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

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...

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Main Authors: Yeong, C.H., Blackshaw, P.E., Ng, K.H., Abdullah, B.J.J., Blaauw, M., Dansereau, R.J., Perkins, A.C.
Format: Article
Language:English
English
Published: Elsevier 2011
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Online Access:http://eprints.um.edu.my/4148/1/sm-153.pdf
http://eprints.um.edu.my/4148/2/Production_and_first_use_of_%28SmCl3%29-Sm-153-ion_exchange_resin_capsule_formulation_for_assessing_gastrointestinal_motility.pdf
http://eprints.um.edu.my/4148/
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Institution: Universiti Malaya
Language: English
English
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Summary: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.