PLGA micro and nanoparticles in delivery of peptides and proteins; problems and approaches

References

• Chi EY, Krishnan S, Randolph TW, Carpenter JF. Physical stability of proteins in aqueous solution: mechanism and driving forces in nonnative protein aggregation. Pharm Res 2003;20:1325–1336
   PubMed Web of Science ®Google Scholar
• Iyer PV, Ananthanarayan L. Enzyme stability and stabilization – aqueous and non-aqueous environment. Process Biochem 2008;43:1019–1032
   Web of Science ®Google Scholar
• Kim HK, Park TG. Microencapsulation of dissociable human growth hormone aggregates within poly(D,L-lactic-co-glycolic acid) microparticles for sustained release. Int J Pharm 2001;229:107–116
   PubMed Web of Science ®Google Scholar
• Kim SJ, Hahn SK, Kim MJ, et al. Development of a novel sustained release formulation of recombinant human growth hormone using sodium hyaluronate microparticles. J Control Release 2005;104:323–335
   PubMed Web of Science ®Google Scholar
• Varshochian R, Jeddi-Tehrani M, Mahmoudi AR, et al. The protective effect of albumin on bevacizumab activity and stability in PLGA nanoparticles intended for retinal and choroidal neovascularization treatments. Eur J Pharm Sci 2013;50:341–352
   PubMed Web of Science ®Google Scholar
• Tong R, Gabrielson NP, Fan TM, Cheng J. Polymeric nanomedicines based on poly(lactide) and poly(lactide-co-glycolide). Curr Opin Solid State Mater Sci 2012;16:323–332
   PubMed Web of Science ®Google Scholar
• Zhou Y, Zhang L, Zhao W, et al. Nanoparticle-mediated delivery of TGF-beta1 miRNA plasmid for preventing flexor tendon adhesion formation. Biomaterials 2013;34:8269–8278
   PubMed Web of Science ®Google Scholar
• Muthu MS. Nanoparticles based on PLGA and its copolymer: an overview. Asian J Pharm 2009;3:266–273
   Google Scholar
• Lassalle Vn, Ferreira MaLn. PLA nano- and microparticles for drug delivery: an overview of the methods of preparation. Macromol Biosci 2007;7:767–783
   PubMed Web of Science ®Google Scholar
• Wei G, Lu LF, Lu WY. Stabilization of recombinant human growth hormone against emulsification-induced aggregation by Pluronic surfactants during microencapsulation. Int J Pharm 2007;338:125–132
   PubMed Web of Science ®Google Scholar
• Stevanović M, Uskoković D. Poly(lactide-co-glycolide)-based micro and nanoparticles for the controlled drug delivery of vitamins. Curr Nanosci 2009;5:1–15
   Web of Science ®Google Scholar
• Yanga Y-Y, Chiab H-H, Chung T-S. Effect of preparation temperature on the characteristics and release profiles of PLGA microspheres containing protein fabricated by double-emulsion solvent extraction/evaporation method. J Control Release 2000;69:81–96
   PubMed Web of Science ®Google Scholar
• Soppimath KS, Aminabhavi TM, Kulkarni AR, Rudzinski WE. Biodegradable polymeric nanoparticles as drug delivery devices. J Control Release 2001;70:1–20
   PubMed Web of Science ®Google Scholar
• Saez V, Herna'ndez JR, Peniche C. Microspheres as delivery systems for the controlled release of peptides and proteins. Biotecnologia Aplicada 2007;24:108–116
   Google Scholar
• Al-Tahami K, Singh J. Smart polymer based delivery systems for peptides and proteins. Recent Pat Drug Deliv Formul 2007;1:65–71
   PubMedGoogle Scholar
• Narayani R. Polymeric delivery systems in biotechnology: a mini review. Trends Biomater Artif Organs. 2007;21:14–19
   Google Scholar
• Pai SS, Tilton RD, Przybycien TM. Poly(ethylene glycol)-modified proteins: implications for poly(lactide-co-glycolide)-based microsphere delivery. Am Assoc Pharm Sci 2009;11:88–98
   Google Scholar
