A rapid-acting, long-acting insulin formulation based on a phospholipid complex loaded PHBHHx nanoparticles

Biomaterials

Volumn 33, Issue 5, 2012, Pages 1583-1588

  Peng, Qiang ^a   Zhang, Zhi Rong ^a   Gong, Tao ^a   Chen, Guo Qiang ^b   Sun, Xun ^a  

^a SICHUAN UNIVERSITY   (China)

^b TSINGHUA UNIVERSITY   (China)

Author keywords

Biodegradable nanoparticles; Diabetes; Insulin; PHBHHx; Phospholipid complex; Sustained and controlled release

Indexed keywords

BIODEGRADABLE NANOPARTICLE; BURST RELEASE; CONTROLLED DELIVERY; CONTROLLED RELEASE; DELIVERY SYSTEMS; DIABETIC RATS; ENTRAPMENT EFFICIENCY; HYDROPHILIC PROTEIN; HYDROPHOBIC POLYMERS; HYPOGLYCAEMIC; IN-VITRO; INSULIN RELEASE; LONG LASTING; MEAN PARTICLE SIZE; PATIENT COMPLIANCE; PHBHHX; POLY(HYDROXYBUTYRATE-CO-HYDROXYHEXANOATE) (PHBHHX); SOLVENT EVAPORATION METHOD; SPHERICAL SHAPE; THERAPEUTIC EFFECTS;

BIOCHEMISTRY; BIODEGRADABLE POLYMERS; HYDROPHILICITY; MEDICAL PROBLEMS; NANOPARTICLES; PHOSPHOLIPIDS; ZETA POTENTIAL;

INSULIN;

HYDROXYBUTYRIC ACID; LONG ACTING INSULIN; NANOPARTICLE; PHOSPHOLIPID; POLY(HYDROXYBUTYRATE CO HYDROXYHEXANOATE); UNCLASSIFIED DRUG;

ANIMAL EXPERIMENT; ANIMAL MODEL; ARTICLE; BIOAVAILABILITY; BIODEGRADATION; CONTROLLED DRUG RELEASE; CONTROLLED STUDY; DIABETES MELLITUS; DRUG DELIVERY SYSTEM; DRUG FORMULATION; DRUG SOLUBILITY; HYPOGLYCEMIA; IN VITRO STUDY; INSULIN RELEASE; MALE; NONHUMAN; PARTICLE SIZE; PATIENT COMPLIANCE; PRIORITY JOURNAL; RAT; SUSTAINED DRUG RELEASE; ZETA POTENTIAL;

3-HYDROXYBUTYRIC ACID; ANIMALS; BLOOD GLUCOSE; CHEMISTRY, PHARMACEUTICAL; FREEZE DRYING; HEXANOIC ACIDS; HYPOGLYCEMIC AGENTS; INJECTIONS, SUBCUTANEOUS; INSULIN, LONG-ACTING; MALE; NANOPARTICLES; PHOSPHOLIPIDS; RATS; RATS, SPRAGUE-DAWLEY; SOLUBILITY; TIME FACTORS; WATER;

RATTUS;

EID: 83355162688     PISSN: 01429612     EISSN: 18785905     Source Type: Journal    
DOI: 10.1016/j.biomaterials.2011.10.072     Document Type: Article

References (52)

