Methods and systems for the delivery of a therapeutic agent
View Patent ↗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.
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 3 C—O—(CH 2 CH 2 O) 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° 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° 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 3 C—O—(CH 2 CH 2 O) 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 μl to 300 μl.
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.