Biocompatibility of poly(d,l-lactic-co-hydroxymethyl glycolic acid) microspheres after subcutaneous and subcapsular renal injection

International Journal of Pharmaceutics

Volumn 482, Issue 1-2, 2015, Pages 99-109

  Kazazi Hyseni, F ^a   Zandstra, J ^b   Popa, E R ^b   Goldschmeding, R ^c   Lathuile, A A R ^d   Veldhuis, G J ^d   Van Nostrum, C F ^a   Hennink, W E ^a   Kok, R J ^a  

^a UTRECHT UNIVERSITY   (Netherlands)

^b UNIVERSITY MEDICAL CENTER GRONINGEN   (Netherlands)

^c UNIVERSITY MEDICAL CENTER UTRECHT   (Netherlands)

^d NANOMI B V   (Netherlands)

Author keywords

Biocompatibility; Cytocompatibility; Monodisperse microspheres; PLHMGA

Indexed keywords

COPOLYMER; MICROSPHERE; POLY( LACTIC CO HYDROXYMETHYL GLYCOLIC ACID); UNCLASSIFIED DRUG; BIOMATERIAL; DRUG CARRIER; POLY(LACTIDE-CO-HYDROXYMETHYL GLYCOLIDE); POLYESTER;

ANIMAL CELL; ANIMAL CELL CULTURE; ANIMAL EXPERIMENT; ANIMAL TISSUE; ARTICLE; BIOCOMPATIBILITY; CELL PROLIFERATION ASSAY; CELLS BY BODY ANATOMY; CHEMICAL STRUCTURE; DEGRADATION; DIFFERENTIAL SCANNING CALORIMETRY; DRUG DELIVERY SYSTEM; DRUG FORMULATION; FOREIGN BODY REACTION; GIANT CELL; IMMUNOHISTOCHEMISTRY; IN VITRO STUDY; INFLAMMATION; MACROPHAGE; MALE; MYOFIBROBLAST; NONHUMAN; PRIORITY JOURNAL; RAT; SUBCAPSULAR RENAL INJECTION; SUBCUTANEOUS RENAL INJECTION; SYNTHESIS; ANIMAL; CELL LINE; CELL PROLIFERATION; CHEMICALLY INDUCED; DRUG EFFECTS; DRUG STABILITY; INTRADERMAL DRUG ADMINISTRATION; KIDNEY; PATHOLOGY;

ADMINISTRATION, CUTANEOUS; ANIMALS; BIOCOMPATIBLE MATERIALS; CELL LINE; CELL PROLIFERATION; DRUG CARRIERS; DRUG STABILITY; FOREIGN-BODY REACTION; KIDNEY; MALE; MICROSPHERES; POLYESTERS; RATS;

EID: 84922749845     PISSN: 03785173     EISSN: 18733476     Source Type: Journal    
DOI: 10.1016/j.ijpharm.2014.12.014     Document Type: Article

References (54)

