Formation of stable submicron peptide or protein particles by thin film freezing
Abstract
The present invention includes compositions and methods for preparing micron-sized or submicron-sized particles by dissolving a water soluble effective ingredient in one or more solvents; spraying or dripping droplets solvent such that the effective ingredient is exposed to a vapor-liquid interface of less than 50, 100, 150, 200, 250, 200, 400 or 500 cm.sup.-1 area/volume to, e.g., increase protein stability; and contacting the droplet with a freezing surface that has a temperature differential of at least 30.degree. C. between the droplet and the surface, wherein the surface freezes the droplet into a thin film with a thickness of less than 500 micrometers and a surface area to volume between 25 to 500 cm.sup.-1.
- Inventors:
- Issue Date:
- Research Org.:
- Board of Regents, The University of Texas System, Austin, TX (United States)
- Sponsoring Org.:
- USDOE
- OSTI Identifier:
- 1351888
- Patent Number(s):
- 9622974
- Application Number:
- 14/603,211
- Assignee:
- BOARD OF REGENTS, THE UNIVERSITY OF TEXAS
- Patent Classifications (CPCs):
-
A - HUMAN NECESSITIES A61 - MEDICAL OR VETERINARY SCIENCE A61P - SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
Y - NEW / CROSS SECTIONAL TECHNOLOGIES Y10 - TECHNICAL SUBJECTS COVERED BY FORMER USPC Y10T - TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- DOE Contract Number:
- FG02-04ER15549
- Resource Type:
- Patent
- Resource Relation:
- Patent File Date: 2015 Jan 22
- Country of Publication:
- United States
- Language:
- English
- Subject:
- 37 INORGANIC, ORGANIC, PHYSICAL, AND ANALYTICAL CHEMISTRY; 36 MATERIALS SCIENCE
Citation Formats
Johnston, Keith P., Engstrom, Joshua, and Williams, III, Robert O. Formation of stable submicron peptide or protein particles by thin film freezing. United States: N. p., 2017.
Web.
Johnston, Keith P., Engstrom, Joshua, & Williams, III, Robert O. Formation of stable submicron peptide or protein particles by thin film freezing. United States.
Johnston, Keith P., Engstrom, Joshua, and Williams, III, Robert O. Tue .
"Formation of stable submicron peptide or protein particles by thin film freezing". United States. https://www.osti.gov/servlets/purl/1351888.
@article{osti_1351888,
title = {Formation of stable submicron peptide or protein particles by thin film freezing},
author = {Johnston, Keith P. and Engstrom, Joshua and Williams, III, Robert O.},
abstractNote = {The present invention includes compositions and methods for preparing micron-sized or submicron-sized particles by dissolving a water soluble effective ingredient in one or more solvents; spraying or dripping droplets solvent such that the effective ingredient is exposed to a vapor-liquid interface of less than 50, 100, 150, 200, 250, 200, 400 or 500 cm.sup.-1 area/volume to, e.g., increase protein stability; and contacting the droplet with a freezing surface that has a temperature differential of at least 30.degree. C. between the droplet and the surface, wherein the surface freezes the droplet into a thin film with a thickness of less than 500 micrometers and a surface area to volume between 25 to 500 cm.sup.-1.},
doi = {},
journal = {},
number = ,
volume = ,
place = {United States},
year = {2017},
month = {4}
}
Works referenced in this record:
Commercial challenges of protein drug delivery
journal, January 2005
- Brown, Larry R.
- Expert Opinion on Drug Delivery, Vol. 2, Issue 1, p. 29-42
Advances in ultrarapid freezing for the preservation of cellular ultrastructure
journal, January 1986
- Gilkey, John C.; Staehelin, L. Andrew
- Journal of Electron Microscopy Technique, Vol. 3, Issue 2, p. 177-210
Role of calcium phosphate nanoclusters in the control of calcification
journal, April 2009
- Holt, Carl; Sørensen, Esben S.; Clegg, Roger A.
- FEBS Journal, Vol. 276, Issue 8, p. 2308-2323
Concentrated Dispersions of Equilibrium Protein Nanoclusters That Reversibly Dissociate into Active Monomers
journal, January 2012
- Johnston, Keith P.; Maynard, Jennifer A.; Truskett, Thomas M.
- ACS Nano, Vol. 6, Issue 2, p. 1357-1369
Reversible Self-Association of a Concentrated Monoclonal Antibody Solution Mediated by Fab–Fab Interaction That Impacts Solution Viscosity
journal, October 2008
- Kanai, Sonoko; Liu, Jun; Patapoff, Thomas W.
- Journal of Pharmaceutical Sciences, Vol. 97, Issue 10, p. 4219-4227
Protein Inhalation Powders: Spray Drying vs Spray Freeze Drying
journal, January 1999
- Maa, Yuh‐Fun; Nguyen, Phuong‐Anh; Sweeney, Theresa
- Pharmaceutical Research, Vol. 16, Issue 2, p. 249-254
Novel ultra-rapid freezing particle engineering process for enhancement of dissolution rates of poorly water-soluble drugs
journal, January 2007
- Overhoff, Kirk A.; Engstrom, Josh D.; Chen, Bo
- European Journal of Pharmaceutics and Biopharmaceutics, Vol. 65, Issue 1, p. 57-67
Solution-Based Particle Formation of Pharmaceutical Powders by Supercritical or Compressed Fluid Co2 and Cryogenic Spray-Freezing Technologies
journal, January 2001
- Rogers, True L.; Johnston, Keith P.; Williams, Robert O.
