Particle engineering techniques for inhaled biopharmaceuticals

Perry's chemical engineers' handbook

(2008) · Choice Reviews Online · doi:10.5860/choice.45-4393 · Cited by 10,121

Perry's chemical engineers' handbook

(1998) · Choice Reviews Online · doi:10.5860/choice.35-3079 · Cited by 5,897

Novel hydrophilic chitosan-polyethylene oxide nanoparticles as protein carriers

Calvo, P., Remu��n-L�pez, C., Vila-Jato, J. L., & Alonso, M. J. (1997) · Journal of Applied Polymer Science · doi:10.1002/(sici)1097-4628(19970103)63:1<125::aid-app13>3.0.co;2-4 · Cited by 1,856

Microencapsulated chitosan nanoparticles for lung protein delivery

Grenha, A., Seijo, B., & Remuñán-López, C. (2005) · European Journal of Pharmaceutical Sciences · doi:10.1016/j.ejps.2005.04.009 · Cited by 469

Phase transformation considerations during process development and manufacture of solid oral dosage forms

Zhang, G. (2004) · Advanced Drug Delivery Reviews · doi:10.1016/j.addr.2003.10.009 · Cited by 462

Human Insulin from Recombinant DNA Technology

Johnson, I. S. (1983) · Science · doi:10.1126/science.6337396 · Cited by 401

Elements of materials science and engineering

Vlack, V., & Lawrence, H. (1959) · Cited by 377

Protein Inhalation Powders: Spray Drying vs Spray Freeze Drying

Maa, Y.-F., Nguyen, P.-A., Sweeney, T., Shire, S. J., & Hsu, C. C. (1999) · Pharmaceutical Research · doi:10.1023/a:1018828425184 · Cited by 356

Particle formation with supercritical fluids—a review

Tom, J. W., & Debenedetti, P. G. (1991) · Journal of Aerosol Science · doi:10.1016/0021-8502(91)90013-8 · Cited by 342

Polymorphism in Molecular Crystals: Stabilization of a Metastable Form by Conformational Mimicry

Davey, R. J., Blagden, N., Potts, G. D., & Docherty, R. (1997) · Journal of the American Chemical Society · doi:10.1021/ja9626345 · Cited by 339

Formation of microparticulate protein powder using a supercritical fluid antisolvent

Yeo, S., Lim, G., Debendetti, P. G., & Bernstein, H. (1993) · Biotechnology and Bioengineering · doi:10.1002/bit.260410308 · Cited by 305

A MORPHOLOGIC AND CYTOCHEMICAL STUDY ON THE GREAT ALVEOLAR CELL

SOROKIN, S. P. (1966) · Journal of Histochemistry & Cytochemistry · doi:10.1177/14.12.884 · Cited by 266

Beware of proteins in DMSO

Jackson, M., & Mantsch, H. H. (1991) · Biochimica et Biophysica Acta (BBA) - Protein Structure and Molecular Enzymology · doi:10.1016/0167-4838(91)90563-f · Cited by 263

Strategies for particle design using supercritical fluid technologies

York, P. (1999) · Pharmaceutical Science & Technology Today · doi:10.1016/s1461-5347(99)00209-6 · Cited by 232

Inhaled insulin1Abbreviations: DM, diabetes mellitus; AIDs, acquired immune deficiency syndrome; SC, subcutaneous; DCCT, Diabetes Control and Complications Trial; IDDM, insulin-dependent diabetes mellitus; NIDDM, non-insulin-dependent diabetes mellitus; i.v., intravenous; DDPC, di-decanoyl-alpha-phosphatidylcholine; AUC, area under the curve; INH, inhaled; Cmax, maximum serum concentration; Cmin, minimum serum concentration; Tmax, time of maximum serum concentration; NS, not significant; HbA1c, hemoglobin A1c; OA, oral agent; SD, standard deviation; MDI, metered dose inhaler; DPI, dry powder inhaler; MMAD, mass median aerodynamic diameter; CMC, critical micelle concentration; SR, sustained release; PLGA, poly lactic acid-co-glycolic acid; GI, gastrointestinal, GSD, geometric standard deviation; TLC, total lung capacity; VC, vital capacity; SMK, smokers; MW, molecular weight; MP, melting point.1

Patton, J. S., Bukar, J., & Nagarajan, S. (1999) · Advanced Drug Delivery Reviews · doi:10.1016/s0169-409x(98)00074-x · Cited by 193

The Effect of Formulation Excipients on Protein Stability and Aerosol Performance of Spray-Dried Powders of a Recombinant Humanized Anti-IgE Monoclonal Antibody1

