Bioequivalence test for iron-containing formulations

An equivalence and biological technology, applied in biological testing, biological material analysis, medical preparations containing active ingredients, etc., can solve problems such as undefined kinetic parameters such as T

Inactive Publication Date: 2005-10-19
VIFOR (INT) AG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Indeed, specific kinetic parameters such as T 75 and link it to bioequivalence

Method used

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  • Bioequivalence test for iron-containing formulations
  • Bioequivalence test for iron-containing formulations

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0060] Embodiment 1: the application of in vitro test in the control semi-finished product iron sucrose solution:

[0061] At a neutral pH of about 7, a saturated ferric chloride solution was contacted with a 10% w / v sodium carbonate solution. The resulting colloidal ferric hydroxide gel was washed with sufficient purified water to remove any traces of sodium chloride present as a by-product of the reaction.

[0062] A sufficient amount of saturated sucrose solution was added to the colloidal ferric hydroxide gel in a volume equal to that in which the final solution contained about 4.0% w / w elemental iron. The pH of the solution was adjusted to 10.7 with sodium hydroxide, and the solution was mixed at 90°C for 36 hours. QC samples collected during the collection process were used to determine pH, iron content and conduct in vitro bioequivalence tests. If the result is within the allowable limit, add purified water to adjust the volume of the solution so that the final iron c...

Embodiment 2

[0078]Example 2: Application of In Vitro Tests in Controlling Iron Sucrose Solutions Suitable for Injection Use

[0079] An iron sucrose solution suitable for injection was prepared by diluting the semi-finished solution described in Example 1 with water for injection to a final iron concentration of 20 mg / mL. The pH of the resulting solution was adjusted to 10.8 with sodium hydroxide, and then mixed uniformly. The solution was transferred through a stainless steel supply line and filtered through two in-line sterile 0.2 micron filter units into sterile fill bottles. Filters and filling bottles are placed under laminar flow in designated filling chambers with a constant cleanliness class 100.

[0080] All equipment used during filling is identified, sterilized and documented. The corks are washed, siliconized, depyrogenated and sterilized. Glassware was washed with deionized water and finally rinsed with water for injection before depyrogenation.

[0081] The vial filler i...

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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.

Description

field of invention [0001] The present invention relates to a rapid method for evaluating the bioequivalence of iron in iron supplement formulations, in particular iron-carbohydrate complexes, based on the kinetics of the reduction of iron(III) to iron(II) in a sample of the formulation. The invention also relates to quality control methods and related kits. Background of the invention [0002] Iron dextran was developed for the treatment of iron deficiency conditions, initially by intramuscular injection in patients with iron deficiency anemia who could not tolerate various oral iron salt preparations. See, eg, Lawrence, "Development and Comparison of Iron Dextran Products," PDA Journal of Pharmaceutical Science & Technology 52(5):190-197 (1998). Later, iron dextran was also administered intravenously and was found to produce similar beneficial effects. [0003] Various iron-containing preparations have been developed. Intravenous colloidal ferric hydroxide preparations, ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N31/00A61K31/295G01N31/22G01N33/20G01N33/84
CPCG01N33/84A61K31/295G01N31/22Y10T436/143333Y10T436/142222
Inventor M·J·赫勒内克R·A·朗格R·P·劳伦斯
Owner VIFOR (INT) AG
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