Claims for Patent: 8,217,033

Summary for Patent: 8,217,033

Title:	Methods and compositions 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 (Reyjavik, IS) University of Iceland (Reykjavik, IS)
Application Number:	12/469,448
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,217,033
Patent Claims:	1. A liquid pharmaceutical composition formulated for intranasal administration, comprising: i) midazolam or a pharmaceutically salt thereof; and ii) a methoxy-polyethylene glycol selected from the group consisting of methoxy-polyethylene glycol 350 and methoxy-polyethylene glycol 550. 2. The pharmaceutical composition of claim 1, further comprising propylene glycol. 3. The pharmaceutical composition of claim 2, further comprising water. 4. The pharmaceutical composition of claim 1, wherein the methoxy-polyethylene glycol is methoxy-polyethylene glycol 350. 5. The pharmaceutical composition of claim 3, wherein the methoxy-polyethylene glycol is methoxy-polyethylene glycol 350. 6. The pharmaceutical composition of claim 1, further comprising polyethylene glycol. 7. The pharmaceutical composition of claim 5, further comprising polyethylene glycol. 8. The pharmaceutical composition of claim 1, further comprising ethyl alcohol. 9. The pharmaceutical composition of claim 6, wherein the polyethylene glycol is polyethylene glycol 400. 10. The pharmaceutical composition of claim 7, wherein the polyethylene glycol is polyethylene glycol 400. 11. The pharmaceutical composition of claim 1, wherein the midazolam is present in a concentration from 0.001% (w/v) to 20% (w/v). 12. The pharmaceutical composition of claim 1, further comprising water. 13. The pharmaceutical composition of claim 10, wherein the midazolam is present in a concentration from 0.001% (w/v) to 20% (w/v). 14. The pharmaceutical composition of claim 9, wherein the methoxypolyethylene glycol is methoxy-polyethylene glycol 350. 15. A method of administering midazolam to a mammal, the method comprising administering a pharmaceutical composition to a mucosal surface of the mammal, the pharmaceutical composition comprising: midazolam or a pharmaceutically acceptable salt thereof; and a methoxy-polyethylene glycol selected from the group consisting of methoxy polyethylene glycol 350 and methoxy-polyethylene glycol 550. 16. The method of claim 15, wherein the mucosal surface is a nasal membrane, buccal membrane, pulmonal membrane, ocular membrane, or rectal membrane. 17. The method of claim 15, wherein the mucosal surface is a nasal membrane. 18. The method of claim 15, wherein the midazolam has a peak concentration (T.sub.max) in the blood of the mammal within 30 minutes after administration of the midazolam. 19. The method of claim 15, wherein the midazolam has a peak concentration (T.sub.max) in the blood of the mammal within 15 minutes after administration of the midazolam. 20. The method of claim 15, wherein the pharmaceutical composition is administered in a volume of 50 .mu.l to 300 .mu.l. 21. The method of claim 15, wherein the mammal is a human.