349
Views
24
CrossRef citations to date
0
Altmetric
Review

Dry powder inhalation systems for pulmonary delivery of therapeutic peptides and proteins

, &
Pages 429-442 | Published online: 07 Apr 2008

Bibliography

  • Taylor K. Pulmonary Drug Delivery. Churchill Livingstone. Edinburgh 2002
  • Codrons V, Vanderbist F, Verbeeck RK, et al. Systemic delivery of parathyroid hormone (1-34) using inhalation dry powders in rats. J Pharm Sci 2003;92:938-50
  • Barnett AH, Lange P, Dreyer M, et al. Long-term tolerability of inhaled human insulin (Exubera) in patients with poorly controlled type 2 diabetes. Int J Clin Pract 2007;61:1614-25
  • Agu RU, Ugwoke MI, Armand M, et al. The lung as a route for systemic delivery of therapeutic proteins and peptides. Respir Res 2001;2:198-209
  • Purewal TS. Formulation of Metered Dose Inhalers. Interpharm, Illinois; 1998
  • Smyth HD, Hickey AJ. Carriers in drug powder delivery: implications for inhalation system design. Am J Drug Deliv 2005;3:117-32
  • Wearley LL. Recent progress in protein and peptide delivery by non-invasive routes. Crit Rev Ther Drug Carrier Syst 1991;8:1331-94
  • Patton JS, Fishburn CS, Weers JG. The lungs as a portal of entry for systemic drug delivery. Proc Am Thorac Soc 2004;1:338-44
  • Hastings RH, Grady M, Sakuma T, et al. Clearance of different-sized proteins from the alveolar space in humans and rabbits. J Appl Physiol 1992;73:1310-6
  • Kobayashi S, Kondo S, Juni K. Permeability of peptides and proteins in human cultured alveolar A549 cell monolayer. Pharm Res 1995;12:1115-9
  • Effros RM, Mason GR. Measurements of pulmonary epithelial permeability in vivo. Am Rev Respir Dis 1983;127:S59-65
  • Mostov KE, Simister NE. Transcytosis. Cell 1985;43:389-90
  • Patton JS. Mechanisms of macromolecule absorption by the lungs. Adv Drug Deliv Rev 1996;19:3-36
  • Newman SP. Dry powder inhalers for optimal drug delivery. Expert Opin Biol Ther 2004;4:23-33
  • Onoue S, Iwasa S, Kojima T, et al. Structural transition of glucagon in the concentrated solution observed by electrophoretic and spectroscopic techniques. J Chromatogr A 2006;1109(2):167-73
  • Onoue S, Ohshima K, Debari K, et al. Mishandling of the therapeutic peptide glucagon generates cytotoxic amyloidogenic fibrils. Pharm Res 2004;21:1274-83
  • Onoue S, Yamada S, Yajima T. Bioactive analogues and drug delivery systems of vasoactive intestinal peptide (VIP) for the treatment of asthma/COPD. Peptides 2007;28:1640-50
  • Kohler D. Novolizer: the new technology for the management of asthma therapy. Curr Opin Pulm Med 2003;9(Suppl 1):S11-6
  • Sandoz. Inhaler. US5341801 (1994)
  • Ashurst II, Malton A, Prime D, et al. Latest advances in the development of dry powder inhalers. Pharm Sci Technol Today 2000;3:246-56
  • Glaxo Group. Devices for administering medicaments to patients. US4811731; 1989
  • Boehringer Ingelheim. Capsule holder. WO9428958; 1994
  • Hovione. Medicament inhaler and method. EP666085; 1995
  • Orion Pharma. Dosing device. GB2165159; 1986
  • Astrazeneca. Aerosol formulations of peptides and proteins. WO9619197; 1996
  • Schering Corp. Inhaler for powdered medications. US5829434; 1998
  • Direct-Haler. An inhaler. WO96022802; 1996
  • Asta Medica. Pharmaceutical powder cartridge with integrated metering device and inhaler for powdered medicaments. US5840279; 1998
  • Hitachi. Suction type medicator. WO9833540; 2001
  • Vectura Delivery Devices. Inhalers. WO0100262; 2001
  • Dura Pharmaceuticals. Dry powder inhaler. US5921237; 1999
  • Fisons. Medicament inhalation device and formulation. EP0407028; 1990
  • Newman SP. Therapeutic Aerosols. Butterworths, London. 1984
  • Bell JH, Hartley PS, Cox JS. Dry powder aerosols. Part I: A new powder inhalation device. J Pharm Sci 1971;60:1559-64
  • Dahl R, Backer V, Ollgaard B, et al. Assessment of patient performance of the HandiHaler compared with the metered dose inhaler four weeks after instruction. Respir Med 2003;97:1126-33
