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Process cycle development of freeze drying for therapeutic proteins with stability evaluation / Jun Yeul Lim ; Nam Ah Kim ; Dae Gon Lim ; Ki Hyun Kim ; Du Hyung Choi ; Seong Hoon Jeong 1

Abstract 1

Introduction 1

Denaturation stresses and instability issues during freeze drying 4

Critical temperatures and freeze drying steps 6

Excipients for freeze drying of protein drugs 13

Conclusion 15

References 15

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Development of orodispersible tablets of taste masked rizatriptan benzoate using hydroxypropyl β cyclodextrin Urmila N. Dungarwal, Sanjay B. Patil pp.537-545

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Process cycle development of freeze drying for therapeutic proteins with stability evaluation Jun Yeul Lim, Nam Ah Kim, Dae Gon Lim, Ki Hyun Kim, Du Hyung Choi, Seong Hoon Jeong pp.519-536

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Employing an optimized spray-drying process to produce ezetimibe tablets with an improved dissolution profile Sungyub Kim, Biki Gupta, Cheol Moon, Euichaul Oh, Jee-Heon Jeong, Chul Soon Yong, Jong Oh Kim pp.583-592

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참고문헌 (127건) : 자료제공( 네이버학술정보 )

참고문헌 목록에 대한 테이블로 번호, 참고문헌, 국회도서관 소장유무로 구성되어 있습니다.
번호 참고문헌 국회도서관 소장유무
1 Freeze-drying of nanocapsules: impact of annealing on the drying process. 네이버 미소장
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7 Factors affecting short-term and long-term stabilities of proteins 네이버 미소장
8 Thermally Induced Denaturation of Lyophilized Bovine Somatotropin and Lysozyme As Impacted by Moisture and Excipients 네이버 미소장
9 Protein stability during freezing: separation of stresses and mechanisms of protein stabilization. 네이버 미소장
10 Study of the Individual Contributions of Ice Formation and Freeze-Concentration on Isothermal Stability of Lactate Dehydrogenase during Freezing 네이버 미소장
11 Rational design of lyophilized high concentration protein formulations-mitigating the challenge of slow reconstitution with multidisciplinary strategies 네이버 미소장
12 Cryoprotection of phosphofructokinase with organic solutes: Characterization of enhanced protection in the presence of divalent cations 네이버 미소장
13 Comparison of Solute-Induced Protein Stabilization in Aqueous Solution and in the Frozen and Dried States 네이버 미소장
14 Rational Design of Stable Lyophilized Protein Formulations: Some Practical Advice 네이버 미소장
15 Development of an efficient single-step freeze-drying cycle for protein formulations. 네이버 미소장
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26 Microscopic mechanism for cold denaturation. 네이버 미소장
27 The hydrophobic effect and its role in cold denaturation 네이버 미소장
28 Esfandiary R., Gattu SK., Stewart JM., Patel SM (2016),Effect of freezing on lyophilization process performance and drug product cake appearance. J Pharm Sci 105,1427–1433 미소장
29 Annealing as a tool for the optimization of lyophilization and ensuring of the stability of protein-loaded PLGA nanoparticles 네이버 미소장
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32 Solid aqueous solutions 네이버 미소장
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34 Controlled ice nucleation in the field of freeze-drying: Fundamentals and technology review 네이버 미소장
35 Gelman Constantin J., Schneider M., Corti HR (2016),The glass transition temperature of saccharide aqueous solutions estimated with the free volume/percolation model. J Phys Chem B 120,5047–5055 미소장
36 Characterization of the head organizer in hydra. 네이버 미소장
37 Effect of Initial Buffer Composition on pH Changes During Far-From-Equilibrium Freezing of Sodium Phosphate Buffer Solutions 네이버 미소장
38 The effect of protein concentration on the viscosity of a recombinant albumin solution formulation 네이버 미소장
39 Thermodynamic incompatibility of proteins and polysaccharides in solutions 네이버 미소장
40 Hageman MJ (1988),The role of moisture in protein stability. Drug Dev Ind Pharm 14,2047–2070 미소장
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42 Impact of freezing procedure and annealing on the physico-chemical properties and the formation of mannitol hydrate in mannitol–sucrose–NaCl formulations 네이버 미소장
43 Physicohemical characterization of the freezing behavior of mannitol-human serum albumin formulations 네이버 미소장
44 Heller MC., Carpenter JF., Randolph TW (1996),Effects of phase separating systems on lyophilized hemoglobin. J Pharm Sci 85,1358–1362 미소장
45 Manipulation of Lyophilization-Induced Phase Separation: Implications For Pharmaceutical Proteins 네이버 미소장
46 Conformational Stability of Lyophilized PEGylated Proteins in a Phase-Separating System 네이버 미소장
47 Protein formulation and lyophilization cycle design: prevention of damage due to freeze-concentration induced phase separation. 네이버 미소장
48 Measurement of glass transition temperatures of freeze-concentrated solutes by differential scanning calorimetry. 네이버 미소장
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50 Electrolyte-induced changes in glass transition temperatures of freeze-concentrated solutes. 네이버 미소장
51 Freeze drying of pharmaceuticals in vials: Influence of freezing protocol and sample configuration on ice morphology and freeze-dried cake texture 네이버 미소장
52 Izutsu K-I., Yoshioka S., Terao T (1993),Decreased protein-stabilizing effects of cryoprotectants due to crystallization. Pharm Res 10,1232–1237 미소장
53 Izutsu K-I., Yoshioka S., Kojima S., Randolph TW., Carpenter JF (1996),Effects of sugars and polymers on crystallization of poly (ethylene glycol) in frozen solutions: phase separation between incompatible polymers. Pharm Res 13,1393–1400 미소장
