IP Library › Patent Application 19397103
Patent Application
App. No. 19/397,103

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

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Patent No.
US None
App. No.
19/397,103
Abstract

This present invention provides gemcabene pharmaceutically acceptable salts having a PSD90 of 35 μm to about 90 μm, methods for purifying crude gemcabene, pharmaceutically acceptable salts of purified gemcabene, pharmaceutical compositions of a gemcabene pharmaceutically acceptable salt and therapeutic and prophylactic methods useful for various conditions, including dyslipidemia.

Claims (9)

1 .- 15 . (canceled)

16 . A pharmaceutically acceptable salt of gemcabene, the pharmaceutically acceptable salt having a PSD90 ranging from 35 μm to about 90 μm as measured by laser light diffraction and providing a plasma gemcabene AUC (0-24) ranging from about 200 μg·hr/mL at steady state to about 6000 μg·hr/mL at steady state when administered to a human subject at a dose of about 50 mg to about 900 mg.

17 . The pharmaceutically acceptable salt of claim 16 , wherein the pharmaceutically acceptable salt has a dissolution profile characterized by a % dissolution value of (1) at least 80% in pH 5.0 potassium acetate buffer at 37° C.±5° C. in no more than 45 minutes as measured by high-performance liquid chromatography using a detection wavelength of 210 nm or (2) at least 70% in pH 5.0 potassium acetate buffer at 37° C.±5° C. in no more than 30 minutes as measured by high-performance liquid chromatography using a detection wavelength of 210 nm.

18 . The pharmaceutically acceptable salt of claim 16 , wherein the pharmaceutically acceptable salt is a calcium salt.

19 . A pharmaceutically acceptable salt of gemcabene, the pharmaceutically acceptable salt having a PSD90 ranging from 35 μm to about 90 μm as measured by laser light diffraction and providing a plasma gemcabene AUC last ranging from about 50 μg·hr/mL to about 7500 μg·hr/mL after a single dose administration of about 50 mg to about 900 mg to a human subject.

20 . The pharmaceutically acceptable salt of claim 19 , wherein the pharmaceutically acceptable salt has a dissolution profile characterized by a % dissolution value of (1) at least 80% in pH 5.0 potassium acetate buffer at 37° C.±5° C. in no more than 45 minutes as measured by high-performance liquid chromatography using a detection wavelength of 210 nm or (2) at least 70% in pH 5.0 potassium acetate buffer at 37° C.±5° C. in no more than 30 minutes as measured by high-performance liquid chromatography using a detection wavelength of 210 nm.

21 . The pharmaceutically acceptable salt of claim 19 , wherein the pharmaceutically acceptable salt is a calcium salt.

22 . A composition comprising an effective amount of the pharmaceutically acceptable salt of claim 16 and a pharmaceutically acceptable carrier or vehicle.

23 . A composition comprising an effective amount of the pharmaceutically acceptable salt of claim 19 and a pharmaceutically acceptable carrier or vehicle.