Liquid naloxone spray
AssigneeHikma Pharmaceuticals USA Inc.
InventorsKiran Amancha, Chandeshwari Chilampalli, Thrimoorthy Potta, Ningxin Yan, Venkat R. Goskonda
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Abstract
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.
Claims12
A liquid spray formulation comprising:
- from about 2% to about 10% w/w naloxone or a pharmaceutically acceptable salt thereof as the sole active ingredient;
- from about 20% to about 50% w/w ethanol;
- from about 5% to about 10% w/w propylene glycol;
- from about 35% to about 73% w/w water;
- and
- from about 0.005% to about 0.01% w/w edetate disodium dihydrate,
- wherein w/w denotes weight by total weight of the formulation.
Dependencies are inferred from the claim text.