• Wu F, Jin T. Polymer-based sustained-release dosage forms for protein drugs, challenges, and recent advances. AAPS PharmSciTech 2008;9:1218–1229
   PubMed Web of Science ®Google Scholar
• Herbert P, Murphy K, Johnson O, et al. A large-scale process to produce microencapsulation proteins. Pharm Res 1998;15:357–361
   PubMed Web of Science ®Google Scholar
• Ravi S, Peh KK, Darwis Y, et al. Development and characterization of polymeric microspheres for controlled release protein loaded drug delivery system. Indian J Pharm Sci 2008;70:303–309
   PubMed Web of Science ®Google Scholar
• Kang F, Singh J. Effect of additives on the release of a model protein from PLGA microspheres. AAPS PharmSciTech 2001;2:1–7
   Google Scholar
• Dickerson RN, Allison ML, Maish GO, 3rd, et al. Improved safety with intravenous insulin therapy for critically ill patients with renal failure. Nutrition 2013 (in press)
   PubMed Web of Science ®Google Scholar
• Polgreen LE, Thomas W, Orchard PJ, et al. Effect of recombinant human growth hormone on changes in height, bone mineral density, and body composition over 1–2 years in children with Hurler or Hunter syndrome. Mol Genet Metab 2013 (in press)
   Web of Science ®Google Scholar
• Klintman J, Hillarp A, Berntorp E, Astermark J. Long-term anti-FVIII antibody response in Bethesda-negative haemophilia A patients receiving continuous replacement therapy. Br J Haematol 2013;163:385–392
   PubMed Web of Science ®Google Scholar
• Uprichard J, Adamidou D, Goddard NJ, et al. Factor IX replacement to cover total knee replacement surgery in haemophilia B: a single-centre experience, 2000–2010. Haemophilia 2012;18:46–49
   PubMed Web of Science ®Google Scholar
• Locatelli F, Mandolfo S, Menegato Adorati M, et al. Efficacy and safety of once-monthly continuous erythropoietin receptor activator in patients with chronic renal anemia. J Nephrol 2013;26:1114–1121
   PubMed Web of Science ®Google Scholar
• Paul M, Ram R, Kugler E, et al. Subcutaneous vs. intravenous G-CSF for the treatment of neutropenia in hospitalized hemato-oncological patients: randomized controlled trial. Am J Hematol 2013 (in press)
   PubMed Web of Science ®Google Scholar
• Yang JL, Shi YK, He XH, et al. Evaluation of the role of rhIL-11 on hematological recovery in lymphoma patients after autologous hematopoietic stem cell transplantation. Zhonghua Zhong Liu Za Zhi 2012;34:469–472
   PubMedGoogle Scholar
• Karlberg H, Lindegren G, Mirazimi A. Comparison of antiviral activity of recombinant and natural interferons against crimean-congo hemorrhagic Fever virus. Open Virol J 2010;4:38–41
   PubMedGoogle Scholar
• Chen AY, Zeremski M, Chauhan R, et al. Persistence of hepatitis C virus during and after otherwise clinically successful treatment of chronic hepatitis C with standard pegylated interferon alpha-2b and ribavirin therapy. PLoS One 2013;8:e80078
   Web of Science ®Google Scholar
• Patti F, Morra VB, Amato MP, et al. Subcutaneous interferon beta-1a may protect against cognitive impairment in patients with relapsing-remitting multiple sclerosis: 5-year follow-up of the COGIMUS study. PLoS One 2013;8:e74111
   PubMed Web of Science ®Google Scholar
• Hallett M, Albanese A, Dressler D, et al. Evidence-based review and assessment of botulinum neurotoxin for the treatment of movement disorders. Toxicon 2013;67:94–114
   PubMed Web of Science ®Google Scholar
• Spanholtz TA, Holzbach T, Wallmichrath J, et al. Treatment of Dupuytren's contracture by means of injectable collagenase: first clinical experiences. Handchir Mikrochir Plast Chir 2011;43:275–280
   PubMed Web of Science ®Google Scholar
