Drug delivery device and method for employing the same

• US 5,788,959 A
• Filed: 04/24/1995
• Issued: 08/04/1998
• Est. Priority Date: 04/24/1995
• Status: Expired due to Fees

• Current Assignee: University of Maryland Baltimore County (University of Maryland)
• Original Assignee: University of Maryland Baltimore County (University of Maryland)
• Inventors: Singh, Manish
• Primary Examiner(s): Russel, Jeffrey E.
• Application Number:
  US08/426,980
• Time in Patent Office: 1,198 Days
• Field of Search: 424/400, 424/422, 424/423, 424/424, 424/425, 424/426, 424/484, 424/488, 424/499, 424/78.08, 424/85.1, 424/85.2, 424/85.4, 424/85.5, 424/85.7, 424/130.1 , 424/485, 424/486, 424/487, 424/178.1, 514/777, 514/772.3, 514/8, 514/12, 514/21, 514/3, 514/773, 514/779, 514/774, 514/772.1, 514/782.788, 530/351, 530/384, 530/387.1
• US Class Current: 424/85.1
• CPC Class Codes: A61K 9/2031 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
• CPC Class Codes: A61K 9/205 Polysaccharides, e.g. alginate, gums; Cyclodextrin
• CPC Class Codes: A61K 9/2063 Proteins, e.g. gelatin

Abstract

The present invention relates a drug delivery device which comprises a single phase matrix of two oppositely charged polymers (one positive and one negative), which releases a drug by combined mechanisms employing hindered diffusion, swelling and erosion. The present invention also relates to a method for employing these devices.

Claims

1. A drug delivery device comprising a single phase matrix solution of a negatively-charged water-soluble polymer and a positively-charged water-soluble polymer, wherein said matrix solution has dispersed therein a pharmaceutically active ingredient which is different from said negatively-charged water-soluble polymer and said positively-charged water-soluble polymer.

2. The drug delivery device of claim 1, wherein said negatively-charged polymer is selected from the group consisting of succinylated collagen, carboxymethylated chitosan, hyaluronic acid, polyacrylic acid, sodium alginate, chondroitin sulfate, heparin and albumin.

3. The drug delivery device of claim 2, wherein said negatively-charged polymer is succinylated collagen or carboxymethylated chitosan.

4. The drug delivery device of claim 3, wherein said succinylated collagen or carboxymethylated chitosan is cross-linked.

5. The drug delivery device of claim 1, wherein said positively-charged polymer is selected from the group consisting of chitosan, methylated collagen, a polyamino acid, and lysozyme.

6. The drug delivery device of claim 5, wherein said polyamino acid is polylysine or polyarginine.

7. The drug delivery device of claim 5, wherein said positively-charged polymer is lysozyme.

8. The drug delivery device of claim 1, wherein said pharmaceutically active ingredient has a molecular weight of about 5,000 daltons to about 300,000 daltons.

9. The drug delivery device of claim 8, wherein said pharmaceutically active ingredient has a molecular weight of about 10,000 daltons to about 100,000 daltons.

10. The drug delivery device of claim 8, wherein said pharmaceutically active ingredient is selected from the group consisting of interferon, growth factor, antibody, interleukin, insulin, and erythropoietin.

11. The drug delivery device of claim 10, wherein said growth factor is selected from the group consisting of human growth hormone, colony stimulating factor, and bone morphogenic protein.

12. The drug delivery device of claim 8, wherein said pharmaceutically active ingredient is selected from the group consisting of Factor VIII, Factor IX, Protein C.

13. The drug delivery device of claim 1, wherein one of the polymers is cross-linked.

28. The drug delivery device of claim 1, wherein said negatively-charged polymer is succinylated collagen and said positively-charged polymer is polylysine.

14. A method for sustaining release of a pharmaceutically active ingredient in a subject, comprising:

administering to a subject a drug delivery device comprising a single phase matrix solution of a negatively-charged water-soluble polymer and a positively-charged water-soluble polymer, wherein said matrix solution has dispersed therein a pharmaceutically active ingredient which is different from said negatively-charged water-soluble polymer and said positively-charged water-soluble polymer.

15. The method of claim 14, wherein said negatively-charged polymer is selected from the group consisting of succinylated collagen, carboxymethylated chitosan, hyaluronic acid, polyacrylic acid, sodium, alginate, chondroitin sulfate, heparin and albumin.

16. The method of claim 15, wherein said negatively-charged polymer is succinylated collagen or carboxymethylated chitosan.

17. The method of claim 16, wherein said negatively-charged polymer is non-cross-linked, succinylated collagen or carboxymethylated chitosan, and administrating is carried out by injecting said device into said subject.

18. The method of claim 16, wherein said negatively-charged polymer is cross-linked, succinylated collagen or carboxymethylated chitosan, and administrating is carried out by implanting said device into said subject.

19. The method of claim 14, wherein said positively-charged polymer is selected from the group consisting of chitosan, methylated collagen, a polyamino acid, and lysozyme.

20. The method of claim 19, wherein said polyamino acid is polylysine or polyarginine.

21. The method of claim 19, wherein said positively-charged polymer is lysozyme.

22. The method of claim 14, wherein said pharmaceutically active ingredient has a molecular weight of about 5,000 daltons to about 300,000 daltons.

23. The method of claim 22, wherein said pharmaceutically active ingredient has a molecular weight of about 10,000 daltons to about 100,000 daltons.

24. The method of claim 14, wherein said pharmaceutically active ingredient is selected from the group consisting of interferon, growth factor, antibody, interleukin, insulin, and erythropoietin.

25. The method of claim 24, wherein said growth factor is selected from the group consisting of Factor VIII, Factor IX, Protein C, human growth hormone, colony stimulating factor, and bone morphogenic protein.

26. The method of claim 22, wherein said pharmaceutically active ingredient is selected from the group consisting of Factor VIII, Factor IX, Protein C.

27. The method of claim 14, wherein one of the polymers is cross-linked.

29. The method of claim 14, wherein said negatively-charged polymer is succinylated collagen and said positively-charged polymer is polylysine.