Andya, J. D., Maa, Y.-F., Costantino, H. R., Nguyen, P.-A., Dasovich, N., Sweeney, T. D., Hsu, C. C., & Shire, S. J. (1999) · Pharmaceutical Research · doi:10.1023/a:1018805232453 · Cited by 190

Protein Spray-Freeze Drying. Effect of Atomization Conditions on Particle Size and Stability

Costantino, H. R., Firouzabadian, L., Hogeland, K., Wu, C., Beganski, C., Carrasquillo, K. G., Córdova, M., Griebenow, K., Zale, S. E., & Tracy, M. A. (2000) · Pharmaceutical Research · doi:10.1023/a:1007570030368 · Cited by 186

Polymeric Microspheres Prepared by Spraying into Compressed Carbon Dioxide

Bodmeier, R., Wang, H., Dixon, D. J., Mawson, S., & Johnston, K. P. (1995) · Pharmaceutical Research · doi:10.1023/a:1016276329672 · Cited by 173

Microencapsulation of proteins by rapid expansion of supercritical solution with a nonsolvent

Mishima, K., Matsuyama, K., Tanabe, D., Yamauchi, S., Young, T. J., & Johnston, K. P. (2000) · AIChE Journal · doi:10.1002/aic.690460418 · Cited by 170

Biopharmaceuticals: recent approvals and likely directions

Walsh, G. (2005) · Trends in biotechnology · doi:10.1016/j.tibtech.2005.07.005 · Cited by 152

Improved Lung Delivery from a Passive Dry Powder Inhaler Using an Engineered PulmoSphere® Powder

Duddu, S. P., Sisk, S. A., Walter, Y. H., Tarara, T. E., Trimble, K. R., Clark, A. R., Eldon, M. A., Elton, R. C., Pickford, M., Hirst, P. H., et al. (2002) · Pharmaceutical Research · doi:10.1023/a:1015322616613 · Cited by 150

Phase Behavioral Effects on Particle Formation Processes Using Supercritical Fluids

Palakodaty, S., & York, P. (1999) · Pharmaceutical Research · doi:10.1023/a:1011957512347 · Cited by 144

Spray Dried Powders and Powder Blends of Recombinant Human Deoxyribonuclease (rhDNase) for Aerosol Delivery

Chan, H., Clark, A., Gonda, I., Mumenthaler, M., & Hsu, C. C. (1997) · Pharmaceutical Research · doi:10.1023/a:1012035113276 · Cited by 141

The Effect of Process and Formulation Variables on the Properties of Spray-dried β-Galactosidase

Broadhead, J., Rouan, S. K. E., Hau, I., & Rhodes, C. T. (1994) · Journal of Pharmacy and Pharmacology · doi:10.1111/j.2042-7158.1994.tb03828.x · Cited by 141

Pulmonary delivery of growth hormone using dry powders and visualization of its local fate in rats

Bosquillon, C., Préat, V., & Vanbever, R. (2004) · Journal of Controlled Release · doi:10.1016/j.jconrel.2004.01.027 · Cited by 140

Preparation of peptide and protein powders for inhalation

Johnson, K. (1997) · Advanced Drug Delivery Reviews · doi:10.1016/s0169-409x(97)00506-1 · Cited by 139

Pharmaceutical Technology

Mollet, H., & Grubenmann, A. (2000) · Wiley eBooks · doi:10.1002/9783527612925.ch12 · Cited by 136

A novel particle engineering technology to enhance dissolution of poorly water soluble drugs: spray-freezing into liquid

Rogers, T. L., Nelsen, A. C., Hu, J., et al. (2002) · European Journal of Pharmaceutics and Biopharmaceutics · doi:10.1016/s0939-6411(02)00063-2 · Cited by 134

Delivery systems for penetration enhancement of peptide and protein drugs: design considerations.

Kompella, U. B., & Lee, V. H. L. (2001) · Advanced Drug Delivery Reviews · doi:10.1016/s0169-409x(00)00137-x · Cited by 131

Protein spray freeze drying. 2. Effect of formulation variables on particle size and stability

Costantino, H. R., Firouzabadian, L., Wu, C., et al. (2002) · Journal of Pharmaceutical Sciences · doi:10.1002/jps.10059 · Cited by 129

Spray freezing into liquid versus spray-freeze drying: Influence of atomization on protein aggregation and biological activity

Yu, Z., Johnston, K. P., & Williams, R. O. (2005) · European Journal of Pharmaceutical Sciences · doi:10.1016/j.ejps.2005.08.010 · Cited by 116

