Carrier-free combination for dry powder inhalation of antibiotics in the treatment of lung infections in cystic fibrosis

International Journal of Pharmaceutics

Volumn 451, Issue 1-2, 2013, Pages 112-120

  Pilcer, Gabrielle ^a   De Bueger, Véronique ^a   Traina, Karl ^b   Traore, Hamidou ^c   Sebti, Thami ^c   Vanderbist, Francis ^c   Amighi, Karim ^a  

^a UNIVERSITÉ LIBRE DE BRUXELLES   (Belgium)

^b Aptis   (Belgium)

^c Laboratoires SMB SA   (Belgium)

Author keywords

Antibiotics; Carrier free; Clarithromycin; Dry powder inhaler (DPI); Spray drying; Tobramycin

Indexed keywords

CLARITHROMYCIN; TOBRAMYCIN;

ARTICLE; CYSTIC FIBROSIS; DRUG FORMULATION; DRUG RELEASE; DRY POWDER INHALATION; FLOW RATE; LASER DIFFRACTION; LUNG INFECTION; NONHUMAN; PARTICLE SIZE; PRIORITY JOURNAL; PSEUDOMONAS AERUGINOSA; SCANNING ELECTRON MICROSCOPY; SPRAY DRYING; X RAY DIFFRACTION;

ADMINISTRATION, INHALATION; ANTI-BACTERIAL AGENTS; BACTERIAL INFECTIONS; CLARITHROMYCIN; CRYSTALLIZATION; CYSTIC FIBROSIS; DRUG COMBINATIONS; DRUG COMPOUNDING; DRUG SYNERGISM; DRY POWDER INHALERS; LUNG; LUNG DISEASES; MICROSCOPY, ELECTRON, SCANNING; PARTICLE SIZE; POWDERS; TISSUE DISTRIBUTION; TOBRAMYCIN; X-RAY DIFFRACTION;

EID: 84878571643     PISSN: 03785173     EISSN: 18733476     Source Type: Journal    
DOI: 10.1016/j.ijpharm.2013.04.069     Document Type: Article

References (43)

