Advances in the pulmonary delivery of poorly water-soluble drugs: influence of solubilization on pharmacokinetic properties

References

• Sanders M. (2007). Inhalation therapy: An historical review. Prim Care Respir J, 16(2), 71–81.
   PubMedGoogle Scholar
• Derom E, Thorsson L. (2001). Factors affecting the clinical outcome of aerosol therapy. In Bisgaard H, O'Callaghan C, Smaldone GC, eds. Drug delivery to the lung, vol. 162. New York, NY: Marcel Dekker, Inc., 143–71.
   Google Scholar
• Chow AHL, Tong HHY, Chattopadhyay P, Shekunov BY. (2007). Particle engineering for pulmonary drug delivery. Pharm Res, 24(3):411–37.
   PubMed Web of Science ®Google Scholar
• Yang W, Peters JI, Williams RO, III. (2008). Inhaled nanoparticles. A current review. Int J Pharm, 356(1–2):239–47.
   PubMed Web of Science ®Google Scholar
• Agu RU, Ugwoke MI, Armand M, Kinget R, Verbeke N. (2001). The lung as a route for systemic delivery of therapeutic proteins and peptides. Respir Res, 2(4):198–209.
   PubMed Web of Science ®Google Scholar
• Gonda, I. (2006). Systemic delivery of drugs to humans via inhalation. J Aerosol Med, 19(1):47–53.
   PubMedGoogle Scholar
• Patton JS, Byron PR. (2007). Inhaling medicines: Delivering drugs to the body through the lungs. Nat Rev Drug Discov, 6(1):67–74.
   PubMed Web of Science ®Google Scholar
• Patton JS, Fishburn CS, Weers JG. (2004). The lungs as a portal of entry for systemic drug delivery. Proc Am Thorac Soc, 1(4), 338–44.
   PubMedGoogle Scholar
• Bisgaard H, O'Callaghan C, Smaldone GC., eds. (2002). Drug delivery to the lung, vol. 162. New York, NY: Marcel Dekker, Inc.
   Google Scholar
• Byron PR. (1987). Pulmonary targeting with aerosols. Pharm Technol, 11(5):42, 44, 46, 48, 50, 52, 54, 56.
   Google Scholar
• Cloutier MM. (2007). Respiratory physiology. Philadelphia, PA: Mosby.
   Google Scholar
• Finney MJ, Anderson SD, Black JL. (1987). The effect of non-isotonic solutions on human isolated airway smooth muscle. Respir Physiol, 69(3):277–86.
   PubMedGoogle Scholar
• Martin GP, Bell AE, Marriott C. (1988). An in vitro method for assessing particle deposition from metered pressurized aerosols and dry powder inhalers. Int J Pharm, 44(1–3):57–63.
   Google Scholar
• Bermejo M, Gonzalez-Alvarez I. (2008). How and where are drugs absorbed?. In Gad SC, ed. Preclinical development handbook: ADME and biopharmaceutical properties. Hoboken, NJ: John Wiley & Sons, Inc., 249–80.
   Google Scholar
• Martinez MN, Amidon GL. (2002). A mechanistic approach to understanding the factors affecting drug absorption: A review of fundamentals. J Clin Pharmacol, 42(6):620–43.
   PubMed Web of Science ®Google Scholar
• Sakagami M. (2006). In vivo, in vitro and ex vivo models to assess pulmonary absorption and disposition of inhaled therapeutics for systemic delivery. Adv Drug Deliv Rev, 58(9–10): 1030–60.
   PubMed Web of Science ®Google Scholar
• Miller FJ. (2000). Dosimetry of particles: critical factors having risk assessment implications. Inhal Toxicol, 12(Suppl. 3):389–95.
   PubMedGoogle Scholar
• Lipinski CA., Lombardo F, Dominy BW, Feeney PJ. (1997). Experimental and computational approaches to estimate solubility and permeability in drug discovery and development settings. Adv Drug Deliv Rev, 23(1–3):3–25.
   Web of Science ®Google Scholar
• Pouton CW. (2006). Formulation of poorly water-soluble drugs for oral administration: Physicochemical and physiological issues and the lipid formulation classification system. Eur J Pharm Sci, 29(3–4), 278–87.
