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Alkylated cyclodextrin compositions and processes for preparing and using the same
专利权人:
CYDEX PHARMACEUTICALS INC.
发明人:
Lopes, Álvaro,Monteiro, Daniel,Antle, Vincent
申请号:
NZ70732313
公开号:
NZ707323A
申请日:
2013.10.21
申请国别(地区):
NZ
年份:
2018
代理人:
摘要:
The present invention related to low-chloride alkylated cyclodextrin compositions, along with processes for preparing and using the same. The processes comprise mixing a cyclodextrin with an alkylating agent to form a reaction milieu comprising an alkylated cyclodextrin, one or more unwanted components, and one or more drug-degrading impurities; conducting one or more separations to remove the one or more unwanted components from the reaction milieu to form a partially purified solution comprising the alkylated cyclodextrin and the one or more drug-degrading impurities, wherein the one or more separations are ultrafiltration, diafiltration, centrifugation, extraction, solvent precipitation, or dialysis; preparing a phosphate-free activated carbon having a residual conductivity of 10 µS or less by a process comprising subjecting activated carbon to a first carbon washing process comprising adding water, soaking the carbon in the water, and draining the water; and treating the partially purified solution with the phosphate-free activated carbon having a residual conductivity of 10 µS or less and producing the alkylated cyclodextrin; wherein the alkylated cyclodextrin composition has an absorption of less than 0.5 A.U. due to a drug-degrading agent, as determined by UV/vis spectrophotometry at a wavelength of 245 nm to 270 nm for an aqueous solution containing 300 mg of the composition per mL of solution in a cell having a 1 cm path length. The processes of the present invention provide alkylated cyclodextrins with low levels of drug-degrading agents and chloride.
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中国工程科技知识中心
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