Evaluation of the Transwell System for Characterization of Dissolution Behavior of Inhalation Drugs: Effects of Membrane and Surfactant

Molecular Pharmaceutics

Volumn 12, Issue 8, 2015, Pages 2618-2624

  Rohrschneider, Marc ^a   Bhagwat, Sharvari ^b   Krampe, Raphael ^b   Michler, Victoria ^b   Breitkreutz, Jörg ^c   Hochhaus, Günther ^b  

^a BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG   (Germany)

^b UNIVERSITY OF FLORIDA HEALTH   (United States)

^c HEINRICH HEINE UNIVERSITY   (Germany)

Author keywords

dissolution medium; dissolution methods; inhalation; inhaled corticosteroids; Transwell

Indexed keywords

BUDESONIDE; CICLESONIDE; CORTICOSTEROID; DODECYL SULFATE SODIUM; FLUTICASONE PROPIONATE; SURFACTANT; FLUTICASONE; GENERIC DRUG; ORAL SPRAY; PREGNANE DERIVATIVE;

ARTICLE; DRUG ABSORPTION; DRUG PENETRATION; DRUG SOLUBILITY; FILTERS AND MEMBRANES; FLOW; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMIDITY; IN VITRO STUDY; PRIORITY JOURNAL; TEMPERATURE; CELL CULTURE; DEVICES; DRUG EFFECTS; EVALUATION STUDY; HUMAN; INHALATIONAL DRUG ADMINISTRATION; MEMBRANE; ORAL SPRAY; PHYSIOLOGY; PROCEDURES; RESPIRATORY CARE; RESPIRATORY FUNCTION; SOLUBILITY; TISSUE CULTURE TECHNIQUE; VALIDATION STUDY;

ADMINISTRATION, INHALATION; ADRENAL CORTEX HORMONES; BUDESONIDE; CELLS, CULTURED; DRUGS, GENERIC; FLUTICASONE; HUMANS; MEMBRANES; ORAL SPRAYS; PREGNENEDIONES; RESPIRATORY THERAPY; RESPIRATORY TRACT ABSORPTION; SOLUBILITY; SURFACE-ACTIVE AGENTS; TISSUE CULTURE TECHNIQUES;

EID: 84938326367     PISSN: 15438384     EISSN: 15438392     Source Type: Journal    
DOI: 10.1021/acs.molpharmaceut.5b00221     Document Type: Article

References (32)

