Administration of steroid hormones

• US 4,877,774 A
• Filed: 09/09/1987
• Issued: 10/31/1989
• Est. Priority Date: 09/09/1987
• Status: Expired due to Term

• Current Assignee: United States Department Of Health And Human Services (Government of the United States of America)
• Original Assignee: United States Department Of Health And Human Services (Government of the United States of America)
• Inventors: Harman, Mitchell, Pitha, Josef, Uekama, Kaneto
• Primary Examiner(s): Sneed, H. M. S.
• Assistant Examiner(s): Saba, J.
• Application Number:
  US07/094,597
• Time in Patent Office: 783 Days
• Field of Search: 514/58, 514/946, 514/960, 514/178, 514/26
• US Class Current: 514/26
• CPC Class Codes: A61K 31/56 Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
• CPC Class Codes: A61K 31/565 not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
• CPC Class Codes: A61K 31/57 substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
• CPC Class Codes: A61K 47/6951 using cyclodextrin cyclodextrins used as simple excipients A61K47/40
• CPC Class Codes: B82Y 5/00 Nanobiotechnology or nanomedicine, e.g. protein engineering or drug delivery

Abstract

Crystalline complexes of steroid hormones with gamma-cyclodextrin are prepared by mixing the components together. Tablets can be formed from the complexes, which can be administered by contact with the mucosa to provide effective transfer of the hormones into the systemic circulation, gradually eliminating the hormones therefrom.

Claims

1. A method for administering steroid hormones to a patient needing supplemental steroid hormones by direct contact with mucosa or the conjuctiva comprising contacting the mucosa of said patient needing supplemental steroid hormones with an effective amount of a steroid hormone complexed with crystalline gamma-cyclodextrin.

2. The method of claim 1 wherein the steroid hormones are selected from the group consisting of testosterone, estradiol, and progesterone.

3. The method of claim 2 wherein the steroid hormone is testosterone.

7. The method of claim 1 wherein the complex is administered sublingually.

8. The method of claim 1 wherein the complex is administered buccally.

9. The method of claim 1 wherein the complex is administered rectally.

10. The method of claim 1 wherein the complex is administered ocularly.

4. A method of treating a mammal needing supplemental steroid hormones by administering steroid hormones comprising contacting the mucosa of said mammal needing supplemental steroid hormones with an effective amount of a crystalline complex of a steroid hormone with gamma-cyclodextrin.

5. The method of claim 4 wherein the steroid hormone is selected from the group consisting of testosterone, estradiol, and progesterone.

6. The method of claim 5 wherein the steroid hormone is testosterone.