Colistin powders with high aerosolisation efficiency for respiratory infection: Preparation and in vitro evaluation

Journal of Pharmaceutical Sciences

Volumn 102, Issue 10, 2013, Pages 3736-3747

  Morton, David A V ^b   Yu, Heidi H ^b   Jacob, Jovan ^b   Wang, Jiping ^b   Li, Jian ^b  

^a Tony)   (Australia)

^b MONASH UNIVERSITY   (Australia)

Author keywords

Aerosolisation efficiency; Colistin; Dry powder inhaler; Respiratory infections; Spray drying

Indexed keywords

COLISTIN; WATER;

ACINETOBACTER BAUMANNII; AEROSOL; ANTIMICROBIAL ACTIVITY; ARTICLE; DRUG EFFICACY; DRUG FORMULATION; DRUG STORAGE; HUMIDITY; IN VITRO STUDY; MINIMUM INHIBITORY CONCENTRATION; NONHUMAN; PARTICLE SIZE; POWDER; RESPIRATORY TRACT INFECTION; SPRAY DRYING; WATER ABSORPTION;

AEROSOLISATION EFFICIENCY; COLISTIN; DRY POWDER INHALER; RESPIRATORY INFECTIONS; SPRAY DRYING;

ACINETOBACTER BAUMANNII; ADMINISTRATION, INHALATION; AEROSOLS; CHEMISTRY, PHARMACEUTICAL; COLISTIN; DRUG STABILITY; DRUG STORAGE; DRY POWDER INHALERS; HUMIDITY; PARTICLE SIZE; POWDERS; RESPIRATORY TRACT INFECTIONS;

EID: 84883824014     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.23685     Document Type: Article

References (46)