1. J.M. Anderson Biological responses to materials Annu. Rev. Mater Sci. 31 2001 81 110
2. J.M. Anderson, and M.S. Shive Biodegradation and biocompatibility of PLA and PLGA microspheres Adv. Drug Deliv. Rev. 28 1997 5 24
3. K.A. Athanasiou, G.G. Niederauer, and C.M. Agrawal Sterilization, toxicity, biocompatibility and clinical applications of polylactic acid/polyglycolic acid copolymers Biomaterials 17 1996 93 102
4. H.W. Avdovich, M.J. Lebelle, C. Savard, and W.L. Wilson Nuclear magnetic resonance identification and estimation of solvent residues in cocaine Forensic Sci. Int. 49 1991 225 235
5. Zn single comparator methods for standardization in INAA J. Radioanal. Nucl. Chem. Art. 191 1995 387 401
6. J.A. Cadée, L.A. Brouwer, W. Den Otter, W.E. Hennink, and M.J.A. Van Luyn A comparative biocompatibility study of microspheres based on crosslinked dextran or poly(lactic-co-glycolic) acid after subcutaneous injection in rats J. Biomed. Mater. Res. 56 2001 600 609
7. J.A. Champion, A. Walker, and S. Mitragotri Role of particle size in phagocytosis of polymeric microspheres Pharm. Res. 25 2008 1815 1821
8. P.Y.W. Dankers, M.J.A. van Luyn, A. Huizinga-van der Vlag, G.M.L. van Gemert, A.H. Petersen, E.W. Meijer, H.M. Janssen, A.W. Bosman, and E.R. Popa Development and in-vivo characterization of supramolecular hydrogels for intrarenal drug delivery Biomaterials 33 2012 5144 5155
9. C.J. De Groot, M.J.A. Van Luyn, W.N.E. Van Dijk-Wolthuis, J.A. Cadée, J.A. Plantinga, W.D. Otter, and W.E. Hennink In vitro biocompatibility of biodegradable dextran-based hydrogels tested with human fibroblasts Biomaterials 22 2001 1197 1203
10. A. Desmoulière, I.A. Darby, and G. Gabbiani Normal and pathologic soft tissue remodeling: role of the myofibroblast, with special emphasis on liver and kidney fibrosis Lab. Invest. 83 2003 1689 1707
11. C.D. Dijkstra, E.A. Dopp, P. Joling, and G. Kraal The heterogeneity of mononuclear phagocytes in lymphoid organs: distinct macrophage subpopulations in the rat recognized by monoclonal antibodies ED1, ED2 and ED3 Immunology 54 1985 589 599
12. EMEA Guideline on the Specification Limits for Residues of Metal Catalysts 2007 European Medicines Agency London Doc. Ref. EMEA/CHMP/SWP/4446/2000
13. T. Estey, J. Kang, S.P. Schwendeman, and J.F. Carpenter BSA degradation under acidic conditions: a model for protein instability during release from PLGA delivery systems J. Pharm. Sci. 95 2006 1626 1639
14. FDA Guidance Documents, December, 1997. International Conference on Harmonization (ICH) - Guidance for Industry: Q3C Impurities: Residual Solvents.
15. A.H. Ghassemi, M.J. van Steenbergen, H. Talsma, C.F. van Nostrum, W. Jiskoot, D.J.A. Crommelin, and W.E. Hennink Preparation and characterization of protein loaded microspheres based on a hydroxylated aliphatic polyester, poly(lactic-co-hydroxymethyl glycolic acid) J. Controlled Release 138 2009 57 63
16. A.H. Ghassemi, M.J. Van Steenbergen, H. Talsma, C.F. Van Nostrum, D.J.A. Crommelin, and W.E. Hennink Hydrophilic polyester microspheres: effect of molecular weight and copolymer composition on release of BSA Pharm. Res. 27 2010 2008 2017
17. A.H. Ghassemi, M.J. van Steenbergen, A. Barendregt, H. Talsma, R.J. Kok, C.F. van Nostrum, D.J. Crommelin, and W.E. Hennink Controlled release of octreotide and assessment of peptide acylation from poly(d,l-lactide-co-hydroxymethyl glycolide) compared to PLGA microspheres Pharm. Res. 29 2012 110 120
18. K. Grodowska, and A. Parczewski Organic solvents in the pharmaceutical industry Acta Pol. Pharm. 67 2010 3 12
19. S. Hermeling, D.J. Crommelin, H. Schellekens, and W. Jiskoot Structure-immunogenicity relationships of therapeutic proteins Pharm. Res. 21 2004 897 903
