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AssigneeHikma Pharmaceuticals USA Inc.
InventorsKiran Amancha, Chandeshwari Chilampalli, Thrimoorthy Potta, Ningxin Yan, Venkat R. Goskonda, Eshwaran Narayanan
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The invention provides stable liquid formulations containing naloxone, a pharmaceutically acceptable salt or a derivative thereof. The invention further provides methods for treating opioid overdose, opioid dependence, and congenital insensitivity to pain with anhidrosis by administering the liquid formulations of the present invention intranasally to a patient in need thereof. Further, the invention provides a method of treating opioid dependence, opioid overdose, and congenital insensitivity to pain with anhidrosis by administering intranasally the naloxone formulations of the present invention.
A liquid spray formulation comprising about 9% w/w naloxone, a pharmaceutically acceptable salt thereof, about 66% w/w water, about 5.0% w/w propylene glycol and about 20.0% w/w ethanol, and about 0.01% w/w edetate disodium dihydrate, wherein the formulation does not contain an isotonicity agent or a buffer, wherein w/w denotes weight by weight of the total formulation.
A liquid spray formulation comprising about 9% w/w naloxone, a pharmaceutically acceptable salt thereof, about 36% w/w water, about 5.0% w/w propylene glycol and about 50.0% w/w ethanol, and about 0.005% w/w edetate disodium dihydrate, wherein the formulation does not contain an isotonicity agent or a buffer and, wherein w/w denotes weight by weight of the total formulation.
Dependencies are inferred from the claim text.