Online citations, reference lists, and bibliographies.
← Back to Search

Dry Powders Of Stable Protein Formulations From Aqueous Solutions Prepared Using Supercritical CO(2)-assisted Aerosolization.

S. Sellers, G. S. Clark, R. Sievers, J. Carpenter
Published 2001 · Medicine, Chemistry

Cite This
Download PDF
Analyze on Scholarcy
Share
We report on the use of a new supercritical carbon dioxide-assisted aerosolization coupled with bubble drying technology to prepare stabilized, dry, finely divided powders from aqueous protein formulations. In this study, the feasibility of this new technology was tested using two model proteins, lysozyme and lactate dehydrogenase (LDH). In the absence of excipients, lysozyme was observed to undergo perturbations of secondary structure observed by solid-state infrared spectroscopy. In the presence of sucrose, this unfolding was minimized. Lysozyme did not, however, undergo irreversible loss of activity, as all lysozyme powders generated by supercritical CO(2)-assisted aerosolization (with or without excipients) regained almost complete activity on reconstitution. The more labile LDH suffered irrecoverable loss of activity on reconstituting after supercritical CO(2)-assisted aerosolization and bubble drying in the absence of carbohydrate stabilizers. LDH could be stabilized throughout the nebulization, drying, and rehydration processes with the addition of sucrose, and almost complete preservation of activity was achieved with the further addition of a surface active agent, such as Tween 20, to the aqueous formulation prior to processing.
This paper references
10.1006/ABBI.1996.0305
Physical factors affecting the storage stability of freeze-dried interleukin-1 receptor antagonist: glass transition and protein conformation.
B. Chang (1996)
10.1016/S0939-6411(98)00005-8
Application of infrared spectroscopy to development of stable lyophilized protein formulations.
J. Carpenter (1998)
10.1016/0014-5793(89)81813-7
The cold‐induced denaturation of lactate dehydrogenase at sub‐zero temperatures in the absence of perturbants
R. H. Hatley (1989)
10.1002/AIC.690320310
Effects of surfactants on mass transfer during spray drying
D. Frey (1986)
10.1021/JA00268A066
Rapid precipitation of low vapor pressure solids from supercritical fluid solutions: the formation of thin films and powders
R. C. Petersen (1986)
10.1023/A:1016296801447
Optimization of Lyophilization Conditions for Recombinant Human Interleukin-2 by Dried-State Conformational Analysis Using Fourier-Transform Infrared Spectroscopy
S. Prestrelski (2004)
10.1002/JPS.2600660927
Thermal Decomposition of Amorphous β-Lactam Antibacterials
M. Pikal (1977)
10.1016/S0006-3495(96)79740-0
Stability of dry liposomes in sugar glasses.
W. Sun (1996)
10.1152/JAPPL.1998.85.2.379
Recent advances in pulmonary drug delivery using large, porous inhaled particles.
D. Edwards (1998)
10.1021/IE00071A021
Rapid expansion of supercritical fluid solutions: solute formation of powders, thin films, and fibers
D. Matson (1987)
10.1002/BIP.360250307
Examination of the secondary structure of proteins by deconvolved FTIR spectra
D. Byler (1986)
10.1021/JS980175V
Tween protects recombinant human growth hormone against agitation-induced damage via hydrophobic interactions.
N. Bam (1998)
10.1016/0168-3659(94)90155-4
Bioavailability of pulmonary delivered peptides and proteins: α-interferon, calcitonins and parathyroid hormones
J. Patton (1994)
10.1021/BI00435A044
An infrared spectroscopic study of the interactions of carbohydrates with dried proteins.
J. Carpenter (1989)
10.1021/JS980374E
Solid-state chemical stability of proteins and peptides.
M. Lai (1999)
10.1016/0020-711x(93)90096-w
In vivo pathways of degradation and strategies for protein stabilization
T. Ahern (1992)
Micronization by means of supercritical fluids: possibility of application to pharmaceutical field.
G. Donsi (1991)
10.1016/0169-409X(92)90002-8
(D) Routes of delivery: Case studies
J. Patton (1992)
10.1152/JAPPL.1998.84.1.263
Supercritical fluid-aerosolized vitamin E pretreatment decreases leak in isolated oxidant-perfused rat lungs.
B. Hybertson (1998)
The effects of cooling rate on solid phase transitions and associated vial breakage occurring in frozen mannitol solutions.