1. Vigersky R.A. An overview of management issues in adult patients with type 2 diabetes mellitus. J Diabetes Sci Technol 2011, 5:245-250.
2. Herold K.C., Hagopian W., Auger J.A., Poumian-Ruiz E., Taylor L., Donaldson D., et al. Anti-CD3 monoclonal antibody in new-onset type 1 diabetes mellitus. N Engl J Med 2002, 346:1692-1698.
3. Baeyens L., De Breuck S., Lardon J., Mfopou J.K., Rooman I., Bouwens L. In vitro generation of insulin-producing β cells from adult exocrine pancreatic cells. Diabetologia 2005, 48:49-57.
4. Bonner-Weir S., Weir G.C. New sources of pancreatic β-cells. Nat Biotechnol 2005, 23:857-861.
5. Trucco M. Regeneration of the pancreatic β cell. J Clin Invest 2005, 115:5-12.
6. Thyssen S., Arany E., Hill D.J. Ontogeny of regeneration of beta-cells in the neonatal rat after treatment with streptozotocin. Endocrinology 2006, 147:2346-2356.
7. Nir T., Melton D.A., Dor Y. Recovery from diabetes in mice by beta cell regeneration. J Clin Invest 2007, 117:2553-2561.
8. Xu X., D'Hoker J., Stangé G., Bonné S., De Leu N., Xiao X., et al. β cells can be generated from endogenous progenitors in injured adult mouse pancreas. Cell 2008, 132:197-207.
9. Thorel F., Népote V., Avril I., Kohno K., Desgraz R., Chera S., et al. Conversion of adult pancreatic α-cells to β-cells after extreme β-cell loss. Nature 2010, 464:1149-1154.
10. Kidron M., Dinh S., Menachem Y., Abbas R., Variano B., Goldberg M., et al. A novel per-oral insulin formulation: proof of concept study in non-diabetic subjects. Diabet Med 2004, 21:354-357.
11. Wajcberg E., Miyazaki Y., Triplitt C., Cersosimo E., Defronzo R.A. Dose-response effect of a single administration of oral hexyl-insulin monoconjugate 2 in healthy nondiabetic subjects. Diabetes Care 2004, 27:2868-2873.
12. Prego C., Garcia M., Torres D., Alonso M.J. Transmucosal macromolecular drug delivery. J Control Release 2005, 101:151-162.
13. Sarmento B., Ribeiro A., Veiga F., Sampaio P., Neufeld R., Ferreira D. Alginate/chitosan nanoparticles are effective for oral insulin delivery. Pharm Res 2007, 24:2198-2206.
14. Sarmento B., Martins S., Ferreira D., Souto E.B. Oral insulin delivery by means of solid lipid nanoparticles. Int J Nanomedicine 2007, 2:743-749.
15. 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.
16. Tuesca A.D., Reiff C., Joseph J.I., Lowman A.M. Synthesis, characterization and in vivo efficacy of PEGylated insulin for oral delivery with complexation hydrogels. Pharm Res 2009, 26:727-739.
17. Cui F., Shi K., Zhang L., Tao A., Kawashima Y. Biodegradable nanoparticles loaded with insulin-phospholipid complex for oral delivery: preparation, in vitro characterization and in vivo evaluation. J Control Release 2006, 114:242-250.
18. Sajadi Tabassi S.A., Hosseinzadeh H., Ramezani M., Moghimipour E., Mohajeri S.A. Isolation, characterization and study of enhancing effects on nasal absorption of insulin in rat of the total saponin from Acanthophyllum squarrosum. Curr Drug Deliv 2006, 3:399-404.
19. Wang J., Tabata Y., Morimoto K. Aminated gelatin microspheres as a nasal delivery system for peptide drugs: evaluation of in vitro release and in vivo insulin absorption in rats. J Control Release 2006, 113:31-37.
20. El-Dakrouri W.A., Ibrahim H.K., Ghorab M.K., Ghroab M.M. Enhancement of the intranasal delivery of insulin via a novel mucoadhesive carbopol gel. J Pharm Pharmacol 2010, 62:866-872.
21. Duan X., Mao S. New strategies to improve the intranasal absorption of insulin. Drug Discov Today 2010, 15:416-427.
22. Liu J., Gong T., Fu H., Wang C., Wang X., Chen Q., et al. Solid lipid nanoparticles for pulmonary delivery of insulin. Int J Pharm 2008, 356:333-344.
23. Amidi M., Krudys K.M., Snel C.J., Crommelin D.J., Della Pasqua O.E., Hennink W.E., et al. Efficacy of pulmonary insulin delivery in diabetic rats: use of a model-based approach in the evaluation of insulin powder formulations. J Control Release 2008, 127:257-266.
24. Bi R., Shao W., Wang Q., Zhang N. Solid lipid nanoparticles as insulin inhalation carriers for enhanced pulmonary delivery. J Biomed Nanotechnol 2009, 5:84-92.
25. Klingler C., Müller B.W., Steckel H. Insulin-micro- and nanoparticles for pulmonary delivery. Int J Pharm 2009, 377:173-179.
26. Hamishehkar H., Emami J., Najafabadi A.R., Gilani K., Minaiyan M., Mahdavi H., et al. Effect of carrier morphology and surface characteristics on the development of respirable PLGA microcapsules for sustained-release pulmonary delivery of insulin. Int J Pharm 2010, 389:74-85.
27. Heinemann L. New ways of insulin delivery. Int J Clin Pract Suppl 2010, 166:29-40.
28. Liu J., Gong T., Wang C., Zhong Z., Zhang Z. Solid lipid nanoparticles loaded with insulin by sodium cholate-phosphatidylcholine-based mixed micelles: preparation and characterization. Int J Pharm 2007, 340:153-162.
