Gamma scintigraphic pulmonary deposition study of glycopyrronium/formoterol metered dose inhaler formulated using co-suspension delivery technology

European Journal of Pharmaceutical Sciences

Volumn 111, Issue , 2018, Pages 450-457

  Taylor, Glyn ^a   Warren, Simon ^a   Dwivedi, Sarvajna ^b   Sommerville, Mark ^b   Mello, Lauren ^b   Orevillo, Chad ^b   Maes, Andrea ^b   Martin, Ubaldo J ^b   Usmani, Omar S ^c  

^a Cardiff Scintigraphics Ltd   (United Kingdom)

^b ASTRAZENECA   (United Kingdom)

^c ROYAL BROMPTON HOSPITAL   (United Kingdom)

Author keywords

Co suspension delivery technology; Formoterol fumarate dihydrate; Gamma scintigraphy; Glycopyrronium; Metered dose inhaler; Pulmonary deposition

Indexed keywords

FORMOTEROL FUMARATE PLUS GLYCOPYRRONIUM BROMIDE; PERTECHNETIC ACID TC 99M; PLACEBO; BRONCHODILATING AGENT; FORMOTEROL FUMARATE; GLYCOPYRRONIUM; MUSCARINIC RECEPTOR BLOCKING AGENT;

ADULT; AEROSOL; ARTICLE; CLINICAL ARTICLE; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG DELIVERY SYSTEM; DRUG SAFETY; DRUG TOLERABILITY; GAMMA SCINTIGRAPHY; HEADACHE; HUMAN; ISOTOPE LABELING; LUNG FUNCTION; MALE; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; RADIOACTIVITY; RANDOMIZED CONTROLLED TRIAL; SINGLE BLIND PROCEDURE; SINGLE DRUG DOSE; ADMINISTRATION AND DOSAGE; DRUG COMBINATION; INHALATIONAL DRUG ADMINISTRATION; LUNG; METERED DOSE INHALER; MIDDLE AGED; PHARMACOKINETICS; SCINTISCANNING; SUSPENSION;

ADMINISTRATION, INHALATION; ADULT; AEROSOLS; BRONCHODILATOR AGENTS; CROSS-OVER STUDIES; DRUG COMBINATIONS; DRUG DELIVERY SYSTEMS; FORMOTEROL FUMARATE; GLYCOPYRROLATE; HUMANS; LUNG; MALE; METERED DOSE INHALERS; MIDDLE AGED; MUSCARINIC ANTAGONISTS; RADIONUCLIDE IMAGING; SUSPENSIONS;

EID: 85032345768     PISSN: 09280987     EISSN: 18790720     Source Type: Journal    
DOI: 10.1016/j.ejps.2017.10.026     Document Type: Article

References (31)

