Intravaginal delivery system

• US 5,694,947 A
• Filed: 04/11/1996
• Issued: 12/09/1997
• Est. Priority Date: 06/17/1993
• Status: Expired due to Term

• Current Assignee: Leiras Oy (Bayer AG)
• Original Assignee: Leiras Oy (Bayer AG)
• Inventors: Talling, Christine, Lehtinen, Matti
• Primary Examiner(s): Brown, Michael A.
• Application Number:
  US08/564,253
• Time in Patent Office: 607 Days
• Field of Search: 128/830-841
• US Class Current: 128/833
• CPC Class Codes: A61F 6/08 Pessaries, i.e. devices worn in the vagina to support the uterus, remedy a malposition or prevent conception , e.g. combined with devices protecting against contagion
• CPC Class Codes: A61K 9/0036 Devices retained in the vagina or cervix for a prolonged period, e.g. intravaginal rings, medicated tampons, medicated diaphragms
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: A61P 5/24 of the sex hormones

Abstract

Intravaginal delivery system including a flexible support means, and a delivery means carried by the support means and containing an active agent wherein the support means comprises a core member substantially in the form of an open ring, and the delivery means comprises at least one polymer body which encircles the core member in a beltwise manner along a portion of a length of the core member.

Claims

1. Intravaginal delivery system comprising a flexible support means, and a delivery means carried by the support means and containing an active agent wherein the support means comprises a core member substantially in the form of an open ring, and the delivery means comprises at least one polymer body which encircles the core member in a beltwise manner along a portion of a length of the core member.

2. The delivery system according to claim 1 wherein the polymer body comprises a substance which is selected from the group consisting of polysiloxane, polyurethane and EVA-copolymer.

3. The delivery system according to claim 1 wherein the support means comprises a material selected from the group consisting of a crosslinked rubber, a flexible thermoplastic resin, a thermoplastic elastomer, a polyurethane and a thermoplastic polyolefin.

4. The delivery system according to claim 1 wherein the polymer body has an inner surface which is in contact with a material which substantially prevents the migration of the active agent from the polymer body into the support means.

5. The delivery system of claim 4 wherein the support means consists essentially of a material preventing the migration of active agent.

6. The delivery system according to claim 1 wherein the delivery means is formed by two sleeve-like bodies each containing a different active agent.

7. The delivery system according to claim 1 wherein the polymer body contains a progestational agent or an estrogenic agent.

8. The delivery system according to claim 1 wherein the delivery system comprises two sleeve-like bodies, both containing the same active agent.

9. The delivery system according to claim 1 wherein the polymer body is coated with a membrane allowing diffusion of the active agent.

10. Method for preparing a delivery system according to claim 1, wherein the diameter of the polymer body containing the active agent and the polymer is enlarged mechanically or by swelling, and is mounted in this condition onto the core member, and is allowed to tighten onto the support means.

11. The method according to claim 10 wherein the polymer body is made by coextrusion together with a polymeric membrane which forms an outer layer on the sleeve when mounted on the core member.

12. Method of treating menopause in a human female comprising implanting in the vagina of the female a device for delivering a selected drug for treating menopause, the device comprising a flexible support mechanism and a delivery mechanism carried by the support mechanism, the delivery mechanism containing a selected drug, wherein the support mechanism comprises a core member substantially in the form of an open ring and wherein the delivery mechanism comprises at least one polymer body which encircles the core member in a beltwise manner along a portion of a length of the core member.