• Manchanda R, Fernandez-Fernandez A, Nagesetti A, McGoron AJ. Preparation and characterization of a polymeric (PLGA) nanoparticulate drug delivery system with simultaneous incorporation of chemotherapeutic and thermo-optical agents. Colloids Surf B: Biointerfaces 2010;75:260–267
   PubMed Web of Science ®Google Scholar
• Vandervoort J, Ludwig A. Biocompatible stabilizers in the preparation of PLGA nanoparticles: a factorial design study. Int J Pharm 2002;238:77–92
   PubMed Web of Science ®Google Scholar
• Perrin DE, English JP. Polyglycolide and polylactide. In: Domb AJ, Kost J, Wiseman DM, eds. Handbook of biodegradable polymers. Amsterdam: CRC Press; 1997:3–28
   Google Scholar
• Vrignaud S, Benoit J-P, Saulnier P. Strategies for the nanoencapsulation of hydrophilic molecules in polymer-based nanoparticles. Biomaterials 2011;32:8593–8604
   PubMed Web of Science ®Google Scholar
• Jain RA. The manufacturing techniques of various drug loaded biodegradable poly (lactide-co-glycolide) (PLGA) devices. Biomaterials 2000;21:2475–2490
   PubMed Web of Science ®Google Scholar
• Costantino HR, Johnson OL, Zale SE. Relationship between encapsulated drug particle size and initial release of recombinant human growth hormone from biodegradable microspheres. J Pharm Sci 2004;93:2624–2634
   PubMed Web of Science ®Google Scholar
• Johnson OL, Jaworowicz W, Cleland JL, et al. The stabilization and encapsulation of human growth hormone into biodegradable microspheres. Pharm Res 1997;14:730–735
   PubMed Web of Science ®Google Scholar
• Nan A, Ghandehari H. Structure, properties, and characterization of polymeric biomaterials. In: Mahato RI, ed. Biomaterials for delivery and targeting of proteins and nucleic acids. Washington, DC: CRC Press; 2005:8–9
   Google Scholar
• Panyam J, Dali MM, Sahoo SK, et al. Polymer degradation and in vitro release of a model protein from poly (d,l-lactide-co-glycolide) nano-and microparticles. J Control Release 2003;92:173–187
   PubMed Web of Science ®Google Scholar
• Brannon-Peppas L, Vert M. Polylactic and polyglycolic acids as drug delivery carriers. In: Wise DL, ed. Handbook of pharmaceutical controlled release technology. New York: Marcel Dekker, Inc.; 2000:99–130
   Google Scholar
• van de Weert M, Hennink WE, Jiskoot W. Protein instability in poly (lactic-co-glycolic acid) microparticles. Pharm Res 2000;17:1159–1167
   PubMed Web of Science ®Google Scholar
• Pollauf EJ, Berkland C, Kim KK, Pack DW. In vitro degradation of polyanhydride/polyester core-shell double-wall microspheres. Int J Pharm 2005;301:294–303
   PubMed Web of Science ®Google Scholar
• Rao JP, Geckeler KE. Polymer nanoparticles: preparation techniques and size-control parameters. Progress Polym Sci 2011;36:887–913
   Web of Science ®Google Scholar
• Gupta VK, Karar P, Ramesh S, et al. Nanoparticle formulation for hydrophilic & hydrophobic drugs. Int J Res Pharm Sci 2010;1:163–169
   Google Scholar
• Sourabhan S, Kaladhar K, Sharma CP. Method to enhance the encapsulation of biologically active molecules in PLGA nanoparticles. Trends Biomater Artif Organs 2009;22:211–215
   Google Scholar
• Fu K, Harrell R, Zinski K, et al. A potential approach for decreasing the burst effect of protein from PLGA microspheres. J Pharm Sci 2003;92:1582–1591
   PubMed Web of Science ®Google Scholar
• Yeo Y, Park K. Control of encapsulation efficiency and initial burst in polymeric microparticle systems. Arch Pharm Res 2004;27:1–12
   PubMed Web of Science ®Google Scholar
• Cismaru L, Popa M. Polymeric nanoparticles with biomedical applications. Revue Roumaine de Chimie 2010;55:433–442
   Web of Science ®Google Scholar
• Mohanraj V, Chen Y. Nanoparticles-a review. Tropical J Pharm Res 2007;5:561–573
