Patent ID: 9364547
Filing Date: 2016-06-14
CPC Classification: A61K,A61P,A61Q

Claim Text:
1. A method of treating a pregnant female subject at risk of preterm birth, said method comprising administering to the female subject a tablet or capsule oral pharmaceutical composition comprising: a therapeutically effective amount of 17-hydroxyprogesterone caproate with a mean particle diameter size of 50 micron or less and a pharmaceutically acceptable carrier wherein (a) said pharmaceutically acceptable carrier includes (i) a poloxamer, a polyethylene glycol sorbitan fatty acid ester, a sorbitan fatty acid ester, a polyethylene glycol glycerol fatty acid ester, sodium lauryl sulfate, sodium dioctyl sulfosuccinate, a lecithin, a bile salt or a combination thereof; or (ii) a lipophilic additive and (b) said pharmaceutical composition, when measured using a USP Type-II dissolution apparatus in 900 mL of simulated intestinal fluid having 0.5% (w/v) of sodium lauryl sulfate at 50 RPM at 37° C., releases at least 20 wt % of the 17-hydroxyprogesterone caproate at 60 minutes.