1. de Backer, W., Devolder, A., Poli, G., Acerbi, D., Monno, R., Herpich, C., Sommerer, K., Meyer, T., Mariotti, F., Lung deposition of BDP/formoterol HFA pMDI in healthy volunteers, asthmatic, and COPD patients. J. Aerosol Med. Pulm. Drug Deliv. 23 (2010), 137–148.
2. Bateman, E.D., Ferguson, G.T., Barnes, N., Gallagher, N., Green, Y., Henley, M., Banerji, D., Dual bronchodilation with QVA149 versus single bronchodilator therapy: the SHINE study. Eur. Respir. J. 42 (2013), 1484–1494.
3. Battisti, W.P., Wager, E., Baltzer, L., Bridges, D., Cairns, A., Carswell, C.I., Citrome, L., Gurr, J.A., Mooney, L.A., Moore, B.J., Pena, T., Sanes-Miller, C.H., Veitch, K., Woolley, K.L., Yarker, Y.E., Good publication practice for communicating company-sponsored medical research: GPP3. Ann. Intern. Med. 163 (2015), 461–464.
4. Biddiscombe, M.F., Meah, S.N., Underwood, S.R., Usmani, O.S., Comparing lung regions of interest in gamma scintigraphy for assessing inhaled therapeutic aerosol deposition. J. Aerosol Med. Pulm. Drug Deliv. 24 (2011), 165–173.
5. Boyd, B., Noymer, P., Liu, K., Okikawa, J., Hasegawa, D., Warren, S., Taylor, G., Ferguson, E., Schuster, J., Farr, S., Gonda, I., Effect of gender and device mouthpiece shape on bolus insulin aerosol delivery using the AERx pulmonary delivery system. Pharm. Res. 21 (2004), 1776–1782.
6. Brand, P., Hederer, B., Austen, G., Dewberry, H., Meyer, T., Higher lung deposition with Respimat Soft Mist inhaler than HFA-MDI in COPD patients with poor technique. Int. J. Chron. Obstruct. Pulmon. Dis. 3 (2008), 763–770.
7. Celli, B., Crater, G., Kilbride, S., Mehta, R., Tabberer, M., Kalberg, C.J., Church, A., Once-daily umeclidinium/vilanterol 125/25 mcg in COPD: a randomized, controlled study. Chest 145 (2014), 981–991.
8. Chrystyn, H., Methods to determine lung distribution of inhaled drugs - could gamma scintigraphy be the gold standard?. Br. J. Clin. Pharmacol. 49 (2000), 525–528.
9. Clark, A.R., Understanding penetration index measurements and regional lung targeting. J. Aerosol Med. Pulm. Drug Deliv. 25 (2012), 179–187.
10. Darquenne, C., Fleming, J.S., Katz, I., Martin, A.R., Schroeter, J., Usmani, O.S., Venegas, J., Schmid, O., Bridging the gap between science and clinical efficacy: physiology, imaging, and modeling of aerosols in the lung. J. Aerosol Med. Pulm. Drug Deliv. 29 (2016), 107–126.
11. Devadason, S.G., Chan, H.K., Haeussermann, S., Kietzig, C., Kuehl, P.J., Newman, S., Sommerer, K., Taylor, G., Validation of radiolabeling of drug formulations for aerosol deposition assessment of orally inhaled products. J. Aerosol Med. Pulm. Drug Deliv. 25:Suppl. 1 (2012), S6–S9.
12. Farr, S.J., Rowe, A.M., Rubsamen, R., Taylor, G., Aerosol deposition in the human lung following administration from a microprocessor controlled pressurised metered dose inhaler. Thorax 50 (1995), 639–644.
13. Global Initiative for Chronic Obstructive Lung Disease, Global strategy for the diagnosis, management and prevention of COPD, global initiative for chronic obstructive lung diseases (GOLD). Available at: http://www.goldcopd.org, 2017. (Accessed 18 November 2016)
14. Hanania, N.A., Tashkin, D.P., Kerwin, E.M., Donohue, J.F., Denenberg, M., O'Donnell, D.E., Quinn, D., Siddiqui, S., Orevillo, C., Maes, A., Reisner, C., Long term safety and efficacy of glycopyrrolate/formoterol metered dose inhaler using novel Co-Suspension™ Delivery Technology in patients with chronic obstructive pulmonary disease. Respir. Med. 26 (2017), 105–115.
15. Hirst, P.H., Pitcairn, G.R., Weers, J.G., Tarara, T.E., Clark, A.R., Dellamary, L.A., Hall, G., Shorr, J., Newman, S.P., In vivo lung deposition of hollow porous particles from a pressurized metered dose inhaler. Pharm. Res. 19 (2002), 258–264.
16. Leach, C.L., Kuehl, P.J., Chand, R., McDonald, J.D., Respiratory tract deposition of HFA-beclomethasone and HFA-fluticasone in asthmatic patients. J. Aerosol Med. Pulm. Drug Deliv. 29 (2016), 127–133.
