Steroid hormone products and methods for preparing them

Abstract

The present invention relates to steroid hormone products, such as oral contraceptive products, including at least one steroid active ingredient mixed with an excipient and having improved dissolution and release rate properties. The invention further relates to methods for making such steroid hormone products, wherein a mixture of the hormone and the excipient is subjected to sufficient mechanical energy to form a powder blend wherein the hormone is stabilized by the excipient in substantially non-crystalline form.

1 . An oral contraceptive product having improved dissolution and release rate properties, said product comprising from about 50 μg to about 300 μg of norgestimate in admixture with lactose, wherein substantially all of said norgestimate is in non-crystalline form and wherein said lactose stabilizes said norgestimate in its non-crystalline form, and from about 10 μg to about 50 μg of ethinyl estradiol.