   PubMed Web of Science ®Google Scholar
• Rasenack N, Mueller BW. (2005). Poorly water-soluble drugs for oral delivery—a challenge for pharmaceutical development: Part I: physicochemical and biopharmaceutical background/strategies in pharmaceutical development. Pharm Ind, 67(3):323–6.
   Web of Science ®Google Scholar
• Stegemann S, Leveiller F, Franchi D, de Jong H, Linden H. (2007). When poor solubility becomes an issue: From early stage to proof of concept. Eur J Pharm Sci, 31(5):249–61.
   PubMed Web of Science ®Google Scholar
• USP 31 – NF 26. (2008). Rockville, MD: The United States Pharmacopeial Convention.
   Google Scholar
• Center for Drug Evaluation and Research (CDER). (1997). Guidance for industry: Dissolution testing of immediate release solid oral dosage forms. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070237.pdf [accessed July 13, 2009].
   Google Scholar
• Zhou H. (2008). Water-insoluble drugs and their pharmacokinetic behaviors. In: Liu R, ed. Water-insoluble drug formulation. 2nd ed. Hoboken, NJ: Taylor & Francis Ltd.
   Google Scholar
• Drake RE, Laine GA, Allen SJ, Katz J, Gabel JC. (1987). A model of the lung interstitial-lymphatic system. Microvasc Res, 34(1):96–107.
   PubMed Web of Science ®Google Scholar
• Newhouse MT, Hirst PH, Duddu SP, Walter YH, Tarara TE, Clark AR, . (2003). Inhalation of a dry powder tobramycin PulmoSphere formulation in healthy volunteers. Chest, 124(1), 360–6.
   PubMed Web of Science ®Google Scholar
• Lipworth BJ, Jackson CM. (2000). Safety of inhaled and intranasal corticosteroids: Lessons for the new millennium. Drug Saf, 23(1):11–33.
   PubMed Web of Science ®Google Scholar
• Kelly HW. (1998). Establishing a therapeutic index for the inhaled corticosteroids: Part I. Pharmacokinetic/pharmacodynamic comparison of the inhaled corticosteroids. J Allergy Clin Immunol, 102(4 Pt. 2):S36–51.
   PubMed Web of Science ®Google Scholar
• Edsbaecker S. (2001). Uptake, retention, and biotransformation of corticosteroids in the lung and airways. In: Schleimer RP, O'Byrne PM, Szefler SJ, Brattsand R, eds. Inhaled steroids in asthma: oftimizing effects in the airways, vol. 163. New York, NY: Marcel Dekker, Inc., 213–44.
   Google Scholar
• Brindley C, Falcoz C, Mackie AE, Bye, A. (2000). Absorption kinetics after inhalation of fluticasone propionate via the Diskhaler, Diskus, and metered-dose inhaler in healthy volunteers. Clin Pharmacokin, 39(Suppl. 1):1–8.
   PubMedGoogle Scholar
• Freiwald M, Valotis A, Kirschbaum A, McClellan M, Murdter T, Fritz P, . (2005). Monitoring the initial pulmonary absorption of two different beclomethasone dipropionate aerosols employing a human lung reperfusion model. Respir Res, 6:21.
   PubMed Web of Science ®Google Scholar
• Hochhaus G. (2007). Pharmacokinetic and pharmacodynamic properties important for inhaled corticosteroids. Ann Allergy Asthma Immunol, 98(2 Suppl. 2):S7–15.
   Web of Science ®Google Scholar
• Kinnarinen T, Jarho P, Jaervinen K, Jaervinen T. (2003). The in vitro pulmonary deposition of a budesonide/gamma -cyclodextrin inclusion complex. J Incl Phenom Macrocycl Chem, 44(1–4):97–100.
   Web of Science ®Google Scholar
• Laehelmae S, Kirjavainen M, Kela M, Herttuainen J, Vahteristo M, Silvasti M, . (2005). Equivalent lung deposition of budesonide in vivo: A comparison of dry powder inhalers using a pharmacokinetic method. Br J Clin Pharmacol, 59(2):167–73.
