The effect of ethanol on the formation and physico-chemical properties of particles generated from budesonide solution-based pressurized metered-dose inhalers

Drug Development and Industrial Pharmacy

Volumn 39, Issue 11, 2013, Pages 1625-1637

  Zhu, Bing ^a,b   Traini, Daniela ^a,b   Chan, Hak Kim ^a   Young, Paul M ^a,b  

^a UNIVERSITY OF SYDNEY   (Australia)

^b University of Sydney   (Australia)

Author keywords

Aerosol performance; Budesonide; Ethanol; Particle formation; Solution base pMDI

Indexed keywords

ALCOHOL; BUDESONIDE; FLUORINATED HYDROCARBON;

AEROSOL; ANALYTICAL EQUIPMENT; ARTICLE; CALORIMETER; CHEMICAL ANALYSIS; DIFFERENTIAL SCANNING CALORIMETRY; DRUG DELIVERY SYSTEM; DRUG FORMULATION; DRUG SOLUBILITY; FLOWMETER; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; IMPACTOR; IN VITRO STUDY; LASER DIFFRACTION; LIQUID; MEASUREMENT; MEDICAL DEVICE; METERED DOSE INHALER; MORPHOLOGY; PARTICLE SIZE; PHYSICAL CHEMISTRY; PRESSURIZED METERED DOSE INHALER; QUANTITATIVE ANALYSIS; SCANNING ELECTRON MICROSCOPE; THERMOGRAVIMETRY; THROAT; VAPOR PRESSURE;

ADMINISTRATION, INHALATION; AEROSOL PROPELLANTS; AEROSOLS; ANTI-INFLAMMATORY AGENTS; BUDESONIDE; DRUG COMPOUNDING; DRUG DELIVERY SYSTEMS; ETHANOL; GLUCOCORTICOIDS; HUMANS; HYDROCARBONS, FLUORINATED; METERED DOSE INHALERS; MICROSCOPY, ELECTRON, SCANNING; PARTICLE SIZE; PHYSICOCHEMICAL PHENOMENA; POROSITY; SOLUBILITY; SOLUTIONS; SOLVENTS; SURFACE PROPERTIES; VOLATILIZATION;

EID: 84885675537     PISSN: 03639045     EISSN: 15205762     Source Type: Journal    
DOI: 10.3109/03639045.2012.728230     Document Type: Article

References (49)