20. S.S. Huang, I.H. Li, P.D. Hong, and M.K. Yeh Development of Yersinia pestis F1 antigen-loaded microspheres vaccine against plague Int. J. Nanomed. 9 2014 813 822
21. ISO Guidelines, April 23, 2013. Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, International Standard ISO-10993 (draft guidance for FDA).
22. W. Jiang, R.K. Gupta, M.C. Deshpande, and S.P. Schwendeman Biodegradable poly(lactic-co-glycolic acid) microparticles for injectable delivery of vaccine antigens Adv. Drug Deliv. Rev. 57 2005 391 410
23. 13C NMR data to aid the identification and quantification of residual solvents by NMR spectroscopy Magn. Reson. Chem. 43 2005 497 509
24. V.B. Joshi, S.M. Geary, and A.K. Salem Biodegradable particles as vaccine antigen delivery systems for stimulating cellular immune responses Hum. Vaccin. Immunother. 9 2013 2584 2590
25. F. Kazazi-Hyseni, M. Landin, A. Lathuile, G.J. Veldhuis, S. Rahimian, W.E. Hennink, R.J. Kok, and C.F. van Nostrum Computer modeling assisted design of monodisperse PLGA microspheres with controlled porosity affords zero order release of an encapsulated macromolecule for 3 months Pharm. Res. 31 2014 2844 2856
26. S.J. Kim, J.G. Park, J.H. Kim, J.S. Heo, J.W. Choi, Y.S. Jang, J. Yoon, S.J. Lee, and I.K. Kwon Development of a biodegradable sirolimus-eluting stent coated by ultrasonic atomizing spray J. Nanosci. Nanotechnol. 11 2011 5689 5697
27. D.S. Kohane, M. Lipp, R.C. Kinney, D.C. Anthony, D.N. Louis, N. Lotan, and R. Langer Biocompatibility of lipid-protein-sugar particles containing bupivacaine in the epineurium J. Biomed. Mater. Res. 59 2002 450 459
28. S.A. Koopal, M. Iglesias Coma, A.T.M.G. Tiebosch, and A.J.H. Suurmeijer Low-temperature heating overnight in Tris-HCl buffer pH 9 is a good alternative for antigen retrieval in formalin-fixed paraffin-embedded tissue Appl. Immunohistochem. 6 1998 228 233
29. M. Leemhuis, J.A. Kruijtzer, C.F. Nostrum, and W.E. Hennink In vitro hydrolytic degradation of hydroxyl-functionalized poly(alpha-hydroxy acid)s Biomacromolecules 8 2007 2943 2949
30. M. Leemhuis, C.F. Van Nostrum, J.A.W. Kruijtzer, Z.Y. Zhong, M.R. Ten Breteler, P.J. Dijkstra, J. Feijen, and W.E. Hennink Functionalized poly(a-hydroxy acid)s via ring-opening polymerization: toward hydrophilic polyesters with pendant hydroxyl groups Macromolecules 39 2006 3500 3508
31. Y. Liu, A.H. Ghassemi, W.E. Hennink, and S.P. Schwendeman The microclimate pH in poly(d,l-lactide-co-hydroxymethyl glycolide) microspheres during biodegradation Biomaterials 33 2012 7584 7593
32. J.U. Menon, P. Ravikumar, A. Pise, D. Gyawali, C.C. Hsia, and K.T. Nguyen Polymeric nanoparticles for pulmonary protein and DNA delivery Acta Biomater. 10 2014 2643 2652
33. T. Nakashima, M. Shimizu, and M. Kukizaki Particle control of emulsion by membrane emulsification and its applications Adv. Drug Deliv. Rev. 45 2000 47 56
34. T.G. Park, W. Lu, and G. Crotts Importance of in vitro experimental conditions on protein release kinetics, stability and polymer degradation in protein encapsulated poly (d,l-lactic acid-co-glycolic acid) microspheres J. Controlled Release 33 1995 211 222
35. P.A. Patten, and H. Schellekens The immunogenicity of biopharmaceuticals. Lessons learned and consequences for protein drug development Dev. Biol. (Basel) 112 2003 81 97
36. R. Rabson, N.E. Tolbert, and P.C. Kearney Formotion of serine and glyceric acid by the glycolate pathway Arch. Biochem. Biophys. 98 1962 154 163
37. E. Reguera-Nuñez, C. Roca, E. Hardy, M. de la Fuente, N. Csaba, and M. Garcia-Fuentes Implantable controlled release devices for BMP-7 delivery and suppression of glioblastoma initiating cells Biomaterials 35 2014 2859 2867
38. N. Samadi, A. Abbadessa, A. Di Stefano, C.F. van Nostrum, T. Vermonden, S. Rahimian, E.A. Teunissen, M.J. van Steenbergen, M. Amidi, and W.E. Hennink The effect of lauryl capping group on protein release and degradation of poly(d,l-lactic-co-glycolic acid) particles J. Controlled Release 172 2013 436 443
