Application of Size Exclusion Chromatography in the Development and Characterization of Nanoparticulate Drug Delivery Systems

References

• Wehr , T. and Rodriguez‐Diaz , R. 2005 . “ Use of size exclusion chromatography in biopharmaceutical development ” . In Analytical Techniques for Biopharmaceutical Development Edited by: Rodriguez‐Diaz , R. , Wehr , T. and Tuck , S. 95 – 112 . New York : Marcel Dekker .
   Google Scholar
• 2006 . The United States Pharmacopeia XXIX Rockville, MD : United States Pharmacopeial Convention Inc. .
   Google Scholar
• Barth , H. , Boyes , B. E. and Jackson , C. 1998 . Size exclusion chromatography and related separation techniques . Anal. Chem. , 70 ( 12 ) : 251R – 278R .
   Web of Science ®Google Scholar
• National Nanotechnology Initiative . What is Nanotechnology? . <http://www.nano.gov/html/facts/whatIsNano.html> Accessed: 01.08.2007.
   Google Scholar
• Shah , P. 2006 . Use of nanotechnologies for drug delivery . MRS Bull. , 31 ( 11 ) : 894 – 899 .
   Web of Science ®Google Scholar
• Yang , H. and Kao , W. J. 2006 . Dendrimers for pharmaceutical and biomedical applications . J. Biomater. Sci., Polym. Ed. , 17 ( 1–2 ) : 3 – 19 .
   PubMed Web of Science ®Google Scholar
• Chan , Y. , Bulmus , V. , Zareie , M. H. , Byrne , F. L. , Barner , L. and Kavallaris , M. 2006 . Acid‐cleavable polymeric core‐shell particles for delivery of hydrophobic drugs . J. Controlled Rel. , 115 ( 2 ) : 197 – 207 .
   PubMed Web of Science ®Google Scholar
• Sukhorukov , G. B. , Rogach , A. L. , Zebli , B. , Liedl , T. , Skirtach , A. G. , Koehler , K. , Antipov , A. A. , Gaponik , N. , Susha , A. S. , Winterhalter , M. and Parak , W. J. 2005 . Nanoengineered polymer capsules: Tools for detection controlled delivery, site‐specific manipulation . Small. , 1 ( 2 ) : 194 – 200 .
   PubMed Web of Science ®Google Scholar
• Osada , K. and Kataoka , K. 2006 . Drug and gene delivery based on supramolecular assembly of PEG‐polypeptide hybrid block copolymers . Adv. Polym. Sci. , 202 : 113 – 153 . Peptide Hybrid Polymers
   Web of Science ®Google Scholar
• Jose Alonso , M. 2004 . Nanomedicines for overcoming biological barriers . Biomed. Pharmacother. , 58 ( 3 ) : 168 – 172 .
   PubMed Web of Science ®Google Scholar
• Shekunov , B. Y. , Chattopadhyay , P. , Seitzinger , J. and Huff , R. 2006 . Nanoparticles of poorly water‐soluble drugs prepared by supercritical fluid extraction of emulsions . Pharm. Res. , 23 ( 1 ) : 196 – 204 .
   PubMed Web of Science ®Google Scholar
• Hasirci , V. , Vrana , E. , Zorlutuna , P. , Ndreu , A. , Yilgor , P. , Basmanav , F. B. and Aydin , E. 2006 . Nanobiomaterials: A review of the existing science and technology, and new approaches . J. Biomater. Sci. Polym. Ed. , 17 ( 11 ) : 1241 – 1268 .
   PubMed Web of Science ®Google Scholar
• Meehan , E. 2006 . Flow injection analysis of polymeric excipients used in pharmaceutical formulations . Int. J. Polym. Anal. Charact. , 11 ( 1 ) : 35 – 45 .
   Web of Science ®Google Scholar
• Wyatt , P. J. 1993 . Light scattering and the absolute characterization of macromolecules . Anal. Chim. Acta. , 272 ( 1 ) : 1 – 40 .
   Web of Science ®Google Scholar
• Roduner , E. 2006 . Size matters: Why nanomaterials are different . Chem. Soc. Rev. , 35 ( 7 ) : 583 – 592 .
   PubMed Web of Science ®Google Scholar
• Baehr , M. , Führer , C. and Puls , J. 1991 . Molecular weight distribution, hemicellulose content and batch conformity of pharmaceutical cellulose powders . Eur. J. Pharm. Biopharm. , 37 ( 3 ) : 136 – 141 .
