Sublingual buprenorphine spray
AssigneeInsys Development Company, Inc.
InventorsKiran P. Amancha, Chandeshwari S. Chilampalli, Venkat R. Goskonda
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Abstract
The invention provides sublingual formulations containing buprenorphine, a pharmaceutically acceptable salt thereof, or a derivative thereof. The invention further provides sublingual formulations containing buprenorphine and naloxone, pharmaceutically acceptable salts thereof or derivatives thereof. The invention further provides a method of treating pain or opioid dependence by administering sublingual formulations containing buprenorphine, a pharmaceutically acceptable salt thereof, or a derivative thereof to a patient in need thereof.
Claims11
A sublingual spray formulation comprising:
- buprenorphine, a pharmaceutically acceptable salt thereof or a derivative thereof is at an amount from about 0.08% to about 1.3% w/w;
- water as a solvent is at an amount from about 38% to about 40% w/w;
- a cosolvent consisting of a mixture of ethanol in an amount of 55% w/w and propylene glycol in an amount of about 5% w/w;
- an antioxidant consisting of a mixture of butylated hydroxyanisole (BHA) in an amount of about 0.01% w/w and butylated hydroxytoluene (BHT) in an amount of about 0.005% w/w;
- and
- menthol at an amount of about 0.05% w/w,
- wherein w/w denotes weight by total weight of the formulation.
Dependencies are inferred from the claim text.