A long-acting formulation of a polypeptide drug exenatide in treatment of diabetes using an injectable block copolymer hydrogel

Biomaterials

Volumn 34, Issue 11, 2013, Pages 2834-2842

  Li, Kun ^a   Yu, Lin ^b   Liu, Xiaojun ^a   Chen, Chang ^b   Chen, Qinghua ^a   Ding, Jiandong ^b  

^a Shanghai Institute of Pharmaceutical Industry   (China)

^b FUDAN UNIVERSITY   (China)

Author keywords

Antidiabetic drug; Exenatide; Oral glucose tolerance test; Peptide delivery; Thermogel; Type II diabetes

Indexed keywords

ANTIDIABETIC DRUG; EXENATIDE; ORAL GLUCOSE TOLERANCE TESTS; PEPTIDE DELIVERY; THERMOGEL; TYPE II;

BLOCK COPOLYMERS; LACTIC ACID; PEPTIDES; POLYETHYLENE GLYCOLS; POLYETHYLENE OXIDES; SOL-GELS; SUGAR (SUCROSE); ZINC COMPOUNDS;

HYDROGELS;

COPOLYMER; EXENDIN 4; POLY(LACTIC ACID CO GLYCOLIC ACID) POLY(ETHYLENE GLYCOL) POLY(LACTIC ACID CO GLYCOLIC ACID) TRIBLOCK COPOLYMER; SUCROSE; UNCLASSIFIED DRUG; ZINC ACETATE;

ANIMAL EXPERIMENT; ARTICLE; DRUG DEGRADATION; DRUG DELIVERY SYSTEM; DRUG FORMULATION; DRUG RELEASE; GLUCOSE TOLERANCE; MALE; MOUSE; NON INSULIN DEPENDENT DIABETES MELLITUS; NONHUMAN; ORAL GLUCOSE TOLERANCE TEST; PRIORITY JOURNAL; TEMPERATURE;

ADMINISTRATION, ORAL; ANIMALS; DIABETES MELLITUS, TYPE 2; DRUG SYNERGISM; EXCIPIENTS; GELS; GLUCOSE TOLERANCE TEST; HYDROGELS; HYPOGLYCEMIC AGENTS; LACTIC ACID; MALE; METAL NANOPARTICLES; MICE; MICE, INBRED ICR; PEPTIDES; POLYETHYLENE GLYCOLS; POLYGLYCOLIC ACID; POLYMERS; SUCROSE; TEMPERATURE; VENOMS; ZINC; ZINC ACETATE;

MUS;

EID: 84873096405     PISSN: 01429612     EISSN: 18785905     Source Type: Journal    
DOI: 10.1016/j.biomaterials.2013.01.013     Document Type: Article

References (52)