   Google Scholar
• Morlock M, Koll H, Winter G, Kissel T. Microencapsulation of rh-erythropoietin, using biodegradable poly (d,l-lactide-co-glycolide): protein stability and the effects of stabilizing excipients. Eur J Pharm Biopharm 1997;43:29–36
   Web of Science ®Google Scholar
• Yang Y-Y, Chung T-S, Ng NP. Morphology, drug distribution, and in vitro release prfiles of biodegradable polymeric microspheres containing protein fabricated by double-emulsion solvent extraction/evaporation method. Biomaterials 2001;22:231–241
   PubMed Web of Science ®Google Scholar
• Feczkó T, Tóth J, Dósa G, Gyenis J. Influence of process conditions on the mean size of PLGA nanoparticles. Chem Eng Process 2011;50:846–853
   Web of Science ®Google Scholar
• Feczkó T, Tóth J, Dósa G, Gyenis J. Optimization of protein encapsulation in PLGA nanoparticles. Chem Eng Process 2011;50:757–765
   Web of Science ®Google Scholar
• Kim HK, Park TG. Microencapsulation of human growth hormone within biodegradable polyester microspheres: protein aggregation stability and incomplete release mechanism. Biotechnol Bioeng 1999;65:659–667
   PubMed Web of Science ®Google Scholar
• Sturesson C, Carlfors J. Incorporation of protein in PLG-microspheres with retention of bioactivity. J Control Release 2000;67:171–178
   PubMed Web of Science ®Google Scholar
• Yang Y-Y, Chia H-H, Chung T-S. Effect of preparation temperature on the characteristics and release profiles of PLGA microspheres containing protein fabricated by double-emulsion solvent extraction/evaporation method. J Control Release 2000;69:81–96
   PubMed Web of Science ®Google Scholar
• Kim HK, Park TG. Comparative study on sustained release of human growth hormone from semi-crystalline poly(L-lactic acid) and amorphous poly(D,L-lactic-co-glycolic acid) microspheres: morphological effect on protein release. J Control Release 2004;98:115–125
   PubMed Web of Science ®Google Scholar
• Takada S, Yamagata Y, Misaki M, et al. Sustained release of human growth hormone from microcapsules prepared by a solvent evaporation technique. J Control Release 2003;88:229–242
   PubMed Web of Science ®Google Scholar
• Hasan AS, Socha M, Lamprecht A, et al. Effect of the microencapsulation of nanoparticles on the reduction of burst release. Int J Pharm 2007;344:53–61
   PubMed Web of Science ®Google Scholar
• Gander B, Wehrli E, Alder R, Merkle H. Quality improvement of spray-dried, protein-loaded D, L-PLA microspheres by appropriate polymer solvent selection. J Microencapsul 1995;12:83–97
   PubMed Web of Science ®Google Scholar
• Kim HK, Chung HJ, Park TG. Biodegradable polymeric microspheres with “open/closed” pores for sustained release of human growth hormone. J Control Release 2006;112:167–174
   PubMed Web of Science ®Google Scholar
• Yuan W, Wu F, Guo M, Jin T. Development of protein delivery microsphere system by a novel S/O/O/W multi-emulsion. Eur J Pharm Sci 2009;36:212–218
   PubMed Web of Science ®Google Scholar
• Cleland JL, Jones AJS. Stable formulations of recombinant human growth hormone and interfron gama for microencapsulation in biodegradable microspheres. Pharm Res 1996;13:1464–1475
   PubMed Web of Science ®Google Scholar
• Kwak HH, Shim WS, Choi MK, et al. Development of a sustained-release recombinant human growth hormone formulation. J Control Release 2009;137:160–165
   PubMed Web of Science ®Google Scholar
• Sah H. Stabilization of proteins against methylene chloride/water interfaceinduced denaturation and aggregation. J Control Release 1999;58:143–151
   PubMed Web of Science ®Google Scholar
