Reproducibility of neutron activated Sm-153 oral dose formulations intended for human administration
Document Type
Article (Restricted)
Publication Date
1-1-2011
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.
Keywords
Gamma scintigraphy Neutron activation Oral dosage formulation Reproducibility Sm-153 gamma-scintigraphic evaluation nuclear-medicine drug-delivery dosage forms tablets capsules colon
Divisions
fac_med
Publication Title
Applied Radiation and Isotopes
Volume
69
Issue
9
Publisher
Elsevier
Additional Information
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