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US 10,292,948 B2Granted
Tapentadol nasal composition
AssigneeTorrent Pharmaceuticals Limited
InventorsJaya Abraham, Vivek Mishra, Vipul Mittal, Kiran Chaudhari
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Abstract
Disclosed herein are pharmaceutical compositions for nasal administration comprising tapentadol, their preparation and their use in the treatment of pain.
Claims20
A unit dose comprising:
- tapentadol or a pharmaceutically acceptable salt thereof in an amount that is equivalent to about 19.3 mg tapentadol free base and at least one nasal carrier;
- wherein after intranasal administration to one nostril of a human, a tapentadol mean Cmax-value achieved by said unit dose ranges from about 40 ng/mL to 65 ng/mL.
A unit dose comprising:
- tapentadol or a pharmaceutically acceptable salt thereof in an amount that is equivalent to about 19.3 mg tapentadol free base and at least one nasal carrier;
- wherein after intranasal administration to two nostrils of a human a tapentadol mean Cmax-value achieved by said unit dose ranges from about 98 ng/mL to 155 ng/mL.
A method of treating pain in a human in need thereof, which comprises:
- intranasally administering to the human a unit dose comprising tapentadol or a pharmaceutically acceptable salt thereof;
- wherein the amount of tapentadol or a pharmaceutically acceptable salt thereof in said unit dose is equivalent to about 19.3 mg tapentadol free base;
- and
- wherein after intranasal administration of the unit dose, a tapentadol mean Cmax-value achieved by said intranasal administration ranges from about 40 ng/mL to 65 ng/mL.
1 more element
A method of treating pain in a human in need thereof, which comprises:
- intranasally administering to the human a unit dose comprising tapentadol or a pharmaceutically acceptable salt thereof;
- wherein the amount of tapentadol or a pharmaceutically acceptable salt thereof in said unit dose is equivalent to about 19.3 mg tapentadol free base;
- and
- wherein after intranasal administration of the unit dose, a tapentadol mean Cmax-value achieved by said intranasal administration to each nostril, ranges from about 98 ng/mL to 155 ng/mL.
1 more element
Dependencies are inferred from the claim text.