title: Epithelial profiling of antibiotic controlled release respiratory formulations.
abstract: OBJECTIVE
  Release profiles of two ciprofloxacin hydrochloride formulations for the treatment of respiratory infection were evaluated using different in vitro methodologies and characterised for aerosol performance and toxicity.
  
  
  METHODS
  Spray-dried ciprofloxacin and ciprofloxacin spray-dried with polyvinyl alcohol as a controlled release (CR) agent at a 50:50 w/w ratio were formulated and physico-chemically characterised. Aerosol performances were assessed in vitro using a liquid impinger. Drug release was performed using a modified Franz cell and a validated air interface Calu-3-modified twin stage impinger (TSI). Ciprofloxacin toxicity was also established in vitro.
  
  
  RESULTS
  Both formulations had a similar size distribution, while CR ciprofloxacin had superior aerosol performance and stability. The release profiles showed the CR formulation to have a higher transport rate compared to ciprofloxacin alone in the cell model. Contrary results were observed using the diffusion cell. Results suggest that the air interface cell model provides a more physiologically relevant model than the modified Franz cell. Toxicity analysis showed that the lung epithelial cells could tolerate a wide range of ciprofloxacin concentrations.
  
  
  CONCLUSIONS
  This study establishes that the in vitro modified TSI air interface Calu-3 model is capable of evaluating the fate of inhaled powder formulations.
authors: Advanced Drug Delivery Group, Faculty of Pharmacy (A15), The University of Sydney, Sydney, NSW 2006, Australia.
authors: Hui Xin
authors: HX
authors: Ong
authors: Daniela
authors: D
authors: Traini
authors: Mary
authors: M
authors: Bebawy
authors: Paul Michael
authors: PM
authors: Young
references: Expert Opin Drug Deliv. 2008 Jun;5(6):641-52
references: 18532920
references: Curr Opin Pediatr. 2007 Feb;19(1):83-8
references: 17224667
references: Pharm Res. 2010 Jan;27(1):151-60
references: 19847626
references: Drug Dev Ind Pharm. 2010 Oct;36(10):1207-14
references: 20374185
references: Int J Pharm. 2005 Nov 23;305(1-2):180-5
references: 16242277
references: Pharm Res. 2005 Jan;22(1):148-52
references: 15771241
references: J Drug Target. 2002 Feb;10(1):31-40
references: 11996084
references: Int J Pharm. 2004 Sep 10;282(1-2):141-9
references: 15336389
references: J Pharm Sci. 2008 Aug;97(8):3356-66
references: 17990305
references: J Pharm Sci. 2009 Aug;98(8):2709-17
references: 19130607
references: J Anat. 2002 Oct;201(4):313-8
references: 12430955
references: Pulm Pharmacol Ther. 2005;18(3):165-70
references: 15707849
references: Eur J Pharm Biopharm. 2008 Jun;69(2):486-95
references: 18226880
references: J Invest Dermatol. 1975 Mar;64(3):190-5
references: 123263
references: Pharm Res. 2003 May;20(5):788-96
references: 12751635
references: Eur J Pharm Biopharm. 2009 Feb;71(2):318-24
references: 18845252
references: J Pharm Sci. 1997 Jun;86(6):690-700
references: 9188051
references: J Microencapsul. 2010;27(7):618-27
references: 20681747
references: AAPS J. 2009 Sep;11(3):465-8
references: 19568940
references: Pharm Res. 2006 Jul;23(7):1482-90
references: 16779708
references: Antimicrob Agents Chemother. 1997 Dec;41(12):2693-8
references: 9420040
references: Eur J Pharm Sci. 2008 Sep 2;35(1-2):12-8
references: 18586091
references: Drug Dev Ind Pharm. 2010 Jan;36(1):119-26
references: 19656005
references: Eur J Pharm Biopharm. 2008 Sep;70(1):145-52
references: 18534832
references: Expert Opin Drug Deliv. 2009 Sep;6(9):897-905
references: 19637984
references: Crit Care Res Pract. 2010;2010:
references: 20948883