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Last Updated: December 16, 2025

Claims for Patent: 11,925,709

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Summary for Patent: 11,925,709

Title:	Tablet formulation for CGRP active compounds
Abstract:	The present invention is directed to compositions comprising an extrudate or solid solution of a compound, or a salt thereof, of Formula I (API): wherein “Ra” is independently —H or —F, in a water-soluble polymer matrix which further comprises a disintegration system allowing a tablet made therefrom to rapidly disintegrate in the environment in which the API is to be released.
Inventor(s):	Mary Ann Johnson, Leonardo Resende Allain, W. Mark Eickhoff, Craig B. Ikeda, Chad D. Brown, Francis J. Flanagan, JR., Rebecca Nofsinger, Melanie Marota, Lisa Lupton, Paresh B. Patel, Hanmi Xi, Wei Xu
Assignee:	Merck Sharp and Dohme LLC
Application Number:	US17/110,398
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,925,709
Patent Claims:	1. A tablet comprising: an extrudate comprising: a water-soluble polymer matrix; a dispersing agent; and a compound of Formula Ia, or a pharmaceutically acceptable salt thereof: wherein each of Rb is —H, wherein the compound of Formula Ia is dispersed within the polymer matrix; and a disintegration system. 2. The tablet according to claim 1, wherein the water-soluble polymer matrix is a water-soluble polyvinylpyrrolidone/vinyl acetate (PVP-VA) copolymer. 3. The tablet according to claim 1, wherein the disintegration system comprises a disintegrant selected from the group consisting of croscarmellose sodium and crospovidone. 4. The tablet according to claim 3, wherein the disintegrant is croscarmellose sodium. 5. The tablet according to claim 1, wherein the dispersing agent is selected from the group consisting of d-alpha tocopherol polyethyleneglycol succinate (TPGS) and polyethoxylated castor oil. 6. The tablet according to claim 5, wherein the dispersing agent is d-alpha tocopherol polyethyleneglycol succinate (TPGS). 7. The tablet according to claim 1, wherein the compound of Formula Ia is present in an amount from about 20 wt % to about 22 wt % of the extrudate. 8. The tablet according to claim 7, wherein the extrudate comprises about 50 wt % of the tablet. 9. The tablet according to claim 1, wherein the tablet has a hardness of from about 12 kP to about 18 kP. 10. The tablet of claim 1, wherein the disintegration system comprises powdered sodium chloride.

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