Sulfoalkyl ether cyclodextrin compositions
AssigneeCyDex Pharmaceuticals, Inc.
InventorVincent D. Antle
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Abstract
SAE-CD compositions are provided, along with methods of making and using the same. The SAE-CD compositions comprise a sulfoalkyl ether cyclodextrin having 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 SAE-CD composition per mL of solution in a cell having a 1 cm path length.
Claims52
A sulfoalkyl ether cyclodextrin (SAE-CD) composition comprising a sulfoalkyl ether cyclodextrin having an average degree of substitution of 4.5 to 7.5, wherein the SAE-CD composition does not contain phosphate in an amount of 200 ppm or more and does not contain underivatized cyclodextrin in an amount of 0.5% wt. or more, and wherein the SAE-CD composition has an absorption of less than 0.5 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 SAE-CD composition per mL of solution in a cell having a 1 cm path length, wherein the amounts of the phosphate and the underivatized cyclodextrin are with respect to the SAE-CD composition.
A sulfoalkyl ether cyclodextrin (SAE-CD) composition comprising a sulfoalkyl ether cyclodextrin having an average degree of substitution of 4.5 to 7.5, wherein the SAE-CD composition does not contain phosphate in an amount of 200 ppm or more and does not contain sulfoalkylating agent in an amount of 20 ppm or more, and wherein the SAE-CD composition has an absorption of less than 0.5 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 SAE-CD composition per mL of solution in a cell having a 1 cm path length, wherein the amounts of the phosphate and the sulfoalkylating agent are with respect to the SAE-CD composition.
A sulfoalkyl ether cyclodextrin (SAE-CD) composition comprising a sulfoalkyl ether cyclodextrin having an average degree of substitution of 4.5 to 7.5, wherein the SAE-CD composition does not contain sulfoalkylating agent in an amount of 0.25% wt. or more, and does not contain phosphate in an amount of 200 ppm or more, and wherein the SAE-CD composition has an absorption of less than 0.5 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 SAE-CD composition per mL of solution in a cell having a 1 cm path length, wherein the amount of the hydrolyzed sulfoalkylating agent with respect to the SAE-CD composition.
A sulfoalkyl ether cyclodextrin (SAE-CD) composition comprising a sulfoalkyl ether cyclodextrin having an average degree of substitution of 4.5 to 7.5, wherein the SAE-CD composition does not contain 200 ppm or more of a phosphate, and does not contain an alkali metal halide salt in an amount of 1% wt. or more, and wherein the SAE-CD composition has an absorption of less than 0.5 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 SAE-CD composition per mL of solution in a cell having a 1 cm path length, wherein the amounts of the phosphate and the alkali metal halide salt are with respect to the SAE-CD composition.
A sulfoalkyl ether cyclodextrin (SAE-CD) composition comprising a sulfoalkyl ether cyclodextrin having an average degree of substitution of 4.5 to 7.5 wherein the SAE-CD composition does not contain:
- 20 ppm or more of a sulfoalkylating agent;
- 0.5% wt. or more of an underivatized cyclodextrin;
- 1% wt. or more of an alkali metal halide salt;
- 200 ppm or more of a phosphate;
- or
- 0.25% wt. or more of a hydrolyzed alkylating agent;
- wherein the SAE-CD composition has an absorption of less than 0.5 AU as determined by UV/vis spectrophotometry at a wavelength of 245 nm to 270 nm for an aqueous solution containing 300 mg of the SAE-CD composition per mL of solution in a cell having a 1 cm path length;
- wherein the amounts of the sulfoalkylating agent, the underivatized cyclodextrin, the alkali metal halide salt, the phosphate, and the hydrolyzed alkylating agent are with respect to the SAE-CD composition.
A sulfoalkyl ether cyclodextrin (SAE-CD) composition comprising a sulfoalkyl ether cyclodextrin having an average degree of substitution of 6 to 7.1 wherein the SAE-CD composition is sulfobutyl ether β-cyclodextrin (SBE-β-CD) that does not contain:
- 200 ppm or more of a phosphate;
- 20 ppm or more of 1,4-butane sultone;
- 0.5% wt. or more of β-cyclodextrin;
- 1% wt. or more of sodium chloride;
- 0.25% wt. or more of 4-hydroxybutane-1-sulfonic acid;
- or
- 0.25% wt. or more of disodium bis(4-sulfobutyl)ether;
- wherein the SAE-CD composition has an absorption of less than 0.5 AU as determined by UV/vis spectrophotometry at a wavelength of 245 nm to 270 nm for an aqueous solution containing 300 mg of the SAE-CD composition per mL of solution in a cell having a 1 cm path length;
- wherein the amounts of the phosphate, the 1,4-butans sultone, the β-cyclodextrin, the sodium chloride, the phosphate, and the hydrolyzed alkylating agent are with respect to the SAE-CD composition.
Dependencies are inferred from the claim text.