Dry powder insufflation of crystalline and amorphous voriconazole formulations produced by thin film freezing to mice

Doffman, 2005, Invasive pulmonary aspergillosis, Expert Review of Anti-Infective Therapy, 3, 613, 10.1586/14787210.3.4.613 Caston-Osorio, 2008, Epidemiology of invasive fungal infection, International Journal of Antimicrobial Agents, 32, S103, 10.1016/S0924-8579(08)70009-8 Cuenca-Estrella, 2008, Update on the epidemiology and diagnosis of invasive fungal infection, International Journal of Antimicrobial Agents, 32, S143, 10.1016/S0924-8579(08)70016-5 Meersseman, 2004, Invasive aspergillosis in critically ill patients without malignancy, American Journal of Respiratory and Critical Care Medicine, 170, 621, 10.1164/rccm.200401-093OC Roffey, 2003, The disposition of voriconazole in mouse, rat, rabbit, guinea pig, dog, and human, Drug Metabolism and Disposition, 31, 731, 10.1124/dmd.31.6.731 FDA, US Department of Health and Human Services, Center for Drug Evaluation and Research (CDER), Guidance for Industry: Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System, 2000. Buchanan, 2007, Solubility and dissolution studies of antifungal drug: hydroxybutenyl-b-cyclodextrin complexes, Cellulose, 14, 35, 10.1007/s10570-006-9076-x Joukhadar, 2009, Concentrations of voriconazole in healthy and inflamed lung in rats, Antimicrobial Agents and Chemotherapy, 53, 2684, 10.1128/AAC.00885-08 Weiler, 2011, Human tissue distribution of voriconazole, Antimicrobial Agents and Chemotherapy, 55, 925, 10.1128/AAC.00949-10 Camps, 2008, Risk factors for invasive fungal infections in haematopoietic stem cell transplantation, International Journal of Antimicrobial Agents, 32, S119, 10.1016/S0924-8579(08)70012-8 Neofytos, 2009, Epidemiology and outcome of invasive fungal infection in adult hematopoietic stem cell transplant recipients: analysis of multicenter prospective antifungal therapy (PATH) alliance registry, Clinical Infectious Diseases, 48, 265, 10.1086/595846 Herbrecht, 2002, Voriconazole versus amphotericin B for primary therapy of invasive aspergillosis, New England Journal of Medicine, 347, 408, 10.1056/NEJMoa020191 Walsh, 2008, Treatment of aspergillosis: clinical practice guidelines of the Infectious Diseases Society of America, Clinical Infectious Diseases, 46, 327, 10.1086/525258 Hyland, 2003, Identification of the cytochrome P450 enzymes involved in the N-oxidation of voriconazole, Drug Metabolism and Disposition, 31, 540, 10.1124/dmd.31.5.540 Pascual, 2008, Voriconazole therapeutic drug monitoring in patients with invasive mycoses improves efficacy and safety outcomes, Clinical Infectious Diseases, 46, 201, 10.1086/524669 Trifilio, 2007, Monitoring plasma voriconazole levels may be necessary to avoid subtherapeutic levels in hematopoietic stem cell transplant recipients, Cancer, 109, 1532, 10.1002/cncr.22568 Tolman, 2009, Characterization and pharmacokinetic analysis of aerosolized aqueous voriconazole solution, European Journal of Pharmaceutics and Biopharmaceutics, 72, 199, 10.1016/j.ejpb.2008.12.014 Tolman, 2009, Inhaled voriconazole for prevention of invasive pulmonary aspergillosis, Antimicrobial Agents and Chemotherapy, 53, 2613, 10.1128/AAC.01657-08 Chow, 2007, Particle engineering for pulmonary drug delivery, Pharmaceutical Research, 24, 411, 10.1007/s11095-006-9174-3 Chan, 2003, Novel alternative methods for the delivery of drugs for the treatment of asthma, Advanced Drug Delivery Reviews, 55, 793, 10.1016/S0169-409X(03)00078-4 Bhavna, 2009, Nano-salbutamol dry powder inhalation: a new approach for treating broncho-constrictive conditions, European Journal of Pharmaceutics and Biopharmaceutics, 71, 282, 10.1016/j.ejpb.2008.09.018 Edwards, 