The formulation, chemical and physical characterisation of clarithromycin-based macrolide solution pressurised metered dose inhaler

Journal of Pharmacy and Pharmacology

Volumn 66, Issue 5, 2014, Pages 639-645

  Saadat, Alessandro ^a   Zhu, Bing ^b   Haghi, Mehra ^b   King, Gregory ^c   Colombo, Gaia ^a   Young, Paul M ^b   Traini, Daniela ^b  

^a UNIVERSITY OF FERRARA   (Italy)

^b University of Sydney   (Australia)

^c UNIVERSITY OF SYDNEY   (Australia)

Author keywords

clarithromycin; cosolvent; lung infection; macrolides; pressurised metered dose inhaler

Indexed keywords

AEROSOL; CLARITHROMYCIN; MACROLIDE; PROPELLANT; SOLUTION AND SOLUBILITY;

AEROSOL; DRUG DELIVERY SYSTEM; DRUG STABILITY; INHALATIONAL DRUG ADMINISTRATION; MEDICINAL CHEMISTRY; METERED DOSE INHALER; PARTICLE SIZE; PNEUMONIA; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; SOLUTION AND SOLUBILITY;

ADMINISTRATION, INHALATION; AEROSOL PROPELLANTS; AEROSOLS; CHEMISTRY, PHARMACEUTICAL; CLARITHROMYCIN; DRUG DELIVERY SYSTEMS; DRUG STABILITY; MACROLIDES; METERED DOSE INHALERS; PARTICLE SIZE; PNEUMONIA; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; SOLUTIONS;

EID: 84898806977     PISSN: 00223573     EISSN: 20427158     Source Type: Journal    
DOI: 10.1111/jphp.12190     Document Type: Article

References (41)

