Reacting ferric hydroxide and sucrose; free of excipients; Iron therapy; anemia
Inventors
Newton, Christopher Benny • Rangisetty, Jagadeesh Babu
Assignees
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Publication Number
US-7674780-B2
Publication Date
2010-03-09
Expiration Date
Abstract
A process is provided for preparing an iron sucrose complex, substantially free of excipients, for providing an iron sucrose complex co-precipitated with sucrose, and for providing iron sucrose complexes in aqueous solution.
Core Innovation
The invention provides processes for preparing an iron sucrose complex and a co-precipitate comprising iron sucrose complex and sucrose. In one process, ferric hydroxide and sucrose are reacted in an aqueous reaction mixture comprising sodium ions, using a selected molar ratio of sucrose to ferric hydroxide, a selected time interval, a selected temperature, and a pH in the range from about 6.5 to about 13.
The process isolates the iron sucrose complex from the reaction mixture and further processes it through dissolution and precipitation steps with water-miscible organic solvents. The isolated iron sucrose complex is dissolved in an aqueous solvent, precipitated by adding at least one water-miscible organic solvent, and collected as purified iron sucrose complex.
The purified iron sucrose complex product is dissolved in an aqueous sucrose solution, and a mixture is formed by adding at least one water-miscible organic solvent in an amount sufficient to co-precipitate iron sucrose complex and sucrose, followed by collection of the co-precipitate. Another aspect describes preparing an aqueous solution containing sucrose and iron sucrose complex using repeated reaction, isolation, precipitation, redissolution, and collection steps, including dissolving the collected co-precipitate in water.
A further aspect provides a process in which a reaction mixture comprising a ferric salt dissolved in an aqueous medium is treated with first and second bases, sucrose is added in a selected molar ratio based on the ferric salt, the mixture is heated with specified equilibration and temperature conditions, then cooled and the co-precipitate is isolated.
Claims Coverage
The provided set includes three independent claims, each directed to a process for preparing iron sucrose complex and, depending on the claim, a co-precipitate comprising iron sucrose complex and sucrose or an aqueous solution containing sucrose and iron sucrose complex. Across the independent claims, the main inventive features focus on controlled reaction conditions, isolation and repeated dissolution/precipitation using water-miscible organic solvents, and formation of co-precipitates comprising both iron sucrose complex and sucrose.
Co-precipitate preparation by ferric hydroxide and sucrose in sodium-containing aqueous mixture
Reacting ferric hydroxide and sucrose in an aqueous reaction mixture comprising sodium ions, at a selected molar ratio of sucrose to ferric hydroxide, for a selected time interval, at a selected temperature, and at a pH in the range from about 6.5 to about 13; isolating iron sucrose complex; dissolving the isolated iron sucrose complex in an aqueous solvent; precipitating the iron sucrose complex by adding at least one water-miscible organic solvent; collecting the purified iron sucrose complex; dissolving the purified iron sucrose complex in an aqueous sucrose solution; co-precipitating iron sucrose complex and sucrose by adding at least one water-miscible organic solvent; and collecting the co-precipitate.
Aqueous solution of sucrose and iron sucrose complex by re-dissolution and co-precipitation
Reacting ferric hydroxide and sucrose in an aqueous reaction mixture comprising sodium ions, at a selected molar ratio of sucrose to ferric hydroxide, for a selected time interval, at a selected temperature, and at a pH in the range from about 6.5 to about 13; isolating iron sucrose complex; dissolving the isolated iron sucrose complex in an aqueous solvent; precipitating the iron sucrose complex by adding at least one water-miscible organic solvent; collecting the purified iron sucrose complex; dissolving the purified iron sucrose complex product in an aqueous sucrose solution; co-precipitating iron sucrose complex and sucrose; collecting the co-precipitate; and dissolving the collected co-precipitate in water.
Co-precipitate formation from ferric salt solution via sequential base treatment
Providing a reaction mixture comprising a ferric salt dissolved in an aqueous medium; adding to the reaction mixture a first base in an amount in the range from about 1 to about 2 equivalents based on the amount of ferric salt; allowing the reaction mixture to equilibrate for a time interval in the range from about 10 to about 60 minutes; adding sucrose to the equilibrated reaction mixture in a selected molar ratio based on the ferric salt; heating the mixture; adding a second base sufficient to adjust the pH of the reaction mixture to a selected pH; heating at a second temperature for a selected time interval; cooling the reaction mixture; and isolating the co-precipitate.
Across the independent claims, the coverage centers on processes that form iron sucrose complex under defined aqueous conditions and purify or assemble products by dissolving and forming mixtures with water-miscible organic solvents to precipitate iron sucrose complex and to co-precipitate iron sucrose complex and sucrose, with subsequent collection and, in one claim, dissolution of the co-precipitate in water.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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