title: Effect of AeroChamber Plus™ on the lung and systemic bioavailability of beclometasone dipropionate/formoterol pMDI.
abstract: OBJECTIVE
  To assess the effect of AeroChamber Plus™ on lung deposition and systemic exposure to extra-fine beclometasone dipropionate (BDP)/formoterol (100/6 µg) pMDI (Foster®). The lung deposition of the components of the combination given with the pMDI was also evaluated using the charcoal block technique.
  
  
  METHODS
  Twelve healthy male volunteers received four inhalations of extra-fine BDP/formoterol (100/6 µg) using (i) pMDI alone, (ii) pMDI and AeroChamber Plus™ and (iii) pMDI and charcoal ingestion.
  
  
  RESULTS
  Compared with pMDI alone, use of AeroChamber Plus™ increased the peak plasma concentrations (C(max)) of BDP (2822.3 ± 1449.9 vs. 5454.9 ± 3197.1 pg ml(-1)), its active metabolite beclometasone 17-monopropionate (17-BMP) (771.6 ± 288.7 vs. 1138.9 ± 495.6 pg ml(-1)) and formoterol (38.4 ± 17.8 vs. 54.7 ± 20.0 pg ml(-1)). For 17-BMP and formoterol, the AUC(0,30 min), indicative of lung deposition, was increased in the AeroChamber Plus™ group by 41% and 45%, respectively. This increase was mainly observed in subjects with inadequate inhalation technique. However, use of AeroChamber Plus™ did not increase the total systemic exposure to 17-BMP and formoterol. Results after ingestion of charcoal confirmed that AUC(0,30 min) can be taken as an index of lung bioavailability and that more than 30% of the inhaled dose of extra-fine BDP/formoterol 100/6 µg was delivered to the lung using the pMDI alone.
  
  
  CONCLUSIONS
  The use of AeroChamber Plus™ optimizes the delivery of BDP and formoterol to the lung in subjects with inadequate inhalation technique. The total systemic exposure was not increased, supporting the safety of extra-fine BDP/formoterol pMDI with AeroChamber Plus™.
authors: The University of Manchester, Medicines Evaluation Unit, Manchester, UK.
authors: Dave
authors: D
authors: Singh
authors: Sara
authors: S
authors: Collarini
authors: Gianluigi
authors: G
authors: Poli
authors: Daniela
authors: D
authors: Acerbi
authors: Alessio
authors: A
authors: Amadasi
authors: Antonio
authors: A
authors: Rusca
references: Chest. 1999 Oct;116(4):935-40
references: 10531156
references: Pediatr Pulmonol. 2003 Mar;35(3):192-9
references: 12567387
references: J Pharmacol Exp Ther. 1997 Nov;283(2):824-32
references: 9353404
references: J Aerosol Med Pulm Drug Deliv. 2010 Jun;23(3):137-48
references: 20109122
references: Eur Respir J. 2000 Nov;16(5):802-7
references: 11153575
references: Endocr Rev. 1984 Winter;5(1):1-24
references: 6323158
references: Thorax. 1999 Mar;54(3):207-12
references: 10325895
references: J Aerosol Med. 2005 Summer;18(2):183-92
references: 15966772
references: Drug Discov Today. 2001 Apr 1;6(7):367-375
references: 11267923
references: Respir Med. 1998 Jul;92 Suppl B:2-6
references: 10193529
references: N Engl J Med. 1997 Nov 13;337(20):1405-11
references: 9358137
references: Eur J Respir Dis Suppl. 1982;119:101-4
references: 6954081
references: Eur Respir J. 2002 Jan;19(1):182-91
references: 11843317
references: Thorax. 1991 Oct;46(10):712-6
references: 1750017
references: Eur J Respir Dis. 1987 Feb;70(2):93-8
references: 3817076
references: Lancet. 1995 Jul 22;346(8969):201-6
references: 7616798
references: Expert Opin Drug Deliv. 2009 Jan;6(1):91-102
references: 19236210
references: Br J Clin Pharmacol. 2007 Mar;63(3):288-91
references: 16981899
references: Clin Pharmacokinet. 2009;48(6):347-58
references: 19650674
references: J Allergy Clin Immunol. 2003 Jan;111(1):57-65
references: 12532097
references: Br J Clin Pharmacol. 2001 May;51(5):400-9
references: 11421996
references: Respir Med. 2002 Aug;96 Suppl D:S3-8
references: 12201079
references: Am J Respir Crit Care Med. 2004 Oct 15;170(8):836-44
references: 15256389
references: J Aerosol Med. 2005 Winter;18(4):379-85
references: 16379614
references: Respir Med. 2009 Jan;103(1):41-9
references: 18977646
references: Am J Med. 1994 Jul;97(1):29-37
references: 7913292
references: Chest. 1993 Nov;104(5):1332-7
references: 8222783
references: Ann Allergy Asthma Immunol. 1999 Apr;82(4):383-9
references: 10227337
references: Pulm Pharmacol Ther. 2007;20(3):290-303
references: 16890465
references: Clin Pharmacokinet. 2004;43(6):349-60
references: 15086274