• Bilati U, Allémann E, Doelker E. Nanoprecipitation versus emulsion-based techniques for the encapsulation of proteins into biodegradable nanoparticles and process-related stability issues. AAPS PharmSciTech 2005;6:594–604
   PubMed Web of Science ®Google Scholar
• Jin T, Zhu J, Wu F, et al. Preparing polymer-based sustained-release systems without exposing proteins to water–oil or water–air interfaces and cross-linking reagents. J Control Release 2008;128:50–59
   PubMed Web of Science ®Google Scholar
• Mok H, Park TG. Water-free microencapsulation of proteins within PLGA microparticles by spray drying using PEG-assisted protein solubilization technique in organic solvent. Eur J Pharm Biopharm 2008;70:137–144
   PubMed Web of Science ®Google Scholar
• Brodbeck KJ, Pushpala S, McHugh AJ. Sustained release of human growth hormone from PLGA solution depot. Pharm Res 1999;16:1825–1829
   PubMed Web of Science ®Google Scholar
• Duncan G, Jess TJ, Mohamed F, et al. The influence of protein solubilisation, conformation and size on the burst release from poly (lactide-co-glycolide) microspheres. J Control Release 2005;110:34–48
   PubMed Web of Science ®Google Scholar
• Govardhan C, Khalaf N, Jung CW, et al. Novel long-acting crystal formulation of human growth hormone. Pharm Res 2005;22:1461–1470
   PubMed Web of Science ®Google Scholar
• Xin-yu J, Chun-shan Z, Ke-wen T. Preparation of PLA and PLGA nanoparticles by binary organic solvent diffusion method. J Cent South Univ Technol 2003;10:202–206
   Web of Science ®Google Scholar
• Lamprecht A, Ubrich N, Pérez MH, et al. Influences of process parameters on nanoparticle preparation performed by a double emulsion pressure homogenization technique. Int J Pharm 2000;196:177–182
   PubMed Web of Science ®Google Scholar
• Lee WL, Hong M, Widjaja E, Loo SCJ. Formation and degradation of biodegradable triple-layered microparticles. Macromol Rapid Commun 2010;31:1193–1200
   PubMed Web of Science ®Google Scholar
• Misak HE, Asmatulu R, Gopu JS, et al. Albumin-based nanocomposite spheres for advanced drug delivery systems. Biotechnol J 2014;9:163–170
   PubMed Web of Science ®Google Scholar
• Berkland C, Pollauf E, Pack DW, Kim KK. Uniform double-walled polymer microspheres of controllable shell thickness. J Control Release 2004;96:101–111
   PubMed Web of Science ®Google Scholar
• Lee C, Choi JS, Kim I, et al. Long-acting inhalable chitosan-coated poly(lactic-co-glycolic acid) nanoparticles containing hydrophobically modified exendin-4 for treating type 2 diabetes. Int J Nanomed 2013;8:2975–2983
   PubMed Web of Science ®Google Scholar
• Rosa GD, Larobina D, Rotonda MIL, et al. How cyclodextrin incorporation affects the properties of protein-loaded PLGA-based microspheres: the case of insulin/hydroxypropyl-beta cyclodextrin system. J Control Release 2005;102:71–83
   PubMed Web of Science ®Google Scholar
• Fresta M, Puglisi G, Giammona G, et al. Pefloxacine mesilate-and ofloxacin-loaded polyethylcyanoacrylate nanoparticles: characterization of the colloidal drug carrier formulation. J Pharm Sci 1995;84:895–902
   PubMed Web of Science ®Google Scholar
• Cleland JL, Mac A, Boyd B, et al. The stability of recombinant human growth hormone in poly(lactic-co-glycolic acid) (PLGA) microspheres. Pharm Res 1997;14:420–425
   PubMed Web of Science ®Google Scholar
• Schoubben A, Blasi P, Giovagnoli S, et al. Novel composite microparticles for protein stabilization and delivery. Eur J Pharm Sci 2009;36:226–234
   PubMed Web of Science ®Google Scholar
• Gaudana R, Khurana V, Parenky A, Mitra AK. Encapsulation of protein-polysaccharide HIP complex in polymeric nanoparticles. J Drug Deliv 2011;2011:1–7
   Google Scholar