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: | , , , , , , |
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| Format: | Article |
| Language: | English English |
| Published: |
Elsevier
2011
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| Subjects: | |
| 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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| 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. |
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