Steroid-decorated antibiotic microparticles for inhaled anti-infective therapy

Journal of Pharmaceutical Sciences

Volumn 103, Issue 4, 2014, Pages 1115-1125

  Lee, Sie Huey ^a,b   Teo, Jeanette ^c   Heng, Desmond ^a   Zhao, Yanli ^b,d   Ng, Wai Kiong ^a   Chan, Hak Kim ^e   Tan, Reginald B H ^a,f  

^a INSTITUTE OF CHEMICAL AND ENGINEERING SCIENCES   (Singapore)

^b Nanyang Technological University   (Singapore)

^c NATIONAL UNIVERSITY HOSPITAL   (Singapore)

^d NANYANG TECHNOLOGICAL UNIVERSITY   (Singapore)

^e UNIVERSITY OF SYDNEY   (Australia)

^f NATIONAL UNIVERSITY OF SINGAPORE   (Singapore)

Author keywords

aerosols; antiinfectives; chronic obstructive pulmonary disease (COPD); combinatorial therapy; community acquired pneumonia (CAP); corticosteroids; dry powder inhaler; formulation; pulmonary drug delivery; spray drying

Indexed keywords

BECLOMETASONE DIPROPIONATE; CIPROFLOXACIN;

AEROSOL; ANTIBACTERIAL ACTIVITY; ANTIMICROBIAL THERAPY; ARTICLE; CONTROLLED STUDY; CRYSTAL STRUCTURE; DRUG FORMULATION; DRUG RELEASE; DRUG SOLUBILITY; DRY POWDER INHALER; FIELD EMISSION SCANNING ELECTRON MICROSCOPY; IN VITRO STUDY; KLEBSIELLA PNEUMONIAE; MINIMUM INHIBITORY CONCENTRATION; MORPHOLOGY; NONHUMAN; PARTICLE SIZE; PSEUDOMONAS AERUGINOSA; RESPIRATORY TRACT INFECTION; SPRAY DRYING; STAPHYLOCOCCUS AUREUS; SURFACE PROPERTY; X RAY DIFFRACTION;

AEROSOLS; ANTIINFECTIVES; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD); COMBINATORIAL THERAPY; COMMUNITY-ACQUIRED PNEUMONIA (CAP); CORTICOSTEROIDS; DRY POWDER INHALER; FORMULATION; PULMONARY DRUG DELIVERY; SPRAY DRYING;

ADMINISTRATION, INHALATION; ANTI-BACTERIAL AGENTS; BACTERIAL INFECTIONS; BECLOMETHASONE; CIPROFLOXACIN; DRY POWDER INHALERS; GLUCOCORTICOIDS; HUMANS; KLEBSIELLA PNEUMONIAE; PNEUMONIA; POWDERS; PSEUDOMONAS AERUGINOSA; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; STAPHYLOCOCCUS AUREUS;

EID: 84896360592     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.23874     Document Type: Article

References (60)