   Web of Science ®Google Scholar
• Mun , S. , Xie , Y. and Wang , N.‐H. L. 2005 . Strategies to control batch integrity in size‐exclusion simulated moving bed chromatography . Ind. Eng. Chem. Res. , 44 ( 9 ) : 3268 – 3283 .
   Web of Science ®Google Scholar
• Takakura , Y. , Mahato , R. I. , Vishikawa , M. and Hashida , M. 1996 . Control of pharmacokinetic profiles of drug‐macromolecule conjugates . Adv. Drug Delivery Rev. , 19 ( 3 ) : 377 – 399 .
   Web of Science ®Google Scholar
• White , G. W. , Katone , T. and Zodda , J. P. 1999 . The use of high‐performance size exclusion chromatography (HPSEC) as a molecular weight screening technique for polygalactouronic acid for use in pharmaceutical applications . J. Pharm. Biomed. Anal. , 20 ( 6 ) : 905 – 912 .
   PubMed Web of Science ®Google Scholar
• Liu , X. M. , Maziarz , E. P. and Heiler , D. J. 2004 . Characterization of implant device materials using size‐exclusion chromatography with mass spectrometry and with triple detection . J. Chromatogr. A , 1034 ( 1–2 ) : 125 – 131 .
   PubMed Web of Science ®Google Scholar
• Gref , R. A. , Setzkom , E. A. and Leslie , W. D. 1965 . A colorimetric method for the determination of parts/million of nonionic surfactants . J. Am. Oil Chem. Soc. , 42 ( 3 ) : 151 – 164 .
   Web of Science ®Google Scholar
• Tercyak , A. M. and Felker , T. E. 1990 . Colorimetric assay for pluronic F‐68 as measured in ioslated rat liver perfusion systems . Anal. Biochem. , 187 ( 1 ) : 54 – 55 .
   PubMed Web of Science ®Google Scholar
• Li , C. , Palmer , W. K. and Johnston , T. P. 1996 . Disposition of poloxamer 407 in rats following a single intraperitoneal injection assessed using a simplified colorimetric assay . J. Pharm. Biomed. Anal. , 14 ( 5 ) : 659 – 665 .
   PubMed Web of Science ®Google Scholar
• Ghebeh , H. , Handa‐Corrigan , A. and Butler , M. 1998 . Development of an assay for the measurement of the surfactant pluronic F‐68 in mammalian cell culture medium . 262 ( 1 ) : 39 – 44 .
   Google Scholar
• Mao , Y. , Thompson , M. J. , Wang , Q. and Tsai , E. W. 2004 . Quantitiation of polxamers in pharmaceutical formulations using size exclusion chromatogrpahy and colorimetric methods . J. Pharm. Biomed. Anal. , 35 ( 5 ) : 1127 – 1142 .
   PubMed Web of Science ®Google Scholar
• Luangtana‐Anan , M. , Opanasopit , P. , Ngawhirunpat , T. , Nunthanid , J. , Sriamornsak , P. , Limmatvapirat , S. and Lim , L. Y. 2005 . Effect of chitosan salts molecular weight on a nanoparticulate carrier for therapeutic protein . Pharm. Dev. Technol. , 10 ( 2 ) : 189 – 196 .
   PubMed Web of Science ®Google Scholar
• Farrugia , C. A. and Groves , M. J. 1999 . Gelatin behavior in dilute aqueous solution: Designing a nanoparticulate fomulation . J. Pharm. Pharmacol. , 51 ( 6 ) : 643 – 649 .
   PubMed Web of Science ®Google Scholar
• Mitra , A. and Lin , S. 2003 . Effect of surfactant on fabrication and characterization of paclitaxel‐loaded polybutylcyanoacrylate nanoparticulate delivery systems . J. Pharm. Pharmacol. , 55 ( 7 ) : 895 – 902 .
   PubMed Web of Science ®Google Scholar
• Kallinteri , P. , Higgins , S. , Hutcheon , A. C. , St. Pourcain , C. B. and Garnett , M. C. 2005 . Novel functionalized biodegradable polymers for nanoparticle drug delivery systems . Biomacromolecules , 6 ( 4 ) : 1885 – 1894 .