1. Ball P, et al. Antibiotic therapy of community respiratory tract infections: strategies for optimal outcomes and minimized resistance emergence. J Antimicrob Chemother 2002; 1: 31-40.
2. Amsden G,. Anti-inflammatory effects of macrolides-an underappreciated benefit in the treatment of community-acquired respiratory tract infections and chronic inflammatory pulmonary conditions? J Antimicrob Chemother 2005; 1: 10-21.
3. Azuma A, Kudoh S,. Diffuse panbronchiolitis in East Asia. Respirology 2006; 3: 249-261.
4. Shinkai M, et al. Macrolide antibiotics modulate ERK phosphorylation and IL-8 and GM-CSF production by human bronchial epithelial cells. Am J Physiol Lung Cell Mol Physiol 2006; 1: L75-L85.
5. Shinkai M, et al. Macrolide antibiotics as immunomodulatory medications: proposed mechanisms of action. Pharmacol Ther 2008; 3: 393-405.
6. Marjanovic N, et al. Macrolide antibiotics broadly and distinctively inhibit cytokine and chemokine production by COPD sputum cells in vitro. Pharmacol Res 2011; 5: 389-397.
7. Hill AT, et al. Evidence for excessive bronchial inflammation during an acute exacerbation of chronic obstructive pulmonary disease in patients with alpha(1)-antitrypsin deficiency (PiZ). Am J Respir Crit Care Med 1999; 6: 1968-1975.
8. White AJ, et al. Resolution of bronchial inflammation is related to bacterial eradication following treatment of exacerbations of chronic bronchitis. Thorax 2003; 8: 680-685.
9. Martinez FJ, et al. Role of macrolide therapy in chronic obstructive pulmonary disease. Int J Chron Obstruct Pulmon Dis 2008; 3: 331-350.
10. Provinciali M, et al. Inflammation, chronic obstructive pulmonary disease and aging. Curr Opin Pulm Med 2011; 17: S3-S10.
11. Mammen MJ, Sethi S,. Macrolide therapy for the prevention of acute exacerbations in chronic obstructive pulmonary disease. Pol Arch Med Wewn 2012; 1-2: 54-59.
12. Yamaya M, et al. Macrolide effects on the prevention of COPD exacerbations. Eur Respir J 2012; 2: 485-494.
13. Simoens S, et al. Preventing COPD exacerbations with macrolides: a review and budget impact analysis. Respir Med 2013; 5: 637-648.
14. Seemungal TA, et al. Long-term erythromycin therapy is associated with decreased chronic obstructive pulmonary disease exacerbations. Am J Respir Crit Care Med 2008; 11: 1139-1147.
15. Albert RK, et al. Azithromycin for prevention of exacerbations of COPD. N Engl J Med 2011; 8: 689-698.
16. Chu SY, et al. Absolute bioavailability of clarithromycin after oral administration in humans. Antimicrob Agents Chemother 1992; 5: 1147-1150.
17. Benninger P, et al. A comparative clarithromycin bioavailability study: determination of clarithromycin and 14-(R)-hydroxyclarithromycin under fasting and fed conditions. Int J Clin Pharmacol Ther 2004; 6: 342-349.
18. Peckham DG,. Macrolide antibiotics and cystic fibrosis. Thorax 2002; 3: 189-190.
19. FDA. CIPRO® (Ciprofloxacin Hydrochloride) TABLETS. West Haven, CT: FDA, 2004.
20. Pukhalsky AL, et al. Anti-inflammatory and immunomodulating effects of clarithromycin in patients with cystic fibrosis lung disease. Mediators Inflamm 2004; 2: 111-117.
21. Ding FM, et al. Low-dose clarithromycin therapy modulates CD4(+) T-cell responses in a mouse model of chronic Pseudomonas aeruginosa lung infection. Respirology 2012; 4: 727-734.
22. Nagata T, et al. Effect of erythromycin on chronic respiratory infection caused by Pseudomonas aeruginosa with biofilm formation in an experimental murine model. Antimicrobial Agents Chemother (Bethesda) 2004; 6: 2251-2259.
23. Yanagihara K, et al. Effect of clarithromycin on chronic respiratory infection caused by Pseudomonas aeruginosa with biofilm formation in an experimental murine model. J Antimicrob Chemother 2002; 5: 867-870.
24. Newhouse M,. Advantages of pressurized canister metered dose inhalers. J Aerosol Med 1991; 3: 139-150.
25. Smyth HD,. Propellant-driven metered-dose inhalers for pulmonary drug delivery. Expert Opin Drug Deliv 2005; 1: 53-74.
26. Gupta A, et al. Balancing ethanol cosolvent concentration with product performance in 134a-based pressurized metered dose inhalers. J Aerosol Med 2003; 2: 167-174.
27. Stein SW, Myrdal PB,. The relative influence of atomization and evaporation on metered dose inhaler drug delivery efficiency. Aerosol Sci Technol 2006; 5: 335-347.
28. Smyth H, et al. Spray pattern analysis for metered dose inhalers I: Orifice size, particle size, and droplet motion correlations. Drug Dev Ind Pharm 2006; 9: 1033-1041.
29. Saleem IY, Smyth HD,. Tuning aerosol particle size distribution of metered dose inhalers using cosolvents and surfactants. Biomed Res Int 2013. doi: 10.1155/2013/574310 [Epub ahead of print].
30. Traini D, et al. A novel apparatus for the determination of solubility in pressurized metered dose inhalers. Drug Dev Ind Pharm 2006; 10: 1159-1163.
31. Lewis D, et al. Towards the bioequivalence of pressurised metered dose inhalers 1: design and characterisation of aerodynamically equivalent beclomethasone dipropionate inhalers with and without glycerol as a non-volatile excipient. Eur J Pharm Biopharm 2014; 86: 31-37.
32. Buttini F, et al. Characterization of particles emitted from two formulations of beclomethasone dipropionate solutoin metered dose inhalers. Respir Drug Deliv 2008; 2008: 581-584.
33. Zhu B, et al. The effect of ethanol on the formation and physico-chemical properties of particles generated from solution-based pressurized metered dose inhalers. Drug Dev Ind Pharm 2013; 39: 1625-1637.
34. Hoye JA, Myrdal PB,. Measurement and correlation of solute solubility in HFA-134a/ethanol systems. Int J Pharm 2008; 1-2: 184-188.
35. Williams RO 3rd, et al. Influence of propellant composition on drug delivery from a pressurized metered-dose inhaler. Drug Dev Ind Pharm 1998; 8: 763-770.
36. Mitchell JP, et al. Aerodynamic particle size analysis of aerosols from pressurized metered-dose inhalers: comparison of Andersen 8-stage cascade impactor, next generation pharmaceutical impactor, and model 3321 Aerodynamic Particle Sizer aerosol spectrometer. AAPS PharmSciTech 2003; 4: E54.
37. British Pharmacopoeia. Formulated preparations: general monographs, preparations for inhalation, 2010.
38. Soine WH, et al. Chemical Stability in Pressurized Inhalers Formulated as Solutions. J Biopharm Sci 1992; 3: 41-47.
39. Nakagawa Y, et al. Physicochemical properties and stability in the acidic solution of a new macrolide antibiotic, clarithromycin, in comparison with erythromycin. Chem Pharm Bull (Tokyo) 1992; 3: 725-728.
40. Grubel P, Cave DR,. Factors affecting solubility and penetration of clarithromycin through gastric mucus. Aliment Pharmacol Ther 1998; 6: 569-576.
41. Valizadeh H, et al. Antibacterial activity of clarithromycin loaded PLGA nanoparticles. Pharmazie 2012; 1: 63-68.