N. Williams (1986)
10.1021/CR60094A004
The Binary System Carbon Dioxide-Water under Pressure.
R. Wiebe (1941)
10.1002/BIT.260410308
Formation of microparticulate protein powder using a supercritical fluid antisolvent
S. Yeo (1993)
10.1615/CRITREVTHERDRUGCARRIERSYST.V12.I2-3.20
Delivery of biotherapeutics by inhalation aerosol.
R. Niven (1995)
10.1016/S0006-3495(93)81120-2
Dehydration-induced conformational transitions in proteins and their inhibition by stabilizers.
S. Prestrelski (1993)
10.1006/ABBI.1993.1310
Separation of freezing- and drying-induced denaturation of lyophilized proteins using stress-specific stabilization. II. Structural studies using infrared spectroscopy.
S. Prestrelski (1993)
10.1006/ABBI.1998.0832
Effects of drying methods and additives on structure and function of actin: mechanisms of dehydration-induced damage and its inhibition.
S. D. Allison (1998)
10.1016/0076-6879(94)32047-0
Infrared methods for study of hemoglobin reactions and structures.
A. Dong (1994)
10.3109/03639049209046327
The spray drying of pharmaceuticals
J. Broadhead (1992)
10.1006/ABBI.1993.1309
Separation of freezing- and drying-induced denaturation of lyophilized proteins using stress-specific stabilization. I. Enzyme activity and calorimetric studies.
J. Carpenter (1993)
10.1248/CPB.42.5
Effect of mannitol crystallinity on the stabilization of enzymes during freeze-drying.
K. Izutsu (1994)
10.1021/BI00175A008
Characterization of the guanidine hydrochloride-denatured state of iso-1-cytochrome c by infrared spectroscopy.
B. Bowler (1994)
10.1021/BI00154A006
Secondary structure of the pentraxin female protein in water determined by infrared spectroscopy: effects of calcium and phosphorylcholine.
A. Dong (1992)
10.3109/10837459709031441
The effect of operating and formulation variables on the morphology of spray-dried protein particles.
Y. Maa (1997)
10.1002/CHIN.199504315
Freeze‐Drying of Proteins. Process, Formulation, and Stability.
M. Pikal (1995)
10.1006/ABBI.1999.1175
Hydrogen bonding between sugar and protein is responsible for inhibition of dehydration-induced protein unfolding.
S. D. Allison (1999)
10.1146/ANNUREV.PHYSIOL.60.1.73
The role of vitrification in anhydrobiosis.
J. Crowe (1998)
10.1021/JS9700661
Pharmaceutical processing with supercritical carbon dioxide.
B. Subramaniam (1997)
10.1002/JPS.2600840407
Infrared spectroscopic studies of lyophilization- and temperature-induced protein aggregation.
A. Dong (1995)
10.1021/BI00465A022
Protein secondary structures in water from second-derivative amide I infrared spectra.
A. Dong (1990)
10.1023/A:1011949805156
Supercritical Fluid Processing of Materials from Aqueous Solutions: The Application of SEDS to Lactose as a Model Substance
S. Palakodaty (2004)
10.1021/JS980399D
Effects of additives on the stability of Humicola lanuginosa lipase during freeze-drying and storage in the dried solid.
L. Kreilgaard (1999)
10.1016/S0021-8502(98)90818-7
Supercritical CO2-assisted methods for the production and pulmonary administration of pharmaceutical aerosols
R. Sievers (1998)
10.1021/BP00022A010
Sub‐Micrometer‐Sized Biodegradable Particles of Poly(L‐Lactic Acid) via the Gas Antisolvent Spray Precipitation Process
T. Randolph (1993)
10.1016/S0168-3659(96)01579-9
Peptide delivery via the pulmonary route: a valid approach for local and systemic delivery
P. Smith (1997)
10.1021/JS950482Q
Precipitation of proteins in supercritical carbon dioxide.
M. Winters (1996)
10.1021/JS960080Y
Surface-induced denaturation of proteins during freezing and its inhibition by surfactants.
B. Chang (1996)



This paper is referenced by
Lipid Nanoparticles at the Current Stage and Prospects – A Review
Christo Tzachev (2013)
10.1016/S0896-8446(02)00162-6
Micronization of antibiotics by supercritical assisted atomization
E. Reverchon (2003)
10.1016/J.CEJ.2007.12.008
Role of phase behavior in micronization of lysozyme via a supercritical anti-solvent process
Shan-Chun Chang (2008)
10.1002/jps.23998
Next generation drying technologies for pharmaceutical applications.
