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benovice ● 2011-05-31 15:33 (5095 d 07:53 ago) Posting: # 7034 Views: 4,512 |
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Dear All, The parameters to compare for Iron Sucrose BE are TSI (Total Serum Iron) & TBI (Transferrin bound Iron). If a formulation passes TBI but not TSI, then what does it indicate and what should be done about it? (All our values were higher for test preparation) We have already tried matching Mol wt, pH, chloride content, Zeta potential, Polydispersibility. Can anyone suggest what parameter should be matched in-vitro to get the in vivo equivalence for TSI? Thanking in advance. |
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benovice ● 2011-06-03 15:03 (5092 d 08:22 ago) @ benovice Posting: # 7060 Views: 3,752 |
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More than 60 posts and still no reply? Anyways, I read some more about it and found out that the reticuloendothelial system uptake of Iron sucrose is Dependant on molecular weight. Since our AUC values were on the higher side, I thought decreasing the Mol wt would help (since mol wt is inversely proportional to uptake). However, when I went thru documents, I found out that we had performed 2 studies; 1 in which test MW was much less than Reference and other with matching MW. But the results of both are identical.... Totally Lost now..... Dear member's please reply. 7060 – 7034 > 60?  [Helmut] |
Ing. Helmut Schütz