1997, Large porous particles for pulmonary drug delivery, Science, 276, 1868, 10.1126/science.276.5320.1868 Yang, 2008, Inhaled nanoparticles – a current review, International Journal of Pharmaceutics, 356, 239, 10.1016/j.ijpharm.2008.02.011 Yang, 2008, High bioavailability from nebulized itraconazole nanoparticle dispersions with biocompatible stabilizers, International Journal of Pharmaceutics, 361, 177, 10.1016/j.ijpharm.2008.05.003 Overhoff, 2009, Use of thin film freezing to enable drug delivery: a review, Journal of Drug Delivery Science and Technology, 19, 89, 10.1016/S1773-2247(09)50016-0 K.P. Johnston, J. Engstrom, J. Tam, A. Watts, Compositions and Methods of Making Brittle-matrix Particles through Blister Pack Freezing, US Patent Application 2010/0221343, 2010. Overhoff, 2007, Novel ultra-rapid freezing particle engineering process for enhancement of dissolution rates of poorly water-soluble drugs, European Journal of Pharmaceutics and Biopharmaceutics, 65, 57, 10.1016/j.ejpb.2006.07.012 United States Pharmacopeia, General Chapter 601: Aerosols, Nasal sprays, Metered-dose inhalers, and Dry powder inhalers, in: USP 32-NF 27, Rockville, MD, USA, 2010. Mitchell, 2003, Practices of coating collection surfaces of cascade impactors: A survey of members of the European Pharmaceutical Aerosol Group (EPAG), 75 Son, 2010, Optimization of an in vitro dissolution test method for inhalation formulations, Dissolution Technologies, 17, 6, 10.14227/DT170210P6 Moore, 1996, Mathematical comparison of dissolution profiles, Pharmaceutical Technology, 20 FDA, US Department of Health and Human Services, Center for Drug Evaluation and Research (CDER), Guidance for Industry: Dissolution Testing of Immediate Release Solid Oral Dosage Forms, 1997. Morello, 2009, Dry-powder pulmonary insufflation in the mouse for application to vaccine or drug studies, Tuberculosis, 89, 371, 10.1016/j.tube.2009.07.001 Lutsar, 2003, Voriconazole concentrations in the cerebrospinal fluid and brain tissue of guinea pigs and immunocompromised patients, Clinical Infectious Diseases, 37, 728, 10.1086/377131 Pascual, 2007, Variability of voriconazole plasma levels measured by new high-performance liquid chromatography and bioassay methods, Antimicrobial Agents and Chemotherapy, 51, 137, 10.1128/AAC.00957-06 Beinborn, 2010, Effect of process variables on morphology of voriconazole formulations produced by thin film freezing, The AAPS Journal, 12 SYMBICORT® prescribing information. <http://www1.astrazeneca-us.com/pi/symbicort/pdf> (cited 07.08.11). FDA-CDER. <http://www.accessdata.fda.gov/scripts/cder/iig/index.cfm> (cited 07.08.11). Liu, 2008, Pulmonary delivery of scutellarin solution and mucoadhesive particles in rats, European Journal of Pharmaceutics and Biopharmaceutics, 70, 845, 10.1016/j.ejpb.2008.07.004 Latge, 1999, Aspergillus fumigatus and aspergillosis, Clinical Microbiology Reviews, 12, 310, 10.1128/CMR.12.2.310 Zhang, 2006, Determination of the surface free energy of crystalline and amorphous lactose by atomic force microscopy adhesion measurement, Pharmaceutical Research, 23, 401, 10.1007/s11095-005-9144-1 Hancock, 2000, What is the true solubility advantage for amorphous pharmaceuticals?, Pharmaceutical Research, 17, 397, 10.1023/A:1007516718048 Tam, 2008, Amorphous cyclosporin nanodispersions for enhanced pulmonary deposition and dissolution, Journal of Pharmaceutical Sciences, 97, 4915, 10.1002/jps.21367 Yang, 2010, Comparison of bioavailability of amorphous versus crystalline itraconazole nanoparticles via pulmonary administration in rats, European Journal of Pharmaceutics and Biopharmaceutics, 75, 33, 10.1016/j.ejpb.2010.01.011 Altiere, 2007, Physiology and pharmacology of the airways, 83