Compositions comprising pgi2-receptor agonists and processes for the preparation thereof

A pharmaceutical composition comprising a compound selected from 2-(((1r,4r)-4-(((4-chlorophenyl)(phenyl)carbamoyloxy)methyl)cyclohexyl)methoxy)acetic acid, having the structure:

• or a pharmaceutically acceptable salt, solvate, or hydrate thereof, in an amount equivalent to about 0.01 mg to about 1 mg of Compound 1,
• wherein the pharmaceutical composition is a tablet;
• wherein the composition comprises at least a first excipient and a second excipient, wherein the first excipient comprises a release modifier having a viscosity of about 2300 mPA seconds to about 3800 mPA seconds when present in an amount of about 2% in water at 20° C. and the second excipient comprises a release modifier having a viscosity of about 75 mPA seconds to about 120 mPA seconds when present in an amount of about 2% in water at 20° C.,
• wherein the composition has a release rate by weight of the compound in an aqueous medium that is one or more of release rates (a), (b) and (c), wherein
• (a) less than or equal to about 40% by weight of the compound is released over the first two hours in the aqueous medium;
• (b) about 40% to about 60% by weight of the compound is released over the first five hours in the aqueous medium;
• and
• (c) more than or equal to about 80% by weight of the compound is released over the first fourteen hours in the aqueous medium,
• wherein the release rate is measured with USP Apparatus 1 (baskets) at 80 to 120 rpm in 400 to 600 mL of an aqueous medium at a pH of 6.3 to 7.3 at a temperature of 37° C.±0.5° C., comprising sodium phosphate at a concentration of 0.04 to 0.06 M.