   PubMed Web of Science ®Google Scholar
• Saari M, Vidgren MT, Koskinen MO, Turjanmaa VMH, Nieminen MM. (1999). Pulmonary distribution and clearance of two beclomethasone liposome formulations in healthy volunteers. Int J Pharm, 181(1):1–9.
   PubMed Web of Science ®Google Scholar
• Mollmann H, Balbach S, Hochhaus G, Barth J, Derendorf H. (1995). Pharmacokinetic-pharmacodynamic correlations of corticosteroids. In: Derendorf H, Hochhaus G, eds. Handbook of pharmacokinetic/pharmacodynamic correlation. Boca Raton, FL: CRC Press, 323–62.
   Google Scholar
• Lipworth BJ. (1996). Pharmacokinetics of inhaled drugs. Br J Clin Pharmacol, 42(6):697–705.
   PubMed Web of Science ®Google Scholar
• Moelmann H, Wagner M, Krishnaswami S, Dimova H, Tang Y, Falcoz C, . (2001). Single-dose and steady-state pharmacokinetic and pharmacodynamic evaluation of therapeutically clinically equivalent doses of inhaled fluticasone propionate and budesonide, given as Diskus or Turbohaler dry-powder inhalers to healthy subjects. J Clin Pharmacol, 41(12):1329–38.
   PubMed Web of Science ®Google Scholar
• Mortimer KJ, Harrison TW, Tang Y, Wu K, Lewis S, Sahasranaman S, . (2006). Plasma concentrations of inhaled corticosteroids in relation to airflow obstruction in asthma. Br J Clin Pharmacol, 62(4), 412–9.
   PubMed Web of Science ®Google Scholar
• Thorsson L, Dahlstroem K, Edsbaecker S, Kaellen A, Paulson J, Wiren JE. (1997). Pharmacokinetics and systemic effects of inhaled fluticasone propionate in healthy subjects. Br J Clin Pharmacol, 43(2):155–61.
   PubMed Web of Science ®Google Scholar
• Thorsson L, Edsbacker S, Kallen A, Lofdahl CG. (2001). Pharmacokinetics and systemic activity of fluticasone via Diskus and pMDI, and of budesonide via Turbuhaler. Br J Clin Pharmacol, 52(5):529–38.
   PubMed Web of Science ®Google Scholar
• Whelan GJ, Blumer JL, Martin RJ, Szefler SJ. (2005). Fluticasone propionate plasma concentration and systemic effect: Effect of delivery device and duration of administration. J Allergy Clin Immunol, 116(3):525–30.
   PubMed Web of Science ®Google Scholar
• Argenti D, Shah B, Heald D. (2000). A study comparing the clinical pharmacokinetics, pharmacodynamics, and tolerability of triamcinolone acetonide HFA-134a metered-dose inhaler and budesonide dry-powder inhaler following inhalation administration. J Clin Pharmacol, 40(5):516–26.
   PubMed Web of Science ®Google Scholar
• Bisgaard H, Nikander K, Munch E. (1998). Comparative study of budesonide as a nebulized suspension vs pressurized metered-dose inhaler in adult asthmatics. Respir Med, 92(1):44–9.
   PubMed Web of Science ®Google Scholar
• Kraft WK, Steiger B, Beussink D, Quiring JN. Fitzgerald N, Greenberg HE, . (2004). The pharmacokinetics of nebulized nanocrystal budesonide suspension in healthy volunteers. J Clin Pharmacol, 44(1):67–72.
   PubMed Web of Science ®Google Scholar
• Shrewsbury SB, Bosco AP, Uster PS. (2009). Pharmacokinetics of a novel submicron budesonide dispersion for nebulized delivery in asthma. Int J Pharm, 365(1–2):12–7.
   PubMedGoogle Scholar
• Hill M. (2007). US patent no. US 2007/0197487 A1. USPTO.
   Google Scholar
• Daley-Yates PT, Price AC, Sisson JR, Pereira A. Dallow N. (2001). Beclomethasone dipropionate: absolute bioavailability, pharmacokinetics and metabolism following intravenous, oral, intranasal and inhaled administration in man. Br J Clin Pharmacol, 51(5):400–9.