39. N. Samadi, C.F. Van Nostrum, T. Vermonden, M. Amidi, and W.E. Hennink Mechanistic studies on the degradation and protein release characteristics of poly(lactic-co-glycolic-co-hydroxymethylglycolic acid) nanospheres Biomacromolecules 14 2013 1044 1053
40. E.I. Shishatskaya, O.N. Voinova, A.V. Goreva, O.A. Mogilnaya, and T.G. Volova Biocompatibility of polyhydroxybutyrate microspheres: in vitro and in vivo evaluation J. Mater. Sci. Mater. Med. 19 2008 2493 2502
41. R.B. Shmueli, M. Ohnaka, A. Miki, N.B. Pandey, R. Lima e Silva, J.E. Koskimaki, J. Kim, A.S. Popel, P.A. Campochiaro, and J.J. Green Long-term suppression of ocular neovascularization by intraocular injection of biodegradable polymeric particles containing a serpin-derived peptide Biomaterials 34 2013 7544 7551
42. O. Skalli, P. Ropraz, A. Trzeciak, G. Benzonana, D. Gillessen, and G. Gabbiani A monoclonal antibody against a-smooth muscle actin: a new probe for smooth muscle differentiation J. Cell Biol. 103 1986 2787 2796
43. G. Spenlehauer, M. Vert, J.P. Benoit, and A. Boddaert In vitro and in vivo degradation of poly(d,l lactide/glycolide) type microspheres made by solvent evaporation method Biomaterials 10 1989 557 563
44. Y. Tabata, and Y. Ikada Effect of the size and surface charge of polymer microspheres on their phagocytosis by macrophage Biomaterials 9 1988 356 362
45. C. Thomasin, G. Corradin, Y. Men, H.P. Merkle, and B. Gander Tetanus toxoid and synthetic malaria antigen containing poly(lactide)/poly(lactide-co-glycolide) microspheres: importance of polymer degradation and antigen release for immune response J. Controlled Release 41 1996 131 145
46. A.A. Van Apeldoorn, H.J. Van Manen, J.M. Bezemer, J.D. De Bruijn, C.A. Van Blitterswijk, and C. Otto Raman imaging of PLGA microsphere degradation inside macrophages J. Am. Chem. Soc. 126 2004 13226 13227
47. M. Vert, J. Mauduit, and S. Li Biodegradation of PLA/GA polymers: increasing complexity Biomaterials 15 1994 1209 1213
48. G.E. Visscher, M.A. Robison, and G.J. Argentieri Tissue response to biodegradable injectable microcapsules J. Biomate. Appl. 2 1987 118 131
49. G.E. Visscher, J.E. Pearson, J.W. Fong, G.J. Argentieri, R.L. Robison, and H.V. Maulding Effect of particle size on the in vitro and in vivo degradation rates of poly(dl-lactide-co-glycolide) microcapsules J. Biomed. Mater. Res. 22 1988 733 746
50. G.E. Visscher, R.L. Robison, H.V. Maulding, J.W. Fong, J.E. Pearson, and G.J. Argentieri Biodegradation of and tissue reaction to 50:50 poly(dl-lactide-co-glycolide) microcapsules J. Biomed. Mater. Res. 19 1985 349 365
51. E. Walter, D. Dreher, M. Kok, L. Thiele, S.G. Kiama, P. Gehr, and H.P. Merkle Hydrophilic poly(dl-lactide-co-glycolide) microspheres for the delivery of DNA to human-derived macrophages and dendritic cells J. Controlled Release 76 2001 149 168
52. J.D. Wink, P.A. Gerety, R.D. Sherif, Y. Lim, N.A. Clarke, C.S. Rajapakse, H.D. Nah, and J.A. Taylor Sustained delivery of rhBMP-2 via PLGA microspheres: cranial bone regeneration without heterotopic ossification or craniosynostosis Plast. Reconstr. Surg. 134 2014 51 59
53. J. Xuan, Y. Lin, J. Huang, F. Yuan, X. Li, Y. Lu, H. Zhang, J. Liu, Z. Sun, H. Zou, Y. Chen, J. Gao, and Y. Zhong Exenatide-loaded PLGA microspheres with improved glycemic control: in vitro bioactivity and in vivo pharmacokinetic profiles after subcutaneous administration to SD rats Peptides 46 2013 172 179
54. J. Zandstra, C. Hiemstra, A.H. Petersen, J. Zuidema, M.M. van Beuge, S. Rodriguez, A.A.R. Lathuile, G.J. Veldhuis, R. Steendam, R.A. Bank, and E.R. Popa Microsphere size influences the foreign body reaction Eur. Cell. Mater. 28 2014 335 347