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Claims for Patent: 9,200,088

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Claims for Patent: 9,200,088

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:13/789,598
Patent Claims: 1. A sulfoalkyl ether cyclodextrin (SAE-CD) composition that can be readily mixed with an active agent, comprising a sulfoalkyl ether cyclodextrin having an average degree of substitution of 4.5 to 7.5 and less than 200 ppm of a phosphate, wherein the SAE-CD composition has an absorption of less than 0.5 A.U. due to a UV-active impurity 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. A sulfoalkyl ether cyclodextrin (SAE-CD) composition that can be readily mixed with an active agent, comprising a sulfoalkyl ether cyclodextrin having an average degree of substitution of 4.5 to 7.5 and less than 200 ppm of a phosphate, wherein the SAE-CD composition has an absorption of less than 0.5 A.U. due to a UV-active drug-degrading agent that degrades aripiprazole as determined b 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.

3. A sulfoalkyl ether cyclodextrin (SAE-CD) composition that can be readily mixed with an active agent, comprising a sulfoalkyl ether cyclodextrin having an average degree of substitution of 4.5 to 7.5 and less than 200 ppm of a phosphate, wherein the SAE-CD composition has an absorption of less than 0.5 A.U. due to one or more UV-active drug-degrading agents selected from the group consisting of a glycosidic moiety, a ring-opened cyclodextrin species, a reducing sugar, and a glucose degradation product as determined by UV/vis spectrophotometry at a wavelength of 245 nm to 270 nm for an aqueous solution containing 300 m of the SAE-CD composition per mL of solution in a cell having a 1 cm path length.

4. A sulfoalkyl ether cyclodextrin (SAE-CD) composition that can be readily mixed with an active agent, comprising a sulfoalkyl ether cyclodextrin having an average degree of substitution of 4.5 to 7.5 and less than 200 ppm of a phosphate, wherein the SAE-CD composition has an absorption of less than 0.5 A.U. due to one or more UV-active drug-degrading agents selected from the group consisting of 3,4-dideoxyglucosone-3-ene, 2-furaldehyde, and 5-hydroxymethyl-2-furaldehyde as determined by UV/vis spectrophotometry at a wavelength of 245 nm to 270 nm for an aqueous solution containing 300 mg the SAE-CD composition per mL of solution in a cell having a 1 cm path length.

5. A sulfoalkyl ether cyclodextrin (SAE-CD) composition that can be readily mixed with an active agent, comprising a sulfoalkyl ether cyclodextrin having an average degree of substitution of 4.5 to 7.5 and less than 200 ppm of a phosphate, wherein the SAE-CD composition has an absorption of less than 0.5 A.U. due to a UV-active drug-degrading agent formed by exposing a cyclodextrin starting material in an alkaline aqueous media to a substituent precursor at a temperature and for a period of time sufficient to produce the sulfoalkyl ether cyclodextrin 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.

6. A sulfoalkyl ether cyclodextrin (SAE-CD) composition that can be readily mixed with an active agent, comprising a sulfoalkyl ether cyclodextrin having an average degree of substitution of 4.5 to 7.5 and less than 200 ppm of a phosphate, wherein the SAE-CD composition has an absorption of less than 0.5 A.U. due to a UV-active drug-degrading impurity 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 SAE-CD composition comprises 2% or less of the drug-degrading impurity after the SAE-CD composition is maintained at a temperature of about 80.degree. C. for a period of about 120 minutes.

7. The SAE-CD composition of claim 6, wherein the SAE-CD composition comprises 0.5% or less of the drug-degrading impurity after the SAE-CD composition is maintained at a temperature of about 80.degree. C. for a period of about 120 minutes.

8. The SAE-CD composition of claim 1, 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 500 mg of the SAE-CD composition per mL of solution in a cell having a 1 cm path length.

9. The SAE-CD composition of claim 1, wherein the SAE-CD composition has an absorption of less than about 0.25 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.

10. The SAE-CD composition of claim 1, wherein the SAE-CD composition has an absorption of less than about 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.

11. The SAE-CD composition of claim 1, comprising less than 100 ppm of a phosphate.

12. The SAE-CD composition of claim 1, wherein the sulfoalkyl ether cyclodextrin is a compound of Formula (I): ##STR00005## wherein: p is 4, 5, or 6; R.sub.1 is independently selected at each occurrence from --OH--O--(C.sub.2-C.sub.6 alkylene)-SO.sub.3-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 --OH--O--(C.sub.2-C.sub.6 alkylene)-SO.sub.3-T.

13. The SAE-CD composition of claim 12, wherein R.sub.1 is independently selected at each occurrence from --OH or --OH--O--(C.sub.2-C.sub.6 alkylene)-SO.sub.3-T, and -T is Na.sup.+ at each occurrence.

14. A formulation, comprising the SAE-CD composition of claim 1 and an active agent.

15. The formulation of claim 14, wherein the formulation has an active agent assay of about 98% or more when the formulation is maintained at a temperature of about 80.degree. C. for a period of about 120 minutes.

16. The formulation of claim 14, wherein the formulation has an active agent assay of about 99.5% or more when the formulation is maintained at a temperature of about 80.degree. C. for a period of about 120 minutes.

17. The formulation of claim 14, wherein the active agent is a pharmaceutically effective active agent and is present in the formulation in an effective amount.
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