Steroid hormone products and methods for preparing them
AssigneeOrtho-McNeil Pharmaceutical, Inc.
InventorsThomas Schultz, Bradley A. Clark, Angela Falzone
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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.
Claims17
A steroid hormone product having improved dissolution and release rate properties, said product comprising a steroid hormone in substantially non-crystalline form in admixture with an excipient, said excipient stabalizing said hormone in its substantially non-crystalline form.
A method of preparing a steroid hormone product having improved dissolution and release rate properties, said method comprising the steps of:
- preparing a mixture comprising at least one steroid hormone and at least one excipient;
- imparting to said mixture sufficient mechanical energy to yield an excipient/hormone powder blend wherein the hormone is stabilized by said excipient in substantially non-crystalline form;
- and
- forming said product from the powder blend.
Dependencies are inferred from the claim text.