1. H. Anwar, and J.W. Costerton Enhanced activity of combination of tobramycin and piperacillin for eradication of sessile biofilm cells of Pseudomonas aeruginosa Antimicrob. Agents Chemother. 34 1990 1666 1671
2. L. Borgstrom, E. Derom, E. Stahl, E. Wahlin-Boll, and R. Pauwels The inhalation device influences lung deposition and bronchodilating effect of terbutaline Am. J. Respir. Crit. Care Med. 153 1996 1636 1640
3. J.M. Buyck, P. Plésiat, H. Traore, F. Vanderbist, P.M. Tulkens, and F. Van Bambeke Increased susceptibility of Pseudomonas aeruginosa to macrolides and ketolides in eukaryotic cell culture media and biological fluids due to decreased expression of oprM and increased outer-membrane permeability Clin. Infect. Dis. 55 2012 534 542
4. A.H. de Boer, H.M.I. Winter, and C.F. Lerk Inhalation characteristics and their effect on in-vitro drug delivery from dry powder inhalers Int. J. Pharm. 130 1996 231 244
5. F. Depreter, and K. Amighi Formulation and in vitro evaluation of highly dispersive insulin dry powder formulations for lung administration Eur. J. Pharm. Biopharm. 76 2010 454 463
6. F. Depreter, A. Burniat, D. Blocklet, S. Lacroix, M. Cnop, F. Fery, N.V. Aelst, G. Pilcer, M. Deleers, S. Goldman, and K. Amighi Comparative pharmacoscintigraphic and pharmacokinetic evaluation of two new formulations of inhaled insulin in type 1 diabetic patients Eur. J. Pharm. Biopharm. 80 2012 4 13
7. R. Eckert, K.M. Brady, E.P. Greenberg, F. Qi, D.K. Yarbrough, J. He, I. McHardy, M.H. Anderson, and W. Shi Enhancement of antimicrobial activity against Pseudomonas aeruginosa by coadministration of G10KHc and tobramycin Antimicrob. Agents Chemother. 50 2006 3833 3838
8. D.E. Geller, W.H. Pitlick, P.A. Nardella, W.G. Tracewell, and B.W. Ramsey Pharmacokinetics and bioavailability of aerolized tobramycin in cystic fibrosis Chest 122 2002 219 226
9. E.J. Giamarellos-Bourboulis, A. Antonopoulou, M. Raftogiannis, P. Koutoukas, T. Tsaganos, and V. Tziortzioti Clarithromycin is an effective immunomodulator when administered late in experimental pyelonephritis by multidrug-resistant Pseudomonas aeruginosa BMC Infect. Dis. 6 2006 31
10. R.L. Gibson, J.L. Burns, and B.W. Ramsey Pathophysiology and management of pulmonary infections in cystic fibrosis Am. J. Respir. Crit. Care Med. 168 2003 918 951
11. M. Guillot, P. Eckart, H. Desrosières, and J. Brouard Macrolides et infection à Pseudomonas aeruginosa Arch. Pediatr. 7 2000 523 530
12. H. Heijerman, E. Westerman, S. Conway, D. Touw, G. Döring for the consensus working group Inhaled medication and inhalation devices for lung disease in patients with cystic fibrosis: a European consensus J. Cystic Fibrosis 8 2009 295 315
13. M.E. Hodson, C.G. Gallagher, and J.R.W. Govan A randomised clinical trial of nebulized tobramycin or colistin in cystic fibrosis Eur. Respir. J. 20 2002 658 664
14. R.A. Howe, and R.C. Spencer Macrolides for the treatment of Pseudomonas aeruginosa infections? Antimicrob. Agents Chemother. 40 1997 153 155
15. O. Kandemir, V. Oztuna, A. Milcan, A. Bayramoglu, H.H. Celik, and C. Bayarslan Clarithromycin destroys biofilms and enhances bactericidal agents in the treatment of Pseudomonas aeruginosa osteomyelitis Clin. Orthop. Relat. Res. 430 2005 171 175
16. E. Kerem, S. Conway, S. Elborn, and H. Heijerman Standards of care for patients with cystic fibrosis: a European consensus J. Cystic fibrosis 4 2005 7 26
17. T.Z. Khan, J.S. Wagener, T. Bost, J. Martinez, F.J. Accurso, and D.W.H. Riches Early pulmonary inflammation in infants with cystic fibrosis Am. J. Respir. Crit. Care Med. 151 1995 1075 1082
18. C. Koch, and N. Hoiby Pathogenesis of cystic fibrosis Lancet 341 1993 1065 1069
19. K. Kondoh, M. Hashiba, and S. Baba Inhibitory activity of clarithromycin on biofilm synthesis with Pseudomonas aeruginosa Acta Otolaryngol. Suppl. 525 1996 56 60
20. M. Kumon, P.C. Kwok, H. Adi, D. Heng, and H.K. Chan Can low-dose combination products for inhalation be formulated in single crystalline particles? Eur. J. Pharm. Sci. 40 2010 16 24
21. B.J. Meakin, D. Ganderton, I. Panza, and P. Ventura The effect of flow rate on drug delivery from the pulvinal, a high resistance dry powder inhaler J. Aerosol. Med. 11 1998 143 152
