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US 2025/0144015 A1Published application
Pharmaceutical Compositions
AssigneesExtrovis AG, Athyna Pharma LLC
InventorKirankumar Kowkuntla
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Abstract
The present disclosure relates to a stable, fast-disintegrating pharmaceutical tablet for buccal or sublingual administration, containing buprenorphine or its pharmaceutically acceptable salt, and naloxone or its pharmaceutically acceptable salt, providing enhanced ease of administration. The stable pharmaceutical tablet disintegrates in a patient's oral cavity, under the tongue, and helps in sublingual absorption of the buprenorphine or its pharmaceutically acceptable salt.
Claims12
A stable pharmaceutical tablet for buccal or sublingual administration, comprising:
- from about 1 mg to about 24 mg of buprenorphine in the form of its base or a pharmaceutically acceptable salt;
- and
- from about 0.5 mg to about 6 mg of naloxone in the form of its base or a pharmaceutically acceptable salt;
- and pharmaceutically acceptable excipients,
- wherein the tablet:
- has an in vitro disintegration time of less than 120 seconds when tested by the disintegration test defined in the United States Pharmacopoeia (USP);
- has a hardness of 2-10 kP;
- has a friability of less than 1%;
- exhibits an in vivo disintegration time of less than 20 minutes;
- and
- releases more than 85% of the buprenorphine in less than 5 minutes and all of the naloxone in less than 20 minutes, when tested in vitro in a dissolution apparatus defined in the United States Pharmacopoeia (USP).
8 more elements
Dependencies are inferred from the claim text.