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Claims for Patent: 4,871,543

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Claims for Patent: 4,871,543

Title: Intravaginal devices
Abstract:The invention concerns an intravaginal device comprising a combination of 17 .beta.-estradiol and a supporting matrix for treating hypoestrogenic women. The device releases continuously 17 .beta.-estradiol at a rate of about 0.5 to about 25 .mu.g/24 h. The invention also comprises a method of preparing the device and a method of treating hypoestrogenic women by using the device.
Inventor(s): Lindskog; Inga M. (Helsingborg, SE), Sjogren; Bengt C. H. (Viken, SE), Andersson; Sven-Borje (Od.ang.kra, SE)
Assignee: Aktiebolaget Leo (Helsingborg, SE)
Application Number:07/060,833
Patent Claims: 1. An intravaginal device for use by hoypoestrogenic women in the form of a ring which consists of a core of a pharmacologically acceptable elastomer and an outer elastomer layer surrounding said core, said core having 17 beta-estradiol homogeneously suspended therein in such a way that the 17 beta-estradiol will be continuously released from the ring at an essentially constant rate of about 0.5 to 25 .mu.g per 24 hours for at least a month.

2. An intravaginal device according to claim 1 wherein the release rate is from about 1 to about 10 .mu.g/24 h.

3. An intravaginal device according to claim 1 wherein the release rate is from about 4 to about 8 .mu.g/24 h.

4. An intravaginal device according to claim 1 wherein said core elastomer is a polydimethylsiloxane and said outer elastomer layer is silicone tubing.

5. A method of treating a woman having symptoms of hypoestrogenicity which comprises positioning within the woman an intravaginal device in the form of a ring which consists of a core of a pharmacologically acceptable elastomer and an outer elastomer layer surrounding said core, said core having 17 beta-estradiol homogeneously suspended therein in such a way that the 17 beta-estradiol will be continuously released from the ring at an essentially constant rate of about 0.5 to 25 .mu.g per 24 hours for at least a month.

6. A method according to claim 5 wherein the release rate is from about 1 to about 10 .mu.g/24 h.

7. A method according to claim 5 wherein the release rate is from about 4 to about 8 .mu.g/24 h.

8. A method according to claim 5 wherein said core elastomer is a polydimethylsiloxane and said outer elastomer layer is silicone tubing.
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