   PubMed Web of Science ®Google Scholar
• Esposito-Festen JE, Zanen P, Tiddens HAWM, Lammers JWJ. (2007). Pharmacokinetics of inhaled monodisperse beclomethasone as a function of particle size. Br J Clin Pharmacol, 64(3):328–34.
   PubMed Web of Science ®Google Scholar
• Lim JGP, Shah B, Rohatagi S, Bell A. (2006). Development of a dry powder inhaler, the Ultrahaler, containing triamcinolone acetonide using in vitro-in vivo relationships. Am J Ther, 13(1):32–42.
   PubMedGoogle Scholar
• Argenti D, Shah B, Heald D. (1999). A pharmacokinetic study to evaluate the absolute bioavailability of triamcinolone acetonide following inhalation administration. J Clin Pharmacol, 39(7):695–702.
   PubMed Web of Science ®Google Scholar
• Hintz RJ., Johnson KC. (1989). The effect of particle size distribution on dissolution rate and oral absorption. Int J Pharm, 51(1):9–17.
   Web of Science ®Google Scholar
• Johnson KC. (2007). Dissolution: Fundamentals of in vitro release and the biopharmaceutics classification system. Drugs Pharm Sci, 165(Pharmaceutical Product Development):1–28.
   Google Scholar
• Takano R, Furumoto K, Shiraki K, Takata N, Hayashi Y, Aso Y, . (2008). Rate-limiting steps of oral absorption for poorly water-soluble drugs in dogs; prediction from a miniscale dissolution test and a physiologically-based computer simulation. Pharm Res, 25(10):2334–44.
   PubMed Web of Science ®Google Scholar
• Sigfridsson K, Forssen S, Hollaender P, Skantze U, de Verdier J. (2007). A formulation comparison, using a solution and different nanosuspensions of a poorly soluble compound. Eur J Pharm Biopharm, 67(2):540–7.
   PubMed Web of Science ®Google Scholar
• Brown TER, Chin TWF. (2008). Superficial fungal infections. In DiPiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey LM, eds. Pharmacotherapy: A pathophysiologic approach. 6th ed. Chicago, IL: McGraw-Hill.
   Google Scholar
• Carver PL. (2008). Invasive fungal infections. In DiPiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey LM. eds. Pharmacotherapy: A pathophysiologic approach. 6th ed. Chicago, IL: McGraw-Hill.
   Google Scholar
• Kauffman CA. (2006). Fungal infections. Proc Am Thorac Soc, 3(1):35–40.
   PubMedGoogle Scholar
• Patterson TF. (2005). Advances and challenges in management of invasive mycoses. Lancet, 366(9490):1013–25.
   PubMed Web of Science ®Google Scholar
• Clemons KV, Stevens DA. (2005). The contribution of animal models of aspergillosis to understanding pathogenesis, therapy and virulence. Med Mycol, 43(Suppl. 1):S101–10.
   PubMed Web of Science ®Google Scholar
• Boucher HW, Groll AH, Chiou CC, Walsh TJ. (2004). Newer systemic antifungal agents: Pharmacokinetics, safety and efficacy. Drugs, 64(18):1997–2020.
   PubMed Web of Science ®Google Scholar
• Wiebe V, Karriker M. (2005). Therapy of systemic fungal infections: A pharmacologic perspective. Clin Tech Small Anim Pract, 20(4):250–7.
   PubMedGoogle Scholar
• Yalkowsky SH, He Y. (2003). Handbook of aqueous solubility data. Boca Raton, FL: CRC Press.
   Google Scholar
• Bennett JE. (2006). Antimicrobial agents: Antifungal agents. In: Brunton LL, Lazo JS, Parker KL, eds. Goodman & Gilman's the pharmacological basis of therapeutics. 11th ed. New York, NY: The McGraw-Hill Companies, Inc.
   Google Scholar
• Miyake K, Irie T, Arima H, Hirayama F, Uekama K, Hirano M, . (1999). Characterization of itraconazole/2-hydroxypropyl-beta-cyclodextrin inclusion complex in aqueous propylene glycol solution. Int J Pharm, 179(2):237–45.
