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Last Updated: December 12, 2025

Claims for Patent: 11,471,413

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Summary for Patent: 11,471,413

Title:	Compositions and methods for treating disorders ameliorated by muscarinic receptor activation
Abstract:	Provided herein is an oral pharmaceutical composition, comprising a plurality of xanomeline beads having a core comprising xanomeline or a salt thereof; and a plurality of trospium beads having a core comprising a salt of trospium.
Inventor(s):	Aimesther BETANCOURT, Bruce Rehlaender, Roch Thibert
Assignee:	Karuna Therapeutics Inc
Application Number:	US17/143,904
Patent Claims:	1. A method comprising administering to a patient in need thereof a dosage form comprising between 50 mg and 125 mg xanomeline and/or a salt thereof and between 20 mg and 30 mg trospium salt, wherein the dosage form releases the xanomeline and/or salt thereof and the trospium salt at comparable rates such that the method achieves an in-vivo plasma profile comprising a median Tmax for xanomeline of 2 hours, and a median Tmax for trospium of 1 hour. 2. The method of claim 1, wherein the in-vivo plasma profile comprises the mean dose-normalized Cmax of between 48.5 and 121.3 pg/mL/mg and the mean dose-normalized Cmax of trospium of between 156 and 375 pg/mL/mg. 3. The method of claim 1, wherein the in-vivo plasma profile comprises a mean dose-normalized AUC0-12 of xanomeline of between 263 and 577 hr·pg/mL/mg and a mean dose-normalized AUC0-12 of trospium of between 881 and 2024 hr·pg/mL/mg. 4. The method of claim 1, wherein the administration is oral. 5. The method of claim 1, wherein the dosage form is administered to the patient for at least 7 days. 6. The method of claim 1, wherein the dosage form is administered to the patient twice daily. 7. The method of claim 1, wherein the xanomeline and/or a salt thereof is xanomeline tartrate. 8. The method of claim 1, wherein the trospium salt is trospium chloride. 9. The method of claim 1, wherein the xanomeline and/or a salt thereof is xanomeline tartrate and the trospium salt is trospium chloride. 10. The method of claim 9, wherein the dosage form is administered to the patient twice daily for at least 7 days. 11. A method comprising administering to a patient in need thereof a dosage form comprising between 50 mg and 125 mg xanomeline and/or a salt thereof and between 20 mg and 30 mg trospium salt, wherein the dosage form releases the xanomeline and/or salt thereof and the trospium salt at comparable rates such that the dosage form has a dissolution rate such that at least 80% of the xanomeline or a salt thereof and the trospium salt is released within 20 minutes in pH 6.8 buffer solution. 12. The method of claim 11, wherein the in-vivo plasma profile comprises the mean dose-normalized Cmax of between 48.5 and 121.3 pg/mL/mg and the mean dose-normalized Cmax of trospium of between 156 and 375 pg/mL/mg. 13. The method of claim 11, wherein the in-vivo plasma profile comprises a mean dose-normalized AUC0-12 of xanomeline of between 263 and 577 hr·pg/mL/mg and a mean dose-normalized AUC0-12 of trospium of between 881 and 2024 hr·pg/mL/mg. 14. The method of claim 11, wherein the in-vivo plasma profile comprises the median Tmax for xanomeline of 2 hours and the median Tmax for trospium of 1 hour. 15. The method of claim 11, wherein the administration is oral. 16. The method of claim 11, wherein the dosage form is administered to the patient for at least 7 days. 17. The method of claim 11, wherein the dosage form is administered to the patient twice daily. 18. The method of claim 11, wherein the xanomeline and/or a salt thereof is xanomeline tartrate. 19. The method of claim 11, wherein the trospium salt is trospium chloride. 20. The method of claim 11, wherein the xanomeline and/or a salt thereof is xanomeline tartrate and the trospium salt is trospium chloride. 21. The method of claim 17, wherein the dosage form is administered to the patient twice daily for at least 7 days.

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