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Original Research

Biophysical evaluation of aminoclay as an effective protectant for protein stabilization during freeze-drying and storage

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Pages 6609-6619 | Published online: 12 Dec 2016

References

  • SchellekensHHow to Predict and Prevent the Immunogenicity of therapeutic ProteinsAmsterdam, RadarwegElsevier B.V.2008
  • ManningMCPatelKBorchardtRTStability of protein pharmaceuticalsPharm Res19896119039182687836
  • WangWLyophilization and development of solid protein pharmaceuticalsInt J Pharm20002031–216010967427
  • ChiEYKrishnanSRandolphTWCarpenterJFPhysical stability of proteins in aqueous solution: mechanism and driving forces in nonnative protein aggregationPharm Res20032091325133614567625
  • GuptaPHallCKVoeglerACEffect of denaturant and protein concentrations upon protein refolding and aggregation: a simple lattice modelProtein Sci1998712264226529865959
  • HillJJShalaevEYZografiGThermodynamic and dynamic factors involved in the stability of native protein structure in amorphous solids in relation to levels of hydrationJ Pharm Sci20059481636166715965985
  • TownsJKMoisture content in proteins: its effects and measurementJ Chromatogr A199570511151277620565
  • KettVMcMahonDWardKFreeze-drying of protein pharmaceuticals – the application of thermal analysisCryo Letters200425638940415660166
  • LimJYKimNALimDGProcess cycle development of freeze drying for therapeutic proteins with stability evaluationJ Pharm Investig2016466519536
  • IzutsuKKadoyaSYomotaCKawanishiTYonemochiETeradaKStabilization of protein structure in freeze-dried amorphous organic acid buffer saltsChem Pharm Bull200957111231123619881273
  • ArakawaTPrestrelskiSJKenneyWCCarpenterJFFactors affecting short-term and long-term stabilities of proteinsAdv Drug Deliv Rev2001461–330732611259845
  • PrestrelskiSJTedeschiNArakawaTCarpenterJFDehydration-induced conformational transitions in proteins and their inhibition by stabilizersBiophys J19936526616717693001
  • CroweJHCarpenterJFCroweLMThe role of vitrification in anhydrobiosisAnnu Rev Physiol199860731039558455
  • OhtakeSKitaYArakawaTInteractions of formulation excipients with proteins in solution and in the dried stateAdv Drug Deliv Rev201163131053107321756953
  • CroweJHCarpenterJFCroweLMAre freezing and dehydration similar stress vectors? A comparison of modes of interaction of stabilizing solutes with biomoleculesCryobiology1990273219231
  • CarpenterJFPikalMJChangBSRational design of stable lyophilized protein formulations: some practical advicePharm Res19971489699759279875
  • CarpenterJFCroweJHArakawaTComparison of solute-induced protein stabilization in aqueous solution and in the frozen and dried statesJ Dairy Sci1990731236273636
  • KreilgaardLFrokjaerSFlinkJMRandolphTWCarpenterJFEffects of additives on the stability of humicola lanuginosa lipase during freeze-drying and storage in the dried solidJ Pharm Sci199988328129010052984
  • SampedroJGGuerraGPardoJ-PTrehalose-mediated protection of the plasma Membrane H-ATPase from Kluyveromyces lactis during freeze-drying and rehydrationCryobiology19983721311389769163
  • SunWQDavidsonPProtein inactivation in amorphous sucrose and trehalose matrices: effects of phase separation and crystallizationBiochim Biophys Acta1998142512352449813347
  • te BooyMPWMde RuiterRAde MeereALJEvaluation of the physical stability of freeze-dried sucrose-containing formulation by differential scanning calorimetryPharm Res1992911091141589394
  • LeblancYBihoreauNJubeMAndreMHTellierZChevreuxGGlycation of polyclonal IgGs: effect of sugar excipients during stability studiesEur J Pharm Sci2016102185190