1. Lowman A.M., Morishita M., Kajita M., Nagai T., Peppas N.A. Oral delivery of insulin using pH-responsive complexation gels. J Pharm Sci 1999, 88:933-937.
2. Khafagy E.S., Morishita M., Onuki Y., Takayama K. Current challenges in non-invasive insulin delivery systems: a comparative review. Adv Drug Deliv Rev 2007, 59:1521-1546.
3. Sonaje K., Lin Y.H., Juang J.H., Wey S.P., Chen C.T., Sung H.W. In vivo evaluation of safety and efficacy of self-assembled nanoparticles for oral insulin delivery. Biomaterials 2009, 30:2329-2339.
4. Chen M.C., Sonaje K., Chen K.J., Sung H.W. A review of the prospects for polymeric nanoparticle platforms in oral insulin delivery. Biomaterials 2011, 32:9826-9838.
5. Jin Y., Song Y.P., Zhu X., Zhou D., Chen C.H., Zhang Z.R., et al. Goblet cell-targeting nanoparticles for oral insulin delivery and the influence of mucus on insulin transport. Biomaterials 2012, 33:1573-1582.
6. Eng J., Kleinman W.A., Singh L., Singh G., Raufman J.P. Isolation and characterization of exendin-4, an exendin-3 analogue from Heloderma suspectum venom. J Biol Chem 1992, 267:7402-7405.
7. Nielsen L.L., Young A.A., Parkes D.G. Pharmacology of exenatide (synthetic exendin-4): a potential therapeutic for improved glycemic control of type 2 diabetes. Regul Pept 2004, 117:77-88.
8. Ionut V., Zheng D., Stefanovski D., Bergman R.N. Exenatide can reduce glucose independent of islet hormones or gastric emptying. Am J Physiol Endocrinol Metab 2008, 295:E269-E277.
9. Xiao L., Chen Q.H., Bao Y.C., Pan F. Release pattern improvement of nomegestrol from biodegradable microspheres by using polymer-alloys as matrix. Asian J Pharm Sci 2010, 5:231-238.
10. Kim H., Park H., Lee J., Kim T.H., Lee E.S., Oh K.T., et al. Highly porous large poly(lactic-co-glycolic acid) microspheres adsorbed with palmityl-acylated exendin-4 as a long-acting inhalation system for treating diabetes. Biomaterials 2011, 32:1685-1693.
11. DeYoung M.B., MacConell L., Sarin V., Trautmann M., Herbert P. Encapsulation of Exenatide in poly-(d, l-lactide-co-glycolide) microspheres produced an investigational long-acting once-weekly formulation for type 2 Diabetes. Diabetes Tech Therap 2011, 13:1145-1154.
12. Wright SG, Christenson T, Yeoh TY, Rickey ME, Hotz JM, Kumar R, et al. Polymer-based sustained release device, Alkermes, Inc. (Cambridge, MA, US). WO Patent WO/2005/110425, November 24, 2005.
13. Jeong B., Bae Y.H., Lee D.S., Kim S.W. Biodegradable block copolymers as injectable drug-delivery systems. Nature 1997, 388:860-862.
14. Hiemstra C., Zhou W., Zhong Z.Y., Wouters M., Feijen J. Rapidly in situ forming biodegradable robust hydrogels by combining stereocomplexation and photopolymerization. J Am Chem Soc 2007, 129:9918-9926.
15. Yu L., Ding J.D. Injectable hydrogels as unique biomedical materials. Chem Soc Rev 2008, 37:1473-1481.
16. Huynh C.T., Nguyen M.K., Lee D.S. Injectable block copolymer hydrogels: achievements and future challenges for biomedical applications. Macromolecules 2011, 44:6629-6636.
17. Vermonden T., Censi R., Hennink W.E. Hydrogels for protein delivery. Chem Rev 2012, 112:2853-2888.
18. Moon H.J., Ko D.Y., Park M.H., Joo M.K., Jeong B. Temperature-responsive compounds as in situ gelling biomedical materials. Chem Soc Rev 2012, 41:4860-4883.
19. Altunbas A., Lee S.J., Rajasekaran S.A., Schneider J.P., Pochan D.J. Encapsulation of curcumin in self-assembling peptide hydrogels as injectable drug delivery vehicles. Biomaterials 2011, 32:5906-5914.
20. Guziewicz N., Best A., Perez-Ramirez B., Kaplan D.L. Lyophilized silk fibroin hydrogels for the sustained local delivery of therapeutic monoclonal antibodies. Biomaterials 2011, 32:2642-2650.
21. Pritchard C.D., O'Shea T.M., Siegwart D.J., Calo E., Anderson D.G., Reynolds F.M., et al. An injectable thiol-acrylate poly(ethylene glycol) hydrogel for sustained release of methylprednisolone sodium succinate. Biomaterials 2011, 32:587-597.
22. Teixeira L.S.M., Bijl S., Pully V.V., Otto C., Rong J., Feijen J., et al. Self-attaching and cell-attracting in-situ forming dextran-tyramine conjugates hydrogels for arthroscopic cartilage repair. Biomaterials 2012, 33:3164-3174.
23. Huynh C.T., Nguyen M.K., Lee D.S. Biodegradable pH/temperature-sensitive oligo(beta-amino ester urethane) hydrogels for controlled release of doxorubicin. Acta Biomater 2011, 7:3123-3130.
24. Yu L., Zhang H., Ding J.D. A subtle end-group effect on macroscopic physical gelation of triblock copolymer aqueous solutions. Angew Chem-Int Edit 2006, 45:2232-2235.
25. Kim J.I., Kim D.Y., Kwon D.Y., Kang H.J., Kim J.H., Min B.H., et al. An injectable biodegradable temperature-responsive gel with an adjustable persistence window. Biomaterials 2012, 33:2823-2834.
26. Jeong B., Bae Y.H., Kim S.W. Thermoreversible gelation of PEG-PLGA-PEG triblock copolymer aqueous solutions. Macromolecules 1999, 32:7064-7069.
27. Bae S.J., Suh J.M., Sohn Y.S., Bae Y.H., Kim S.W., Jeong B. Thermogelling poly(caprolactone-b-ethylene glycol-b-caprolactone) aqueous solutions. Macromolecules 2005, 38:5260-5265.