1. Meijvis SCA, Grutters JC, Thijsen SF, Rijkers GT, Biesma DH, Endeman H,. 2011. Therapy in pneumonia: What is beyond antibiotics? Neth J Med 69 (1): 21-26.
2. Meijvis SCA, van de Garde EMW, Rijkers GT, Bos WJW,. 2012. Treatment with anti-inflammatory drugs in community-acquired pneumonia. J Intern Med 272: 25-35.
3. Wunderink RG, Mandell L,. 2012. Adjunctive therapy in community-acquired pneumonia. Semin Respir Crit Care Med 33: 311-318.
4. American Thoracic Society. 2001. Guidelines for the management of adults with community-acquired pneumonia. Am J Respir Crit Care Med 163: 1730-1754.
5. Mullerova H, Chigbo C, Hagan GW, Woodhead MA, Miravitlles M, Davis KJ, Wedzicha JA,. 2012. The natural history of community-acquired pneumonia in COPD patients: A population database analysis. Respir Med 106: 1124-1133.
6. Bagaitkar J, Demuth DR, Scott DA,. 2008. Tobacco use increases susceptibility to bacterial infection. Tob Induc Dis 4 (1): 12.
7. Taylor AE, Finney-Hayward TK, Quint JK, Thomas CMR, Tudhope SJ, Wedzicha JA, Barnes PJ, Donnelly LE,. 2010. Defective macrophage phagocytosis of bacteria in COPD. Eur Respir J 35: 1039-1047.
8. Berenson CS, Wrona CT, Grove LJ, Maloney J, Garlipp MA, Wallace PK, Stewart CC, Sethi S,. 2006. Impaired alveolar macrophage response to haemophilus antigens in chronic obstructive lung disease. Am J Respir Crit Care Med 174: 31-40.
9. Murphy TF., 2006. The role of bacteria in airway inflammation in exacerbations of chronic obstructive pulmonary disease. Curr Opin Infect Dis 19: 225-230.
10. Sethi S, Maloney J, Grove L, Wrona C, Berenson CS,. 2006. Airway inflammation and bronchial bacterial colonization in chronic obstructive pulmonary disease. Am J Respir Crit Care Med 173: 991-998.
11. Restrepo MI, Mortensen EM, Pugh JA, Anzueto A,. 2006. COPD is associated with increased mortality in patients with community-acquired pneumonia. Eur Respir J 28: 346-351.
12. Nelson S, Bagby GJ, Bainton BG, Wilson LA, Thompson JJ, Summer WR,. 1989. Compartmentalization of intraalveolar and systemic lipopolysaccharide-induced tumor necrosis factor and the pulmonary inflammatory response. J Infect Dis 159 (2): 189-194.
13. Monton C, Ewig S, Torres A, El-Ebiary M, Filella X, Rano A, Xaubet A,. 1999. Role of glucocorticoids on inflammatory response in nonimmunosuppressed patients with pneumonia: A pilot study. Eur Respir J 14: 218-220.
14. Sibille Y, Reynolds HY,. 1990. Macrophages and polymorphonuclear neutrophils in lung defense and injury. Am Rev Respir Dis 141: 471-501.
15. Stahn C, Buttgereit F,. 2008. Genomic and nongenomic effects of glucocorticoids. Nat Clin Pract Rheumatol 4: 525-533.
16. Heller AR, Heller SC, Borkenstein A, Stehr SN, Koch T,. 2003. Modulation of host defense by hydrocortisone in stress doses during endotoxemia. Intensive Care Med 29: 1456-1463.
17. Barnes PJ., 1998. Anti-inflammatory actions of glucocorticoids: Molecular mechanisms. Clin Sci 94: 557-572.
18. Niewoehner DE, Erbland ML, Deupree RH, Collins D, Gross NJ, Light RW, Anderson P, Morgan NA,. 1999. Effect of systemic glucocorticoids on exacerbations of chronic obstructive pulmonary disease. N Engl J Med 340 (25): 1941-1947.
19. Davies L, Angus RM, Calverley PMA,. 1999. Oral corticosteroids in patients admitted to hospital with exacerbations of chronic obstructive pulmonary disease: A prospective randomised controlled trial. Lancet 354: 456-460.
20. De Pascale G, Bello G, Antonelli M,. 2011. Steroids in severe pneumonia: A literature review. Minerva Anestesiol 77 (9): 902-910.
21. Schultz BKE, Allen CH, Kaplan SL,. 2009. Corticosteroids for acute bacterial meningitis. Ann Emerg Med 54: 136-137.
