SUSTAINED RELEASE SYSTEMS OF ASCORBIC ACID PHOSPHATE

• US 20100150981A1
• Filed: 12/11/2008
• Published: 06/17/2010
• Est. Priority Date: 12/11/2008
• Status: Active Grant

• Current Assignee: Ethicon Incorporated (Johnson & Johnson)
• Original Assignee: Advanced Technologies and Regenerative Medicine, LLC
• Inventors: Yang, Chunlin, Li, Yufu, Wohlert, Stephen
• Granted Patent: US 8,034,363 B2
• Time in Patent Office: Days
• US Class Current: 424/423
• CPC Class Codes: A61K 31/375 Ascorbic acid, i.e. vitamin C; Salts thereof
• 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 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61P 17/02 for treating wounds, ulcers, burns, scars, keloids, or the like
• CPC Class Codes: A61P 19/00 Drugs for skeletal disorders
• CPC Class Codes: A61P 19/02 for joint disorders, e.g. arthritis, arthrosis
• CPC Class Codes: A61P 19/04 for non-specific disorders of the connective tissue
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

A novel method of preparing a controlled release composition is disclosed. Specifically, the present invention relates to a method of preparing controlled release compositions of ascorbic acid phosphate and absorbable polymers. Also disclosed is a novel controlled release composition of ascorbic acid phosphate made by the method of the present invention.

Claims

1. A method of making a controlled release composition of ascorbic acid phosphate, comprising the steps of:

drying ascorbic acid phosphate at a temperature of no greater than about 160°

C. for about 30 min; and

,

melt blending the dried ascorbic acid phosphate with an absorbable aliphatic polyester polymer at a temperature of no greater than about 160°

C. to form an ascorbic acid phosphate and polymer composition.

2. The method of claim 1, comprising the additional step of processing the ascorbic acid and polymer composition into a desired form at a temperature of no greater than about 160°

C.

3. The method of claim 1 where the composition comprises ascorbic acid in the amount of about 0.5 wt % to about 20 wt % of the composition.

4. The method of claim 1 where the composition comprises ascorbic acid in the amount of about 2 wt % to about 10 wt % of the composition.

5. The method of claim 1 where the absorbable aliphatic polyester polymer is a homopolymer or copolymer prepared from monomers selected from the group consisting of lactide, glycolide, epsilon-caprolactone, dioxanone, and trimethylene carbonate.

6. The method of claim 1 where the absorbable aliphatic polyester polymer is a copolymer prepared from epsilon-caprolactone and glycolide.

7. The method of claim 2, wherein the composition is formed into a medical device selected from the group consisting of fibers, rods, screws, staples, suture anchors, films and combinations thereof.

8. The process of claim 1, wherein the absorbable polymer and the ascorbic acid phosphate are melt blended for about 5 minutes to about 30 minutes.

9. The process of claim 1, additionally comprising the step of combining the composition with at least one bioactive agent.

10. The process of claim 1, additionally comprising the step of combining the composition with viable tissue.

11. The process of claim 1, additionally comprising the step of combining the composition with cells.

13. The composition of claim 1, wherein the process comprises the additional step of processing the ascorbic acid and polymer composition into a desired form at a temperature of no greater than about 160°

C.

18. The composition of claim 13, wherein the composition is formed into a medical device selected from the group consisting of fibers, rods, screws, staples, suture anchors, films and combinations thereof.

12. A controlled release composition, comprising:

a controlled release composition of ascorbic acid phosphate manufactured by the method comprising;

drying ascorbic acid phosphate at a temperature of no greater than 160°

C. for about 30 min; and

,

melt blending the dried ascorbic acid phosphate with an absorbable aliphatic polyester polymer at a temperature of no greater than about 160°

C., thereby forming the ascorbic acid phosphate and polymer composition.

14. The composition of claim 12, wherein the composition comprises ascorbic acid phosphate in the amount of about 0.5 wt % to about 20 wt %.

15. The composition of claim 12, wherein the composition comprises ascorbic acid phosphate in the amount of about 2 wt % to about 10 wt %.

16. The composition of claim 12, wherein the absorbable aliphatic polyester polymer is a homopolymer or copolymer prepared from monomers selected from the group consisting of lactide, glycolide, epsilon-caprolactone, dioxanone, and trimethylene carbonate.

17. The composition of claim 12, wherein the absorbable aliphatic polyester polymer is a copolymer prepared from epsilon-caprolactone and glycolide.

19. The composition of claim 12, wherein the absorbable polymer and the ascorbic acid phosphate are melt blended for about 5 minutes to about 30 minutes.

20. The composition of claim 12, wherein the composition additionally comprises at least one bioactive agent.

21. The composition of claim 12, wherein the composition additionally comprises viable tissue.

22. The process of claim 12, wherein the composition additionally comprises cells.

23. A controlled release composition comprising ascorbic acid phosphate and an absorbable aliphatic polyester polymer having a burst release of no greater than 20 wt % followed by controlled release.

24. A medical device, comprising:

a controlled release composition of ascorbic acid phosphate manufactured by the method comprising;

drying ascorbic acid phosphate at a temperature of no greater than 160°

C. for about 30 min; and

,

melt blending the dried ascorbic acid phosphate with an absorbable aliphatic polyester polymer at a temperature of no greater than about 160°

C., thereby forming the ascorbic acid phosphate and polymer composition.