- Drug Development and Industrial Pharmacy, Vol. 27, Issue 10, p. 1003-1015
Spray freezing into liquid versus spray-freeze drying: Influence of atomization on protein aggregation and biological activity
journal, January 2006
- Yu, Zhongshui; Johnston, Keith P.; Williams, Robert O.
- European Journal of Pharmaceutical Sciences, Vol. 27, Issue 1, p. 9-18
Coarse-Grained Strategy for Modeling Protein Stability in Concentrated Solutions
journal, October 2005
- Cheung, Jason K.; Truskett, Thomas M.
- Biophysical Journal, Vol. 89, Issue 4, p. 2372-2384
Unusual properties of aqueous solutions of l-proline: A molecular dynamics study
journal, November 2005
- Civera, Monica; Sironi, Maurizio; Fornili, Sandro L.
- Chemical Physics Letters, Vol. 415, Issue 4-6, p. 274-278
Vapor Pressure Osmometry Studies of Osmolyte−Protein Interactions: Implications for the Action of Osmoprotectants in Vivo and for the Interpretation of “Osmotic Stress” Experiments in Vitro
journal, April 2000
- Courtenay, E. S.; Capp, M. W.; Anderson, C. F.
- Biochemistry, Vol. 39, Issue 15, p. 4455-4471
Anomalously Large Equilibrium Clusters of Colloids
journal, November 2001
- Groenewold, Jan; Kegel, Willem K.
- The Journal of Physical Chemistry B, Vol. 105, Issue 47, p. 11702-11709
Inhibition of protein aggregation in vitro and in vivo by a natural osmoprotectant
journal, August 2006
- Ignatova, Z.; Gierasch, L. M.
- Proceedings of the National Academy of Sciences, Vol. 103, Issue 36, p. 13357-13361
Enhancement of thermal stability and inhibition of protein aggregation by osmolytic effect of hydroxyproline
journal, January 2007
- Kar, Karunakar; Kishore, Nand
- Biopolymers, Vol. 87, Issue 5-6, p. 339-351
Theoretical analysis of excipient concentrations during the final ultrafiltration/diafiltration step of therapeutic antibody
journal, July 2009
- Miao, Fudu; Velayudhan, Ajoy; DiBella, Elsie
- Biotechnology Progress, Vol. 25, Issue 4, p. 964-972
Thermophysical Properties of Trehalose and Its Concentrated Aqueous Solutions
journal, January 1997
- Miller, Danforth P.; de Pablo, Juan J.; Corti, Horacio
- Pharmaceutical Research, Vol. 14, Issue 5, p. 578-590
Phase Behavior of Small Attractive Colloidal Particles
journal, January 1996
- Rosenbaum, D.; Zamora, P. C.; Zukoski, C. F.
- Physical Review Letters, Vol. 76, Issue 1, p. 150-153
Coarse-Grained Strategy for Modeling Protein Stability in Concentrated Solutions. II: Phase Behavior
journal, March 2006
- Shen, Vincent K.; Cheung, Jason K.; Errington, Jeffrey R.
- Biophysical Journal, Vol. 90, Issue 6, p. 1949-1960
Challenges in the development of high protein concentration formulations
journal, June 2004
- Shire, Steven J.; Shahrokh, Zahra; Liu, Jun
- Journal of Pharmaceutical Sciences, Vol. 93, Issue 6, p. 1390-1402
Protein−solute interactions affect the outcome of ultrafiltration/diafiltration operations
journal, September 2004
- Stoner, Michael R.; Fischer, Norm; Nixon, Lori
- Journal of Pharmaceutical Sciences, Vol. 93, Issue 9, p. 2332-2342
Is Random Close Packing of Spheres Well Defined?
journal, March 2000
- Torquato, S.; Truskett, T. M.; Debenedetti, P. G.
- Physical Review Letters, Vol. 84, Issue 10, p. 2064-2067
Molecular Mechanisms of Cryoprotection in Aqueous Proline: Light Scattering and Molecular Dynamics Simulations
journal, April 2008
- Troitzsch, R. Z.; Vass, H.; Hossack, W. J.
- The Journal of Physical Chemistry B, Vol. 112, Issue 14, p. 4290-4297
Enhancement of Protein Crystal Nucleation by Critical Density Fluctuations
journal, September 1997
- Wolde, Pieter Rein ten; Frenkel, Daan
- Science, Vol. 277, Issue 5334, p. 1975-1978
The thermodynamic mechanism of protein stabilization by trehalose
journal, February 1997
- Xie, Guifu; Timasheff, Serge N.
- Biophysical Chemistry, Vol. 64, Issue 1-3, p. 25-43
Structure and thermodynamics of colloidal protein cluster formation: Comparison of square-well and simple dipolar models
journal, September 2009
- Young, Teresa M.; Roberts, Christopher J.
- The Journal of Chemical Physics, Vol. 131, Issue 12, Article No. 125104
Macromolecular Crowding and Confinement: Biochemical, Biophysical, and Potential Physiological Consequences
journal, June 2008
- Zhou, Huan-Xiang; Rivas, Germán; Minton, Allen P.
- Annual Review of Biophysics, Vol. 37, Issue 1, p. 375-397