Bioequivalence test for iron-containing formulations

Details Bioequivalence test for iron-containing formulations Bioequivalence test for iron-containing formulations

2005-06-28

2005-06-28

Wallenhorst, Maureen M. (Department: 1743)

Chemistry: analytical and immunological testing

Metal or metal containing

Mn, te, re, fe, ru, os, co, rh, ir, ni, pd, pt

C436S073000, C436S093000, C436S094000

Reexamination Certificate

active

06911342

ABSTRACT:
A rapid method for assessing the bioequivalence of iron in iron-supplement formulations, particularly iron-sucrose formulations is described, which is based upon the kinetics of reduction of iron (III) to iron (II) in a sample of the formulation. Quality control methods and associated kits also are described.

REFERENCES:
patent: 5624668 (1997-04-01), Lawrence et al.
patent: WO 97/11711 (1997-04-01), None
“USP Monograph for Iron Sucrose Injection”, 2nd Supplement to the USP-NF, pp. 1-5, Jul./Aug. 2002.
“Guidance for Industry, Dissolution Testing of Immediate Release Solid Oral Dosage Forms”, U.S. Dept. of Health and Human Services, Food & Drug Administration, CDER, Aug. 1997.
S. Beshara, et al., “Kinetic analysis of 52Fe-labelled iron(III) hydroxide-sucrose complex following bolus administration using positron emission tomography”,Br J Haematol, vol. 104 (2), pp. 288-295, Feb. 1999.
Richard Lawrence, “Development and Comparison of Iron Dextran Products”,PDA Journal of Pharmaceutical Science&Technology, vol. 52, No. 5, pp. 190-197, Sep./Oct. 1998.
U, Erni, et al., “Chemical Characterization of Iron (III)-Hydroxide-Dextrin Complexes”, Arzheim.-Forsch./Drug. Res., vol. 34, (II), pp. 1555-1559, (1984).

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