1. Reddel, H. K.; Lim, T. K.; Mishima, M.; Wainwright, C. E.; Knight, D. A. Year-in-review 2010: asthma, COPD, cystic fibrosis and airway biology Respirology 2011, 16 (3) 540-552 10.1111/j.1440-1843.2011.01949.x
2. Rossi, G. A.; Cerasoli, F.; Cazzola, M. Safety of inhaled corticosteroids: room for improvement Pulm. Pharmacol. Ther. 2007, 20 (1) 23-35 10.1016/j.pupt.2005.10.008
3. Hochhaus, G.; Mollmann, H.; Derendorf, H.; Gonzalez-Rothi, R. J. Pharmacokinetic/pharmacodynamic aspects of aerosol therapy using glucocorticoids as a model J. Clin. Pharmacol. 1997, 37 (10) 881-892 10.1002/j.1552-4604.1997.tb04262.x
4. Arya, V.; Coowanitwong, I.; Brugos, B.; Kim, W. S.; Singh, R.; Hochhaus, G. Pulmonary targeting of sustained release formulation of Budesonide in neonatal rats J. Drug Targeting 2006, 14, 680-686 10.1080/10611860601010314
5. Hochhaus, G.; Gonzalez-Rothi, R. J.; Lukyanov, A.; Derendorf, H.; Schreier, H.; Dalla Costa, T. Assessment of glucocorticoid lung targeting by ex-vivo receptor binding studies in rats Pharm. Res. 1995, 12 (1) 134-137 10.1023/A:1016259225244
6. Riley, T.; Christopher, D.; Arp, J.; Casazza, A.; Colombani, A.; Cooper, A.; Dey, M.; Maas, J.; Mitchell, J.; Reiners, M.; Sigari, N.; Tougas, T.; Lyapustina, S. Challenges with Developing In Vitro Dissolution Tests for Orally Inhaled Products (OIPs) AAPS PharmSciTech 2012, 13, 978 10.1208/s12249-012-9822-3
7. Forbes, B.; Backman, P.; Christopher, D.; Dolovich, M.; Li, B.; Morgan, B. In Vitro Testing for Orally Inhaled Products: Developments in Science-Based Regulatory Approaches AAPS J. 2015, 17, 837-852 10.1208/s12248-015-9763-3
8. Arora, D.; Shah, K. A.; Halquist, M. S.; Sakagami, M. In vitro aqueous fluid-capacity-limited dissolution testing of respirable aerosol drug particles generated from inhaler products Pharm. Res. 2010, 27 (5) 786-795 10.1007/s11095-010-0070-5
9. Davies, N. M.; Feddah, M. R. A novel method for assessing dissolution of aerosol inhaler products Int. J. Pharm. 2003, 255 (1-2) 175-187 10.1016/S0378-5173(03)00091-7
10. 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 10.1016/j.ijpharm.2009.07.034
11. Son, Y. J.; Horng, M.; Copley, M.; McConville, J. T. Optmization of an In Vitro Dissolution Test Method for Inhalation Formulations Dissolution Technol. 2010, 17, 6-13 10.14227/DT170210P6
12. Thorsson, L.; Edsbäcker, S.; Conradson, T. B. Lung deposition of budesonide from Turbuhaler is twice that from a pressurized metered-dose inhaler P-MDI Eur. Respir. J. 1994, 7 (10) 1839-1844 10.1183/09031936.94.07101839
13. Patton, J. S.; Brain, J. D.; Davies, L. A.; Fiegel, J.; Gumbleton, M.; Kim, K. J.; Sakagami, M.; Vanbever, R.; Ehrhardt, C. The particle has landed - characterizing the fate of inhaled pharmaceuticals J. Aerosol Med. Pulm. Drug Delivery 2010, 23 (Suppl 2) S71-S87 10.1089/jamp.2010.0836
14. Feth, M. P.; Volz, J.; Hess, U.; Sturm, E.; Hummel, R. P. Physicochemical, crystallographic, thermal, and spectroscopic behavior of crystalline and X-ray amorphous ciclesonide J. Pharm. Sci. 2008, 97 (9) 3765-3780 10.1002/jps.21223
15. Guidancefor Industry. SUPAC-MR: Modified ReleaseSolid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry,Manufacturing, and Controls; In Vitro Dissolution Testing and In VivoBioequivalence Documentation. 1997. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070640.pdf. 1997. 14-12-2011.
16. EMEA. CPMP. CPMP/QWP/604/96. Note for Guidance on Qualityof Modified Release Products: A: Oral Dosage Forms. B; TransdermalDosage Forms. Section I (Quality). 1999. http://www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2009/09/WC500003664.pdf. 1999. 14-12-2011.
