Back to results
US 12,667,545 B2Granted
Lyophilized compositions of phenobarbital sodium salt
AssigneeNivagen Pharmaceuticals, Inc.
InventorsBala Tripura Sundari Chodavarapu, Thirupathi Mangali, Jay Shukla, Anand Shukla, Dasaradhi Lakkaraju
Life of this patent
Estimating the term…
Abstract
A composition of, method for producing, and use of an amorphous lyophilized Phenobarbital Sodium having high purity are presented. The amorphous lyophilized Phenobarbital Sodium is storage-stable being essentially void of impurities (e.g., phenyl ethylacetylurea (PEAU), 2-ethyl-2-phenylmalonamide (2EPMM), and/or alpha-phenylbutyrylguanidine (PBG)) upon reconstitution in water.
Claims20
A pharmaceutical product, comprising:
- a container enclosing sterile storage stable lyophilized amorphous phenobarbital;
- wherein the lyophilized phenobarbital is storage stable such that, upon storage at 25° C. and 60% relative humidity for 3 months and reconstitution with water to a concentration of 65 mg/mL, less than 0.05% of degradation products from the phenobarbital are detectable in the reconstituted solution;
- wherein the degradation products are selected form the group consisting of 2-ethyl-2-phenylmalonamide (2EPMM), alpha-phenylbutyrylguanidine (PBG), and phenylethylacetylurea (PEAU);
- and
- wherein the lyophilized phenobarbital is stored under vacuum in the container.
2 more elements
Dependencies are inferred from the claim text.