Dry powders of stable protein formulations from aqueous solutions prepared using supercritical CO2‐assisted aerosolization

Sellers, S. P., Clark, G. S., Sievers, R. E., & Carpenter, J. F. (2001) · Journal of Pharmaceutical Sciences · doi:10.1002/jps.1032 · Cited by 116

Stabilization of proteins in dry powder formulations using supercritical fluid technology

Jovanović, N., Bouchard, A., Hofland, G. W., Witkamp, G.-J., Crommelin, D. J. A., & Jiskoot, W. (2004) · Pharmaceutical Research · doi:10.1023/b:pham.0000048185.09483.e7 · Cited by 111

Oral salmon calcitonin induced suppression of urinary collagen type II degradation in postmenopausal women: A new potential treatment of osteoarthritis

Bagger, Y. Z., Tankó, L. B., Alexandersen, P., Karsdal, M. A., Olson, M., Mindeholm, L., Azria, M., & Christiansen, C. (2005) · Bone · doi:10.1016/j.bone.2005.04.032 · Cited by 109

Ultrasonic atomization for spray drying: a versatile technique for the preparation of protein loaded biodegradable microspheres

Bittner, B., & Kissel, T. (1999) · Journal of Microencapsulation · doi:10.1080/026520499289059 · Cited by 105

Bioavailability of Leuprolide Acetate Following Nasal and Inhalation Delivery to Rats and Healthy Humans

Adjei, A. L., Sundberg, D. P., Miller, J., & Chun, A. (1992) · Pharmaceutical Research · doi:10.1023/a:1018997625726 · Cited by 103

Systemic delivery of parathyroid hormone (1-34) using inhalation dry powders in rats

Codrons, V., Vanderbist, F., Verbeeck, R. K., Arras, M., Lison, D., Véronique Préat, A., & Rita Vanbever, A. (2003) · Journal of Pharmaceutical Sciences · doi:10.1002/jps.10346 · Cited by 102

(D) Routes of delivery: Case studies

Smith, P. L., Wall, D. A., Gochoco, C. H., & Wilson, G. (1992) · Advanced Drug Delivery Reviews · doi:10.1016/0169-409x(92)90005-b · Cited by 94

Formulation strategies for the stabilization of tetanus toxoid in poly(lactide-co-glycolide) microspheres

Sánchez, A., Villamayor, B., Guo, Y.-Y., et al. (1999) · International Journal of Pharmaceutics · doi:10.1016/s0378-5173(99)00178-7 · Cited by 88

(D) Routes of delivery: Case studies

Cullander, C., & Guy, R. H. (1992) · Advanced Drug Delivery Reviews · doi:10.1016/0169-409x(92)90006-c · Cited by 87

Pulmonary Delivery of Salmon Calcitonin Dry Powders Containing Absorption Enhancers in Rats

Kobayashi, S., Kondo, S., & Juni, K. (1996) · Pharmaceutical Research · doi:10.1023/a:1016081301369 · Cited by 85

Effective protein release from PEG/PLA nano-particles produced by compressed gas anti-solvent precipitation techniques

Caliceti, P., Salmaso, S., Elvassore, N., & Bertucco, A. (2003) · Journal of Controlled Release · doi:10.1016/j.jconrel.2003.10.015 · Cited by 84

Inulin is a promising cryo- and lyoprotectant for PEGylated lipoplexes

Hinrichs, W. L. J., Sanders, N. N., Smedt, S. C. D., Demeester, J., & Frijlink, H. W. (2005) · Journal of Controlled Release · doi:10.1016/j.jconrel.2004.12.011 · Cited by 84

Phase behavior of freeze-dried phospholipid–cholesterol mixtures stabilized with trehalose

Ohtake, S., Schebor, C., Palecek, S. P., et al. (2005) · Biochimica et Biophysica Acta (BBA) - Biomembranes · doi:10.1016/j.bbamem.2005.05.001 · Cited by 83

Pulmonary delivery of therapeutic peptides via dry powder inhalation: effects of micronisation and manufacturing

Irngartinger, M., Camuglia, V., Damm, M., Goede, J., & Frijlink, H. W. (2004) · European Journal of Pharmaceutics and Biopharmaceutics · doi:10.1016/j.ejpb.2004.03.016 · Cited by 80

Supercritical antisolvent process for substituted para-linked aromatic polyamides: phase equilibrium and morphology study

Yeo, S., Debenedetti, P. G., Radosz, M., et al. (1993) · Macromolecules · doi:10.1021/ma00075a012 · Cited by 80

Spray freezing into liquid nitrogen for highly stable protein nanostructured microparticles

