Impact of Controlled Ice Nucleation and Lyoprotectants on Nanoparticle Stability during Freeze-drying and upon Storage.
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[1] Alina A. Alexeenko,et al. Best Practices and Guidelines (2022) for Scale-up and Technology Transfer in Freeze Drying Based on Case Studies. Part 2: Past Practices, Current Best Practices, and Recommendations , 2023, AAPS PharmSciTech.
[2] Erkan Senses,et al. Liposomes Under Shear: Structure, Dynamics, and Drug Delivery Applications , 2023, Advanced NanoBiomed Research.
[3] J. Heyes,et al. Lyophilization provides long-term stability for a lipid nanoparticle-formulated, nucleoside-modified mRNA vaccine , 2022, Molecular Therapy.
[4] R. Bogner,et al. Impact of Formulation on the Quality and Stability of Freeze-dried Nanoparticles. , 2021, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.
[5] E. Egito,et al. Unveiling the Amphotericin B degradation pathway and its kinetics in lipid-based solutions. , 2020, Journal of pharmaceutical sciences.
[6] M. Pikal,et al. Correction to: Evaluation of Predictors of Protein Relative Stability Obtained by \Solid-State Hydrogen/Deuterium Exchange Monitored by FTIR , 2020, Pharmaceutical Research.
[7] David M. Wirth,et al. COVID-19 vaccine development and a potential nanomaterial path forward , 2020, Nature Nanotechnology.
[8] J. Mascola,et al. An mRNA Vaccine against SARS-CoV-2 — Preliminary Report , 2020, The New England journal of medicine.
[9] M. Pikal,et al. Stability of Freeze-Dried Protein Formulations: Contributions of Ice Nucleation Temperature and Residence Time in the Freeze-Concentrate. , 2020, Journal of pharmaceutical sciences.
[10] Raj Suryanarayanan,et al. Mechanisms by which crystalline mannitol improves the reconstitution time of high concentration lyophilized protein formulations , 2018, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.
[11] M. Pikal,et al. Impact of Natural Variations in Freeze-Drying Parameters on Product Temperature History: Application of Quasi Steady-State Heat and Mass Transfer and Simple Statistics , 2018, AAPS PharmSciTech.
[12] Francesca Selmin,et al. Lyophilization of Liposomal Formulations: Still Necessary, Still Challenging , 2018, Pharmaceutics.
[13] G. Ritthidej,et al. Amphotericin B-loaded solid lipid nanoparticles (SLNs) and nanostructured lipid carrier (NLCs): effect of drug loading and biopharmaceutical characterizations , 2018, Drug development and industrial pharmacy.
[14] M. Pikal,et al. Effect of Controlled Ice Nucleation on Stability of Lactate Dehydrogenase During Freeze-Drying. , 2017, Journal of pharmaceutical sciences.
[15] F. Dosio,et al. Nanostructured delivery systems with improved leishmanicidal activity: a critical review , 2017, International journal of nanomedicine.
[16] Gerhard Winter,et al. Lyophilized Drug Product Cake Appearance: What Is Acceptable? , 2017, Journal of pharmaceutical sciences.
[17] W. Hinrichs,et al. How sugars protect proteins in the solid state and during drying (review): Mechanisms of stabilization in relation to stress conditions , 2017, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.
[18] S. Rigby,et al. Insights into the influence of the cooling profile on the reconstitution times of amorphous lyophilized protein formulations. , 2015, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.
[19] Bruno Sarmento,et al. Stability study perspective of the effect of freeze-drying using cryoprotectants on the structure of insulin loaded into PLGA nanoparticles. , 2014, Biomacromolecules.
[20] M. Pikal,et al. Protein quantity on the air-solid interface determines degradation rates of human growth hormone in lyophilized samples. , 2014, Journal of pharmaceutical sciences.
[21] Gerhard Winter,et al. Can controlled ice nucleation improve freeze-drying of highly-concentrated protein formulations? , 2013, Journal of pharmaceutical sciences.
[22] M. Pikal,et al. Investigations on polyplex stability during the freezing step of lyophilization using controlled ice nucleation--the importance of residence time in the low-viscosity fluid state. , 2013, Journal of pharmaceutical sciences.
[23] S. Ghanbarzadeh,et al. The effects of lyophilization on the physico-chemical stability of sirolimus liposomes. , 2013, Advanced pharmaceutical bulletin.
[24] K. Imamura,et al. Impact of compression, physical aging, and freezing rate on the crystallization characteristics of an amorphous sugar matrix , 2012 .
