US 12,576,054 B2 · Vigabatrin liquid pharmaceutical composition

Abstract

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.

Claims15

Dependent claims

A ready-to-drink liquid pharmaceutical composition consisting of:

vigabatrin, or a pharmaceutically acceptable salt thereof, in the range from about 0.1 wt % to about 20 wt %;
at least one preservative in the range from about 0.001 wt % to about 1.0 wt %;
at least one sweetening agent in the range from about 0.05 wt % to about 40.0 wt %;
at least one flavoring agent in the range from about 0.001 wt % to about 10.0 wt %;
and
quantum satis (q.s.) purified water;
wherein the liquid pharmaceutical composition:
(i) is a ready to use premixture that does not require reconstitution or dilution prior to administration to a patient;
and
(ii) is stable for at least six months at temperatures ranging from 2° C. to 30° C., and wherein total impurities are not more than 0.04 wt %.

7 more elements

Dependencies are inferred from the claim text.

Vigabatrin liquid pharmaceutical composition

Life of this patent

Vigabatrin liquid pharmaceutical composition

Life of this patent

Abstract

Claims15