Abuse deterrent compositions and methods of use
AssigneeInspirion Delivery Technologies, LLC
InventorsManish S. Shah, Ray J. DiFalco, Stefan Aigner
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Abstract
Orally administrable pharmaceutical compositions, methods of administration, and methods of making the same are provided. The pharmaceutical compositions provide abuse deterrent properties.
Claims27
An orally administrable pharmaceutical composition comprising a drug, wherein the composition is configured such that when the pharmaceutical composition is administered intranasally in physically compromised form to a subject, the area under the curve (AUC) of a major metabolite of the drug after a period of time is at least 15% of the AUC of the major metabolite achieved after oral administration of an intact form of the pharmaceutical composition after the same period of time.
An orally administrable pharmaceutical composition comprising 60 mg of morphine or a salt thereof, wherein the composition is configured such that when the pharmaceutical composition is administered intranasally in physically compromised form to a subject, the area under the curve (AUC) of morphine-6-glucuronide (M6G) after a period of time is at least 100 ng·h/mL.
An orally administrable pharmaceutical composition comprising 60 mg of morphine or a salt thereof, wherein the composition is configured such that when the pharmaceutical composition is administered intranasally in physically compromised form to a subject, the area under the curve (AUC) of morphine-6-glucuronide (M6G) after a period of time is at least 0.1 ng·h/mL, wherein the period of time is selected from the group consisting of 0.5 hour, 1 hour, and 2 hours.
An orally administrable pharmaceutical composition comprising morphine or a salt thereof, wherein the composition is configured such that when the pharmaceutical composition is administered intranasally in physically compromised form to a subject, the area under the curve (AUC) of morphine-6-glucuronide (M6G) after a period of time is at least about 0.5 ng·h/mL/mg (ng·h/mL per mg of morphine).
Dependencies are inferred from the claim text.