  • Pover GM, Langdon CG, Jones SR, et al. Evaluation of a breath operated powder inhaler. J Int Med Res 1988;16:201-3
  • Villax P, Brito V, Steckel H. Development and Performance of a New Simple Dry Powder Inhaler Operating at Low Airflow Rates. Davis Horwood International, Raleigh, NC; 2002
  • Han R, Papadopoulos G, Greenspan B. Investigation of powder dispersion inside a SPIROS dry powder inhaler using particle image velocimetry. Powd Technol 2002;125:266-78
  • Parry-Billings M, Boyes R, Clisby L, et al. Design, development and performance of a multidose dry powder inhaler. Pharm Technol Europe 2000:38-45
  • Dahl R, Creemers JP, Van Noord J, et al. Comparable efficacy and tolerability of formoterol (Foradil) administered via a novel multi-dose dry powder inhaler (Certihaler) or the Aerolizer dry powder inhaler in patients with persistent asthma. Respiration 2004;71:126-33
  • Wetterlin K. Turbuhaler: a new powder inhaler for administration of drugs to the airways. Pharm Res 1988;5:506-8
  • Fan B, Yang T, Keaton D. Application of Computer Modeling in the Design and Development of the New Mometasone Furoate Dry Powder Inhaler (F-dpi) Nozzle. Serentec Press, Raleigh, NC; 2000
  • Meakin BJ, Ganderton D, Panza I, et al. The effect of flow rate on drug delivery from the Pulvinal, a high-resistance dry powder inhaler. J Aerosol Med 1998;11:143-52
  • Keating GM, Faulds D. Airmax: a multi-dose dry powder inhaler. Drugs 2002;62:1887-97
  • Seppala OR, Aalto E, Annila I, et al. The efficacy of a new salbutamol metered-dose powder inhaler in comparison with two other inhaler devices. Respir Med 2001;95:949-53
  • De Boer AH, Gjaltema D, Hagedoorn P, et al. Comparative in vitro performance evaluation of the Novopulmon 200 Novolizer and Budesonid-Ratiopharm Jethaler: two novel budesonide dry powder inhalers. Pharmazie 2004;59:692-9
  • Byron PR. Aerosol Formulation, Generation, and Delivery using Non-metered and Metered Systems. CRC Press, Boca Raton, FL; 1990
  • Suarez S, Hickey AJ. Drug properties affecting aerosol behavior. Respir Care 2000;45:652-66
  • Labiris NR, Dolovich MB. Pulmonary drug delivery. Part I: physiological factors affecting therapeutic effectiveness of aerosolized medications. Br J Clin Pharmacol 2003;56:588-99
  • Chrystyn H. Is total particle dose more important than particle distribution? Respir Med 1997;91(Suppl A):17-9
  • Astrazeneca. Dry powder pharmaceutical formulation. WO0027373; 2000
  • Telko MJ, Hickey AJ. Dry powder inhaler formulation. Respir Care 2005;50:1209-27
  • Thibert R, Parry-Billings M, Shott M. Clickhaler dry powder inhaler: focussed in vitro proof of principle evaluation of a new chemical entity for asthma. Int J Pharm 2002;239:149-56
  • De Boer AH, Hagedoorn P, Gjaltema D, et al. Air classifier technology (ACT) in dry powder inhalation. Part 4: performance of air classifier technology in the Novolizer multi-dose dry powder inhaler. Int J Pharm 2006;310:81-9
  • Endo K, Amikawa S, Matsumoto A, et al. Erythritol-based dry powder of glucagon for pulmonary administration. Int J Pharm 2005;290:63-71
  • Itoham Foods. Powdery preparations and methods for producing the same. WO0243703; 2002
  • British Technology Group. Aerosol carriers. US5376386; 1994
  • Pharmaceutical Discovery Corp. Method for drug delivery to the pulmonary system. US6428771; 2002
  • Pharmaceutical Discovery Corp. Microparticles for lung delivery comprising diketopiperazine. US6071497; 2000
  • Massachusetts Institute of Technology. Amorphous porous particles for deep lung delivery. US6447752; 2002
  • Nektar Therapeutics. Methods and compositions for delivering macromolecules to or via the respiratory tract. US7141236; 2006
  • Taisho Pharmaceutical. Radial spherical crystallization product, process for producing the same and dry powder preparation containing the crystallization product. WO04110585; 2004