  • FischerSHoernschemeyerJMahlerHCGlycation during storage and administration of monoclonal antibody formulationsEur J Pharm Sci20087014250
  • KhanTAAmaniSNaeemAGlycation promotes the formation of genotoxic aggregates in glucose oxidaseAmino Acids20124331311132222198547
  • SinghRBardenAMoriTBeilinLAdvanced glycation end-products: a reviewDiabetologia200144212914611270668
  • BanksDDHamblyDMScavezzeJLSiskaCCStackhouseNLGadgilHSThe effect of sucrose hydrolysis on the stability of protein therapeutics during accelerated formulation studiesJ Pharm Sci200998124501451019388069
  • PatilAJMannSSelf-assembly of bio–inorganic nanohybrids using organoclay building blocksJ Mater Chem200818394605
  • YangLShaoYHanHKImproved pH-dependent drug release and oral exposure of telmisartan, a poorly soluble drug through the formation of drug–aminoclay complexInt J Pharm20144711–225826324834880
  • YangLShaoYHanHKAminoclay–lipid hybrid composite as a novel drug carrier of fenofibrate for the enhancement of drug release and oral absorptionInt J Nanomedicine2016111067107627042061
  • PatilAJLiMDujardinEMannSNovel bioinorganic nanostructures based on mesolamellar intercalation or single-molecule wrapping of DNA using organoclay building blocksNano Lett2007792660266517705435
  • PatilAJMuthusamyEMannSFabrication of functional protein–organoclay lamellar nanocomposites by biomolecule-induced assembly of exfoliated aminopropyl-functionalized magnesium phyllosilicatesJ Mater Chem20051535–3638383843
  • PatilAJMuthusamyEMannSSynthesis and self-assembly of organoclay-wrapped biomoleculesAngew Chem Int Ed2004433749284933
  • HanHKLeeYCLeeMYPatilAJShinHJMagnesium and calcium organophyllosilicates: synthesis and in vitro cytotoxicity studyACS Appl Mater Interfaces2011372564257221609130
  • YangLLeeY-CKimMIBiodistribution and clearance of aminoclay nanoparticles: implication for in vivo applicability as a tailor-made drug delivery carrierJ Mater Chem B201424375677574
  • LewisLMJohnsonREOldroydMECharacterizing the freeze-drying behavior of model protein formulationsAAPS PharmSciTech20101141580159021057905
  • KentwrightAThompsonMRHydrodynamic structure of bovine serum albumin determined by transient electric birefringenceBiophys J1975152 pt 11371411167468
  • ChatterjeeKShalaevEYSuryanarayananRPartially crystalline systems in lyophilization: II. Withstanding collapse at high primary drying temperatures and impact on protein activity recoveryJ Pharm Sci200594480982015729705
  • WangWProtein aggregation and its inhibition in biopharmaceuticsInt J Pharm20052891–213015652195
  • AllisonSDDongACarpenterJFCounteracting effects of thiocyanate and sucrose on chymotrypsinogen secondary structure and aggregation during freezing, drying, and rehydrationBiophys J1996714202220328889176
  • BylerDMSusiHApplication of computerized infrared and Raman spectroscopy to conformation studies of casein and other food proteinsJ Ind Microbiol199837388
  • FarnsworthPNGroth–VasselliBGreenfieldNJEffects of temperature and concentration on bovine lens h-crystallin secondary structure: a circular dichroism spectroscopic studyInt J Biol Macromol19972042832919253648
  • SunCYangJWuXHuangXWangFLiuSUnfolding and refolding of bovine serum albumin induced by cetylpyridinium bromideBiophys J20058853518352415731386
  • FontePSoaresSSousaFStability study perspective of the effect of freeze-drying using cryoprotectants on the structure of insulin loaded into PLGA nanoparticlesBiomacromolecules201415103753376525180545
  • LibrizziFVitranoECordoneLDehydration and crystallization of trehalose and sucrose glasses containing carbonmonoxy-myoglobinBiophys J19997652727273410233087
  • CroweLMReidDSCroweJHIs trehalose special for preserving dry biomaterials?Biophys J1996714208720938889183