1. Talbot GH, Bradley J, Edwards JE, Gilbert D, Scheld M, Bartlett JG. 2006. Bad bugs need drugs: An update on the development pipeline from the Antimicrobial Availability Task Force of the Infectious Diseases Society of America. Clin Infect Dis 42(5):657-668.
2. Li J, Nation RL, Milne RW, Turnidge JD, Coulthard K. 2005. Evaluation of colistin as an agent against multi-resistant in Gram-negative bacteria. Int J Antimicrob Agents 25(1):11-25.
3. Bergen PJ, Li J, Rayner CR, Nation RL. 2006. Colistin methanesulfonate is an inactive prodrug of colistin against Pseudomonas aeruginosa. Antimicrob Agents Chemother 50(6):1953-1958.
4. Antoniu SA, Cojocaru I. 2012. Inhaled colistin for lower respiratory tract infections. Expert Opin Drug Deliv 9(3):333-342.
5. Garonzik SM, Li J, Thamlikitkul V, Paterson DL, Shoham S, Jacob J, Silveira FP, Forrest A, Nation RL. 2011. Population pharmacokinetics of colistin methanesulfonate and formed colistin in critically ill patients from a multicenter study provide dosing suggestions for various categories of patients. Antimicrob Agents Chemother 55(7):3284-3294.
6. Hartzell JD, Neff R, Ake J, Howard R, Olson S, Paolino K, Vishnepolsky M, Weintrob A, Wortmann G. 2009. Nephrotoxicity associated with intravenous colistin (colistimethate sodium) treatment at a tertiary care medical center. Clin Infect Dis 48(12):1724-1728.
7. Markou N, Markantonis SL, Dirnitrakis E, Panidis D, Boutzouka E, Karatzas S, Rafailidis P, Apostolakos H, Baltopoulos G. 2008. Colistin serum concentrations after intravenous administration in critically ill patients with serious multidrug-resistant, gram-negative bacilli infections: A prospective, open-label, uncontrolled study. Clin Ther 30(1):143-151.
8. Ratjen F, Rietschel E, Kasel D, Schwiertz R, Starke K, Beier H, van Koningsbruggen S, Grasemann H. 2006. Pharmacokinetics of inhaled colistin in patients with cystic fibrosis. J Antimicrob Chemother 57(2):306-311.
9. Hoiby N. 2011. Recent advances in the treatment of Pseudomonas aeruginosa infections in cystic fibrosis. BMC Med 9:32.
10. Pilcer G, Amighi K. 2010. Formulation strategy and use of excipients in pulmonary drug delivery. Int J Pharm 392(1-2):1-19.
11. Reychler G, Keyeux A, Cremers C, Veriter C, Rodenstein DO, Liistro G. 2004. Comparison of lung deposition in two types of nebulization: Intrapulmonary percussive ventilation vs jet nebulization. Chest 125(2):502-508.
12. Geller DE, Konstan MW, Noonberg SB, Conrad C. 2007. Novel tobramycin inhalation powder in cystic fibrosis subjects: Pharmacokinetics and safety. Pediatr Pulmonol 42(4):307-313.
13. de Boer AH, Le Brun PPH, van der Woude HG, Hagedoorn P, Heijerman HGM, Frijlink HW. 2002. Dry powder inhalation of antibiotics in cystic fibrosis therapy, part 1: Development of a powder formulation with colistin sulfate for a special test inhaler with an air classifier as de-agglomeration principle. Eur J Pharm Biopharm 54(1):17-24.
14. de Boer AH, Hagedoorn P, Westerman EM, Le Brun PPH, Heijerman HGM, Frijlink HW. 2006. Design and in vitro performance testing of multiple air classifier technology in a new disposable inhaler concept (Twincer®) for high powder doses. Eur J Pharm Sci 28(3):171-178.
15. Chan HK, Chew NYK. 2003. Novel alternative methods for the delivery of drugs for the treatment of asthma. Adv Drug Deliv Rev 55(7):793-805.
16. Morton DAV, Jong T, Li J, Hale JD, Nation RL, Larson I. 2011. Investigating the particle engineering of colistin for pulmonary delivery. In Respiratory Drug Delivery Europe 2011, Respir Drug Deliv, pp 367-372.
17. Vehring R. 2008. Pharmaceutical particle engineering via spray drying. Pharm Res 25(5):999-1022.
18. Telko MJ, Hickey AJ. 2005. Dry powder inhaler formulation. Respir Care 50:209-227.
19. Perez F, Hujer AM, Hujer KM, Decker BK, Rather PN, Bonomo RA. 2007. Global challenge of multidrug-resistant Acinetobacter baumannii. Antimicrob Agents Chemother 51(10):3471-3484.
20. Chan JGY, Chan HK, Prestidge CA, Denman JA, Young PM, Traini D. 2013. A novel dry powder inhalable formulation incorporating three first-line anti-tubercular antibiotics. Eur J Pharm Biopharm 83(2):285-292.
21. Asking L, Olsson B. 1997. Calibration at different flow rates of a multistage liquid impinger. Aerosol Sci Technol 27(1):39-49.
22. Pilcer G, Vanderbist F, Amighi K. 2009. Spray-dried carrier-free dry powder tobramycin formulations with improved dispersion properties. J Pharm Sci 98(4):1463-1475.
