公开(公告)号：US20240358664A1

公开(公告)日：2024-10-31

申请号：US18318697

申请日：2023-05-16

申请人： PYROS PHARMACEUTICALS, INC.

发明人： Nrupa Patel ,  Raenel V. Gibson ,  Michael M. Smith ,  Edwin Urrutia

IPC分类号： A61K31/197 ,  A61J1/14 ,  A61J7/00 ,  A61K9/00 ,  A61K47/14 ,  A61K47/26 ,  A61K47/46

CPC分类号： A61K31/197 ,  A61J1/1468 ,  A61J7/0053 ,  A61K9/0095 ,  A61K47/14 ,  A61K47/26 ,  A61K47/46

摘要： The embodiments of the present invention relate to a stable liquid vigabatrin pharmaceutical compositions in the liquid form of a solution. Particularly, the stable vigabatrin liquid pharmaceutical composition is manufactured as a ready-to-use industrialized premixture that does not require reconstitution or dilution prior to administration to a patient. The vigabatrin liquid pharmaceutical composition is stable six months or longer at room temperature and has levels of total impurities and Vigabatrin-related compound A that are both not more than 0.04% at, or prior to, six months. In some embodiments, the composition has improved stability and patient compliance. In some embodiments, the compositions may be advantageous for the patients having swallowing difficulties or when the patients are unable to take solid oral dosage forms. In some embodiments, the composition improves compliance with ketogenic diet.