[25] Wolfgang Friess,et al. The freezing step in lyophilization: physico-chemical fundamentals, freezing methods and consequences on process performance and quality attributes of biopharmaceuticals. , 2011, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.
[26] S. Inghelbrecht,et al. Freeze-drying of nanosuspensions, 1: freezing rate versus formulation design as critical factors to preserve the original particle size distribution. , 2011, Journal of pharmaceutical sciences.
[27] Kenneth L. Kearns,et al. Glasses crystallize rapidly at free surfaces by growing crystals upward , 2011, Proceedings of the National Academy of Sciences.
[28] H. M. Nielsen,et al. Stabilization of liposomes during drying , 2011, Expert opinion on drug delivery.
[29] I. Trelea,et al. Effect of controlled ice nucleation on primary drying stage and protein recovery in vials cooled in a modified freeze-dryer. , 2009, Journal of biomechanical engineering.
[30] Reinhard Lipowsky,et al. Tension-induced vesicle fusion: pathways and pore dynamics. , 2008, Soft matter.
[31] M. Pikal,et al. Prediction of the onset of crystallization of amorphous sucrose below the calorimetric glass transition temperature from correlations with mobility. , 2007, Journal of pharmaceutical sciences.
[32] S. Stainmesse,et al. Freeze-drying of nanoparticles: formulation, process and storage considerations. , 2006, Advanced drug delivery reviews.
[33] Lian Yu,et al. Surface Crystallization of Indomethacin Below Tg , 2006, Pharmaceutical Research.
[34] Toru Suzuki,et al. Ice Recrystallization in Sucrose Solutions Stored in a Temperature Range of -21°C to -50°C , 2005 .
[35] T. Labuza,et al. Glass Transition and Crystallization of Amorphous Trehalose-sucrose Mixtures , 2005 .
[36] Michael J. Pikal,et al. Heat and mass transfer scale-up issues during freeze drying: II. Control and characterization of the degree of supercooling , 2004, AAPS PharmSciTech.
[37] I. Katkov,et al. Prediction of the glass transition temperature of water solutions: comparison of different models. , 2004, Cryobiology.
[38] J. Carpenter,et al. The ice nucleation temperature determines the primary drying rate of lyophilization for samples frozen on a temperature-controlled shelf. , 2001, Journal of pharmaceutical sciences.
[39] S. Varia,et al. Moisture sorption behavior of selected bulking agents used in lyophilized products. , 2000, PDA journal of pharmaceutical science and technology.
[40] E. Topp,et al. Solid-state chemical stability of proteins and peptides. , 1999, Journal of pharmaceutical sciences.
[41] F. Princivalle,et al. Polymorphic Amorphous and Crystalline Forms of Trehalose , 1998 .
[42] J H Crowe,et al. Trehalose and sucrose protect both membranes and proteins in intact bacteria during drying , 1995, Applied and environmental microbiology.
[43] George Zografi,et al. Non-Isothermal and Isothermal Crystallization of Sucrose from the Amorphous State , 1994, Pharmaceutical Research.
[44] Michael J. Pikal,et al. The secondary drying stage of freeze drying: drying kinetics as a function of temperature and chamber pressure☆ , 1990 .
[45] M. Pikal,et al. Process control in freeze drying: determination of the end point of sublimation drying by an electronic moisture sensor. , 1989, Journal of parenteral science and technology : a publication of the Parenteral Drug Association.
[46] Geoffrey Lee,et al. Measurement of shrinkage and cracking in lyophilized amorphous cakes. Part I: final-product assessment. , 2015, Journal of pharmaceutical sciences.
[47] C. Yomota,et al. Thermotropic phase behavior of hydrogenated soybean phosphatidylcholine-cholesterol binary liposome membrane. , 2014, Chemical & pharmaceutical bulletin.
[48] K. Ward,et al. Applications of Headspace Moisture Analysis for Investigating the Water Dynamics within a Sealed Vial Containing Freeze-dried Material. , 2011, PDA journal of pharmaceutical science and technology.
[49] N. Rajagopalan,et al. Effect of stopper processing conditions on moisture content and ramifications for lyophilized products: comparison of "low" and "high" moisture uptake stoppers. , 2007, PDA journal of pharmaceutical science and technology.
[50] E. C. van Winden. Freeze-drying of liposomes: theory and practice. , 2003, Methods in enzymology.
[51] M. Pikal,et al. Moisture transfer from stopper to product and resulting stability implications. , 1992, Developments in biological standardization.
[52] R. Hartel,et al. Sugar crystallization in food products. , 1991, Critical reviews in food science and nutrition.