Intranasal opioid compositions, delivery devices and methods of using same
First Claim
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1. A method for providing analgesia to a subject in need thereof, the method comprising intranasally administering to the subject, using an intranasal unit dose delivery device, a pharmaceutical composition comprising:
- an effective amount of butorphanol or a pharmaceutically acceptable salt thereof, and a liquid nasal carrier, wherein upon intranasal administration of the composition to a subject, the subject exhibits one or more of;
a Tmax butorphanol plasma concentration of at most about 0.75 hr;
a Cmax butorphanol plasma concentration of about 1000 pg/ml to about 10,000 pg/ml; and
/or an AUC butorphanol plasma concentration of about 5000 pg*hr/ml to about 18,000 pg*hr/ml.
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Abstract
The present invention relates to pharmaceutical compositions comprising opioids and a liquid nasal carrier, to delivery devices comprising such compositions, and to methods of manufacture and use of such compositions.
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Citations
26 Claims
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1. A method for providing analgesia to a subject in need thereof, the method comprising intranasally administering to the subject, using an intranasal unit dose delivery device, a pharmaceutical composition comprising:
- an effective amount of butorphanol or a pharmaceutically acceptable salt thereof, and a liquid nasal carrier, wherein upon intranasal administration of the composition to a subject, the subject exhibits one or more of;
a Tmax butorphanol plasma concentration of at most about 0.75 hr;
a Cmax butorphanol plasma concentration of about 1000 pg/ml to about 10,000 pg/ml; and
/or an AUC butorphanol plasma concentration of about 5000 pg*hr/ml to about 18,000 pg*hr/ml. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9)
- an effective amount of butorphanol or a pharmaceutically acceptable salt thereof, and a liquid nasal carrier, wherein upon intranasal administration of the composition to a subject, the subject exhibits one or more of;
- 10. An intranasal unit-dose delivery device comprising one or more sealed vessels containing a sterilized, preservative-free pharmaceutical composition, said composition comprising an effective amount of butorphanol tartrate and liquid nasal carrier, wherein upon positioning the device 1 cm away from a detection laser beam, actuating the device to produce a spray plume perpendicular to said laser beam, and detecting droplet size distribution of the spray plume with said laser beam, the spray plume has a maximum droplet size of about 1 to about 4 μ
Specification