   PubMedGoogle Scholar
• Rhee Y-S, Park C-W, Nam T-Y, Shin Y-S, Chi S-C, Park E-S. (2007). Formulation of parenteral microemulsion containing itraconazole. Arch Pharm Res, 30(1):114–23.
   PubMed Web of Science ®Google Scholar
• Gold W, Stout HA., Pagano JF, Donovick R. (1956). Amphotericins A and B, antifungal antibiotics produced by a streptomycete. I. In vitro studies. Antibiot Ann, 579–85.
   Google Scholar
• Bennett JE. (2001). Antimicrobial agents: antifungal agents. In: Hardman JG, Limbird LE, eds. Goodman & Gilman's the pharamcological basis of therapeutics. 10th ed. Chicago, IL: McGraw-Hill, 1295–9.
   Google Scholar
• Graybill JR, Revankar SG, Patterson TF. (1998). Antifungal agents and antifungal susceptibility testing. In: Ajello L, Hay RJ, eds. Medical mycology, 9th ed., vol. 4. New York, NY: Oxford University Press, Inc., 163–5.
   Google Scholar
• Brajtburg J, Powderly WG, Kobayashi GS., Medoff G. (1990). Amphotericin B: Current understanding of mechanisms of action. Antimicrob Agents Chemother, 34(2), 183–8.
   PubMed Web of Science ®Google Scholar
• Diot P. Rivoire B, Le Pape A, Lemarie E, Dire D, Furet Y, . (1995). Deposition of amphotericin B aerosols in pulmonary aspergilloma. Eur Respir J, 8(8):1263–8.
   PubMed Web of Science ®Google Scholar
• Koizumi T, Kubo K, Kaneki T, Hanaoka M, Hayano T, Miyahara T, . (1998). Pharmacokinetic evaluation of amphotericin B in lung tissue: Lung lymph distribution after intravenous injection and airspace distribution after aerosolization and inhalation of amphotericin B. Antimicrob Agents Chemother, 42(7):1597–600.
   PubMed Web of Science ®Google Scholar
• Lowry CM, Marty FM, Vargas SO, Lee JT., Fiumara K, Deykin A, . (2007). Safety of aerosolized liposomal versus deoxycholate amphotericin B formulations for prevention of invasive fungal infections following lung transplantation: A retrospective study. Transpl Infect Dis, 9(2):121–5.
   PubMed Web of Science ®Google Scholar
• Marra F, Partovi N, Wasan KM, Kwong EH, Ensom MHH, Cassidy SM, . (2002). Amphotericin B disposition after aerosol inhalation in lung transplant recipients. Ann Pharmacother, 36(1):46–51.
   PubMed Web of Science ®Google Scholar
• Monforte V, Roman A, Gavalda J, Lopez R, Pou L, Simo M, . (2003). Nebulized amphotericin B concentration and distribution in the respiratory tract of lung transplanted patients. Transplantation, 75(9):1571–4.
   PubMed Web of Science ®Google Scholar
• Ruijgrok EJ, Vulto AG, Van Etten EWM. (2000). Aerosol delivery of amphotericin B desoxycholate (Fungizone) and liposomal amphotericin B (AmBisome): Aerosol characteristics and in-vivo amphotericin B deposition in rats. J Pharm Pharmacol, 52(6):619–27.
   PubMed Web of Science ®Google Scholar
• Rogers TL, Nelsen AC, Sarkari M, Young TJ, Johnston KP, Williams RO, III. (2003). Enhanced aqueous dissolution of a poorly water soluble drug by novel particle engineering technology: Spray-freezing into liquid with atmospheric freeze-drying. Pharm Res, 20(3), 485–93.
   PubMed Web of Science ®Google Scholar
• Overhoff KA, Engstrom JD, Chen B, Scherzer BD, Milner TE, Johnston KP, . (2007). Novel ultra-rapid freezing particle engineering process for enhancement of dissolution rates of poorly water-soluble drugs. Eur J Pharm Biopharm, 65(1):57–67.
   PubMed Web of Science ®Google Scholar
• Hu J, Johnston KP, Williams RO, III. (2004). Nanoparticle engineering processes for enhancing the dissolution rates of poorly water soluble drugs. Drug Dev Ind Pharm, 30(3):233–45.
