Patent ID: 7112341

Claim:
A stabilized dry powder composition for delivery to the deep lung of a mammalian subject, comprising: (i) a pharmacologically effective amount of follicle-stimulating hormone (FSH), FSH glycoform, or mixture thereof, wherein the FSH, FSH glycoform, or mixture thereof is selected from the group consisting of mammalian urinary-derived FSH, FSH glycoform, or mixture thereof and recombinantly derived FSH, FSH glycoform, or mixture thereof; and (ii) a pharmaceutically acceptable excipient, wherein the composition comprises particles having a bulk density from 0.1 to 10 grams per cubic centimeter, wherein the composition possesses a specific activity of at least 50 IU/mg FSH, wherein the composition comprises a solid state matrix that imparts a stabilizing environment for the FSH, FSH glycoform, or mixture thereof, wherein the solid state matrix is crystalline, an amorphous glass, or a mixture thereof, and wherein the composition maintains at least about 70% of its initial bioactivity when stored for one month at room temperature under ambient conditions.