Optimization of an in vitro dissolution test method for inhalation formulations

Dissolution Technologies

Volumn 17, Issue 2, 2010, Pages 6-13

  Son, Yoen Ju ^a   Horng, Michelle ^a   Copley, Mark ^b   McConville, Jason T ^a  

^a UNIVERSITY OF TEXAS AT AUSTIN   (United States)

^b Copley Scientific Limited ^*  (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

BUDESONIDE; DIPALMITOYLPHOSPHATIDYLCHOLINE; SALBUTAMOL SULFATE;

AEROSOL; ARTICLE; CONTROLLED DRUG RELEASE; DEVICE; DISSOLUTION; DRUG DELIVERY SYSTEM; DRUG FORMULATION; DRUG RELEASE; IN VITRO STUDY; INHALATION; INHALER; MEMBRANE; PARTICLE SIZE; POWDER INHALER; QUALITY CONTROL; SEPARATION TECHNIQUE;

EID: 77954688195     PISSN: 1521298X     EISSN: None     Source Type: Journal    
DOI: 10.14227/DT170210P6     Document Type: Article

References (21)

1. Gray, V. A.; Hickey, A. J.; Balmer, P.; Davies, N. M.; Dunbar, C.; Foster, T. S.; Olsson, B. L.; Sakagami, M.; Shah, V. P.; Smurthwaite, M. J.; Veranth, J. M.; Zaidi, K. The Inhalation Ad Hoc Advisory Panel for the USP Performance Tests of Inhalation Dosage Forms. Pharm. Forum 2008, 34 (4), 1068-1074.
2. Patton, J. S. Mechanisms of macromolecule absorption by the lungs. Adv. Drug Deliver. Rev. 1996, 19 (1), 3-36.
3. Asada, M.; Takahashi, H.; Okamoto, H.; Tanino, H.; Danjo, K. Theophylline particle design using chitosan by the spray drying. Int. J. Pharm. 2004, 270 (1-2), 167-174.
4. Jaspart, S.; Bertholet, P.; Piel, G.; Dogne, J. M.; Delattre, L.; Evrard, B. Solid lipid microparticles as a sustained release system for pulmonary drug delivery. Eur. J. Pharm. Biopharm. 2007, 65 (1), 47-56.
5. Learoyd, T. P.; Burrows, J. L.; French, E.; Seville, P. C. Chitosan-based spray-dried respirable powders for sustained delivery of terbutaline sulfate. Eur. J. Pharm. Biopharm. 2008, 68, (2), 224-234.
6. Davies, N. M.; Feddah, M. I. R. A novel method for assessing dissolution of aerosol inhaler products. Int. J. Pharm. 2003, 255 (1-2), 175-187.
7. Cook, R. O.; Pannu, R. K.; Kellaway, I. W. Novel sustained release microspheres for pulmonary drug delivery. J. Control. Release 2005, 104 (1), 79-90.
8. McConville, J. T.; Patel, N.; Ditchburn, N.; Tobyn, M. J.; Staniforth, J. N.; Woodcock, P. Use of a novel modified TSI for the evaluation of controlled-release aerosol formulations. I. Drug Dev. Ind. Pharm. 2000, 26 (11), 1191-1198.
9. Ansoborlo, E.; Guilmette, R. A.; Hoover, M. D.; Chazel, V.; Houpert, P.; Henge-Napoli, M. H. Application of in vitro dissolution tests to different uranium compounds and comparison with in vivo data. Radiat. Prot. Dosim. 1998, 79 (1-4), 33-37.
10. Sdraulig, S.; Franich, R.; Tinker, R. A.; Solomon, S.; O'Brien, R.; Johnston, P. N. In vitro dissolution studies of uranium bearing material in simulated lung fluid. J. Environ. Radioactiv. 2008, 99 (3), 527-538.
11. Kwon, M. J.; Bae, J. H.; Kim, J. J.; Na, K.; Lee, E. S. Long acting porous microparticle for pulmonary protein delivery. Int. J. Pharm. 2007, 333 (1-2), 5-9.
12. Ungaro, F.; De Rosa, G.; Miro, A.; Quaglia, F.; La Rotonda, M. I. Cyclodextrins in the production of large porous particles: Development of dry powders for the sustained release of insulin to the lungs. Eur. J. Pharm. Sci. 2006, 28 (5), 423-432.
13. Son, Y. J.; McConville, J. T. Development of a standardized dissolution test method for inhaled pharmaceutical formulations. Int. J. Pharm. 2009, 382 (1-2), 15-22.
14. Feddah, M. R.; Brown, K. F.; Gipps, E. M.; Davies, N. M. In-Vitro Characterisation of Metered Dose Inhaler Versus Dry Powder Inhaler Glucocorticoid Products: Influence of Inspiratory Flow Rates. J. Pharm. Pharm. Sci. 2000, 3 (3), 317-324.
15. Harris, J. A.; Stein, S. W.; Myrdal, P. B. Evaluation of the TSI aerosol impactor 3306/3321 system using a redesigned impactor stage with solution and suspen- sion metered-dose inhalers. AAPS PharmSciTech 2006, 7 (1), E1-E8.
16. <1092> The Dissolution Procedure: Development and Validation. In United States Pharmacopeia and National Formulary USP 32-NF 27. The United States Pharmacopeial Convention, Inc.: Rockville, MD, 2009.
17. Marre, S.; Palmeri, J. Theoretical study of aerosol filtration by nucleopore filters: The intermediate crossover regime of Brownian diffusion and direct interception. J. Colloid Interf. Sci. 2001, 237 (2), 230-238.
18. Rzepka, S.; Neidhart, B. Transport processes through track-etch membrane filters in a reagent delivery cell. Fresen. J. Anal. Chem. 2000, 366 (4), 336-340.
19. Marple, V. A.; Roberts, D. L.; Romay, F. J.; Miller, N. C.; Truman, K. G.; Holroyd, M. J.; Mitchell, J. P.; Hochrainer, D. Next generation pharmaceutical impactor (A new impactor for pharmaceutical inhaler testing). Part I: Design. J. Aerosol Med. 2003, 16 (3), 283-299.
20. Moss, O. R. Simulants of lung interstitial fluid. Health Phys. 1979, 36, 447-448.
21. Veldhuizen, R.; Nag, K.; Orgeig, S.; Possmayer, F. The role of lipids in pulmonary surfactant. BBA-Mol. Basis Dis. 1998, 1408 (2-3), 90-108.