Degradable therapeutic delivery device

• US 8,784,868 B2
• Filed: 03/05/2013
• Issued: 07/22/2014
• 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: Smith, Molly K., Arehart, Kelly D., Huang, Lei, Yang, Shu-Ping, Huang, Yanbin
• Primary Examiner(s): FISHER, ABIGAIL L
• Application Number:
  US13/785,626
• Publication Number:
  US 20130245134A1
• Time in Patent Office: 504 Days
• Field of Search: 424/430, 424/426, 525/10
• US Class Current: 424/430
• 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 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 that is at least trifunctional having at least four carbon atoms in the alkyl chain, a steroid, isomers thereof or mixtures thereof, the biodegradable polymer containing ester bonds that degrade by hydrolysis, wherein the biodelivery device is a vaginal insert.

2. The biodelivery device as defined in claim 1, wherein the polyol comprises butanetriol.

3. The biodelivery device 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.

4. The biodelivery device as defined in claim 1, wherein the biodelivery device further comprises a therapeutic or medicinal agent in addition to the crosslinked reaction product of the polyacid and the polyol.

5. The biodelivery device as defined in claim 4, 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 antiglaucoma 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 ophthalmic agent, an angiogenic factor, an immunosuppressant, an anti-allergenic agent, a spermicide, a humectant, an emollient, a hormone, or mixtures thereof.

6. The biodelivery device as defined in claim 4, wherein the therapeutic or medicinal agent includes hydroxy groups that react with the biodegradable polymer during formation of the biodegradable polymer,

7. The biodelivery device as defined in claim 6, 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.

8. The biodelivery device as defined in claim 1, wherein the biodegradable polymer comprises a crosslinked reaction product of the polyol, the polyacid, and a hydroxy acid.

9. The biodelivery device as defined in claim 1, wherein the polyol is a steroid and comprises estradiol, testosterone, progesterone, or isomers thereof.

10. The biodelivery device as defined in claim 1, wherein the polyol is at least trifunctional.

11. The biodelivery device as defined in claim 1, wherein the polyacid is at least trifunctional.

12. The biodelivery device as defined in claim 1, wherein the polyol comprises cyclohexane diol.

13. The biodelivery device as defined in claim 1, wherein the biodelivery device is configured to completely degrade when placed in a vaginal environment for a period of time from about 10 days to about 60 days.

14. the biodelivery device as defined in claim 1, wherein the insert member is configured to reduce the pH of a vaginal environment as the polymer biodegrades.