22. Buonsenso D, Serranti D, Valentini P,. 2010. Management of central nervous system tuberculosis in children: Light and shade. Eur Rev Med Pharmacol Sci 14: 845-853.
23. Brouwer MC, McIntyre P, de Gans J, Prasad K, van de Beek D,. 2010. Corticosteroids for acute bacterial meningitis (review). Cochrane Database Syst Rev (9): 1-73.
24. Strang JI., 1994. Rapid resolution of tuberculous pericardial effusions with high dose prednisone and anti-tuberculous drugs. J Infect 28 (3): 251-254.
25. Odio CM, Ramirez T, Arias G, Abdelnour A, Hidalgo I, Herrera ML, Bolanos W, Alpizar J, Alvarez P,. 2003. Double blind, randomized, placebo-controlled study of dexamethasone therapy for hematogenous septic arthritis in children. Pediatr Infect Dis J 22: 883-888.
26. Dellinger RP, Levy MM, Rhodes A, Annane D, Gerlach H, Opal SM, Sevransky JE, Sprung CL, Douglas IS, Jaeschke R, Osborn TM, Nunnally ME, Townsend SR, Reinhart K, Kleinpell RM, Angus DC, Deutschman CS, Machado FR, Rubenfeld GD, Webb SA, Beale RJ, Vincent J-L, Moreno R,. 2013. Surviving sepsis campaign: International guidelines for management of severe sepsis and septic shock: 2012. Crit Care Med 41 (2): 580-637.
27. Lee SH, Heng D, Ng WK, Chan H-K, Tan RBH,. 2011. Nano spray drying: A novel method for preparing protein nanoparticles for protein therapy. Int J Pharm 403: 192-200.
28. Heng D, Lee SH, Ng WK, Tan RBH,. 2011. The nano spray dryer B-90. Expert Opin Drug Deliv 8 (7): 965-972.
29. Elmore RL, Contois ME, Kelly J, Noe A, Poirier A,. 1996. Stability and compatibility of admixtures of intravenous ciprofloxacin and selected drugs. Clin Ther 18 (2): 246-255.
30. Loughlin G, Eigen H, Eds. 1994. Respiratory disease in children: Diagnosis and management. Baltimore, Maryland: Williams and Wilkins.
31. Coates AL, Allen PD, MacNeish CF, Ho SL, Lands LC,. 2001. Effect of size and disease on estimated deposition of drugs administered using jet nebulization in children with cystic fibrosis. Chest 119 (4): 1123-1130.
32. Traini D, Young PM,. 2009. Delivery of antibiotics to the respiratory tract: An update. Expert Opin Drug Deliv 6 (9): 897-905.
33. Dompeling E, van Schayck CP, Molema J, Folgering H, van Grunsven PM, van Weel C,. 1992. Inhaled beclomethasone improves the course of asthma and COPD. Eur Respir J 5: 945-952.
34. Davis R, Markham A, Balfour JA,. 1996. Ciprofloxacin. An updated review of its pharmacology, therapeutic efficacy and tolerability. Drugs 51 (6): 1019-1074.
35. Zhanel GG, Ennis K, Vercaigne L, Walkty A, Gin AS, Embil J, Smith H, Hoban DJ,. 2002. A critical review of the fluoroquinolones: Focus on respiratory tract infections. Drugs 62 (1): 13-59.
36. Stass H, Nagelschmitz J, Willmann S, Delesen H, Gupta A, Baumann S,. 2013. Inhalation of a dry powder ciprofloxacin formulation in healthy subjects: A phase I study. Clin Drug Invest 33: 419-427.
37. Wilson R, Welte T, Polverino E, De Soyza A, Greville H, O'Donnell A, Alder J, Reimnitz P, Hampel B,. 2013. Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis: A phase II randomised study. Eur Respir J 41: 1107-1115.
38. Serisier D., 2012. Inhaled antibiotics for lower respiratory tract infections: Focus on ciprofloxacin. Drugs Today (Barc) 48 (5): 339-351.
39. Weir DC, Burge PS,. 1993. Effects of high dose inhaled beclomethasone dipropionate, 750 μg and 1500 μg twice daily, and 40 mg per day oral prednisolone on lung function, symptoms, and bronchial hyperresponsiveness in patients with non-asthmatic chronic airflow obstruction. Thorax 48: 309-316.
40. Ben, Slimane A, Chehimi MM, Vaulay M-J,. 2004. Polypyrrole-coated poly(vinyl chloride) powder particles: Surface chemical and morphological characterisation by means of X-ray photoelectron spectroscopy and scanning electron microscopy. Colloids Polym Sci 282: 314-323.
