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Last Updated: March 29, 2024

Details for Patent: 9,616,135


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Title:2-iminobiotin formulations and uses thereof
Abstract: The disclosure relates to improving the aqueous solubility of 2-iminobiotin. In a particular aspect, the disclosure pertains to formulations suitable for administration of 2-iminobiotin to mammals suffering from disorders or conditions that benefit from that administration.
Inventor(s): Leufkens; Paul W. T. J. ('s-Hertogenbosch, NL)
Assignee: Neurophyxia B.V. (Hertogenbosch, NL)
Filing Date:Apr 01, 2015
Application Number:14/676,419
Claims:1. An aqueous, soluble formulation of 2-iminobiotin, having a pH between 3 and 7, and comprising: 0.5 mg/ml or more of 2-iminobiotin, and between 2.5 to 40% of a substituted beta-cyclodextrin, wherein the substituted beta-cyclodextrin is selected from sulfobutyl-ether-beta cyclodextrin (SBE-CD) and hydroxyipropyl-beta cyclodextrin.

2. The formulation according to claim 1 having a pH between 4 and 7, and comprising 2 mg/ml or more of 2-iminobiotin and 2.5 to 20% of a substituted beta-cyclodextrin.

3. The formulation according to claim 1 having a pH between 4 and 6.5, and comprising 0.5 to 3.5 mg/ml or more of 2-iminobiotin and between 5 to 40% of a substituted beta-cyclodextrin.

4. The formulation according to claim 2 having a pH of 4 and comprising 3.5 mg/ml or more of 2-iminobiotin and between 2.5 to 40% of a substituted beta-cyclodextrin.

5. The formulation according to claim 1 having a pH between 4 and 5 and comprising between 0.5 to 5 mg/ml of 2-iminobiotin, and 2.5 to 5% of SBE-CD.

6. The formulation of claim 3, comprising between 5% and 10% SBE-CD.

7. The formulation of claim 4, comprising between 2.5% and 10% SBE-CD.

8. The formulation of claim 5, comprising between 4 mg/ml and 5 mg/ml of 2-iminobiotin.

9. A method of treating perinatal asphyxia in a neonate, the method comprising: administering the formulation according to claim 1 to a neonate in need thereof or to the neonate's mother, to treat perinatal asphyxia in the neonate.

10. The method of claim 9, wherein the formulation is administered to the neonate's mother prior to and/or during labor.

11. The method according to claim 9, wherein the treatment further comprises subjecting the neonate to hypothermia.

12. A method of treating a neonate for complications associated with childbirth, the method comprising: administering the formulation according to claim 1 to a neonate in need thereof or to the neonate's mother, to treat the effects of complications during childbirth.

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