In-vitro method for testing bioequivalence of iron-sucrose formulation
AssigneeAstron Research Limited
InventorsSamir SHAH, Keyur PATEL, Sanjay DASH, Kuldeep Dilip KARNIK, Ashish SEHGAL, Bhavesh Vallabhabhai PATEL, Jayanta Kumar MANDAL
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Abstract
The present disclosure relates to an in vitro method for measuring the T75 of reduction kinetics of iron from Fe+3 to Fe+2 in an iron-sucrose complex and hence assessing the bioequivalency of iron-sucrose composition. According to the disclosed method, T75 of reduction kinetics of iron in an iron-sucrose complex in between 25 to 50 minutes indicates bioequivalent iron-sucrose composition.
Claims14
1) A method for accessing the bioequivalence of iron in iron-sucrose injectable composition comprising:
- determining T75 for the reduction kinetics of the iron-sucrose complex in a solution of an inorganic acid;
- wherein the T75 in between 25 to 50 minutes indicate an effective bioequivalence of iron in the iron-sucrose complex when administered to a subject.
2) A method for accessing the bioequivalence of iron in iron-sucrose injectable composition comprising:
- determining T75 for the reduction kinetics of the iron-sucrose complex in a solution without the addition of a reducing agent;
- wherein the T75 in between 25 to 50 minutes indicate an effective bioequivalence of iron in the iron-sucrose complex when administered to a subject.
8) A method for accessing the bioequivalence of iron in iron-sucrose injectable composition comprising:
- determining T75 for the reduction kinetics of the iron-sucrose complex in a solution of an inorganic acid and without the addition of a reducing agent;
- wherein the T75 in between 25 to 50 minutes indicate an effective bioequivalence of iron in the iron-sucrose complex when administered to a subject.
Dependencies are inferred from the claim text.