WO2023047424A4

WO2023047424A4 - Pharmaceutical acceptable iron (iii) coordination complex having high phosphate binding capacity and preparation thereof

Info

Publication number: WO2023047424A4
Application number: PCT/IN2022/051044
Authority: WO
Inventors: Sunil Kumar AGARWAL; Manoj Mukhopadhyay; Avijit Sehanobish; Saunak Sarbajna
Original assignee: West Bengal Chemical Industries Limited; Eskag Pharma Pvt Ltd.
Priority date: 2022-04-29
Filing date: 2022-11-30
Publication date: 2023-09-07
Also published as: WO2023047424A1

Abstract

The present invention relates to a pharmaceutical acceptable iron (III) coordination complex having high phosphate binding capacity prepared through a cost-effective and an organic solvent free route. The present invention provides a pharmaceutical composition of iron (III) coordination complex which not only releases the desired amount of elemental iron in the desired pH level which is absorbed and assimilated into iron stores but also binds the ferric iron with the higher dietary phosphate which is finally excreted through stool being insolvable. The pharmaceutical composition is industrially acceptable, consumable with less or no side-effects, more effective.

Claims

AMENDED CLAIMS received by the International Bureau on 21 July 2023 (21 .07.2023)

CLAIMS:

1. A pharmaceutically acceptable Iron (III) coordination complex prepared through an organic solvent free route and represented by formula I;

characterized in that, the complex having:

— purity of 90-95% pure

— Phosphate binding capacity in the range of70.26-90 mg-P/g of elemental Iron at pH 7.5 ;

— moisture content in the range of 19.05 to 28 %.

— particle size distribution in the range of Dv (0.1)- 125pm, Dv (0.5)- 726pm and Dv (0.9)- 1940pm.

2. The coordination complex as claimed in claim 1, wherein the purity of Iron (III) coordination complex and water adduct in solution is 70-80%.

3. The coordination complex as claimed in claim 1, wherein the complex is present in the amorphous form.

4. The pharmaceutically acceptable Iron (III) coordination complex as claimed in claim 1, wherein the complex comprises of ferric tricitratedecahydrate.

18

AMENDED SHEET (ARTICLE 19)

5. A process for preparing the pharmaceutically acceptable iron (III) coordination complex through an organic free solvent route comprising the steps of: a. reacting an anhydrous ferric halide with a metal salt of acid in water with stirring at a temperature ranging between 55-85°C for a period of 24-36 hour to obtain a brown precipitate; b. filtering the brown precipitate obtained in step (a) in a nitrogen gas atmosphere at an optimum pressure range to obtain wet cake material; c. drying the wet cake material obtained in step (b) at a temperature in the range of 55 to 85°C for a period of 1 to 8 hours followed by sequential increasing of temperature at 5 degree per 30 to 35 minutes to obtain the pharmaceutically acceptable Iron (III) coordination complex.

6. The process as claimed in claim 5, wherein the ferric halide used is in the range of 50 to 65%. . The process as claimed in claim 6, wherein the halide is a chloride.

8. The process as claimed in claim 5, wherein the metal salt is used in the range of 50 to 65%.

9. The process as claimed in claim 5, wherein the metal salt of acid is citric acid.

10. The process as claimed in claim 9, wherein the metal in metal salt is a sodium based salt.

11. The process as claimed in claim 5, wherein the stirring in step (a) is maintained in the range of 25-40 rpm.

19

AMENDED SHEET (ARTICLE 19)

12. The process as claimed in claim 5, wherein the filtering is performed in step (a) in a nitrogen gas atmosphere at pressure in the range of 600-700 mmHg. 13. The process as claimed in claim 5, wherein the drying is done in drying chamber at a temperature ranging between 50 to 85 °C for a period of 60- 480 minutes.

20

AMENDED SHEET (ARTICLE 19)