   PubMed Web of Science ®Google Scholar
• Yang W, Tam J, Miller DA, Zhou J, McConville JT, Johnston KP, . (2008). High bioavailability from nebulized itraconazole nanoparticle dispersions with biocompatible stabilizers. Int J Pharm, 361(1–2):177–88.
   PubMedGoogle Scholar
• Purvis T, Vaughn Jason M, Rogers True L, Chen X, Overhoff Kirk A, Sinswat P, . (2006). Cryogenic liquids, nanoparticles, and microencapsulation. Int J Pharm, 324(1), 43–50.
   PubMedGoogle Scholar
• Hoeben BJ, Burgess DS, McConville JT, Najvar LK, Talbert RL, Peters JI, . (2006). In vivo efficacy of aerosolized nanostructured itraconazole formulations for prevention of invasive pulmonary aspergillosis. Antimicrob Agents Chemother, 50(4):1552–4.
   PubMed Web of Science ®Google Scholar
• McConville JT, Overhoff KA, Sinswat P, Vaughn JM, Frei BL, Burgess DS, . (2006). Targeted high lung concentrations of itraconazole using nebulized dispersions in a murine model. Pharm Res, 23(5):901–11.
   PubMed Web of Science ®Google Scholar
• Vaughn JM, McConville JT, Burgess D, Peters JI, Johnston KP, Talbert RL, . (2006). Single dose and multiple dose studies of itraconazole nanoparticles. Eur J Pharm Biopharm, 63(2):95–102.
   PubMed Web of Science ®Google Scholar
• Ewing P, Blomgren B, Ryrfeldt A, Gerde P. (2006). Increasing exposure levels cause an abrupt change in the absorption and metabolism of acutely inhaled benzo(a)pyrene in the isolated, ventilated, and perfused lung of the rat. Toxicol Sci, 91(2):332–40.
   PubMed Web of Science ®Google Scholar
• Bruesewitz C, Schendler A, Funke A, Wagner T, Lipp R. (2007). Novel poloxamer-based nanoemulsions to enhance the intestinal absorption of active compounds. Int J Pharm, 329(1–2), 173–81.
   PubMedGoogle Scholar
• Wong SM, Kellaway IW, Murdan S. (2006). Enhancement of the dissolution rate and oral absorption of a poorly water soluble drug by formation of surfactant-containing microparticles. Int J Pharm, 317(1):61–8.
   PubMedGoogle Scholar
• Vermeij P, Blok D. (1996). New peptide and protein drugs. Pharm World Sci, 18(3):87–93.
   PubMed Web of Science ®Google Scholar
• Goldberg M, Gomez-Orellana I. (2003). Challenges for the oral delivery of macromolecules. Nat Rev Drug Discov, 2(4):289–95.
   PubMed Web of Science ®Google Scholar
• Kumar TRS, Soppimath K, Nachaegari SK. (2006). Novel delivery technologies for protein and peptide therapeutics. Curr Pharm Biotechnol, 7(4):261–76.
   PubMed Web of Science ®Google Scholar
• Morishita M, Peppas NA. (2006). Is the oral route possible for peptide and protein drug delivery?. Drug Discov Today, 11(19 & 20):905–10.
   PubMed Web of Science ®Google Scholar
• Shoyele SA, Slowey A. (2006). Prospects of formulating proteins/peptides as aerosols for pulmonary drug delivery. Int J Pharm, 314(1):1–8.
   PubMed Web of Science ®Google Scholar
• Blot F, Faurisson F, Bernard N, Sellam S, Friard S, Tavakoli R, . (1999). Nebulized cyclosporine in the rat: Assessment of regional lung and extrapulmonary deposition. Transplantation, 68(2):191–5.
   PubMed Web of Science ®Google Scholar
• Mitruka SN, Pham SM, Zeevi A, Li S, Cai J, Burckart GJ, . (1998). Aerosol cyclosporine prevents acute allograft rejection in experimental lung transplantation. J Thorac Cardiovasc Surg, 115(1):28–37.
