Pharmaceutical composition comprising tadalafil or pharmaceutically acceptable salt thereof and dutasteride or pharmaceutically acceptable salt thereof exhibiting novel dissolution rate

A pharmaceutical composition comprising:

• granules comprising 5 mg of tadalafil or a pharmaceutically acceptable salt thereof;
• and
• granules comprising 0.5 mg of dutasteride or a pharmaceutically acceptable salt thereof as active ingredients,
• wherein a dissolution rate of tadalafil under dissolution conditions of a 50 rpm paddle rate in 500 mL of an eluate comprising 0.25% SLS at pH 1.2 is 60 to 75% in 5 minutes and more than 80% in 30 minutes,
• wherein a dissolution rate of dutasteride under dissolution conditions of a 50 rpm paddle rate in 500 mL of an eluate comprising water and 0.1% SLS is 50% or more at 15 minutes and 85% or more at 30 minutes,
• wherein the particle size of the granules comprising tadalafil or a pharmaceutically acceptable salt thereof is such that D10 is 30 μm or less, D50 is 70 to 130 μm, and D90 is 250 to 350 μm,
• wherein the particle size of the granules comprising dutasteride or a pharmaceutically acceptable salt thereof is such that D10 is 15 μm or less, D50 is 25 to 40 μm, and D90 is 90 to 150 μm,
• wherein the granules comprising tadalafil are granules prepared by preparing a suspension comprising tadalafil, a surfactant, a water-soluble polymer, and a solvent and granulating the same, and
• wherein the granules comprising dutasteride are granules prepared by dissolving dutasteride in a mixed oil solution comprising diethylene glycol monoethyl ether and mono/di-glyceride, adsorbing the resulting solution on an adsorbent, and granulating the same.