US Patent:
20110312927, Dec 22, 2011
Inventors:
Satish Kumar Nachaegari - Salt Lake City UT, US
Chandrashekar Giliyar - Salt Lake City UT, US
Chidambaram Nachiappan - Sandy UT, US
Linus Fonkwe - West Valley City UT, US
Mahesh Patel - Salt Lake City UT, US
Srinivasan Venkateshwaran - Salt Lake City UT, US
International Classification:
A61K 31/57
A61P 15/00
A61P 15/08
Abstract:
The present invention provides for progesterone containing pharmaceutical oral dosage forms and related methods. The oral dosage forms can each include an amount of progesterone as well as a pharmaceutically acceptable carrier. The oral dosage forms can be formulated to have at least one of the following characteristics: the oral dosage form produces an pregnane metabolite mean blood plasma level of less than about 1000 nmol/L; the oral dosage form produces an pregnane metabolites mean blood plasma level, after administration of single dose of progesterone composition, such that the ratio of pregnane metabolite level to parent progesterone level of less than 10:1; has a dissolution rate in vitro, when measure using a USP Type-1 dissolution apparatus in 900 mL of deionized water with 2.0% (w/v) of sodium lauryl sulfate at 100 rpm, such that the oral dosage form releases at least 10 wt % of the progesterone within the first 30 minutes and/or releases less than 45 wt % in the first 4 hours; and the oral dosage form produces a ratio of mean plasma progesterone AUC to the amount of progesterone administered of more than 1.5×10hr/mL:1