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Critical Reviews™ in Therapeutic Drug Carrier Systems
Импакт фактор: 2.9 5-летний Импакт фактор: 3.72 SJR: 0.736 SNIP: 0.818 CiteScore™: 4.6

ISSN Печать: 0743-4863
ISSN Онлайн: 2162-660X

Выпуски:
Том 37, 2020 Том 36, 2019 Том 35, 2018 Том 34, 2017 Том 33, 2016 Том 32, 2015 Том 31, 2014 Том 30, 2013 Том 29, 2012 Том 28, 2011 Том 27, 2010 Том 26, 2009 Том 25, 2008 Том 24, 2007 Том 23, 2006 Том 22, 2005 Том 21, 2004 Том 20, 2003 Том 19, 2002 Том 18, 2001 Том 17, 2000 Том 16, 1999 Том 15, 1998 Том 14, 1997 Том 13, 1996 Том 12, 1995

Critical Reviews™ in Therapeutic Drug Carrier Systems

DOI: 10.1615/CritRevTherDrugCarrierSyst.v21.i1.20
46 pages

Drug Delivery to the Nasal Cavity: In Vitro and In Vivo Assessment

Stephen P. Newman
Pharmaceutical Profiles Ltd., Mere Way, Ruddington Fıelds, Nottingham NG11 6JS, UK
Gary R. Pitcairn
Pharmaceutical Profiles Ltd., Nottingham, UK
Richard N. Dalby
University of Maryland School of Pharmacy, Baltimore, Maryland, USA

Краткое описание

Drugs are given intranasally for both local and systemic applications, and the use of the intranasal route is predicted to rise dramatically in the next 10 years. Nasal drug delivery may be assessed by a variety of means, but high reliance is often placed upon in vitro testing methodology (emitted dose, droplet or particle size distribution, spray pattern, and plume geometry). Spray pattern and plume geometry define the shape of the expanding aerosol cloud, while droplet size determines the likelihood of deposition within the nasal cavity by inertial impaction. Current FDA guidance recommends these methods as a means of documenting bioavailability (BA) and bioequivalence (BE) for topically acting solution formulations, because they can be performed reproducibly and are more discriminating among products. Nasal drug delivery in vivo may be determined by several radionuclide imaging methods: the two-dimensional imaging technique of gamma scintigraphy has been used most widely, but the three-dimensional method of positron emission tomography (PET) is being used increasingly often. In some situations a good in vitro/in vivo correlation (IVIVC) exists; for instance, negligible penetration into the lungs has been demonstrated in the case of nasal pump sprays delivering large droplets, while a clear difference may be shown in intranasal deposition between two aerosols with markedly different size distributions. However, recent studies have shown a poorer IVIVC for two similar nasal pump sprays, where significant differences in in vitro parameters were not reflected in differences in nasal deposition in vivo. It is suggested that radionuclide imaging data may have an important role to play as an adjunct to in vitro testing in BA and BE assessments and may provide a clearer understanding of the changes in in vitro parameters that are important for predicting differences in in vivo performance.


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