US 12,290,499 B2
Vigabatrin liquid pharmaceutical composition
Nrupa Patel, Robbinsville, NJ (US); Raenel V. Gibson, Gambier, OH (US); Michael M. Smith, New York, NY (US); and Edwin Urrutia, Brooklyn, NY (US)
Assigned to PYROS PHARMACEUTICALS, INC., Parsippany, NY (US)
Filed by PYROS PHARMACEUTICALS, INC., Parsippany, NJ (US)
Filed on Jun. 28, 2024, as Appl. No. 18/759,349.
Application 18/759,349 is a continuation of application No. 18/318,697, filed on May 16, 2023.
Application 18/318,697 is a continuation of application No. PCT/US2022/078202, filed on Oct. 17, 2022.
Claims priority of provisional application 63/378,383, filed on Oct. 5, 2022.
Claims priority of provisional application 63/375,909, filed on Sep. 16, 2022.
Prior Publication US 2024/0398741 A1, Dec. 5, 2024
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/197 (2006.01); A61J 1/14 (2023.01); A61J 7/00 (2006.01); A61K 9/00 (2006.01); A61K 47/14 (2017.01); A61K 47/26 (2006.01); A61K 47/46 (2006.01)
CPC A61K 31/197 (2013.01) [A61J 1/1468 (2015.05); A61J 7/0053 (2013.01); A61K 9/0095 (2013.01); A61K 47/14 (2013.01); A61K 47/26 (2013.01); A61K 47/46 (2013.01)] 19 Claims
 
1. A ready-to-use liquid oral pharmaceutical composition consisting of:
about 0.1 wt % to about 20 wt % of vigabatrin or a pharmaceutically acceptable salt thereof;
about 0.001 wt % to about 1.0 wt % of at least one preservative;
about 0.01 wt % to about 40.0 wt % of at least one sweetening agent;
about 0.001 wt % to about 10.0 wt % of at least one flavoring agent; and
quantum satis (q.s.) purified water;
wherein the composition is stable for at least six months at temperatures ranging from 2° C. to 30° C., and
wherein the total concentration of 5-vinylpyrrolidin-2-one and other impurities is not more than 0.04 wt %.