You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 28, 2024

Details for Patent: 8,877,230


✉ Email this page to a colleague

« Back to Dashboard


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)
Filing Date:Dec 10, 2011
Application Number:13/316,494
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.

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.