17. Nave, R.; Gunawardena, K. A.; Zech, K.; Bethke, T. D. Pharmacokinetic disposition of inhaled ciclesonide and its metabolite desisobutyryl-ciclesonide in healthy subjects and patients with asthma are similar Int. J. Clin. Pharmacol. Ther. 2006, 44 (1) 1-7 10.5414/CPP44001
18. Bethke, T. D.; Nave, R.; Zech, K.; Gunawardena, K. A. Pharmacokinetics of ciclesonide and its active principle in asthma patients and healthy subjects after single-dose inhalation J. Allergy Clin. Immunol. 2003, 111 (suppl) S217 abstract 593 10.1016/S0091-6749(03)80752-2
19. Thorsson, L.; Edsbäcker, S.; Källén, A.; Löfdahl, C.-G. Pharmacokinetics and systemic activity of fluticasone via Diskus® and pMDI, and of budesonide via Turbuhaler® Br. J. Clin. Pharmacol. 2001, 52 (5) 529-538 10.1046/j.0306-5251.2001.01493.x
20. Amidon, G. L.; Lennernäs, H.; Shah, V. P.; Crison, J. R. A Theoretical Basis for a Biopharmaceutic Drug Classification: The Correlation of in Vitro Drug Product Dissolution and in Vivo Bioavailability Pharm. Res. 1995, 12 (3) 413-420 10.1023/A:1016212804288
21. Ku, M. S. Use of the Biopharmaceutical Classification System in early drug development AAPS J. 2008, 10 (1) 208-12 10.1208/s12248-008-9020-0
22. Olsson, B.; Bondesson, E.; Borgström, L.; Edsbäcker, S.; Eirefelt, S.; Ekelund, K.; Gustavsson, L.; Hegelund-Myrbäck, T. In Controlled Pulmonary Drug Delivery; Smyth, H. D. C.; Hickey, A. J., Eds.; Springer New York: New York, NY, 2011; Chapter 2.
23. Edsbäcker, S.; Wollmer, P.; Selroos, O.; Borgström, L.; Olsson, B.; Ingelf, J. Do airway clearance mechanisms influence the local and systemic effects of inhaled corticosteroids? Pulm. Pharmacol. Ther. 2008, 21 (2) 247-58 10.1016/j.pupt.2007.08.005
24. May, S.; Jensen, B.; Wolkenhauer, M.; Schneider, M.; Lehr, C.-M. Dissolution techniques for in vitro testing of dry powders for inhalation Pharm. Res. 2012, 29 (8) 2157-66 10.1007/s11095-012-0744-2
25. Akella, A.; Deshpande, S. R. Pulmonary surfactants and their role in pathophysiology of lung disorders Indian J. Exp. Biol. 2013, 51, 5-22
26. Coowanitwong, I.; Arya, V.; Kulvanich, P.; Hochhaus, G. Slow release formulations of inhaled rifampin AAPS J. 2008, 10 (2) 342-8 10.1208/s12248-008-9044-5
27. Forbes, B.; Colombo, P.; Brambilla, G.; Saunders, M.; Jones, S. A.; Buttini, F. Important Considerations Regarding the Bioequivalence of Particles Emitted from Beclometasone Dipropionate Solution Metered Dose Inhalers Respir. Drug Delivery 2010, 3, 609-614
28. O'Hara, T.; Dunne, A.; Butler, J.; Devane, J. A review of methods used to compare dissolution profile data Pharm. Sci. Technol. Today 1998, 1 (5) 214-223 10.1016/S1461-5347(98)00053-4
29. van Amerongen, I. A.; de Ronde, H. A. G.; Klooster, N. T. M. Physical-chemical characterization of semisolid topical dosage form using a new dissolution system Int. J. Pharm. 1992, 86, 9-15 10.1016/0378-5173(92)90025-W
30. Bhatt, H.; Naik, B.; Dharamsi, A. Solubility Enhancement of Budesonide and Statistical Optimization of Coating Variables for Targeted Drug Delivery J. Pharm. 2014, 2014, 1 10.1155/2014/262194
31. Tokumura, T.; Miyazaki, E.; Isaka, H.; Kaneko, N.; Kanou, M. Solubility of fluticasone propionate in aqueous solutions measured by a method avoiding its adsorption to experimental tools Int. Res. J. Pharm. Appl. Sci. 2014, 4 (4) 19-24
32. Baumann, D.; Bachert, C.; Högger, P. Dissolution in nasal fluid, retention and anti-inflammatory activity of fluticasone furoate in human nasal tissue ex vivo Clin. Exp. Allergy 2009, 39 (10) 1540-50 10.1111/j.1365-2222.2009.03306.x