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Last Updated: November 27, 2020

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Claims for Patent: 9,750,822

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Summary for Patent: 9,750,822
Title:Sulfoalkyl ether cyclodextrin compositions
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.
Inventor(s): Antle; Vincent D. (Olathe, KS)
Assignee: Cydex Pharmaceuticals, Inc. (San Diego, CA)
Application Number:15/233,748
Patent Claims: 1. A sulfoalkyl ether cyclodextrin (SAE-CD) composition comprising a sulfoalkyl ether cyclodextrin having less than 200 ppm of a phosphate, wherein the SAE-CD composition has an absorption of less than 0.2 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.

2. The SAE-CD composition of claim 1, wherein the SAE-CD composition has an absorption of less than 0.15 A.U., as determined by UV/vis spectrophotometry at a wavelength of 245 nm to 270 nm for an aqueous solution containing 500 mg of the SAE-CD composition per mL of solution in a cell having a 1 cm path length.

3. The SAE-CD composition of claim 1, wherein the SAE-CD composition has an absorption of less than 0.1 A.U., as determined by UV/vis spectrophotometry at a wavelength of 245 nm to 270 nm for an aqueous solution containing 500 mg of the SAE-CD composition per mL of solution in a cell having a 1 cm path length.

4. The SAE-CD composition of claim 1, wherein the SAE-CD composition has an absorption of less than 0.05 A.U., as determined by UV/vis spectrophotometry at a wavelength of 245 nm to 270 nm for an aqueous solution containing 500 mg of the SAE-CD composition per mL of solution in a cell having a 1 cm path length.

5. The SAE-CD composition of claim 1, wherein the SAE-CD is a compound of Formula (I): ##STR00005## wherein: p is 4, 5, or 6; and R.sub.1 is independently selected at each occurrence from --OH or --O--(C.sub.2-C.sub.6 alkylene)-SO.sub.3.sup.--T, wherein T is independently selected at each occurrence from pharmaceutically acceptable cations, provided that at least one R.sub.1 is --OH and at least one R.sub.1 is --O--(C.sub.2-C.sub.6 alkylene)-SO.sub.3.sup.--T.

6. The SAE-CD composition of claim 5, wherein the SAE-CD has an average degree of substitution of 4.5 to 7.5.

7. The SAE-CD composition of claim 5, wherein R.sub.1 is independently selected at each occurrence from --OH or --O--(C.sub.4 alkylene)-SO.sub.3.sup.--T, and -T is Na.sup.+ at each occurrence.

8. The SAE-CD composition of claim 5, wherein the SAE-CD is sulfobutyl ether .beta.-cyclodextrin having the structure: ##STR00006## wherein: each R is independently --H or --(CH.sub.2).sub.4SO.sub.3Na; and the average degree of substitution of --(CH.sub.2).sub.4SO.sub.3Na is 6.0 to 7.1 per cyclodextrin molecule.

9. The SAE-CD composition of claim 1 further comprising an active agent.

10. The SAE-CD composition of claim 1, wherein the SAE-CD composition comprises: less than 10 ppm of a sulfoalkylating agent; less than 0.2% wt. of an underivatized cyclodextrin; less than 0.5% wt. of an alkali metal halide salt; and less than 0.1% wt. of a hydrolyzed sulfoalkylating agent.

11. The SAE-CD composition of claim 1, wherein the SAE-CD composition comprises: less than 250 ppb of a sulfoalkylating agent; less than 0.1% wt. of an underivatized cyclodextrin; less than 0.1% wt. of an alkali metal halide salt; and less than 0.08% wt. of a hydrolyzed sulfoalkylating agent.

12. A sulfoalkyl ether cyclodextrin (SAE-CD) composition comprising a sulfoalkyl ether cyclodextrin having less than 150 ppm of a phosphate, wherein the SAE-CD composition has an absorption of less than 0.2 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.

13. The SAE-CD composition of claim 12, wherein the SAE-CD composition has an absorption of less than 0.2 A.U., as determined by UV/vis spectrophotometry at a wavelength of 245 nm to 270 nm for an aqueous solution containing 500 mg of the SAE-CD composition per mL of solution in a cell having a 1 cm path length.

14. The SAE-CD composition of claim 12, wherein the SAE-CD composition has an absorption of less than 0.15 A.U., as determined by UV/vis spectrophotometry at a wavelength of 245 nm to 270 nm for an aqueous solution containing 500 mg of the SAE-CD composition per mL of solution in a cell having a 1 cm path length.

15. The SAE-CD composition of claim 12, wherein the SAE-CD composition has an absorption of less than 0.1 A.U., as determined by UV/vis spectrophotometry at a wavelength of 245 nm to 270 nm for an aqueous solution containing 500 mg of the SAE-CD composition per mL of solution in a cell having a 1 cm path length.

16. The SAE-CD composition of claim 12, wherein the SAE-CD composition has an absorption of less than 0.05 A.U., as determined by UV/vis spectrophotometry at a wavelength of 245 nm to 270 nm for an aqueous solution containing 500 mg of the SAE-CD composition per mL of solution in a cell having a 1 cm path length.

17. The SAE-CD composition of claim 12, wherein the sulfoalkyl ether cyclodextrin is a compound of Formula (I): ##STR00007## wherein: p is 4, 5, or 6; R.sub.1 is independently selected at each occurrence from --OH or --O--(C.sub.2-C.sub.6 alkylene)-SO.sub.3.sup.--T, wherein T is independently selected at each occurrence from pharmaceutically acceptable cations, provided that at least one R.sub.1 is --OH and at least one R.sub.1 is --O--(C.sub.2-C.sub.6 alkylene)-SO.sub.3.sup.--T.

18. The SAE-CD composition of claim 17, wherein the SAE-CD has an average degree of substitution of 4.5 to 7.5.

19. The SAE-CD composition of claim 17, wherein R.sub.1 is independently selected at each occurrence from --OH or --O--(C.sub.4 alkylene)-SO.sub.3.sup.--T, and -T is Na.sup.+ at each occurrence.

20. The SAE-CD composition of claim 17, wherein the SAE-CD is sulfobutyl ether .beta.-cyclodextrin having the structure: ##STR00008## wherein: each R is independently --H or --(CH.sub.2).sub.4SO.sub.3Na; and the average degree of substitution of --(CH.sub.2).sub.4SO.sub.3Na is 6.0 to 7.1 per cyclodextrin molecule.

21. The SAE-CD composition of claim 12 further comprising an active agent.

22. The SAE-CD composition of claim 12, wherein the SAE-CD composition comprises: less than 10 ppm of a sulfoalkylating agent; less than 0.2% wt. of an underivatized cyclodextrin; less than 0.5% wt. of an alkali metal halide salt; and less than 0.1% wt. of a hydrolyzed sulfoalkylating agent.

23. The SAE-CD composition of claim 12, wherein the SAE-CD composition comprises: less than 250 ppb of a sulfoalkylating agent; less than 0.1% wt. of an underivatized cyclodextrin; less than 0.1% wt. of an alkali metal halide salt; and less than 0.08% wt of a hydrolyzed sulfoalkylating agent.

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