Validation of radiolabeling of drug formulations for aerosol deposition assessment of orally inhaled products

Journal of Aerosol Medicine and Pulmonary Drug Delivery

Volumn 25, Issue SUPPL.1, 2012, Pages

  Devadason, Sunalene G ^a   Chan, Hak Kim ^b   Haeussermann, Sabine ^c   Kietzig, Claudius ^c   Kuehl, Philip J ^d   Newman, Stephen ^e   Sommerer, Knut ^c   Taylor, Glyn ^f  

^a UNIVERSITY OF WESTERN AUSTRALIA   (Australia)

^b UNIVERSITY OF SYDNEY   (Australia)

^c Inamed GmbH   (Germany)

^d LOVELACE RESPIRATORY RESEARCH INSTITUTE   (United States)

^e Scientific Consultant   (United Kingdom)

^f CARDIFF UNIVERSITY   (United Kingdom)

Author keywords

aerosol deposition studies; radiolabeling methods

Indexed keywords

BECLOMETASONE DIPROPIONATE; PENTETIC ACID; TECHNETIUM 99M; TRACER;

AERODYNAMIC PARTICLE SIZE DISTRIBUTION; AEROSOL; ARTICLE; DRUG DELIVERY SYSTEM; DRUG DISTRIBUTION; DRUG FORMULATION; DRY POWDER; HUMAN; ISOTOPE LABELING; METERED DOSE INHALER; NEBULIZER; PARTICLE SIZE; POWDER INHALER; RELIABILITY; SCINTIGRAPHY; VALIDATION PROCESS;

ADMINISTRATION, INHALATION; AEROSOLS; DRUG DELIVERY SYSTEMS; HUMANS; LUNG; PARTICLE SIZE; PHARMACEUTICAL PREPARATIONS; RADIONUCLIDE IMAGING; RADIOPHARMACEUTICALS; TISSUE DISTRIBUTION;

EID: 84870827504     PISSN: 19412711     EISSN: 19412703     Source Type: Journal    
DOI: 10.1089/jamp.2012.1Su3     Document Type: Article

References (10)

1. Snell NJ, and Ganderton D: Assessing lung deposition of inhaled medications. Consensus statement from a workshop of the British Association for Lung Research, held at the Institute of Biology, London, U.K. on 17 April 1998. Respir Med. 1999;93:123-133. (Pubitemid 29062720)
2. Farr SJ. The physico-chemical basis of radiolabelling metered dose inhalers with 99mTc. J Aerosol Med. 1996;9(Suppl 1): S27-S35.
3. Newman S, Hollingworth A, and Clark A: Effect of different modes of inhalation on drug delivery from a dry powder inhaler. Int J Pharmacol. 1994;102:127-132. (Pubitemid 24042986)
4. Clark A: Medical aerosol inhalers. Aerosol Sci Technol. 1995;22:374-391.
5. Dolovich M: In vitro measurements of delivery of medications from MDIs and spacer devices. J Aerosol Med. 1996;9(Suppl 1):S49-S58. (Pubitemid 26134883)
6. Dolovich M: Standards for in-vitro/in vivo measurements of MDIs. J Aerosol Med. 1996;9(Suppl 1):S1-S3.
7. European Medicines Agency Committee for Medicinal Products for Human Use. Guideline on the requirements for clinical documentation for orally inhaled products (OIP) including the requirements for demonstration of therapeutic equivalence between two inhaled products for use in the treatment of asthma and chronic obstructive pulmonary disease (COPD) in adults and for use in the treatment of asthma in children and adolescents. 2009. Available at www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2009/09/ WC500003504.pdf. Accessed October 7, 2012.
8. Evans C, Cipolla D, Chesworth T, Agurell E, Ahrens A, Conner D, Dissanayake S, Dolovich M, Doub W, Fuglsang A, Arieta AG, Golden M, Hermann R, Hochhaus G, Holmes S, Lafferty P, Lyapustina S, Nair P, O'Connor D, Parkins D, Peterson I, Reisner C, Sandell D, Singh GJP, Weda M, and Watson P: Equivalence considerations for orally inhaled products for local action - ISAM/IPAC-RS European Workshop Report. J Aerosol Med Pulm Drug Deliv. 2012;25: 117-139.
9. Roller CM, Zhang G, Troedson RG, Leach CL, Le Souef PN, and Devadason SG: Spacer inhalation technique and deposition of extrafine aerosol in asthmatic children. Eur Respir J. 2007;29:299-306. (Pubitemid 46231907)
10. Devadason SG, and Roller CM: Assessment of validation criteria for 99mTc labelling methods for HFA-pMDI formulations. Respir Drug Deliv. 2012;3:863-866.