GEMCABENE, PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, COMPOSITIONS THEREOF AND METHODS OF USE THEREFOR

• Main Authors: GREENE, Matthew Benjamin, BISGAIER, Charles Larry, ONICIU, Daniela Carmen
• Format: Patent
• Language: English; French; German
• Published: 25.08.2021
• Subjects: ACYCLIC OR CARBOCYCLIC COMPOUNDS; CHEMISTRY; METALLURGY; ORGANIC CHEMISTRY

This invention provides tablets comprising gemcabene calcium salt hydrate Crystal Form 2 or gemcabene calcium salt hydrate Crystal Form C3, each having a PSD90 ranging from 35 μm to 90 μm as measured by laser light diffraction and wherein the tablet has a gemcabene dissolution profile characterized by a % dissolution profile of at least 80% in pH 5.0 potassium acetate buffer at 37° C.±0.5° C. in no more than 45 minutes as measured by ultra-violet/visible light absorption using a detection wavelength range of 216 nm to 230 nm. This invention further provides gemcabene calcium salt hydrate Crystal Forms 4, 5 and 6. The tablets and gemcabene calcium salt hydrate Crystal Forms 4, 5 and 6 are useful for treating or preventing liver disease or an abnormal liver condition, a disorder of lipoprotein or glucose metabolism, a cardiovascular or related vascular disorder, a disease caused by fibrosis (such as liver fibrosis), or a disease associated with inflammation (such as liver inflammation).