and/or lyophilization. The ability to separate the iron- saccharidic complex responsible for hematinic function, including its lyophilized form, also provides a means for preparing analytical material to verify and validate its pharmacological integrity, patient safety and clinical performance, as well as analytical monitoring, standardization and quality control inspection over hematinic manufacturing processes and establishment of standards for use therewith.
L'invention concerne un procédé de séparation et de purification d'espèces hématiniques actives présentes dans des complexes ferro-saccharidiques contenant un complexe de gluconate ferrique de sodium en sucrose, un complexe de sucrose-hydroxyde ferrique et un complexe de saccharate ferrique et d'autres de forme et de fonction similaires, basés sur le complexe ferro-saccharidique à partir d'un ou de plusieurs excipient(s) et de préférence la lyophilisation. La séparation du complexe ferro-saccharidique permet sa quantification analytique, une concentration ou purification ultérieure comme nouveau produit utile, la préparation de compositions de conception nouvelle pour de nouveaux produits pharmaceutiques utiles et/ou la lyophilisation. La possibilité de séparer le complexe ferro-saccharidique responsable de la fonction hématinique, comportant sa forme lyophilisée fournit également un moyen de préparer un matériau analytique afin de vérifier et de valider son intégrité pharmacologique, la sécurité du patient et la performance clinique ainsi que la surveillance analytique et la standardisation et l'inspection de contrôle de qualité des procédés de fabrication hématinique et la détermination de standards d'utilisation de ces derniers.
Beck Robert A.
Mateer Robert A.
Chromaceutical Advanced Technologies Inc.
Moffat & Co.
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