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US 9,493,582 B2Granted
Alkylated cyclodextrin compositions and processes for preparing and using the same
AssigneeCyDex Pharmaceuticals, Inc.
InventorsVincent D. Antle, Alvaro Lopes, Daniel Monteiro
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Abstract
The present invention related to low-chloride alkylated cyclodextrin compositions, along with processes for preparing and using the same. The processes of the present invention provide alkylated cyclodextrins with low levels of drug-degrading agents and chloride.
Claims64
A process for preparing an alkylated cyclodextrin composition comprising an alkylated cyclodextrin, the process comprising:
- (a) 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;
- (b) 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;
- and
- (c) treating the partially purified solution with a phosphate-free activated carbon having a residual conductivity of 10 μS or less and producing the alkylated cyclodextrin.
1 more element
An alkylated cyclodextrin composition, comprising:
- an alkylated cyclodextrin having an average degree of substitution of 2 to 9;
- less than 500 ppm of a phosphate;
- and
- 0.07% (w/w) or less of a chloride;
- wherein the alkylated cyclodextrin composition has an absorption of less than 1 A.U., as determined by UV/vis spectrophotometry at a wavelength of 245 nm to 270 nm for an aqueous solution containing 300 mg of the alkylated cyclodextrin composition per mL of solution in a cell having a 1 cm path length.
2 more elements
An alkylated cyclodextrin composition comprising:
- an alkylated cyclodextrin having an average degree of substitution of 2 to 9;
- less than 500 ppm of a phosphate;
- and
- 0.07% (w/w) or less of a chloride;
- wherein the alkylated cyclodextrin composition has an absorption of 0.5 A.U. or less as determined by UV/vis spectrophotometry at a wavelength of 245 nm to 270 nm for an aqueous solution containing 500 mg of the alkylated cyclodextrin composition per mL of solution in a cell having a 1 cm path length.
2 more elements
An alkylated cyclodextrin composition, comprising:
- an alkylated cyclodextrin having an average degree of substitution of 2 to 9;
- less than 500 ppm of a phosphate;
- and
- 0.07% (w/w) or less of a chloride;
- wherein the alkylated cyclodextrin composition has an absorption of less than 1 A.U., as determined by UV/vis spectrophotometry at a wavelength of 320 nm to 350 nm for an aqueous solution containing 300 mg of the alkylated cyclodextrin composition per mL of solution in a cell having a 1 cm path length.
2 more elements
An alkylated cyclodextrin composition comprising:
- an alkylated cyclodextrin having an average degree of substitution of 2 to 9;
- less than 500 ppm of a phosphate;
- and
- 0.07% (w/w) or less of a chloride;
- wherein the alkylated cyclodextrin composition has an absorption of 0.5 A.U. or less as determined by UV/vis spectrophotometry at a wavelength of 320 nm to 350 nm for an aqueous solution containing 500 mg of the alkylated cyclodextrin composition per mL of solution in a cell having a 1 cm path length.
2 more elements
Dependencies are inferred from the claim text.