   PubMed Web of Science ®Google Scholar
• Peng , T. , Su , J. , Cheng , S.‐X. and Zhou , R.‐X. 2006 . Poly‐α,β‐(N‐(2‐hydroxyethyl)‐l‐aspartamide)‐g‐poly(1,3‐trimethylene carbonate) amphiphilic graft co‐polymer as a potential drug carrier . J. Biomater. Sci. Polym. Ed. , 17 ( 8 ) : 941 – 951 .
   PubMed Web of Science ®Google Scholar
• Sasatsu , M. , Onishi , H. and Machida , Y. 2005 . Preparation of a PLA‐PEG block copolymer using a PLA derivative with a formyl terminal group and its application to nanoparticulate formulation . Int. J. Pharm. , 294 ( 1–2 ) : 233 – 245 .
   PubMedGoogle Scholar
• Fee , C. J. 2003 . Size‐exclusion reaction chromatography (SERC): A new technique for protein PEGylation . Biotechnol. Bioeng. , 82 ( 2 ) : 200 – 206 .
   PubMed Web of Science ®Google Scholar
• Wabnitz , P. A. and Loo , J. A. 2002 . Drug screening of pharmaceutical drug discovery compounds by micro‐size exclusion chromatography . Rapid Commun. Mass Spectrom. , 16 ( 2 ) : 85 – 91 .
   PubMed Web of Science ®Google Scholar
• Mendichi , R. , Rizzo , V. , Gigli , M. and Giacometti Schieroni , A. 1998 . Dilute properties of a polymeric antitumor drug carrier by size‐exclusion chromatography, viscometry and light scattering . J. Appl. Polym Sci. , 70 ( 2 ) : 329 – 338 .
   Web of Science ®Google Scholar
• Mendichi , R. , Rizzo , V. , Gigli , M. and Giacometti Schieroni , A. 2002 . Fractionation and characterization of a conjugate between a polymeric drug‐carrier and the antitumor drug camptothecin . Bioconjugate. Chem. , 13 ( 6 ) : 1253 – 1258 .
   PubMed Web of Science ®Google Scholar
• Gabrielle‐Madelmont , C. , Lesieur , S. and Ollivon , M. 2003 . Characterization of loaded liposomes by size exclusion chromatography . J. Biochem. Biophys. Methods , 56 ( 1–3 ) : 189 – 217 .
   PubMedGoogle Scholar
• Lesieur , S. , Gabrielle‐Madelmont , C. , Paternostre , M. and Ollivon , M. 1993 . Study of size distribution and stability of liposomes by high performance gel exclusion chromatography . Chem. Phys. Lipids , 64 ( 1–3 ) : 57 – 82 .
   Web of Science ®Google Scholar
• Reber , N. , Spohr , R. , Wolf , A. , Omichi , H. , Tamada , M. and Yoshida , M. 1998 . Closure characteristics of a thermally responsive single ion‐track pore determined by size exclusion method . J. Membr. Sci. , 140 ( 2 ) : 275 – 281 .
   Web of Science ®Google Scholar
• Zhu , L. , Seburg , R. A. and Tsai , E. W. 2006 . Determination of surface‐bound hydroxypropylcellulose (HPC) on drug particles in colloidal dispersions using size exclusion chromatography: A comparison of ELS and RI detection . J. Pharm. Biomed. Anal. , 40 ( 5 ) : 1089 – 1096 .
   PubMed Web of Science ®Google Scholar
• Lemarchand , C. , Gref , R. , Lesieur , S. , Hommel , H. , Vacher , B. , Besheer , A. , Maeder , K. and Couvreur , P. 2005 . Physico‐chemical characterization of polysaccharide‐coated nanoparticles . J. Controlled Rel. , 108 ( 1 ) : 97 – 111 .
   PubMed Web of Science ®Google Scholar
• Juliano , R. L. 1988 . Factors affecting the clearance kinetics and tissue distribution of liposomes, microspheres and emulsion . Adv. Drug Del. Rev. , 2 ( 1 ) : 31 – 54 .
   Google Scholar
• Huve , P. , Verrecchia , T. , Bazile , D. and Couvreur , P. 1994 . Simultaneous use of size‐exclusion chromatography and photon correlation spectroscopy for the characterization of Poly(Lactic Acid) nanoparticles . J. Chromatogr. A , 675 ( 1–2 ) : 129 – 139 .
