Therapeutic compositions for bone repair

• US 9,387,250 B2
• Filed: 03/18/2014
• Issued: 07/12/2016
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: Rutgers University, Trustees Of The University Of Pennsylvania (University of Pennsylvania)
• Original Assignee: Rutgers University, Trustees Of The University Of Pennsylvania (University of Pennsylvania)
• Inventors: Wada, Keisuke, Fiorellini, Joseph P., Snyder, Sabrina Sachiko, Uhrich, Kathryn E., Graves, Dana, Morano, Michelle, Rosario-Melndez, Roselin
• Primary Examiner(s): Krass, Frederick
• Assistant Examiner(s): Liu, Tracy
• Application Number:
  US14/218,492
• Publication Number:
  US 20140271864A1
• Time in Patent Office: 847 Days
• US Class Current: 1/1
• CPC Class Codes: A61K 31/192 having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid cannabinoids A61K31/658
• CPC Class Codes: A61K 33/00 Medicinal preparations containing inorganic active ingredients
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 47/542 Carboxylic acids, e.g. a fatty acid or an amino acid
• CPC Class Codes: A61L 27/58 Materials at least partially resorbable by the body
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61P 19/08 for bone diseases, e.g. rachitism, Paget's disease

Abstract

Individuals having diabetes are more prone to fractures, periodontitis, and other bone related issues as compared to healthy individuals. Furthermore, bone healing in diabetic patients is prolonged. The invention provides a method for decreasing bone resorption or increasing bone formation or promoting bone healing in diabetic patients. In particular, a biodegradeable polymer, such as a polyanhydride salicylate is administered at or near a bone defect site, and upon hydrolysis of the polymer will releases biologically active salicylic acid.

Claims

1. A method for decreasing bone resorption or increasing bone formation or promoting bone healing at a site in the body of a diabetic mammal in need thereof comprising, administering at or near the site a biodegradable polymer comprising repeating units of formula (Ia) in the polymer backbone:

2. The method of claim 1, further comprising a second biologically active agent dispersed in a matrix of the polymer.

3. The method of claim 2, wherein the second biologically active agent is a non-steroidal anti-inflammatory, an antibacterial, an analgesic, an antioxidant or a growth factor.

4. The method of claim 1, further comprising a second biologically active agent appended to the polymer backbone.

5. The method of claim 4, wherein the second biologically active agent is a non-steroidal anti-inflammatory, an antibacterial, an analgesic, an antioxidant or a growth factor.

6. The method of claim 1, wherein a composition comprising the biodegradable polymer and a bone allograft are administered to the mammal.

7. The method of claim 6, wherein the composition further comprises mineral oil.

8. The method of claim 1, which is a method to decrease bone resorption.

9. The method of claim 1, which is a method to promote healing of bone.

10. The method of claim 1, wherein the biodegradable polymer is administered at the site of a bone fracture.

11. The method of claim 1, wherein the biodegradable polymer has an average molecular weight of about 1,500 to about 50,000 daltons.

12. The method of claim 1, further comprising administering a membrane at or near the site.

13. The method of claim 3, wherein the growth factor is a bone morphogenetic protein (BMP).

14. The method of claim 1, wherein a composition comprising the biodegradable polymer and a therapeutic agent are administered to the mammal.

15. The method of claim 14, wherein the therapeutic agent is:

a) an anti-inflammatory agent selected from a non-steroidal anti-inflammatory and an anti-inflammatory steroid;

or

b) an agent that promotes bone healing selected from a bis-phosphonate, a hormone and a growth factor.

16. The method of claim 15, wherein the hormone is parathyroid hormone (PTH).

17. The method of claim 15, wherein the growth factor is bone morphogenetic protein (BMP).