23. 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.
24. Zhou Q, Tong Z, Tang P, Citterio M, Yang R, Chan H-K 2013. Effect of device design on the aerosolization of a carrier-based dry powder inhaler-A case study on Aerolizer® Foradile®. AAPS J 15(2):511-522.
25. de Boer AH, Chan HK, Price R. 2012. A critical view on lactose-based drug formulation and device studies for dry powder inhalation: Which are relevant and what interactions to expect? Adv Drug Deliv Rev 64(3):257-274.
26. Decolin D, Leroy P, Nicolas A, Archimbault P. 1997. Hyphenated liquid chromatographic method for the determination of colistin residues in bovine tissues. J Chromatogr Sci 35(12):557-564.
27. Tang P, Kwok PCL, Tong ZB, Yang RY, Raper JA, Chan HK. 2012. Does the United States Pharmacopeia throat introduce de-agglomeration of carrier-free powder from inhalers? Pharm Res 29(7):1797-1807.
28. Chew NYK, Chan HK. 2001. Use of solid corrugated particles to enhance powder aerosol performance. Pharm Res 18(11):1570-1577.
29. Chow AHL, Tong HHY, Chattopadhyay P, Shekunov BY. 2007. Particle engineering for pulmonary drug delivery. Pharm Res 24(3):411-437.
30. York P. 1981. Analysis of moisture sorption hysteresis in hard gelatin capsules, maize starch, and maize starch: Drug powder mixtures. J Pharm Pharmacol 33(1):269-273.
31. Zhu KW, Tan RBH, Ng WK, Shen S, Zhou Q, Heng PWS. 2008. Analysis of the influence of relative humidity on the moisture sorption of particles and the aerosolization process in a dry powder inhaler. J Aerosol Sci 39(6):510-524.
32. Chew NYK, Chan HK. 2002. Effect of powder polydispersity on aerosol generation. J Pharm Pharm Sci 5(2):162-168.
33. Adi S, Adi H, Tang P, Traini D, Chan H-K, Young PM. 2008. Micro-particle corrugation, adhesion and inhalation aerosol efficiency. Eur J Pharm Sci 35(1-2):12-18.
34. de Boer AH, Hagedoorn P, Woolhouse R, Wynn E. 2012. Computational fluid dynamics (CFD) assisted performance evaluation of the Twincer (TM) disposable high-dose dry powder inhaler. J Pharm Pharmacol 64(9):1316-1325.
35. Grasmeijer F, Hagedoorn P, Frijlink HW, de Boer AH. 2012. Characterisation of high dose aerosols from dry powder inhalers. Int J Pharm 437(1-2):242-249.
36. Shur J, Lee S, Adams W, Lionberger R, Tibbatts J, Price R. 2012. Effect of device design on the in vitro performance and comparability for capsule-based dry powder inhalers. AAPS J 14(4):667-676.
37. Tarran R, Trout L, Donaldson SH, Boucher RC. 2006. Soluble mediators, not cilia, determine airway surface liquid volume in normal and cystic fibrosis superficial airway epithelia. J Gen Physiol 127(5):591-604.
38. Andrews JM. 2001. Determination of minimum inhibitory concentrations. J Antimicrob Chemother 48(Suppl 1):5-16.
39. Le Brun PPH, de Boer AH, Mannes GPM, de Fraiture DMI, Brimicombe RW, Touw DJ, Vinks AA, Frijlink HW, Heijerman HGM. 2002. Dry powder inhalation of antibiotics in cystic fibrosis therapy: Part 2. Inhalation of a novel colistin dry powder formulation: A feasibility study in healthy volunteers and patients. Eur J Pharm Biopharm 54(1):25-32.
40. Zhou QT, Armstrong B, Larson I, Stewart PJ, Morton DAV. 2010. Understanding the influence of powder flowability, fluidization and de-agglomeration characteristics on the aerosolization of pharmaceutical model powders. Eur J Pharm Sci 40(5):412-421.
41. Feeley JC, York P, Sumby BS, Dicks H. 2002. Processing effects on the surface properties of alpha-lactose monohydrate assessed by inverse gas chromatography (IGC). J Mater Sci 37(1):217-222.
42. Kumon M, Kwok PCL, Adi H, Heng D, Chan HK. 2010. Can low-dose combination products for inhalation be formulated in single crystalline particles? Eur J Pharm Sci 40(1):16-24.
43. Raula J, Thielmann F, Kansikas J, Hietala S, Annala M, Seppala J, Lahde A, Kauppinen EI. 2008. Investigations on the humidity-induced transformations of salbutamol sulphate particles coated with L-leucine. Pharm Res 25(10):2250-2261.
44. Podczeck F, Newton JM, James MB. 1997. Variations in the adhesion force between a drug and carrier particles as a result of changes in the relative humidity of the air. Int J Pharm 149(2):151-160.
45. Wahl M, Kirsch R, Bröckel U, Trapp S, Bottlinger M. 2006. Caking of urea prills. Chem Eng Technol 29(6):674-678.
46. Adi S, Adi H, Chan HK, Finlay WH, Tong ZB, Yang RY, Yu AB. 2011. Agglomerate strength and dispersion of pharmaceutical powders. J Aerosol Sci 42(4):285-294.