   PubMed Web of Science ®Google Scholar
• Mitruka SN, Won A, McCurry KR, Zeevi A, McKaveney T, Venkataramanan R, . (2000). In the lung aerosol cyclosporine provides a regional concentration advantage over intramuscular cyclosporine. J Heart Lung Transplant, 19(10):969–75.
   PubMed Web of Science ®Google Scholar
• Burckart GJ, Smaldone GC., Eldon MA, Venkataramanan R, Dauber J, Zeevi A, . (2003). Lung deposition and pharmacokinetics of cyclosporine after aerosolization in lung transplant patients. Pharm Res, 20(2), 252–6.
   PubMed Web of Science ®Google Scholar
• Keenan R, Iacono A, Dauber J, Zeevi A, Yousem S, Ohori N, . (1997). Treatment of refractory acute allograft rejection with aerosolized cyclosporine in lung transplant recipients. J Thorac Cardiovasc Surg, 113(2):335–40.
   PubMed Web of Science ®Google Scholar
• Wang T, Noonberg S, Steigerwalt R, Lynch M, Kovelesky RA, Rodriguez CA., . (2007). Preclinical safety evaluation of inhaled cyclosporine in propylene glycol. J Aerosol Med, 20(4):417–28.
   PubMedGoogle Scholar
• Letsou G, Safi H, Reardon M, Ergenoglu M, Li Z, Klonaris C, . (1999). Pharmacokinetics of liposomal aerosolized cyclosporine A for pulmonary immunosuppression. Ann Thorac Surg, 68(6):2044–8.
   PubMed Web of Science ®Google Scholar
• Waldrep JC, Arppe J, Jansa KA, Vidgren M. (1998). Experimental pulmonary delivery of cyclosporin A by liposome aerosol. Int J Pharam, 160(2):239–49.
   Web of Science ®Google Scholar
• Tam JM, McConville JT, Williams RO, III, Johnston KP. (2008). Amorphous cyclosporin nanodispersions for enhanced pulmonary deposition and dissolution. J Pharm Sci, 97(11):4915–33.
   PubMed Web of Science ®Google Scholar
• Adell A. (2004). Antidepressant properties of substance P antagonists: Relationship to monoaminergic mechanisms?. Curr Drug Targets: CNS Neurol Disord, 3(2):113–21.
   PubMedGoogle Scholar
• Diemunsch P, Grelot L. (2003). Potential of substance P antagonists as antiemetics. Antiemetic Ther, 78–97. http://content.karger.com/ProdukteDB/produkte.asp?Aktion=ShowPDF&ArtikelNr=71407&ProduktNr=228876&filename=71407.pdf [accessed July 13, 2009].
   Google Scholar
• Henry JL. (1993). Substance P and inflammatory pain: Potential of substance P antagonists as analgesics. Agents Actions Suppl, 41(Inflammatory Disease Therapy):75–87.
   Google Scholar
• Nakate T, Yoshida H, Ohike A, Tokunaga Y, Ibuki R, Kawashima Y. (2003b). Improvement of pulmonary absorption of cyclopeptide FK224 in rats by co-formulating with beta-cyclodextrin. Eur J Pharm Biopharm, 55(2):147–54.
   PubMed Web of Science ®Google Scholar
• Nakate T, Yoshida H, Ohike A, Tokunaga Y, Ibuki R, Kawashima Y. (2003). Comparison of the lung absorption of FK224 inhaled from a pressurized metered dose inhaler and a dry powder inhaler by healthy volunteers. Eur J Pharm Biopharm, 56(3):319–25.
   PubMed Web of Science ®Google Scholar
• Stavchansky S, Martin A, Loper A. (1979). Solvent system effects on drug absorption. Res Commun Chem Pathol Pharmacol, 24(1):77–85.
   PubMedGoogle Scholar
• Krishna R, Webb MS., St. Onge G, Mayer LD. (2001). Liposomal and nonliposomal drug pharmacokinetics after administration of liposome-encapsulated vincristine and their contribution to drug tissue distribution properties. J Pharmacol Exp Ther, 298(3):1206–12.
   PubMed Web of Science ®Google Scholar
• Mallick S, Pattnaik S, Swain K, De PK. (2007). Current perspectives of solubilization: Potential for improved bioavailability. Drug Dev Ind Pharm, 33(8):865–73.
