Preparation of Active Proteins, Vaccines and Pharmaceuticals as Fine Powders using Supercritical or Near-Critical Fluids
Supercritical or near-critical fluid processes for generating microparticles have enjoyed considerable attention in the past decade or so, with good success for substances soluble in supercritical fluids or organic solvents. In this review, we survey their application to the production of protein pa...
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Published in | Pharmaceutical research Vol. 25; no. 9; pp. 1967 - 1990 |
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Main Authors | , , , , , |
Format | Journal Article |
Language | English |
Published |
Boston
Springer US
01.09.2008
Springer Springer Nature B.V |
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Abstract | Supercritical or near-critical fluid processes for generating microparticles have enjoyed considerable attention in the past decade or so, with good success for substances soluble in supercritical fluids or organic solvents. In this review, we survey their application to the production of protein particles. A recently developed process known as CO
2
-assisted nebulization with a Bubble Dryer® (CAN-BD) has been demonstrated to have broad applicability to small-molecule as well as macromolecule substances (including therapeutic proteins). The principles of CAN-BD are discussed as well as the stabilization, micronization and drying of a wide variety of materials. More detailed case studies are presented for three proteins, two of which are of therapeutic interest: anti-CD4 antibody (rheumatoid arthritis), α
1
-antitrypsin (cystic fibrosis and emphysema), and trypsinogen (a model enzyme). Dry powders were formed in which stability and activity are maintained and which are fine enough to be inhaled and reach the deep lung. Enhancement of apparent activity after CAN-BD processing was also observed in some formulation and processing conditions. |
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AbstractList | Supercritical or near-critical fluid processes for generating microparticles have enjoyed considerable attention in the past decade or so, with good success for substances soluble in supercritical fluids or organic solvents. In this review, we survey their application to the production of protein particles. A recently developed process known as CO2-assisted nebulization with a Bubble Dryer® (CAN-BD) has been demonstrated to have broad applicability to small-molecule as well as macromolecule substances (including therapeutic proteins). The principles of CAN-BD are discussed as well as the stabilization, micronization and drying of a wide variety of materials. More detailed case studies are presented for three proteins, two of which are of therapeutic interest: anti-CD4 antibody (rheumatoid arthritis), α1-antitrypsin (cystic fibrosis and emphysema), and trypsinogen (a model enzyme). Dry powders were formed in which stability and activity are maintained and which are fine enough to be inhaled and reach the deep lung. Enhancement of apparent activity after CAN-BD processing was also observed in some formulation and processing conditions. [PUBLICATION ABSTRACT] Supercritical or near-critical fluid processes for generating microparticles have enjoyed considerable attention in the past decade or so, with good success for substances soluble in supercritical fluids or organic solvents. In this review, we survey their application to the production of protein particles. A recently developed process known as CO 2 -assisted nebulization with a Bubble Dryer® (CAN-BD) has been demonstrated to have broad applicability to small-molecule as well as macromolecule substances (including therapeutic proteins). The principles of CAN-BD are discussed as well as the stabilization, micronization and drying of a wide variety of materials. More detailed case studies are presented for three proteins, two of which are of therapeutic interest: anti-CD4 antibody (rheumatoid arthritis), α 1 -antitrypsin (cystic fibrosis and emphysema), and trypsinogen (a model enzyme). Dry powders were formed in which stability and activity are maintained and which are fine enough to be inhaled and reach the deep lung. Enhancement of apparent activity after CAN-BD processing was also observed in some formulation and processing conditions. Supercritical or near-critical fluid processes for generating microparticles have enjoyed considerable attention in the past decade or so, with good success for substances soluble in supercritical fluids or organic solvents. In this review, we survey their application to the production of protein particles. A recently developed process known as CO2-assisted nebulization with a Bubble Dryer (CAN-BD) has been demonstrated to have broad applicability to small-molecule as well as macromolecule substances (including therapeutic proteins). The principles of CAN-BD are discussed as well as the stabilization, micronization and drying of a wide variety of materials. More detailed case studies are presented for three proteins, two of which are of therapeutic interest: anti-CD4 antibody (rheumatoid arthritis), alpha1-antitrypsin (cystic fibrosis and emphysema), and trypsinogen (a model enzyme). Dry powders were formed in which stability and activity are maintained and which are fine enough to be inhaled and reach the deep lung. Enhancement of apparent activity after CAN-BD processing was also observed in some formulation and processing conditions. |
Author | Yang, Tzung-Horng Carpenter, John F. Villa, Joseph A. Huang, Edward T. S. Cape, Stephen P. Sievers, Robert E. |
Author_xml | – sequence: 1 givenname: Stephen P. surname: Cape fullname: Cape, Stephen P. organization: Center for Pharmaceutical Biotechnology, Department of Chemistry and Biochemistry and CIRES, University of Colorado – sequence: 2 givenname: Joseph A. surname: Villa fullname: Villa, Joseph A. organization: Center for Pharmaceutical Biotechnology, Department of Chemistry and Biochemistry and CIRES, University of Colorado – sequence: 3 givenname: Edward T. S. surname: Huang fullname: Huang, Edward T. S. organization: Center for Pharmaceutical Biotechnology, Department of Chemistry and Biochemistry and CIRES, University of Colorado – sequence: 4 givenname: Tzung-Horng surname: Yang fullname: Yang, Tzung-Horng organization: Biogen Idec, Inc – sequence: 5 givenname: John F. surname: Carpenter fullname: Carpenter, John F. organization: Center for Pharmaceutical Biotechnology, Department of Pharmaceutical Sciences, University of Colorado Health Sciences Center – sequence: 6 givenname: Robert E. surname: Sievers fullname: Sievers, Robert E. organization: Center for Pharmaceutical Biotechnology, Department of Chemistry and Biochemistry and CIRES, University of Colorado, Aktiv-Dry LLC |
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Keywords | α CAN-BD assisted nebulization with a bubble dryer anti-CD4 antibody trypsinogen antitrypsin CO Pharmaceutical technology α1-antitrypsin Antibody Carbon dioxide Nebulization Vaccine Protein Preparation T-Lymphocyte CO2-assisted nebulization with a bubble dryer Fine powder |
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Publisher | Springer US Springer Springer Nature B.V |
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Snippet | Supercritical or near-critical fluid processes for generating microparticles have enjoyed considerable attention in the past decade or so, with good success... |
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SubjectTerms | Aerosols alpha 1-Antitrypsin - chemistry Animals Antibodies - chemistry Biochemistry Biological and medical sciences Biomedical and Life Sciences Biomedical Engineering and Bioengineering Biomedicine Carbon Dioxide - chemistry CD4 Antigens - immunology Chemistry, Pharmaceutical Chromatography, Supercritical Fluid - instrumentation Drug Stability Enzyme Stability Expert Review General pharmacology Humans Medical Law Medical sciences Nebulizers and Vaporizers Particle Size Pharmaceutical technology. Pharmaceutical industry Pharmacology Pharmacology. Drug treatments Pharmacology/Toxicology Pharmacy Powders Protein Denaturation Proteins Proteins - chemistry Scientific method Solvents - chemistry Technology, Pharmaceutical - instrumentation Technology, Pharmaceutical - methods Trypsinogen - chemistry Vaccines - chemistry |
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Title | Preparation of Active Proteins, Vaccines and Pharmaceuticals as Fine Powders using Supercritical or Near-Critical Fluids |
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