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

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

Applied radiation and isotopes : including data, instrumentation and methods for use in agriculture, industry and medicine (2011-05-10)
C H Yeong, P E Blackshaw, K H Ng, B J J Abdullah, M Blaauw, R J Dansereau, A C Perkins
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 (10mg 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.

MATERIALS
Product Number
Brand
Product Description

Supelco
Guaifenesin, certified reference material, pharmaceutical secondary standard
Sigma-Aldrich
Guaiacol glyceryl ether, ≥98% (GC)