Claims for Patent: 9,687,495

Summary for Patent: 9,687,495

Title:	Methods and systems for the delivery of a therapeutic agent
Abstract:	The present invention provides a liquid pharmaceutical composition comprising a therapeutic agent and an alkoxy-polyethylene glycol, for example, methoxy-polyethylene glycol, for administration of the therapeutic agent to the mammal. The compositions can be applied to a membrane, for example, a nasal membrane during intranasal administration. The invention also provides methods of administering such compositions to a mammal.
Inventor(s):	Gizurarson; Sveinbjorn (Reykjavik, IS)
Assignee:	HANANJA EHF (Reykjavik, IS) UNIVERSITY OF ICELAND (Reykjavik, IS)
Application Number:	15/040,576
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,687,495
Patent Claims:	1. A system for intranasal administration of a liquid pharmaceutical composition formulated for intranasal administration comprising: a) a nasal spray device; and b) a liquid pharmaceutical composition formulated for intranasal administration disposed in the nasal spray device, the liquid pharmaceutical composition comprising i) a therapeutically effective amount of a therapeutic agent that is a benzodiazepine, a pharmaceutically acceptable salt thereof or combinations thereof; and ii) a methoxy-polyethylene glycol of Formula I H.sub.3C--O--(CH.sub.2CH.sub.2O).sub.n--H (I) wherein n is a number in the range of 1 to 25. 2. The system of claim 1, wherein the nasal spray device comprises a single-dose amount of the liquid pharmaceutical composition. 3. The system of claim 1, wherein the nasal spray device comprises a multi-dose amount of the liquid pharmaceutical composition. 4. The system according to claim 1, wherein the therapeutic agent is midazolam, or a pharmaceutically acceptable salt thereof. 5. The system according to claim 1, wherein n is 2-15. 6. The system according to claim 1, wherein n is 3-15. 7. The system according to claim 1, wherein the methoxy-polyethylene glycol is mPEG 350, mPEG 550, or a combination thereof. 8. The system according to claim 1, wherein the therapeutic agent comprises from about 0.001% (w/v) to about 20% (w/v) of the composition. 9. The system according to claim 1, wherein the methoxypolyethylene glycol comprises from about 0.5% (v/v) to about 70% (v/v) of the composition. 10. The system according to claim 1, wherein the methoxy-polyethylene glycol comprises 1% (v/v) to 60% (v/v) of the composition. 11. The system according to claim 1, wherein the composition further comprises water. 12. The system according to claim 1, wherein the composition at a temperature of 20.degree. C. has a viscosity in the range of from 1.5 cP to 60 cP. 13. The system according to claim 1, wherein the composition at a temperature of 20.degree. C. has a viscosity in the range of from 5 cP to 25 cP. 14. The system according to claim 1, wherein the composition has a pH in the range of from 4.5 to 8.5. 15. A method of administering a therapeutic agent to a mammal, the method comprising administering to an intranasal mucosal membrane of the mammal a liquid pharmaceutical composition comprising a) a therapeutically effective amount of a therapeutic agent selected from benzodiazepine, a pharmaceutically acceptable salt thereof or combinations thereof; and b) a methoxy-polyethylene glycol of Formula I H.sub.3C--O--(CH.sub.2CH.sub.2O).sub.n--H (I) wherein n is a number in the range of from about 1 to about 25. 16. The method of claim 15, wherein the pharmaceutical composition is administered in a volume of 50 .mu.l to 300 .mu.l. 17. The method of claim 15, wherein the mammal is a human. 18. The method of claim 15, wherein n is in the range of 2 to 12.