  • Chiesi Farmaceutici. Powder particles with smooth surface for use in inhalation therapy. WO0105429; 2001
  • Elan Pharma International. Liquid droplet aerosols of nanoparticulate drugs. US6811767; 2004
  • Advanced Inhalation Research. Large porous particles by spray-drying. WO0113892; 2001
  • Nektar Therapeutics. Particle formation methods and their products. US7115280; 2006
  • Epic Therapeutics. Sustained release microspheres. US6458387; 2002
  • Massachusetts Institute of Technology. Aerodynamically light particles for pulmonary drug delivery. US6977087; 2005
  • Isf Societa Per Azioni. Pharmaceutical compositions for intranasal administration of calcitonin. US5183802; 1993
  • Ab Astra. Systemic administration of a therapeutic preparation. US5506203; 1996
  • Ab Astra. Therapeutic preparation for inhalation. US5518998; 1996
  • Astrazeneca. Compositions for inhalation. US6632456; 2003
  • Ab Astra. Therapeutic preparation for inhalation. US5658878; 1997
  • Glaxosmithkline. Pharmaceutical compositions containing a calcitonin. WO9408622; 1994
  • Astra Aktiebolag. Powder formulations containing melezitose as a diluent. US6004574; 1999
  • Generex Pharmaceuticals. Method for administering insulin. US6432383; 2002
  • Louey MD, Stewart PJ. Particle interactions involved in aerosol dispersion of ternary interactive mixtures. Pharm Res 2002;19:1524-31
  • Young PM, Cocconi D, Colombo P, et al. Characterization of a surface modified dry powder inhalation carrier prepared by ‘particle smoothing’. J Pharm Pharmacol 2002;54:1339-44
  • Zeng XM, Martin GP, Marriott C, et al. The use of lactose recrystallised from carbopol gels as a carrier for aerosolised salbutamol sulphate. Eur J Pharm Biopharm 2001;51:55-62
  • Chan HK, Clark A, Gonda I, et al. Spray dried powders and powder blends of recombinant human deoxyribonuclease (rhDNase) for aerosol delivery. Pharm Res 1997;14:431-7
  • Li HY, Birchall J. Chitosan-modified dry powder formulations for pulmonary gene delivery. Pharm Res 2006;23:941-50
  • Shahiwala A, Misra A. A preliminary pharmacokinetic study of liposomal leuprolide dry powder inhaler: a technical note. AAPS Pharm Sci Tech 2005;6:E482-486
  • Staniforth, JN. Pre-formulation aspects of dry powder aerosols. In: Respiratory drug delivery V. Interpharm Press, Buffalo Grove, IL: USA 1996
  • Patton JS. Deep-lung delivery of therapeutic proteins. Chemtech 1997:34-8
  • Ostrander KD, Hovey DC, Knapp DA, et al. Potential Delivery of Advantages of Spray-dried Nanocrystal Colloidal Budesonide with Clickhaler. Serentec Press, Raleigh, NC; 2000
  • Edwards DA, Hanes J, Caponetti G, et al. Large porous particles for pulmonary drug delivery. Science 1997;276:1868-71
  • Bot AI, Tarara TE, Smith DJ, et al. Novel lipid-based hollow-porous microparticles as a platform for immunoglobulin delivery to the respiratory tract. Pharm Res 2000;17:275-83
  • York P. Strategies for particle design using supercritical fluid technologies. Pharm Sci Technol Today 1999;2:430-40
  • Blair J, Mao L, Hodgers E. Modification of the Pulmonary Absorption of Cyclosporin using SoliDose Technology. Serentec Press, Raleigh, NC; 2000
  • Wilson BR, Grant MI, Steiner SS, et al. Technospheres for Pulmonary and Nasal Applications. Davis Horwood, Raleigh, NC; 2002
  • Mandal TK. Inhaled insulin for diabetes mellitus. Am J Health Syst Pharm 2005;62:1359-64
  • Pandey R, Sharma S, Khuller GK. Nebulization of liposome encapsulated antitubercular drugs in guinea pigs. Int J Antimicrob Agents 2004;24:93-4
  • Vyas SP, Kannan ME, Jain S, et al. Design of liposomal aerosols for improved delivery of rifampicin to alveolar macrophages. Int J Pharm 2004;269:37-49
  • Suarez S, O'Hara P, Kazantseva M, et al. Respirable PLGA microspheres containing rifampicin for the treatment of tuberculosis: screening in an infectious disease model. Pharm Res 2001;18:1315-9