Yu, Z., Garcia, A. S., Johnston, K. P., & Williams, R. O. (2004) · European Journal of Pharmaceutics and Biopharmaceutics · doi:10.1016/j.ejpb.2004.04.018 · Cited by 79

Process Variable Implications for Residual Solvent Removal and Polymer Morphology in the Formation of Gentamycin-Loaded Poly (L-lactide) Microparticles

Falk, R., & Randolph, T. W. (1998) · Pharmaceutical Research · doi:10.1023/a:1011991808423 · Cited by 75

The influence of operating conditions on the dense gas precipitation of model proteins

Thiering, R., Dehghani, F., Dillow, A. K., & Foster, N. R. (2000) · Journal of Chemical Technology & Biotechnology · Cited by 60

Targeting colloidal particulates to thoracic lymph nodes

Liu, J., Wong, H. L., Moselhy, J., Bowen, B. M., Wu, X. Y., & Johnston, M. R. (2006) · Lung Cancer · doi:10.1016/j.lungcan.2005.11.006 · Cited by 57

Biopharmaceuticals and biotechnology medicines: an issue of nomenclature

Walsh, G. (2002) · European Journal of Pharmaceutical Sciences · doi:10.1016/s0928-0987(01)00222-6 · Cited by 53

The effects of polyvinyl alcohol on the in vitro stability and delivery of spray-dried protein particles from surfactant-free HFA 134a-based pressurised metered dose inhalers

Liao, Y., Brown, M. B., Jones, S. A., et al. (2005) · International Journal of Pharmaceutics · doi:10.1016/j.ijpharm.2005.07.013 · Cited by 42

Freeze-Drying of tert-Butanol/Water Cosolvent Systems: A Case Report on Formation of a Friable Freeze-Dried Powder of Tobramycin Sulfate

Wittaya‐areekul, S., Needham, G. F., Milton, N., Roy, M. L., & Nail, S. L. (2002) · Journal of Pharmaceutical Sciences · doi:10.1002/jps.10113 · Cited by 40

(D) Routes of delivery: Case studies

Ho, N. F. H., Barsuhn, C. L., Burton, P. S., & Merkle, H. P. (1992) · Advanced Drug Delivery Reviews · doi:10.1016/0169-409x(92)90003-9 · Cited by 37

Inhalable Drugs for Systemic Therapy

Corkery, K. J. (2000) · Respiratory Care · doi:10.1177/002013240004500706 · Cited by 37

(D) Routes of delivery: Case studies

Edman, P., & Björk, E. (1992) · Advanced Drug Delivery Reviews · doi:10.1016/0169-409x(92)90001-7 · Cited by 34

Evaluation of the potential of air jet milling of solid protein-poly(acrylate) complexes for microparticle preparation

Schlocker, W., GSCHLIESER, S., & Bernkop‐Schnürch, A. (2005) · European Journal of Pharmaceutics and Biopharmaceutics · doi:10.1016/j.ejpb.2005.09.001 · Cited by 33

Low-temperature manufacturing of fine pharmaceutical powders with supercritical fluid aerosolization in a Bubble Dryer®

Sievers, R. E., Huang, E. T. S., Villa, J. A., et al. (2001) · Pure and Applied Chemistry · doi:10.1351/pac200173081299 · Cited by 32

Design, functionalization strategies and biomedical applications of targeted biodegradable/biocompatible polymer-based nanocarriers for drug delivery

Nicolas, J., Mura, S., Brambilla, D., Mackiewicz, N., & Couvreur, P. (2013) · Chem. Soc. Rev. · doi:10.1039/c2cs35265f · Cited by 1,270

Non-invasive delivery strategies for biologics

Anselmo, A. C., Gokarn, Y., & Mitragotri, S. (2019) · Nature Reviews Drug Discovery · doi:10.1038/nrd.2018.183 · Cited by 665

Influence of particle size on regional lung deposition – What evidence is there?

Carvalho, T. C., Peters, J. I., & Williams III, R. O. (2011) · International Journal of Pharmaceutics · doi:10.1016/j.ijpharm.2010.12.040 · Cited by 614

3D Printing technologies for drug delivery: a review

Prasad, L. K., & Smyth, H. (2016) · Drug Development and Industrial Pharmacy · doi:10.3109/03639045.2015.1120743 · Cited by 454

Nano spray drying: A novel method for preparing protein nanoparticles for protein therapy

Lee, S. H., Heng, D., Ng, W. K., Chan, H.-K., & Tan, R. B. H. (2011) · International Journal of Pharmaceutics · doi:10.1016/j.ijpharm.2010.10.012 · Cited by 405