54 Izutsu K-I., Heller MC., Randolph TW., Carpenter JF (1998),Effect of salts and sugars on phase separation of polyvinylpyrrolidone-dextran solutions induced by freeze-concentration. J Chem Soc 94,411–417 미소장
55 Analytical methods and formulation factors to enhance protein stability in solution 소장
56 Jezek J., Darton NJ., Derham BK., Royle N., Simpson I (2013),Biopharmaceutical formulations for pre-filled delivery devices. Exper Opin Drug Del 10,811–828 미소장
57 Effect of process conditions on recovery of protein activity after freezing and freeze-drying 네이버 미소장
58 Mannitol–Sucrose Mixtures—Versatile Formulations for Protein Lyophilization 네이버 미소장
59 Freeze-drying of proteins with glass-forming oligosaccharide-derived sugar alcohols 네이버 미소장
60 Near-infrared spectroscopic determination of residual moisture in lyophilized sucrose through intact glass vials. 네이버 미소장
61 Kasper JC., Friess W (2011),The freezing step in lyophilization: physico-chemical fundamentals, freezing methods and consequences on process performance and quality attributes of biopharmaceuticals. Eur J Pharm Biopharm 78,248–263 미소장
62 Recent advances and further challenges in lyophilization 네이버 미소장
63 Characterization of the sucrose/glycine/water system by differential scanning calorimetry and freeze-drying microscopy. 네이버 미소장
64 Katakam M., Banga AK (1995),Aggregation of insulin and its prevention by carbohydrate excipients. PDA J Pharm Sci Tech 49,160–165 미소장
65 Kendrick B., Chang B., Carpenter J (1995),Detergent stabilization of proteins against surface and freezing denaturation. Pharm Res 12(supple):S85 미소장
66 Basal buffer systems for a newly glycosylated recombinant human interferon-β with biophysical stability and DoE approaches 네이버 미소장
67 Solid‐state chemical stability of proteins and peptides 네이버 미소장
68 Replacing succinate with glycolate buffer improves the stability of lyophilized interferon-γ 네이버 미소장
69 Evaluation of etanercept stability as exposed to various sugars with biophysical assessment. 네이버 미소장
70 Mechanistic elements of protein cold denaturation. 네이버 미소장
71 Freeze-drying of mannitol-trehalose-sodium chloride-based formulations: the impact of annealing on dry layer resistance to mass transfer and cake structure. 네이버 미소장
72 Formulations of sugars with amino acids or mannitol--influence of concentration ratio on the properties of the freeze-concentrate and the lyophilizate. 네이버 미소장
73 Effects of formulation and process variables on the aggregation of freeze-dried interleukin-6 (IL-6) after lyophilization and on storage. 네이버 미소장
74 Characterization of Murine Monoclonal Antibody to Tumor Necrosis Factor (TNF-MAb) Formulation for Freeze-Drying Cycle Development 네이버 미소장
75 Stability of protein pharmaceuticals. 네이버 미소장
76 Formulation of proteins in vacuum-dried glasses. II. Process and storage stability in sugar-free amino acid systems. 네이버 미소장
77 Controlling the physical form of mannitol in freeze-dried systems 네이버 미소장
78 Meister E., Gieseler H (2009),Freeze-dry microscopy of protein/sugar mixtures: drying behavior, interpretation of collapse temperatures and a comparison to corresponding glass transition data. J Pharm Sci 98,3072–3087 미소장
79 Freeze-Drying: In Situ Observations Using Cryoenvironmental Scanning Electron Microscopy and Differential Scanning Calorimetry 네이버 미소장
80 Thermophysical Properties of Trehalose and Its Concentrated Aqueous Solutions 네이버 미소장
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83 Nema S., Kenneth EA (1993),Freeze-thaw studies of a model protein, lactate dehydrogenase, in the presence of cryoprotectants. PDA J Pharm Sci Tech 47,76–83 미소장
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85 Physical state of l-histidine after freeze-drying and long-term storage 네이버 미소장
86 Lyophilization of protein formulations in vials: Investigation of the relationship between resistance to vapor flow during primary drying and small‐scale product collapse 네이버 미소장
87 Patapoff TW., Overcashier DE (2002),The importance of freezing on lyophilization cycle development. BioPharm Intl 15,16–21 미소장
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99 Cold Denaturation of Protein 네이버 미소장
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116 Design of Freeze-Drying Processes for Pharmaceuticals: Practical Advice 네이버 미소장
117 Tang XC., Pikal MJ (2005),The effect of stabilizers and denaturants on the cold denaturation temperatures of proteins and implications for freeze-drying. Pharm Res 22,1167–1175 미소장
118 Freeze-Drying Process Design by Manometric Temperature Measurement: Design of a Smart Freeze-Dryer 네이버 미소장
119 Recombinant Human Albumin as a Stabilizer for Biological Materials and for the Preparation of International Reference Reagents 네이버 미소장
120 Characterization of the Physical Stability of a Lyophilized IgG1 mAb after Accelerated Shipping-Like Stress 네이버 미소장
121 Stabilization Challenges and Formulation Strategies Associated with Oral Biologic Drug Delivery Systems 네이버 미소장
122 Lyophilization and development of solid protein pharmaceuticals 네이버 미소장
123 Effects of annealing lyophilized and spray‐lyophilized formulations of recombinant human interferon‐γ 네이버 미소장
124 Williams NA., Lee Y., Poll GP., Jennings TA (1986),The effects of cooling rate on solid phase transitions and associated vial breakage occurring in frozen mannitol solutions. PDA J Pharm Sci Tech 40,135–141 미소장
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