   Web of Science ®Google Scholar
• Steinhauser , I. , Spänkuchm , B. , Strebhardt , K. and Langer , K. 2006 . Trastuzumab‐modified nanoparticles: Optimisation of preparation and uptake in cancer cells . Biomaterials , 27 ( 28 ) : 4975 – 4983 .
   PubMed Web of Science ®Google Scholar
• Bazille , D. V. , Ropert , C. , Huve , P. , Verrecchia , T. , Marland , M. , Frydman , M. , Veillard , M. and Spenleuhauer , G. 1992 . Body distribution of fully biodegradable [14C]‐Poly(d l‐lactic acid) nanoparticles coated with albumin after parenteral administration to rats . Biomaterials , 13 ( 15 ) : 1093 – 1102 .
   PubMed Web of Science ®Google Scholar
• Seijo , B. , Fattal , E. , Roblot‐Treupel , L. and Couvreur , P. 1990 . Design of nanoparticles of less than 50 nm diameter: Preparation, characterization and drug loading . Int. J. Pharm. , 62 ( 1 ) : 1 – 7 .
   Web of Science ®Google Scholar
• Nguyen , L. T. , Wienceck , J. M. and Kirsch , L. E. 2003 . Characterization methods for the physical stability of biopharmaceuticals . PDA J. Pharm. Sci. Technol. , 57
   PubMedGoogle Scholar
• Jani , P. , Halbert , G. W. , Langridge , J. and Florence , A. T. 1990 . Nanoparticles uptake by rat gastrointestinal mucosa: Quantitation and particle size dependency . J. Pharm. Pharmacol. , 42 ( 12 ) : 821 – 826 .
   PubMed Web of Science ®Google Scholar
• Aprahamian , M. , Michel , C. , Humbert , W. , Devissaguet , J.‐P. and Damge , C. 1987 . Transmucosal passage of polyalkylcyanoacrylate nanocapsules as a new drug carrier in the small intestine . Biol. Cell. , 61 ( 1–2 ) : 69 – 76 .
   PubMed Web of Science ®Google Scholar
• Landry , F. B. , Bazille , D. V. , Spenlehauer , G. , Veillard , M. and Kreuter , J. 1996 . Influence of coating agents on the degradation of poly(d l,‐lactic acid) nanoparticles in model digestive fluids (USP XXII) . S.T.P. Pharm. Sci. , 6 ( 3 ) : 195 – 202 .
   Web of Science ®Google Scholar
• Gref , R. , Quellec , P. , Sanchez , A. , Calvo , P. , Dellacherie , E. and Alonso , M. J. 2001 . Development and characterization of CyA‐loaded poly(lactic acid)‐poly(ethylene glycol)peg micro‐ and nanoparticles. comparison with conventional PLA particulate carriers . Eur. J. Pharm. Biopharm. , 51 ( 2 ) : 111 – 118 .
   PubMed Web of Science ®Google Scholar
• Ismailos , G. , Reppas , C. , Dressman , J. B. and Macheras , P. 1991 . Unusual solubility behavior of cyclosporin A in aqueous media . J. Pharm. Pharmacol. , 43 ( 4 ) : 287 – 289 .
   PubMed Web of Science ®Google Scholar
• Taylor , N. E. , Mark , A. E. , Vallat , P. , Brunne , R. M. , Testa , B. and Van Gunteren , W. F. 1993 . Solvent dependent conformation and hydrogen bonding capacity of cyclosporin A: Evidence from partition coefficinet and molecular dynamics simulations . J. Med. Chem. , 36 ( 24 ) : 3757 – 3764 .
   PubMed Web of Science ®Google Scholar
• Sautel , M. and Kristulović , A. M. 2005 . Pharmaceutical analysis beyond compendial requirements . J. Sep. Sci. , 28 ( 13 ) : 1529 – 1538 .
   PubMed Web of Science ®Google Scholar
• Romero , I. G. and Pasch , H. 2005 . High‐throughput screening of the chemical composition distribution of random styrene‐butyl acrylate copolymers . e‐Polymers , 42 ( 1 ) : 1 – 13 .
   Google Scholar
• Renn , C. N. and Synovec , R. E. 1988 . Improved detection in superspeed size‐exclusion chromatography by reducing on‐column dilution and detector noise . Anal. Chem. , 60 ( 17 ) : 1829 – 1832 .
   Web of Science ®Google Scholar