Reproducibility of neutron activated Sm-153 oral dose formulations intended for human administration

Yeong, C.H. and Blackshaw, P.E. and Ng, K.H. and Abdullah, B.J.J. and Blaauw, M. and Dansereau, R.J. and Perkins, A.C. (2011) Reproducibility of neutron activated Sm-153 oral dose formulations intended for human administration. Applied Radiation and Isotopes, 69 (9). pp. 1181-1184. ISSN 0969-8043, DOI https://doi.org/10.1016/j.apradiso.2011.04.017.

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Abstract

Neutron activation of Sm-152 offers a method of radiolabeling for the in vivo study of oral dose formulations by gamma scintigraphy. Reproducibility measurements are needed to ensure the robustness of clinical studies. 204 enteric-coated guaifenesin core tablets (10 mg of Sm(2)O(3)) were irradiated by thermal neutrons to achieve 1 MBq at 48 h. Administered activities were 0.86 +/- 0.03 MBq. Good reproducibility (CV=3.5) was observed over 24 weeks ensuring that volunteer doses were within the dose reference level of 0.8 mSv.

Item Type: Article
Funders: UNSPECIFIED
Additional Information: ISI Document Delivery No.: 787DT Times Cited: 2 Cited Reference Count: 14 Cited References: Ahrabi SF, 2000, EUR J PHARM SCI, V10, P225, DOI 10.1016/S0928-0987(00)00070-1 AWANG MB, 1993, J LABELLED COMPD RAD, V33, P941, DOI 10.1002/jlcr.2580331008 HUDA W, 1989, J NUCL MED, V30, P260 Honkanen O, 2004, EUR J PHARM SCI, V21, P671, DOI 10.1016/j.ejps.2004.01.008 Marvola J, 2004, INT J PHARM, V281, P3, DOI 10.1016/j.ijpharm.2004.05.022 Marvola T, 2008, INT J PHARM, V349, P24, DOI 10.1016/j.ijpharm.2007.07.033 PARR A, 1987, PHARMACEUT RES, V4, P524, DOI 10.1023/A:1016491925109 PARR A, 1985, J PHARM SCI, V74, P590, DOI 10.1002/jps.2600740524 PARR AF, 1987, PHARMACEUT RES, V4, P486, DOI 10.1023/A:1016475421474 Perkins A, 2000, NUCL MED COMMUN, V21, P415, DOI 10.1097/00006231-200005000-00001 Perkins AC, 1996, PHARM WORLD SCI, V18, P97, DOI 10.1007/BF00417757 TSE JW, 1989, J NUCL MED, V30, P202 Wilding IR, 2001, ADV DRUG DELIVER REV, V46, P103, DOI 10.1016/S0169-409X(00)00135-6 WILSON C, 1992, GAMMA SCINTIGRAPHY S, P1 Yeong, C. H. Blackshaw, P. E. Ng, K. H. Abdullah, B. J. J. Blaauw, M. Dansereau, R. J. Perkins, A. C. Procter and Gamble Ltd.; University of Malaya Institute of Research Management and MonitoringFS367/2008C, PS010/2008B This work was supported by Procter and Gamble Ltd. The authors would like to thank Mehmet Sarilar, Reactor Institute Delft for support with irradiation and sample preparation and to acknowledge University of Malaya Institute of Research Management and Monitoring for the research Grants FS367/2008C and PS010/2008B. Pergamon-elsevier science ltd Oxford
Uncontrolled Keywords: Gamma scintigraphy Neutron activation Oral dosage formulation Reproducibility Sm-153 gamma-scintigraphic evaluation nuclear-medicine drug-delivery dosage forms tablets capsules colon
Subjects: R Medicine
Divisions: Faculty of Medicine
Depositing User: Mr Ahmad Azwan Azman
Date Deposited: 08 Jan 2013 01:57
Last Modified: 08 Jan 2013 01:57
URI: http://eprints.um.edu.my/id/eprint/4148

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