In-vitro method for testing bioequivalence of iron-sucrose formulation
The present disclosure relates to an in vitro method for measuring the T 75 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, T 75 of reduction kinetics of iron in an iron-sucrose complex in between 25 to 50 minutes indicates bioequivalent iron-sucrose composition.
1. A method for accessing the bioequivalence of iron in iron-sucrose injectable composition comprising:
determining T 75 for the reduction kinetics of the iron-sucrose complex in a solution of an inorganic acid; wherein the T 75 in between 25 to 50 minutes indicates an effective bioequivalence of iron in the iron-sucrose complex when administered to a subject.
2. The method as disclosed in claim 1 , wherein the solution contains an inorganic acid selected from a group comprising of hydrochloric acid, nitric acid, phosphoric acid and the likes thereof.
3. The method as disclosed in claim 1 , wherein the pH of the solution is in between 1 to 4.
4. The method as disclosed in claim 1 , wherein the T 75 is in between 30 to 40 minutes.
5. The method as disclosed in claim 1 , wherein the determination of T 75 for the reduction kinetics is preformed using a spectrophotometric method.
6. The method according to claim 5 , wherein the spectrophotometric method comprises of UV/VIS spectroscopy.
7. A method for accessing the bioequivalence of iron in an iron-sucrose injectable composition comprising:
determining T 75 for the reduction kinetics of the iron-sucrose complex in a solution without the addition of a reducing agent; wherein the T 75 in between 25 to 50 minutes indicates an effective bioequivalence of iron in the iron-sucrose complex when administered to a subject.
8. The method as disclosed in claim 7 , wherein the solution contains an inorganic acid selected from a group comprising of hydrochloric acid, nitric acid, phosphoric acid and the likes thereof.
9. The method as disclosed in claim 7 , wherein the pH of the solution is in between 1 to 4.
10. The method as disclosed in claim 7 , wherein the determination of T 75 for the reduction kinetics is preformed using a spectrophotometric method.
11. The method as disclosed in claim 7 , wherein the T 75 is in between 30 to 40 minutes.
12. A method for accessing the bioequivalence of iron in an iron-sucrose injectable composition comprising:
determining T 75 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 T 75 in between 25 to 50 minutes indicates an effective bioequivalence of iron in the iron-sucrose complex when administered to a subject.
13. The method as disclosed in claim 12 , wherein pH of the solution is in between 1-4.
14. The method as disclosed in claim 12 , wherein the preferable T 75 is in between 30 to 40 minutes.