28. Zhang Z., Lai Y.X., Yu L., Ding J.D. Effects of immobilizing sites of RGD peptides in amphiphilic block copolymers on efficacy of cell adhesion. Biomaterials 2010, 31:7873-7882.
29. Zhang Z., Ni J., Chen L., Yu L., Xu J.W., Ding J.D. Biodegradable and thermoreversible PCLA-PEG-PCLA hydrogel as a barrier for prevention of post-operative adhesion. Biomaterials 2011, 32:4725-4736.
30. Kang Y.M., Kim G.H., Il Kim J., Kim D.Y., Lee B.N., Yoon S.M., et al. In vivo efficacy of an intratumorally injected in situ-forming doxorubicin/poly(ethylene glycol)-b-polycaprolactone diblock copolymer. Biomaterials 2011, 32:4556-4564.
31. Huynh C.T., Nguyen M.K., Kim J.H., Kang S.W., Kim B.S., Lee D.S. Sustained delivery of doxorubicin using biodegradable pH/temperature-sensitive poly(ethylene glycol)-poly(beta-amino ester urethane) multiblock copolymer hydrogels. Soft Matter 2011, 7:4974-4982.
32. Park S.H., Choi B.G., Moon H.J., Cho S.H., Jeong B. Block sequence affects thermosensitivity and nano-assembly: PEG-L-PA-DL-PA and PEG-DL-PA-L-PA block copolymers. Soft Matter 2011, 7:6515-6521.
33. Lee B.H., Song S.C. Synthesis and characterization of biodegradable thermosensitive poly(organophosphazene) gels. Macromolecules 2004, 37:4533-4537.
34. Il Kim J., Kim B., Chun C., Lee S.H., Song S.C. MRI-monitored long-term therapeutic hydrogel system for brain tumors without surgical resection. Biomaterials 2012, 33:4836-4842.
35. Seo B.B., Park M.R., Chun C., Lee J.Y., Song S.C. The biological efficiency and bioavailability of human growth hormone delivered using injectable, ionic, thermosensitive poly(organophosphazene)-polyethylenimine conjugate hydrogels. Biomaterials 2011, 32:8271-8280.
36. Loh X.J., Goh S.H., Li J. New biodegradable thermogelling copolymers having very low gelation concentrations. Biomacromolecules 2007, 8:585-593.
37. Loh X.J., Vu P.N.N., Kuo N.Y., Li J. Encapsulation of basic fibroblast growth factor in thermogelling copolymers preserves its bioactivity. J Mater Chem 2011, 21:2246-2254.
38. Cheng Y.H., Yang S.H., Lin F.H. Thermosensitive chitosan-gelatin-glycerol phosphate hydrogel as a controlled release system of ferulic acid for nucleus pulposus regeneration. Biomaterials 2011, 32:6953-6961.
39. Kim Y.J., Choi S., Koh J.J., Lee M., Ko K.S., Kim S.W. Controlled release of insulin from injectable biodegradable triblock copolymer. Pharm Res 2001, 18:548-550.
40. Shim M.S., Lee H.T., Shim W.S., Park I., Lee H., Chang T., et al. Poly(D, L-lactic acid-co-glycolic acid)-b-poly(ethylene glycol)-b-poly (D, L-lactic acid-co-glycolic acid) triblock copolymer and thermoreversible phase transition in water. J Biomed Mater Res 2002, 61:188-196.
41. Choi S., Kim S.W. Controlled release of insulin from injectable biodegradable triblock copolymer depot in ZDF rats. Pharm Res 2003, 20:2008-2010.
42. Yu L., Chang G.T., Zhang H., Ding J.D. Injectable block copolymer hydrogels for sustained release of a PEGylated drug. Int J Pharm 2008, 348:95-106.
43. Yu L., Zhang H., Ding J.D. Effect of precipitate agents on temperature-responsive sol-gel transitions of PLGA-PEG-PLGA copolymers in water. Colloid Polym Sci 2010, 288:1151-1159.
44. Yu L., Zhang Z., Ding J.D. Influence of LA and GA sequence in the PLGA block on the properties of thermogelling PLGA-PEG-PLGA block copolymers. Biomacromolecules 2011, 12:1290-1297.
45. Chang G.T., Ci T.Y., Yu L., Ding J.D. Enhancement of the fraction of the active form of an antitumor drug topotecan via an injectable hydrogel. J Control Release 2011, 156:21-27.
46. Yu L., Zhang Z., Ding J.D. In vitro degradation and protein release of transparent and opaque physical hydrogels of block copolymers at body temperature. Macromol Res 2012, 20:234-243.
47. Yu L., Chang G.T., Zhang H., Ding J.D. Temperature-induced spontaneous sol-gel transitions of poly(D, L-lactic acid-co-glycolic acid)-b- poly(ethylene glycol)-b-poly(D, L-lactic acid-co-glycolic acid) triblock copolymers and their end-capped derivatives in water. J Polym Sci Part A: Polym Chem 2007, 45:1122-1133.
48. Yu L., Zhang Z., Zhang H., Ding J.D. Mixing a sol and a precipitate of block copolymers with different block ratios leads to an injectable hydrogel. Biomacromolecules 2009, 10:1547-1553.
49. Yu L., Zhang Z., Zhang H., Ding J.D. Biodegradability and biocompatibility of thermoreversible hydrogels formed from mixing a sol and a precipitate of block copolymers in water. Biomacromolecules 2010, 11:2169-2178.
50. Choi S.Z., Lee S.O., Jang K.U., Chung S.H., Park S.H., Kang H.C., et al. Antidiabetic stilbene and anthraquinone derivatives from Rheum undulatum. Arch Pharm Res 2005, 28:1027-1030.
51. Andrikopoulos S., Blair A.R., Deluca N., Fam B.C., Proietto J. Evaluating the glucose tolerance test in mice. Am J Physiol-Endocrinol Metab 2008, 295:E1323-E1332.
52. Zhang H., Yu L., Ding J.D. Roles of hydrophilic homopolymers on the hydrophobic-association-induced physical gelling of amphiphilic block copolymers in water. Macromolecules 2008, 41:6493-6499.