17. Martinez, F.J., Rabe, K.F., Ferguson, G.T., Fabbri, L.M., Rennard, S., Feldman, G.J., Sethi, S., Spangenthal, S., Gottschlich, G., Rodriguez-Roisin, R., Arora, S., Siler, T.M., Siddiqui, S., Darken, P., Fischer, T., Maes, A., Golden, M., Orevillo, C., Reisner, C., Efficacy and safety of glycopyrrolate/formoterol metered dose inhaler formulated using co-suspension delivery technology in patients with COPD. Chest 151 (2017), 340–357.
18. Newman, S., Salmon, A., Nave, R., Drollmann, A., High lung deposition of 99mTc-labeled ciclesonide administered via HFA-MDI to patients with asthma. Respir. Med. 100 (2006), 375–384.
19. Newman, S., Bennett, W.D., Biddiscombe, M., Devadason, S.G., Dolovich, M.B., Fleming, J., Haeussermann, S., Kietzig, C., Kuehl, P.J., Laube, B.L., Sommerer, K., Taylor, G., Usmani, O.S., Zeman, K.L., Standardization of techniques for using planar (2D) imaging for aerosol deposition assessment of orally inhaled products. J. Aerosol Med. Pulm. Drug Deliv. 25:Suppl. 1 (2012), S10–S28.
20. Nikander, K., Prince, I., Coughlin, S., Warren, S., Taylor, G., Mode of breathing-tidal or slow and deep-through the I-neb Adaptive Aerosol Delivery (AAD) system affects lung deposition of (99m)Tc-DTPA. J. Aerosol Med. Pulm. Drug Deliv. 23:Suppl. 1 (2010), S37–S43.
21. Rabe, K., Martinez, F., Rodriguez-Roisin, R., Fabbri, L.M., Ferguson, G.T., Jones, P., Rennard, S., Golden, M., Darken, P., Orevillo, C., Fischer, T., Reisner, C., PT003, a novel co-suspension MDI glycopyrronium/formoterol fixed-dose combination is superior to monocomponents in patients with COPD. Eur. Respir. J., 46(Suppl. 59), 2015 abs PA4363.
22. United States Pharmacopeial Convention, I, [601] Inhalation and nasal drug products: aerosols, sprays, and powders - performance quality tests. C.7 Apparatus 6 for inhalation aerosol and sprays - next generation impactor (without pre-separator). 2017 U.S. Pharmacopoeia-National Formulary [USP 40 NF 35]. Rockville, MD, 2017, 498.
23. Usmani, O.S., Treating the small airways. Respiration 84 (2012), 441–453.
24. Usmani, O.S., Barnes, P.J., Assessing and treating small airways disease in asthma and chronic obstructive pulmonary disease. Ann. Med. 44 (2012), 146–156.
25. Usmani, O.S., Biddiscombe, M.F., Barnes, P.J., Regional lung deposition and bronchodilator response as a function of beta2-agonist particle size. Am. J. Respir. Crit. Care Med. 172 (2005), 1497–1504.
26. Vehring, R., Hartman, M.S., Schultz, R., Joshi, V., Sommerville, M., Cummings, R.H., Smith, A., Golden, M., Dwivedi, S.K., Reisner, C., Glycopyrrolate and formoterol fumarate monotherapy and combination metered dose inhalers with high dose uniformity and stable aerosol properties. Poster presented at the Annual Meeting of the American Thoracic Society, New Orleans, LA, USA, 14–19 May, 2010.
27. Vehring, R., Lechuga-Ballesteros, D., Joshi, V., Noga, B., Dwivedi, S.K., Cosuspensions of microcrystals and engineered microparticles for uniform and efficient delivery of respiratory therapeutics from pressurized metered dose inhalers. Langmuir 28 (2012), 15015–15023.
28. Warren, S., Taylor, G., Smith, J., Buck, H., Parry-Billings, M., Gamma scintigraphic evaluation of a novel budesonide dry powder inhaler using a validated radiolabeling technique. J. Aerosol Med. 15 (2002), 15–25.
29. Weers, J., Metzheiser, B., Taylor, G., Warren, S., Meers, P., Perkins, W.R., A gamma scintigraphy study to investigate lung deposition and clearance of inhaled amikacin-loaded liposomes in healthy male volunteers. J. Aerosol Med. Pulm. Drug Deliv. 22 (2009), 131–138.
30. Yu, A.P., Guérin, A., Ponce de Leon, D., Ramakrishnan, K., Wu, E.Q., Mocarski, M., Blum, S., Setyawan, J., Therapy persistence and adherence in patients with chronic obstructive pulmonary disease: multiple versus single long-acting maintenance inhalers. J. Med. Econ. 14 (2011), 486–496.
31. Yu, A.P., Guérin, A., Ponce de Leon, D., Ramakrishnan, K., Wu, E.Q., Mocarski, M., Blum, S.I., Setyawan, J., Clinical and economic outcomes of multiple versus single long-acting inhalers in COPD. Respir. Med. 105 (2011), 1861–1871.