   PubMed Web of Science ®Google Scholar
• Wax PM, Becker CE, Curry SC. (2003). Unexpected ‘gas’ casualties in Moscow: A medical toxicology perspective. Ann. Emerg. Med. 41(5):700–5.
   PubMed Web of Science ®Google Scholar
• Hung O, Pliura D. (2008). Comparative phase I PK study of aerosolized free and liposome-encapsulated fentanyl (AeroLEF™) demonstrates rapid and extended plasma fentanyl concentrations following inhalation. Paper presented at the 27th annual scientific meeting of the American Pain Society.
   Google Scholar
• Hung OR, Whynot SC, Varvel JR, Shafer SL. (1995). Pharmacokinetics of inhaled liposome-encapsulated fentanyl. Anesthesiology, 83(2):277–84.
   PubMed Web of Science ®Google Scholar
• Mather LE., Woodhouse A, Ward ME, Farr SJ, Rubsamen RA, Eltherington LG. (1998). Pulmonary administration of aerosolized fentanyl: Pharmacokinetic analysis of systemic delivery. Br J Clin Pharmacol, 46(1):37–43.
   PubMed Web of Science ®Google Scholar
• LAB International Inc. (2005, October 26). LAB International announces positive preliminary results from additional Phase 1 fentanyl TAIFUN® trial, http://www.akelapharma.com/modules.php?op=modload&name=News&file=article&sid=17 [accessed December 28, 2008].
   Google Scholar
• Overhoff KA, Clayborough R, Crowley M. (2008). Review of the TAIFUN multidose dry powder inhaler technology. Drug Dev Ind Pharm, 34(9):960–5.
   PubMed Web of Science ®Google Scholar
• Miyake K, Arima H, Irie T, Hirayama F, Uekama K. (1999). Enhanced absorption of cyclosporin A by complexation with dimethyl-beta-cyclodextrin in bile duct-cannulated and -noncannulated rats. Biol Pharm Bull, 22(1):66–72.
   PubMed Web of Science ®Google Scholar
• Porter CJH, Pouton CW, Cuine JF, Charman WN. (2008). Enhancing intestinal drug solubilization using lipid-based delivery systems. Adv Drug Deliv Rev, 60(6):673–91.
   PubMed Web of Science ®Google Scholar
• Hickey AJ. (2002). Delivery of drugs by the pulmonary route. In: Banker GS, Rhodes CT, eds. Drugs and the Pharmaceutical Sciences, 4th ed. vol. 121. New York, NY: Marcel Dekker, 479–99.
   Google Scholar
• Winkler J, Hochhaus G, Derendorf H. (2004). How the lung handles drugs: Pharmacokinetics and pharmacodynamics of inhaled corticosteroids. Proc Am Thorac Soc, 1(4):356–63.
   PubMedGoogle Scholar
• Williams AC, Barry BW. (2004). Penetration enhancers. Adv Drug Deliv Rev, 56(5):603–18.
   PubMed Web of Science ®Google Scholar
• Jarabek A, Asgharian B, Miller F. (2005). Dosimetric adjustments for interspecies extrapolation of inhaled poorly soluble particles (PSP). Inhal Toxicol, 17(7–8):317–34.
   PubMed Web of Science ®Google Scholar
• Carrier RL, Miller LA, Ahmed I. (2007). The utility of cyclodextrins for enhancing oral bioavailability. J. Control Release, 123(2):78–99.
   PubMed Web of Science ®Google Scholar
• Challa R, Ahuja A, Ali J, Khar RK. (2005). Cyclodextrins in drug delivery: An updated review. AAPS Pharm Sci Tech, 6(2):E329–57.
   PubMed Web of Science ®Google Scholar
• Bekersky I, Fielding RM, Dressler DE, Lee JW, Buell DN, Walsh TJ. (2002). Plasma protein binding of amphotericin B and pharmacokinetics of bound versus unbound amphotericin B after administration of intravenous liposomal amphotericin B (AmBisome) and amphotericin B deoxycholate. Antimicrob Agents Chemother, 46(3):834–40.
   PubMed Web of Science ®Google Scholar