22. T. Nagata, H. Mukae, J. Kadota, T. Hayashi, T. Fujii, M. Kuroki, R. Shirai, K. Yanagihara, K. Tomono, T. Koji, and S. Kohno Effect of erythromycin on chronic respiratory infection caused by Pseudomonas aeruginosa with biofilm formation in an experimental murine model Antimicrob. Agents Chemother. 48 2004 2251 2259
23. M. Newhouse, P. Hirst, S. Duddu, Y. Walter, T. Tarara, A. Clark, and J. Weers Inhalation of a dry powder tobramycin pulmosphere formulation in healthy volunteers Chest 124 2003 360 366
24. G. Pilcer, T. Sebti, and K. Amighi Formulation and characterization of lipid-coated tobramycin particles for dry powder inhalation Pharm. Res. 23 2006 931 940
25. G. Pilcer, F. Vanderbist, and K. Amighi Correlations between cascade impactor analysis and laser diffraction techniques for the determination of the particle size of aerosolized powder formulations Int. J. Pharm. 358 2008 75 81
26. G. Pilcer, J. Goole, B. Van Gansbeke, D. Blocklet, C. Knoop, F. Vanderbist, and K. Amighi Pharmacoscintigraphic and pharmacokinetic evaluation of tobramycin DPI formulations in cystic fibrosis patients Eur. J. Pharm. Biopharm. 68 2008 413 421
27. G. Pilcer, F. Vanderbist, and K. Amighi Spray-dried carrier-free dry powder tobramycin formulations with improved dispersion properties J. Pharm. Sci. 98 2009 1463 1475
28. G. Pilcer, and K. Amighi Formulation strategy and use of excipients in pulmonary drug delivery Int. J. Pharm. 392 2010 1 19
29. G. Pilcer, N. Wauthoz, and K. Amighi Lactose characteristics and the generation of the aerosol Adv. Drug. Deliv. Rev. 64 2012 233 256
30. C. Pitchayajittipong, J. Shur, and R. Price Engineering of crystalline combination inhalation particles of a long-acting β2-agonist and a corticosteroid Pharm. Res. 26 2009 2657 2666
31. B.W. Ramsey, M.S. Pepe, J.M. Quan, K.L. Otto, A.B. Montgomery, J. Williams-Warren, K.M. Vasiljev, D. Borowitz, C.M. Bowman, B.C. Marshall, S. Marshall, and A.L. Smith Intermittent administration of inhaled tobramycin in patients with cystic fibrosis. Cystic Fibrosis Inhaled Tobramycin Study Group N. Engl. J. Med. 340 1999 23 30
32. B.K. Rubin, H. Druce, O.E. Ramirez, and R. Palmer Effect of clarithromycin on nasal mucus properties in healthy subjects and in patients with purulent rhinitis Am. J. Respir. Crit. Care Med. 155 1997 2018 2023
33. M.J. Schultz Macrolide activities beyond their antimicrobial effects: macrolides in diffuse panbronchiolitis and cystic fibrosis J. Antimicrob. Chemother. 54 2004 21 28
34. V.P. Shah, Y. Tsong, P. Sathe, and J.P. Liu In vitro dissolution profile comparison-statistics and analysis of the similarity factor f2 Pharm. Res. 15 1998 889 896
35. M. Shinkai, Y.S. Lopez-Boado, and B.K. Rubin Clarithromycin has an immunomodulatory effect on ERK-mediated inflammation induced by Pseudomonas aeruginosa flagellin J. Antimicrob. Chemother. 59 2007 1096 1101
36. Y.J. Son, and J.T. McConville Development of a standardized dissolution test method for inhaled pharmaceutical formulations Int. J. Pharm. 382 2009 15 22
37. J. Tamaoki, K. Isono, N. Sakai, T. Kanemura, and K. Konno Erythromycin inhibits Cl secretion across canine tracheal epithelial cells Eur. Respir. J. 5 1992 234 238
38. G. Tanaka, M. Shigeta, H. Komatsuzawa, M. Sugai, H. Suginaka, and T. Usui Effect of clarithromycin on Pseudomonas aeruginosa biofilms Chemotherapy 46 2000 36 42
39. M. Telko, and A.J. Hickey Dry powder inhaler formulation Respir. Care 50 2005 1209 1227
40. M. Tré-Hardy, F. Vanderbist, H. Traore, and M. Devleeschouwer In vitro activity of antibiotic combinations against Pseudomonas aeruginosa biofilm and planktonic cultures Int. J. Antimicrob. Agents 3 2008 329 336
41. M. Tré-Hardy, C. Macé, N. El Manssouri, F. Vanderbist, H. Traore, and M.J. Devleeschouwer Effect of antibiotic co-administration on young and mature biofilms of cystic fibrosis clinical isolates: the importance of the biofilm model Int. J. Antimicrob. Agents 33 2009 40 45
42. M. Tré-Hardy, C. Nagant, N. El Manssouri, F. Vanderbist, H. Traore, M. Vaneechoutte, and J.P. Dehaye Efficacy of the combination of tobramycin and a macrolide in an in vitro Pseudomonas aeruginosa mature biofilm model Antimicrob. Agents Chemother. 54 2010 4409 4415
43. R. Westmeier, and H. Steckel Combination particles containing salmeterol xinafoate and fluticasone propionate: formulation and aerodynamic assessment J. Pharm. Sci. 97 2008 2299 2310