1. Terzano C. (2001). Pressurized metered dose inhalers and add-on devices. Pulm Pharmacol Ther, 14:351-366
2. Evans M, Telfer A, Smith R, Smith B, Lang G, Chen J, et al. (1974). Stratospheric sink for chlorofluoromethanes: Chlorine atomcatalysed destruction of ozone. Nature, 249:811
3. Cicerone RJ, Stolarski RS, Walters S. (1974). Stratospheric ozone destruction by man-made chlorofluoromethanes. Science, 185:1165-1167
4. Wofsy SC, McElroyp MB, Sze ND. (1975). Freon consumption: Implications for atmospheric ozone. Science, 187:535-536
5. Whitham ME, Eagle A. (1994). Alternative propellants: Proprietary rights, toxicological issues and projected licensing problems. RDD IV, 203-209
6. Gupta A, Stein SW, Myrdal PB. (2003). Balancing ethanol cosolvent concentration with product performance in 134a-based pressurized metered dose inhalers. J Aerosol Med, 16:167-174
7. Stein SW, Myrdal PB. (2004). A theoretical and experimental analysis of formulation and device parameters affecting solution MDI size distributions. J Pharm Sci, 93:2158-2175
8. Stein SW, Myrdal PB. (2006). The relative influence of atomization and evaporation on metered dose inhaler drug delivery efficiency. Aerosol Sci Technol, 40:335-347
9. Smyth HD. (2003). The influence of formulation variables on the performance of alternative propellant-driven metered dose inhalers. Adv Drug Deliv Rev, 55:807-828
10. Dalby RN, Byron PR. (1988). Comparison of output particle size distributions from pressurized aerosols formulated as solutions or suspensions. Pharm Res, 5:36-39
11. Brambilla G, Ganderton D, Garzia R, Lewis D, Meakin B, Ventura P. (1999). Modulation of aerosol clouds produced by pressurised inhalation aerosols. Int J Pharm, 186:53-61
12. Ganderton D, Lewis D, Davies R, Meakin B, Brambilla G, Church T. (2002). Modulite: A means of designing the aerosols generated by pressurized metered dose inhalers. Respir Med, 96 SupplD:S3-S8
13. Ganderton D, Lewis D, Davies R, Meakin B, Church T. (2003). The formulation and evaluation of a CFC-free budesonide pressurised metered dose inhaler. Respir Med, 97 SupplD:S4-S9
14. Traini D, Young PM, Price R, Rogueda P. (2006). A novel apparatus for the determination of solubility in pressurized metered dose inhalers. Drug Dev Ind Pharm, 32:1159-1163
15. Haynes A, Shaik MS, Krarup H, Singh M. (2004). Evaluation of the Malvern Spraytec with inhalation cell for the measurement of particle size distribution from metered dose inhalers. J Pharm Sci, 93:349-363
16. Buttini F, Grainger CI, Jones SA, Royall PG, Martin PG, Forbes B.(2008). Characterization of particles emitted from two formulations of beclomethasone dipropionate solutoin metered dose inhalers. RDD, 2:581-584
17. Heng D, Tang P, Cairney JM, Chan HK, Cutler DJ, Salama R et al.(2007). Focused-ion-beam milling: A novel approach to probing the interior of particles used for inhalation aerosols. Pharm Res, 24:1608-1617
18. Hoye JA, Myrdal PB. (2008). Measurement and correlation of solute solubility in HFA-134a/ethanol systems. Int J Pharm, 362:184-188
19. Tajber L, Corrigan DO, Corrigan OI, Healy AM. (2009). Spray drying of budesonide, formoterol fumarate and their composites-I. Physicochemical characterisation. Int J Pharm, 367:79-85
20. Carr AG, Mammucari R, Foster NR. (2011). Particle formation of budesonide from alcohol-modified subcritical water solutions. Int J Pharm, 405:169-180
21. Martin TM, Bandi N, Shulz R, Roberts CB, Kompella UB. (2002). Preparation of budesonide and budesonide-PLA microparticles using supercritical fluid precipitation technology. AAPS PharmSciTech, 3:E18
22. Simonoska Crcarevska M, Glavas Dodov M, Goracinova K.(2008). Chitosan coated Ca-alginate microparticles loaded with budesonide for delivery to the inflamed colonic mucosa. Eur J Pharm Biopharm, 68:565-578
23. Nolan LM, Tajber L, McDonald BF, Barham AS, Corrigan OI, Healy AM. (2009). Excipient-free nanoporous microparticles of budesonide for pulmonary delivery. Eur J Pharm Sci, 37:593-602
24. Hecht JP, King CJ. (2000). Spray drying: Influence of developing drop morphology on drying rates and retention of volatile substances. 1. Single-drop experiments. Ind Eng Chem Res, 39:1756-1765
25. Kuhli M, Weiss M, Steckel H. (2010). Characterisation of solutionbased pressurised metered-dose inhaler aerosols with an optical particle counter. Eur J Pharm Biopharm, 75:393-398
26. Adhikari B, Howes T, Bhandari B, Truong V. (2000). Experimental studies and kinetics of single drop drying and their relevance in drying of sugar rich foods: A review. Int J Food Prop, 3:323-351
27. Vervaet C, Byron PR. (1999). Drug-surfactant-propellant interactions in HFA-formulations. Int J Pharm, 186:13-30
28. Williams III RO, Liu J. (1998). Influence of formulation additives on the vapor pressure of hydrofluoroalkane propellants. Int J Pharm, 166:99-103
29. Williams RO 3rd, Repka M, Liu J. (1998). Influence of propellant composition on drug delivery from a pressurized metered-dose inhaler. Drug Dev Ind Pharm, 24:763-770
30. Hickey A, Evans R. Aerosol generation from propellant-driven metered dose inhalers. Lung Biology In Health And Disease, 94:417-439
31. Ju D, Shrimpton J, Hearn A. (2010). The effect of reduction of propellant mass fraction on the injection profile of metered dose inhalers. Int J Pharm, 391:221-229
32. Lewis DA, Ganderton D, Meakin BJ, Brambilla G. (2004). Theory and practice with solution systems. RDD IX, 109-116
33. Keller M. (1999). Innovations and perspectives of metered dose inhalers in pulmonary drug delivery. Int J Pharm, 186:81-90
34. Gelfand B. (1996). Droplet breakup phenomena in flows with velocity lag. Prog Energ Combust, 22:201-265
35. Hoe S, Traini D, Chan HK, Young PM. (2009). The influence of flow rate on the aerosol deposition profile and electrostatic charge of single and combination metered dose inhalers. Pharm Res, 26:2639-2646
36. Clark AR. Metered atomisation for respiratory drug delivery. PhD Thesis. 1991:Loughborough University, UK.
37. Dunbar C. (1997). Atomizaion mechanism of the pressurized metered dose inhaler. Particulate science and technology, 15:253-271
38. Dunbar CA, Watkins AP, Miller JF. (1997). An experimental investigation of the spray issued from a pMDI using laser diagnostic techniques. J Aerosol Med, 10:351-368
39. Smith KJ, Chan HK, Brown KF. (1998). Influence of flow rate on aerosol particle size distributions from pressurized and breathactuated inhalers. J Aerosol Med, 11:231-245
40. Crosland BM, Johnson MR, Matida EA. (2009). Characterization of the spray velocities from a pressurized metered-dose inhaler. J Aerosol Med Pulm Drug Deliv, 22:85-97
41. Wigley G, Versteeg H, Hodson D. (2002). Near-orifice PDA measurements and atomisation mechanism of a pharmaceutical pressurised metered dose inhaler. Zaragoza, 9:11
42. Smyth HDC. (2003). Multimodal particle size distributions emitted from HFA-134a solution pressurized metered-dose inhalers. AAPS PharmSciTech, 4:76-86
43. Dunbar C, Watkins AP, Miller J. (1997). Theoretical investigation of the spray from a pressurized metered-dose inhaler. Atomization Sprays, 7:417-436
44. El-Sayed TM, Wallack DA, King CJ. (1990). Changes in particle morphology during drying of drops of carbohydrate solutions and food liquids. 1. Effect of composition and drying conditions. Ind Eng Chem Res, 29:2346-2354
45. Steckel H, Müller BW. (1998). Metered-dose inhaler formulations with beclomethasone-17,21-dipropionate using the ozone friendly propellant R 134a. Eur J Pharm Biopharm, 46:77-83
46. Reid ML, Jones SA, Brown MB. (2009). Transient drug supersaturation kinetics of beclomethasone dipropionate in rapidly drying films. Int J Pharm, 371:114-119
47. Dirksen J, Ring T. (1991). Fundamentals of crystallization: Kinetic effects on particle size distributions and morphology. Chem Eng Sci, 46:2389-2427
48. McKenzie L, Oliver M. (2000). Evaluation of the particle formation process after actuation of solution MDIs. J Aerosol Med, 13:59
49. Hecht JP, King CJ. (2000). Spray drying: Influence of developing drop morphology on drying rates and retention of volatile substances. 2. Modeling. Ind Eng Chem Res, 39:1766-1774