Biodegradable Polymer Encapsulated Microsphere Particulate Film and Method of Making Thereof

• US 20110293690A1
• Filed: 04/07/2011
• Published: 12/01/2011
• Est. Priority Date: 05/27/2010
• Status: Abandoned Application

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Tyco Healthcare Group LP (Medtronic Plc)
• Inventors: Stopek, Joshua, Griffin, Jeremy, Elachchabi, Amin
• Application Number:
  US13/081,531
• Publication Number:
  US 20110293690A1
• Time in Patent Office: Days
• US Class Current: 424/443
• CPC Class Codes: A61B 17/07292 Reinforcements for staple line, e.g. pledgets
• CPC Class Codes: A61B 2017/00884 enhancing wound closure
• CPC Class Codes: A61B 2017/00889 antimicrobial, disinfectant
• CPC Class Codes: A61B 2017/00893 pharmaceutically effective
• CPC Class Codes: A61K 31/445 Non condensed piperidines, e.g. piperocaine
• CPC Class Codes: A61K 9/1641 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
• CPC Class Codes: A61K 9/5031 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poly(lactide-co-glycolide)
• CPC Class Codes: A61K 9/7007 Drug-containing films, membranes or sheets A61K9/0041, A61K9/0043, A61K9/006, A61K9/0063 take precedence
• CPC Class Codes: A61L 2300/622 Microcapsules
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence

Abstract

Films containing microsphere particles and processes for forming thereof are disclosed. The microsphere particles encapsulate one or more bioactive agents and may be deposited on a surface of medical devices or be used to form a medical device.

Claims

1. A medical device comprising:

a film including a plurality of poly(lactic-co-glycolic acid) microsphere particles disposed therein, wherein the plurality of poly(lactic-co-glycolic acid) microsphere particles encapsulate at least one bioactive agent; and

a film former.

2. The medical device according to claim 1, wherein the poly(lactic-co-glycolic acid) is of formula:

3. The medical device according to claim 2, wherein x is from about 50 to about 60, y is from about 32 to about 40, and n is from about 300 to about 500.

4. The medical device according to claim 1, wherein the film is formed from a single emulsion.

5. The medical device according to claim 1, wherein the film is formed from a double emulsion.

6. The medical device according to claim 1, wherein the at least one bioactive agent includes a water-soluble drug.

7. The medical device according to claim 6, wherein the water-soluble drug is bupivacaine hydrochloride.

8. The medical device according to claim 6, wherein the film former is polyvinyl alcohol hydrolyzed from about 80% to about 99%.

9. A film comprising:

a dried emulsion including;

a first component including a water-soluble drug and a first polar solvent;

a second component including an aliphatic-polyester and a non-polar solvent; and

a third component including a water-soluble polymer and a second polar solvent.

10. The film according to claim 9, wherein the aliphatic-polyester is present in an amount from about 1% by weight to about 5% by weight of the non-polar solvent.

11. The film according to claim 9, wherein the water-soluble drug is present in an amount from about 1% by weight to about 5% by weight of the first polar solvent.

12. The film according to claim 9, wherein the water-soluble polymer is present in an amount of about 1% by weight of the second polar solvent.

13. The film according to claim 9, wherein the non-polar solvent is methylene chloride.

14. The film according to claim 9, wherein the first polar solvent is methanol.

15. The film according to claim 9, wherein the second polar solvent is water.

16. A process comprising:

forming a first, non-polar composition containing at least one biodegradable polymer, at least one bioactive agent and at least one non-polar solvent;

forming a second, polar composition containing at least one emulsifier and at least one polar solvent;

forming an emulsion by contacting the first, non-polar composition and the second, polar composition;

homogenizing the emulsion to form microsphere particles comprising the at least one biodegradable polymer encapsulating the at least one bioactive agent; and

drying the homogenized emulsion to form a film including the microsphere particles disposed therein.

17. The process according to claim 16, further comprising:

removing the at least one non-polar solvent from the emulsion.

18. The process according to claim 16, wherein the at least one biodegradable polymer is of formula:

19. The process according to claim 18, wherein x is from about 50 to about 60, y is from about 32 to about 40, and n is from about 300 to about 500.

20. The process according to claim 16, wherein the at least one emulsifier is polyvinyl alcohol hydrolyzed from about 80% to about 99%.

21. The process according to claim 16, further comprising:

depositing the homogenized emulsion on at least a portion of a medical device prior to drying the homogenized emulsion.

22. A process comprising:

forming a mixture by contacting a first, non-polar composition comprising at least one biodegradable polymer and at least one non-polar solvent with a second, polar composition comprising least one bioactive agent in at least one polar solvent;

forming an emulsion by contacting the mixture with at least one emulsifier;

homogenizing the emulsion to form microsphere particles comprising the at least one biodegradable polymer encapsulating the at least one bioactive agent; and

drying the homogenized emulsion to form a film including the microsphere particles disposed therein.

23. The process according to claim 22, further comprising:

removing the at least one non-polar solvent from the emulsion.

24. The process according to claim 22, wherein the at least one biodegradable polymer is of formula:

25. The process according to claim 24, wherein the at least one emulsifier is polyvinyl alcohol hydrolyzed from about 80% to about 99%.

26. The process according to claim 22, further comprising:

depositing the homogenized emulsion on at least a portion of a medical device prior to drying the homogenized emulsion.