  • Tsapis N, Bennett D, Jackson B, et al. Trojan particles: large porous carriers of nanoparticles for drug delivery. Proc Natl Acad Sci USA 2002;99:12001-5
  • Kinnarinen T, Jarho P, Jarvinen K, et al. Pulmonary deposition of a budesonide/gamma-cyclodextrin complex in vitro. J Control Rel 2003;90:197-205
  • Wollmer P, Backstrom K, Zhao H, et al. Surface active agents as enhancers of alveolar absorption. Pharm Res 2000;17:38-41
  • Khuller GK, Kapur M, Sharma S. Liposome technology for drug delivery against mycobacterial infections. Curr Pharm Des 2004;10:3263-74
  • Jain RA. The manufacturing techniques of various drug loaded biodegradable poly(lactide-co-glycolide) (PLGA) devices. Biomaterials 2000;21:2475-90
  • O'Hara P, Hickey AJ. Respirable PLGA microspheres containing rifampicin for the treatment of tuberculosis: manufacture and characterization. Pharm Res 2000;17:955-61
  • Pandey R, Khuller GK. Polymer based drug delivery systems for mycobacterial infections. Curr Drug Deliv 2004;1:195-201
  • Rao GC, Kumar MS, Mathivanan N, et al. Nanosuspensions as the most promising approach in nanoparticulate drug delivery systems. Pharmazie 2004;59:5-9
  • Jacobs C, Muller RH. Production and characterization of a budesonide nanosuspension for pulmonary administration. Pharm Res 2002;19:189-94
  • Imai T, Sakai M, Ohtake H, et al. In vitro and in vivo evaluation of the enhancing activity of glycyrrhizin on the intestinal absorption of drugs. Pharm Res 1999;16:80-6
  • Hooton JC, Jones MD, Price R. Predicting the behavior of novel sugar carriers for dry powder inhaler formulations via the use of a cohesive-adhesive force balance approach. J Pharm Sci 2006;95:1288-97
  • Nektar Therapeutics. Methods and compositions for the pulmonary delivery insulin. US6737045; 2004
  • Alkermes. Inhalation device and method. US7278425; 2007
  • Mannkind Corp. Purification and stabilization of peptide and protein pharmaceutical agents. US6652885; 2003
  • Kos Pharmaceuticals. Method of treating a systemic disease. US7056494; 2006
  • Eli Lilly. Method for administering insulinotropic peptides. US6720407; 2004
  • Eli Lilly. GLP-1 formulations with protracted time action. WO0298348; 2002
  • Amylin Pharmaceuticals. Use of exendins and agonists thereof for the treatment of gestational diabetes mellitus. US6506724; 2003
  • Nektar Therapeutics. Dispersible macromolecule compositions and methods for their preparation and use. US6423344; 2002
  • Nektar Therapeutics. Pulmonary delivery of active fragments of parathyroid hormone. US6080721; 2000
  • Pfizer. Growth hormone and growth hormone releasing hormone compositions. US6759393; 2004
  • Chiron Corp. HSA-free formulations of interferon-beta. US6887462; 2005
  • Amgen. Pulmonary administration of granulocyte colony stimulating factor. US5284656; 1994
  • Nektar Therapeutics. Compositions and methods for the pulmonary delivery of aerosolized macromolecules. US6797258; 2004
  • Aradigm Corp. Intrapulmonary delivery of peptide drugs. US5558085; 1996
  • Nektar Therapeutics. Pulmonary administration of dry powder formulations for treating infertility. WO0061178; 2000
  • Amarillo Biosciences. Interferon-alpha mediated upregulation of aquaporin expression. US6506377; 2003
  • Nastech Pharmaceutical Co. Compositions and methods for enhanced mucosal delivery of peptide YY and methods for treating and preventing obesity. US7166575; 2007
  • Aeropharm Technology. Medicinal aerosol formulation (2003)
  • Lenzer J. Inhaled insulin is approved in Europe and United States. Br Med J 2006;332:321
  • Muchmore DB, Silverman B, De La Pena A, et al. The AIR inhaled insulin system: system components and pharmacokinetic/glucodynamic data. Diabetes Technol Ther 2007;9(Suppl 1):S41-7
  • Steiner S, Pfutzner A, Wilson BR, et al. Technosphere/Insulin: proof of concept study with a new insulin formulation for pulmonary delivery. Exp Clin Endocrinol Diabetes 2002;110:17-21
