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Claims for Patent: 8,877,230

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Claims for Patent: 8,877,230

Title:Controlled release delivery system for nasal applications
Abstract: This invention relates to a pernasally administrable preparation for the controlled release of sexual hormones to the systemic circulation, in particular to a formulation which enables its active ingredient to be absorbed in a sustained manner providing a better bioavailability at very low doses and longer duration of action.
Inventor(s): Mattern; Claudia (Stans, CH)
Assignee: Mattern Pharma AG (Vaduz, LI)
Application Number:13/316,494
Patent Claims: 1. A method of treating a patient in need of testosterone replacement therapy with a testosterone nasal gel, said method comprising: administering a testosterone gel to the nasal mucosa of each nostril of a patient in need of testosterone replacement therapy, wherein the testosterone is present within the testosterone gel in an amount of from about 0.5% to about 6% by weight of the testosterone gel, for delivering testosterone to the nasal mucosa to treat the patient in need of testosterone replacement therapy with testosterone; wherein, an elevated testosterone serum level in the patient is achieved following said nasal administration of the testosterone gel to the nasal mucosa of the patient; and wherein, the achieved testosterone serum level in the patient is maintained above the patient's testosterone baseline for at least 6 hours following said nasal administration of the testosterone gel.

2. The method of claim 1, wherein the testosterone gel is provided in a device capable of dispensing multiple, individual doses of the testosterone gel to the nasal mucosa of each nostril.

3. The method of claim 1, wherein the testosterone gel provides for the controlled release of testosterone into systemic circulation after nasal application.

4. The method of claim 1, wherein the testosterone gel provides for sustained serum levels of testosterone.

5. The method of claim 1, wherein the testosterone gel provides for the controlled release of testosterone into the brain after nasal application.

6. The method of claim 1, wherein the serum level is achieved after one said administration of the testosterone gel per nostril.

7. The method of claim 6, wherein the serum level of unbound testosterone is similar to the physiologic daily rhythm of testosterone release.

8. The method of claim 1, wherein said testosterone is maintained at a serum level greater than baseline for at least about 8 hours after nasal administration.

9. The method of claim 1, wherein said testosterone is maintained at a serum level greater than baseline for at least about 10 hours after nasal administration.

10. The method of claim 1, wherein said testosterone is present within the testosterone gel in an amount of from about 2% to about 4% by weight of the testosterone gel.

11. The method of claim 1, wherein said testosterone is present within the testosterone gel in an amount of from about 0.5% to about 2% by weight of the testosterone gel.

12. The method of claim 1, wherein said testosterone is present within the testosterone gel in an amount of about 2% by weight of the testosterone gel.

13. A method for nasally treating a patient in need of testosterone replacement therapy with testosterone, said method comprising: applying a testosterone oleogel to nasal mucosa in each nostril of a patient in need of testosterone replacement therapy for controlled release of testosterone for nasally treating the patient with testosterone; wherein, the testosterone is present within the testosterone oleogel in an amount of from about 0.5% to about 6% by weight of the testosterone oleogel for delivering testosterone to treat the patient in need of testosterone replacement therapy; wherein, an elevated testosterone serum level in the patient is achieved following said application of the testosterone oleogel to the nasal mucosa of the patient; and wherein, sustained serum levels of testosterone are maintained in the patient for at least 6 hours following said nasal administration of the testosterone oleogel to the nasal mucosa of the patient.

14. The method of claim 13, wherein the testosterone oleogel is provided in a device capable of dispensing multiple individual doses of the testosterone oleogel to the nasal mucosa of each nostril multiple.

15. The method of claim 13, wherein the testosterone oleogel provides for the controlled release of testosterone into systemic circulation after the nasal application.

16. The method of claim 13, wherein the testosterone oleogel provides for the controlled release of testosterone into the brain after nasal application.

17. The method of claim 13, wherein the serum level is achieved after one said application of the testosterone oleogel per nostril.

18. The method of claim 13, wherein the serum level of unbound testosterone is similar to the physiologic daily rhythm of testosterone release.

19. The method of claim 13, wherein said testosterone is maintained at a serum level greater than baseline for at least about 8 hours after said nasal administration of the testosterone oleogel.

20. The method of claim 13, wherein said testosterone is maintained at a serum level greater than baseline for at least about 10 hours after said nasal administration of the testosterone oleogel.

21. The method of claim 13, wherein said testosterone is present within the testosterone oleogel in an amount of from about 2% to about 4% by weight of the testosterone oleogel.

22. The method of claim 13, wherein said testosterone is present within the testosterone gel formulation in an amount of from about 0.5% to about 2% by weight of the testosterone oleogel.

23. The method of claim 13, wherein said testosterone is present within the testosterone gel formulation in an amount of about 2% by weight of the testosterone oleogel.
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