29. Peng Q., Gong T., Zuo J., Liu J., Zhao D., Zhang Z. Enhanced oral bioavailability of salvianolic acid B by phospholipid complex loaded nanoparticles. Pharmazie 2008, 63:661-666.
30. Chertok B., David A.E., Yang V.C. Magnetically-enabled and MR-monitored selective brain tumor protein delivery in rats via magnetic nanocarriers. Biomaterials 2011, 32:6245-6253.
31. Sarmento B., Ribeiro A., Veiga F., Ferreira D., Neufeld R. Oral bioavailability of insulin contained in polysaccharide nanoparticles. Biomacromolecules 2007, 8:3054-3060.
32. Liu Y., Li K., Liu B., Feng S.S. A strategy for precision engineering of nanoparticles of biodegradable copolymers for quantitative control of targeted drug delivery. Biomaterials 2010, 31:9145-9155.
33. Peng Q., Zhang Z.R., Sun X., Zuo J., Zhao D., Gong T. Mechanisms of phospholipid complex loaded nanoparticles enhancing the oral bioavailability. Mol Pharm 2010, 7:565-575.
34. Hamad I., AI-Hanbali O., Hunter A.C., Rutt K.J., Andresen T.L., Moghimi S.M. Distinct polymer architecture mediates switching of complement activation pathways at the nanosphere-serum interface: implications for stealth nanoparticle engineering. ACS Nano 2010, 4:6629-6638.
35. Xie S., Wang S., Zhao B., Han C., Wang M., Zhou W. Effect of PLGA as a polymeric emulsifier on preparation of hydrophilic protein-loaded solid lipid nanoparticles. Colloids Surf B Biointerfaces 2008, 67:199-204.
36. Xiong Y.C., Yao Y.C., Zhan X.Y., Chen G.Q. Application of polyhydroxyalkanoates nanoparticles as intracellular sustained drug-release vectors. J Biomater Sci Polym Ed 2010, 21:127-140.
37. Yang M., Zhu S., Chen Y., Chang Z., Chen G., Gong Y., et al. Studies on bone marrow stromal cells affinity of poly (3-hydroxybutyrate-co-3-hydroxyhexanoate). Biomaterials 2004, 25:1365-1373.
38. Qu X.H., Wu Q., Liang J., Qu X., Wang S.G., Chen G.Q. Enhanced vascular-related cellular affinity on surface modified copolyesters of 3-hydroxybutyrate and 3-hydroxyhexanoate (PHBHHx). Biomaterials 2005, 26:6991-7001.
39. Cheng S., Chen G.Q., Leski M., Zou B., Wang Y., Wu Q. The effect of D, L-β-hydroxybutyric acid on cell death and proliferation in L929 cells. Biomaterials 2006, 27:3758-3765.
40. Cheng S., Wu Q., Zhao Y., Zou B., Chen G.Q. Poly(hydroxybutyrate-co- hydroxyhexanoate) Microparticles Stimulate Murine Fibroblast L929 cell proliferation. Polym Degrad Stabil 2006, 91:3191-3196.
41. Sun J., Dai Z.W., Chen G.Q. Oligomers of polyhydroxyalkanoates stimulated calcium ion channels in mammalian cells. Biomaterials 2007, 28:3896-3903.
42. Xi J., Zhang L., Zheng Z., Chen G., Gong Y., Zhao N., et al. Preparation and evaluation of porous poly(3-hydroxybutyrate-co-3-hydroxyhexanoate) hydroxyapatite composite scaffolds. J Biomater Appl 2008, 22:293-307.
43. Wang Y., Bian Y.Z., Wu Q., Chen G.Q. Evaluation of three-dimensional scaffolds prepared from poly(3-hydroxybutyrate-co-3-hydroxyhexanoate) for growth of allogeneic chondrocytes for cartilage repair in rabbits. Biomaterials 2008, 29:2858-2868.
44. Cheng S.T., Chen Z.F., Chen G.Q. The expression of cross-linked elastin by rabbit blood vessel smooth muscle cells cultured in polyhydroxyalkanoate scaffolds. Biomaterials 2008, 29:4187-4194.
45. Bian Y.Z., Wang Y., Aibaidoula G., Chen G.Q., Wu Q. Evaluation of poly(3-hydroxybutyrate-co-3-hydroxyhexanoate) conduits for peripheral nerve regeneration. Biomaterials 2009, 30:217-225.
46. Luo L., Wei X., Chen G.Q. Physical properties and biocompatibility of poly(3-hydroxybutyrate-co-3-hydroxyhexanoate) blended with poly(3-hydro-xybutyrate-co-4-hydroxybutyrate). J Biomater Sci Polym Ed 2009, 20:1537-1553.
47. Zhou J., Peng S.W., Wang Y.Y., Zheng S.B., Wang Y., Chen G.Q. The use of poly(3-hydroxybutyrate-co-3-hydroxyhexanoate) scaffolds for tarsal repair in eyelid reconstruction in the rat. Biomaterials 2010, 31:7512-7518.
48. Yao Y.C., Zhan X.Y., Zou X.H., Wang Z.H., Xiong Y.C., Zhang J., et al. A specific drug targeting system based on polyhydroxyalkanoate granule binding protein PhaP Fused with targeted cell ligands. Biomaterials 2008, 29:4823-4830.
49. Vandana M., Sahoo S.K. Optimization of physicochemical parameters influencing the fabrication of protein-loaded chitosan nanoparticles. Nanomedicine (Lond) 2009, 4:773-785.
50. Tong R., Yala L., Fan T.M., Cheng J. The formulation of aptamer-coated paclitacel-polylactide nanoconjugates and their targeting to cancer cells. Biomaterial 2010, 31:3043-3053.
51. Mesiha M.S., Sidhom M.B., Fasipe B. Oral and subcutaneous absorption of insulin poly(isobutylcyanoacrylate) nanoparticles. Int J Pharm 2005, 288:289-293.
52. Jo H.G., Min K.H., Nam T.H., Na S.J., Park J.H., Jeong S.Y. Prolonged antidiabetic effect of zinc-crystallized insulin loaded glycol chitosan nanoparticles in type 1 diabetic rats. Arch Pharm Res 2008, 31:918-923.