Intravaginal matrix drug delivery devices

• US 20050042292A1
• Filed: 03/27/2003
• Published: 02/24/2005
• Est. Priority Date: 03/27/2002
• Status: Active Grant

• Current Assignee: Allergan Therapeutics LLC (Abbvie Incorporated)
• Original Assignee: Allergan Pharmaceuticals International Ltd. (Abbvie Incorporated)
• Inventors: Muldoon, Brendan, Lorimer, Colin
• Granted Patent: US 9,993,424 B2
• Time in Patent Office: Days
• US Class Current: 424/486
• 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

Abstract

The present invention relates to a process for the preparation of an intravaginal matrix drug delivery device. The process comprises the steps of combining at least one therapeutic agent in a therapeutically effective amount with at least one biocompatible elastomeric polymer to form a mix; curing said mix in a mould having a shape of said intravaginal drug delivery device, to form a polymer matrix; and maturing said polymer matrix to form the intravaginal drug delivery device. The maturing step alters the release rate characteristics of a device prepared in accordance with the process of the invention.

Claims

1. A process for the preparation of an intravaginal matrix drug delivery device, the process comprising the steps of:

combining at least one therapeutic agent in a therapeutically effective amount with at least one biocompatible elastomeric polymer to form a mix;

curing said mix to form a polymer matrix; and

maturing said polymer matrix to form the intravaginal drug delivery device.

2. A process according to claim 1, wherein the curing step is carried out under temperature and time conditions sufficient to produce a shape-retaining polymer matrix.

3. A process according to claim 1, wherein the biocompatible elastomeric polymer is silicone and the curing step is carried out at 50-100°

C. for 1-10.

4. A process according to claim 1, wherein the biocompatible elastomeric polymer is silicone and the curing step is carried out at 15-25°

C. for 1-24 hours.

5. A process according to claim 1, wherein the maturing step is carried out under temperature and time conditions sufficient to produce a device whose release characteristics are altered.

6. A process according to claim 5, wherein the maturing step is carried out under temperature and time conditions sufficient to produce a device whose day 1 release characteristics are altered.

7. A process according to claim 6, wherein the maturing step is carried out under temperature and time conditions sufficient to produce a device whose day 1 release characteristics are increased.

8. A process according to claim 7, wherein less than 30% (w/w) of the at least one therapeutic agent is combined with the at least one biocompatible elastomeric polymer to form the mix.

9. A process according to claim 8, wherein the at least one biocompatible elastomeric polymer is silicone and the at least one therapeutic agent has a solubility in silicone oil at 25°

C. of less than 0.1 mg/ml.

10. A process according to claim 6, wherein the maturing step is carried out under temperature and time conditions sufficient to produce a device whose day 1 release characteristics are decreased.

11. A process according to claim 10, wherein greater than or equal to 30% (w/w) of the at least one therapeutic agent is combined with the at least one biocompatible elastomeric polymer to form the mix.

12. A process according to claim 11, wherein the at least one biocompatible elastomeric polymer is silicone and the at least one therapeutic agent has a solubility in silicone oil at 25°

C. of greater than or equal to 0.1 mg/ml.

13. A process according to claim 5, wherein the maturing step is carried at 40-100°

C. for 2-72 hours.

14. A process according to claim 5, wherein the maturing step is carried out under temperature and time conditions sufficient to produce a device whose release characteristics are substantially independent of shelf life.

15. A process according to claim 1, wherein the process additionally comprises a step of aging the matured polymer matrix.

16. A process according to claim 15, wherein the aging step is carried out at 15-30°

C. for 5-40 days.

17. A process according to claim 15, wherein the maturing step and the aging step are carried out under temperature and time conditions sufficient to produce a device whose release characteristics are substantially independent of shelf life.