Degradable therapeutic delivery device

• US 20070243229A1
• Filed: 04/17/2006
• Published: 10/18/2007
• Est. Priority Date: 04/17/2006
• Status: Active Grant

• Current Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Original Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Inventors: Huang, Lei, Yang, Shu-Ping, Huang, Yanbin, Arehart, Kelly, Smith, Molly
• Granted Patent: US 8,399,012 B2
• Time in Patent Office: Days
• US Class Current: 424/426
• 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 31/00 Medicinal preparations containing organic active ingredients
• CPC Class Codes: A61K 31/19 Carboxylic acids, e.g. valproic acid salicylic acid A61K31/60
• CPC Class Codes: A61K 47/34 Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers A61K47/10 takes precedence
• 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: C08G 63/12 derived from polycarboxylic acids and polyhydroxy compounds
• CPC Class Codes: C08G 63/16 Dicarboxylic acids and dihydroxy compounds
• CPC Class Codes: C08G 63/914 derived from polycarboxylic acids and polyhydroxy compounds

Abstract

A biodegradable biodelivery device is disclosed. The biodelivery device is formed from a polymer comprising the reaction product of a polyol and a polyacid. When exposed to water, the polymer degrades through hydrolysis. Of particular advantage, the polymer can be formed so as to be elastic and flexible. In one embodiment, the polymer is formed into a vaginal insert. As the polymer degrades, the polymer releases acid to a vaginal environment for decreasing the pH of the environment.

Claims

1. A vaginal insert comprising:

an insert member having a shape configured to be inserted into a vagina, the insert member being made from a biodegradable elastic polymer, the polymer comprising a crosslinked reaction product of a polyol and a polyacid, wherein the polyol and polyacid are multi-functional.

2. A vaginal insert as defined in claim 1, wherein one of the polyol and polyacid is at least difunctional and the other is at least trifunctional.

3. A vaginal insert as defined in claim 1, wherein the polymer comprises a crosslinked reaction product of the polyol, the polyacid, and a hydroxy acid.

4. A vaginal insert as defined in claim 1, wherein the insert member is ring-shaped.

5. A vaginal insert as defined in claim 1, wherein the polyol comprises a cyclic alcohol, an alkyl alcohol having at least four carbon atoms in the alkyl chain or mixtures thereof.

6. A vaginal insert as defined in claim 1, wherein the polyol comprises a sugar alcohol.

7. A vaginal insert as defined in claim 6, wherein the sugar alcohol comprises a teritose alcohol, a pentose alcohol, a hexose alcohol, or mixtures thereof.

8. A vaginal insert as defined in claim 1, wherein the polyol comprises a steroid, where the steroid comprises estrogen, testosterone, progesterone and isomers and mixtures thereof.

9. A vaginal insert as defined in claim 1, wherein the polyol comprises xylitol.

10. A vaginal insert as defined in claim 1, wherein the polyol comprises a glycol, butanetriol, arabitol, adonitol, threritol, erythritol, glycerol, dulcitol, inositol, mannitol, sorbitol, isomers thereof or mixtures thereof.

11. A vaginal insert as defined in claim 1, wherein the polyacid comprises citric acid, malic acid, adipic acid, sebacic acid, succinic acid, itaconic acid, glutaric acid, pimelic acid, suberic acid, azelaic acid or mixtures thereof.

12. A vaginal insert as defined in claim 1, wherein the insert member is configured to substantially completely degrade when placed in a vaginal environment for a period of time of from about 10 days to about 60 days.

13. A vaginal insert as defined in claim 1, wherein the insert member further comprises a therapeutic or medicinal agent in addition to the polyol and polyacid.

14. A vaginal insert as defined in claim 13, wherein the therapeutic or medicinal agent is chemically bonded to the elastic polymer.

15. A vaginal insert as defined in claim 14, wherein the therapeutic or medicinal agent includes hydroxy groups that react with the elastic polymer during formation of the polymer.

16. A vaginal insert as defined in claim 1, wherein the insert member is configured to reduce the pH of a vaginal environment as the elastic polymer biodegrades.

17. A vaginal insert as defined in claim 15, wherein the therapeutic or medicinal agent comprises lactic acid or an alkyl alcohol having from about 8 carbon atoms to about 20 carbon atoms in the alkyl chain.

18. A biodelivery device comprising a biodegradable polymer, the biodegradable polymer comprising a crosslinked reaction product of a polyol and a polyacid, wherein the polyol and polyacid are both multi-functional, the polyol comprising a cyclic alcohol, an alkyl alcohol having at least four carbon atoms in the alkyl chain, a steroid, a glycol, arabitol, adonitol, threritol, erythritol, xylitol, dulcitol, inositol, mannitol, sorbitol, isomers thereof or mixtures thereof, the biodegradable polymer containing ester bonds that degrade by hydrolysis.

19. A biodelivery device as defined in claim 18, wherein the polyol comprises polyethylene glycol, butanetriol, arabitol, adonitol, threritol, erythritol, xylitol, dulcitol, inositol, mannitol, sorbitol, isomers thereof or mixtures thereof.

20. A biodelivery device as defined in claim 18, wherein the polyol comprises xylitol.

21. A biodelivery device as defined din claim 18, wherein the polyol comprises arabitol, adonitol, threritol, erythritol, isomers thereof or mixtures thereof.

22. A biodelivery device as defined in claim 18, wherein the polyacid comprises citric acid, malic acid, adipic acid, sebacic acid, succinic acid, itaconic acid, glutaric acid, pimelic acid, suberic acid, azelaic acid or mixtures thereof.

23. A biodelivery device as defined in claim 18, wherein the insert member further comprises a therapeutic or medicinal agent in addition to the polyacid or polyol.

24. A biodelivery device as defined in claim 23, wherein the therapeutic or medicinal agent comprises an antibacterial agent, an antimicrobial agent, an antiparasitic agent, an antibiotic, an antihistamine, a decongestant, an antipruritic, an antimetabolyte, an antiglacoma agent, an anti-cancer agent, an antiviral agent, an antifungal agent, an antimicotic inflammatory agent, an antidiabetic agent, an aesthetic agent, an anti-depressant, an analgesic, an anticoagulant, an aphthlamic agent, an angiogenic factor, an immunosuppressant, an anti-allergenic agent, a spermicide, a humectant, an emollient, a hormone, or mixtures thereof.

25. A biodelivery device as defined in claim 23, wherein the therapeutic or medicinal agents include hydroxy groups that react with the elastic polymer during formation of the polymer.

26. A biodelivery device as defined in claim 25, wherein the therapeutic or medicinal agent comprises lactic acid or an alkyl alcohol having from about 8 carbon atoms to about 20 carbon atoms in the alkyl chain.

27. A biodelivery device as defined in claim 18, wherein the device comprises a prosthetic device.

28. A biodelivery device as defined in claim 18, wherein the device is configured to treat a sinus system of a patient.

29. A biodelivery device as defined in claim 18, wherein the biodegradable polymer comprises a crosslinked reaction product of the polyol, the polyacid, and a hydroxy acid.