  • Mastrandrea LD, Quattrin T. Clinical evaluation of inhaled insulin. Adv Drug Deliv Rev 2006;58:1061-75
  • Henry RR, Mudaliar SR, Howland WC 3rd, et al. Inhaled insulin using the AERx Insulin Diabetes Management System in healthy and asthmatic subjects. Diabetes Care 2003;26:764-9
  • Clarion Pharmaceuticals. Treatment of respiratory diseases utilizing alpha-tocopheryl-phosphocholine. US5883084; 1999
  • Sadrzadeh N, Glembourtt MJ, Stevenson CL. Peptide drug delivery strategies for the treatment of diabetes. J Pharm Sci 2007;96:1925-54
  • Insulin Inhalation, Pfizer/Nektar Therapeutics. HMR 4006, inhaled PEG-insulin – Nektar, PEGylated insulin – Nektar. Drugs Res Dev 2004;5:166-70
  • Patton JS, Bukar JG, Eldon MA. Clinical pharmacokinetics and pharmacodynamics of inhaled insulin. Clin Pharmacokinet 2004;43:781-801
  • Thorens B, Porret A, Buhler L, et al. Cloning and functional expression of the human islet GLP-1 receptor. Demonstration that exendin-4 is an agonist and exendin-(9-39) an antagonist of the receptor. Diabetes 1993;42:1678-82
  • Patton JS. Pulmonary delivery of drugs for bone disorders. Adv Drug Deliv Rev 2000;42:239-48
  • Genentech. Method for collection of aerosolized proteins by inert filtration. US5457044; 1995
  • Itoham Foods. Peptides and medicinal compositions containing the same. WO0448401; 2004
  • Nektar Therapeutics. Stable glassy state powder formulations. US6589560; 2003
  • Sherbrooke University. Use of calcitonin gene-related peptide in the prevention and alleviation of asthma and related bronchospastic pulmonary diseases. US6743429; 2004
  • Pharmagene Laboratories. Use of secretin-receptor ligands in treatment of cystic fibrosis (CF) and chronic obstructive pulmonary disease (COPD). US6780839; 2004
  • Nektar Therapeutics. Method and apparatus for pulmonary administration of dry powder alpha 1-antitrypsin. US5780014; 1998
  • Enanta Pharmaceuticals. Cyclosporins for the treatment of respiratory diseases. US6784156; 2004
  • New York University. Method of treating idiopathic pulmonary fibrosis with aerosolized IFN-gamma. US6964761; 2005
  • Cornell Research Foundation. Stimulation of immune response with low doses of IL-2. WO9741831; 1997
  • Baxter International. Method for preparing small spherical by controlled phase separation. WO0535088; 2005
  • Ohmori Y, Onoue S, Endo K, et al. Development of dry powder inhalation system of novel vasoactive intestinal peptide (VIP) analogue for pulmonary administration. Life Sci 2006;79:138-43
  • Ohmori Y, Yamada S, Maruyama S, et al. Development and pharmacological usefulness of dry powder inhaler of a novel vasoactive intestinal peptide (VIP) analogue. In: Shizuoka Drug Delivery Systems Conference, Volume XII. Kimura R, editor. Progress in Drug Delivery Systems, Shizuoka 2003:1-11
  • Ohmori Y, Maruyama S, Kimura R, et al. Pharmacological effects and lung-binding characteristics of a novel VIP analogue, [R15, 20, 21, L17]-VIP-GRR (IK312532). Regul Pept 2004;123:201-7
  • Tang G, White JE, Gordon RJ, et al. Polyethylene glycol-conjugated superoxide dismutase protects rats against oxygen toxicity. J Appl Physiol 1993;74:1425-31
  • Aeropharm Technology. Method of administering a medicinal aerosol formulation. US6596261; 2003
  • Shiavone H, Wist A, Tzannis ST. Formulation feasibility of drug-loaded PLGA microspheres for pulmonary delivery. 14th Congress of the International Society for Aerosols in Medicine, Baltimore, MD; 2003
  • Byron PR. Determinants of drug and polypeptide bioavailability from aerosols delivered to the lung. Adv Drug Deliv Rev 1990;5:107-32
  • Davis SS. Delivery of peptide and non-peptide drugs through the respiratory tract. Pharm Sci Technol Today 1999;2:450-6
  • Banga AK. Delivery of protein therapeutics. Business Briefing: Pharmatech 2003;198-201

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.