Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai
Reexamination Certificate
2011-06-21
2011-06-21
Jiang, Shaojia Anna (Department: 1623)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Carbohydrate doai
C514S053000, C514S738000, C514S502000, C424S646000, C562S587000
Reexamination Certificate
active
07964568
ABSTRACT:
A process for preparing parenteral iron-saccharidic complexes, and the complexes produced, comprising: (1) providing an aqueous solution or dispersion including (i) Fe(III) and (OH)−ions and (ii) at least one saccharide, to form a reaction mixture, where the molar ratio of (i): (ii) is about 30:1 to about 1:30; and the mixture temperature and pH are at or above the complex assembly point (CAP); and (2) maintaining temperature and pH at or above the CAP for a time sufficient to form an iron-saccharidic complex having a molecular weight of about 25,000 Daltons or more. Control of the temperature and pH efficiently produces a high molecular weight complex. The complex can be separated by precipitation, dialysis and/or column fractionation and, if desired, dried, e.g., lyophilized or spray dried. The process can controllably synthesize complexes of varying molecular weight and/or chemical composition, particularly sodium ferric gluconate and ferric hydroxide-sucrose.
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Beck Robert A.
Kowalski John
Mateer, Jr. Robert A.
Chromaceutical Advanced Technologies, Inc.
Goon Scarlett
Jiang Shaojia Anna
Lerner, David Littenburg, Krumholz & Mentlik, LLP
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