Robert Henry Walters (2014)
10.1211/0022357022043
Ampicillin micronization by supercritical assisted atomization
E. Reverchon (2003)
10.1016/J.ADDR.2007.03.025
Particle design of poorly water-soluble drug substances using supercritical fluid technologies.
Takehiko Yasuji (2008)
10.1007/s13346-012-0088-9
Engineering solid lipid nanoparticles for improved drug delivery: promises and challenges of translational research
D. Mishra (2012)
10.1016/J.EJPB.2006.08.002
Stable high surface area lactate dehydrogenase particles produced by spray freezing into liquid nitrogen.
J. Engstrom (2007)
10.1016/J.ADDR.2007.04.007
Solid lipid nanoparticles as a drug delivery system for peptides and proteins.
A. Almeida (2007)
10.1385/1-59259-922-2:265
Solid-State Protein Formulation
Y. Maa (2005)
10.1016/J.IJPHARM.2004.07.021
Design and process aspects of laboratory scale SCF particle formation systems.
Chandra Vemavarapu (2005)
10.1016/J.POWTEC.2008.10.007
Novel supercritical fluid processing techniques for the production of an aerosol
Stephen Tedeschi (2009)
10.1080/21645515.2017.1356952
Developments in the formulation and delivery of spray dried vaccines
Gaurav Kanojia (2017)
Drying Made Easy : Spray drying a promising technology for the production of stable vaccine and therapeutic protein formulations
Gaurav Kanojia (2018)
10.3929/ETHZ-A-004433773
Gas antisolvent recrystallization of specialty chemicals
G. Muhrer (2002)
10.1002/JPS.20703
Corticosteroid microparticles produced by supercritical-assisted atomization: process optimization, product characterization, and "in vitro" performance.
G. Della Porta (2006)
Formulation, gastrointestinal transit studies and absorption of amphotericin B-containing solid lipid nanoparticles in rats
Hilda Amekyeh (2016)
10.1385/1592599222
Therapeutic Proteins
J. Walker (2005)
10.1016/J.SUPFLU.2013.12.020
A comparative evaluation between utilizing SAS supercritical fluid technique and solvent evaporation method in preparation of Azithromycin solid dispersions for dissolution rate enhancement
E. Adeli (2014)
10.1002/JPS.20842
The challenge of drying method selection for protein pharmaceuticals: product quality implications.
A. M. Abdul-Fattah (2007)
10.1002/bit.22470
Micronization of lysozyme by supercritical assisted atomization
R. Adami (2009)
10.1002/jps.22284
Vaccines with aluminum-containing adjuvants: optimizing vaccine efficacy and thermal stability.
Tanya Clapp (2011)
10.1016/S0378-5173(03)00024-3
Terbutaline microparticles suitable for aerosol delivery produced by supercritical assisted atomization.
E. Reverchon (2003)
10.1007/S00216-006-1002-4
Size prediction of recombinant human growth hormone nanoparticles produced by supercritical fluid precipitation
D. Pyo (2007)
10.1016/J.SUPFLU.2007.03.001
Near-critical fluid micronization of stabilized vaccines, antibiotics and anti-virals
R. Sievers (2007)
Mechanisms of Protein Stability in Lyophilized Samples
Yemin Xu (2014)
10.1016/j.supflu.2019.104710
Supercritical drying of vascular endothelial growth factor in mesenchymal stem cells culture fluids
Won-Su Son (2020)
10.1002/9781118406281.CH11
Micronization and Encapsulation: Application of Supercritical Fluids in Water Removal
M. S. Gomes (2014)
10.1385/1-59259-922-2:243
Principles of Biopharmaceutical Protein Formulation
S. Sellers (2005)
10.4164/SPTJ.43.426
Preparation of Powders with Supercritical Fluids
H. Okamoto (2006)
10.1016/J.SUPFLU.2007.07.008
Supercritical fluid assisted atomization introduced by hydrodynamic cavitation mixer (SAA-HCM) for micronization of levofloxacin hydrochloride
M. Cai (2008)
10.1016/B978-0-444-63660-7.00021-8
Development of a rabies vaccine in cell culture for veterinary use in the lyophilized form
Matheus Gonçalves Severo (2013)
See more
Semantic Scholar Logo Some data provided by SemanticScholar