41. 2009. British Pharmacopoeia Appendix XII C. London, UK: Spottiswoode.
42. Heng D, Lee SH, Kwek JW, Ng WK, Chan H-K, Tan RBH,. 2012. Assessing the combinatorial influence of climate, formulation and device on powder aerosolization using the Taguchi experimental design. Powder Technol 226: 253-260.
43. Heng D, Cutler DJ, Chan H-K, Yun J, Raper JA,. 2008. What is a suitable dissolution method for drug nanoparticles? Pharm Res 25 (7): 1696-1701.
44. Heng D, Cutler DJ, Chan H-K, Yun J, Raper JA,. 2008. Dissolution kinetic behavior of drug nanoparticles and their conformity to the diffusion model. Langmuir 24: 7538-7544.
45. Wikler MA, Clinical and Laboratory Standards Institute 2009: Performance standards for antimicrobial susceptibility testing. Nineteenth informational supplement M100-S19.
46. Lee SH, Teo J, Heng D, Ng WK, Chan H-K, Tan RBH,. 2013. Synergistic combination dry powders for inhaled antimicrobial therapy: Formulation, characterization and in vitro evaluation. Eur J Pharm Biopharm 83 (2): 275-284.
47. Heng D, Lee SH, Ng WK, Chan H-K, Kwek JW, Tan RBH,. 2013. Novel alternatives to reduce powder retention in the dry powder inhaler during aerosolization. Int J Pharm 452 (1-2): 194-200.
48. Adams NP, Jones PW,. 2006. The dose-response characteristics of inhaled corticosteroids when used to treat asthma: An overview of Cochrane systemic reviews. Respir Med 100: 1297-1306.
49. Harris DM, Martin LE, Harrison C, Jack D,. 1973. The effect of oral and inhaled beclomethasone dipropionate on adrenal function. Clin Allergy 3: 243-248.
50. Smith MJ, Hodson ME,. 1983. Effects of long term inhaled high dose beclomethasone dipropionate on adrenal function. Thorax 38: 676-681.
51. McKenzie C., 2011. Antibiotic dosing in critical illness. J Antimicrob Chemother 66 (S2): ii25-ii31.
52. Panidis D, Markantonis SL, Boutzouka E, Karatzas S, Baltopoulos G,. 2005. Penetration of gentamicin into the alveolar lining fluid of critically ill patients with ventilator-associated pneumonia. Chest 128 (2): 545-552.
53. Kumon M, Kwok PCL, Adi H, Heng D, Chan H-K,. 2010. Can low-dose combination products for inhalation be formulated in single crystalline particles? Eur J Pharm Sci 40 (1): 16-24.
54. Vehring R,. 2007. Pharmaceutical particle engineering via spray drying. Pharm Res 25 (5): 999-1022.
55. Adi H, Young PM, Chan H-K, Agus H, Traini D,. 2010. Co-spray-dried mannitol-ciprofloxacin dry powder inhaler formulation for cystic fibrosis and chronic obstructive pulmonary disease. Eur J Pharm Sci 40: 239-247.
56. Chew NYK, Chan H-K,. 2001. In vitro aerosol performance and dose uniformity between the Foradile® Aerolizer® and the Oxis® Turbuhaler®. J Aerosol Med 14 (4): 495-501.
57. Clark AR, Hollingworth AM,. 1993. The relationship between powder inhaler resistance and peak inspiratory conditions in healthy volunteers-Implications for in vitro testing. J Aerosol Med 6 (2): 99-110.
58. Daley-Yates PT, Price AC, Sisson JR, Pereira A, Dallow N,. 2001. Beclomethasone dipropionate: Absolute bioavailability, pharmacokinetics and metabolism following intravenous, oral, intranasal and inhaled administration in man. Br J Clin Pharmacol 51: 400-409.
59. Derendorf H, Hochhaus G, Meibohm B, Mollmann H, Barth J,. 1998. Pharmacokinetics and pharmacodynamics of inhaled corticosteroids. J Allergy Clin Immunol 101 (4): S440-S446.
60. Vo CL, Park C, Lee B-J,. 2013. Current trends and future perspectives of solid dispersions containing poorly water-soluble drugs. Eur J Pharm Biopharm 85: 799-813.