# US 2021/0277041 A1 · Purification Process of Ferric Carboxymaltose

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- Number: US 2021/0277041 A1
- Document ID: US20210277041A1
- Status: Published application
- Kind: A1
- Application number: 17/174,286
- Filed: 2021-02-11
- Published: 2021-09-09
- Earliest claimed: 2020-02-12
- Assignees: RK Pharma Solutions LLC
- Applicants: RK Pharma Solutions LLC
- Inventors: Ravishanker Kovi; Jayaraman Kannapan; Hemant Mande; Rajesh Patel; Ritesh H Panchal; Varun L Zambare
- Web page: https://patentgrep.com/patent/US20210277041A1

## CPC

- C07F 15/025: {without a metal-carbon linkage}
- C07F: ACYCLIC, CARBOCYCLIC OR HETEROCYCLIC COMPOUNDS CONTAINING ELEMENTS OTHER THAN CARBON, HYDROGEN, HALOGEN, OXYGEN, NITROGEN, SULFUR, SELENIUM OR TELLURIUM (metal-containing porphyrins C07D487/22)

## Abstract

The present application provides processes for the purification of ferric carboxymaltose, the process includes the steps of dissolving crude ferric carboxymaltose in a first solvent; charging the ferric carboxymaltose solution in a reaction vessel with a second solvent and precipitating therefrom a ferric carboxymaltose precipitate; and isolating pure ferric carboxymaltose from the ferric carboxymaltose precipitate.

## Claims

### Claim 1

A process for the purification of ferric carboxymaltose, the process comprising:
a. dissolving crude ferric carboxymaltose in a first solvent;
b. charging the ferric carboxymaltose solution in a reaction vessel with a second solvent and precipitating therefrom a ferric carboxymaltose precipitate; and
c. isolating pure ferric carboxymaltose from the ferric carboxymaltose precipitate.

### Claim 2 (depends on 1)

The process of claim 1, wherein the pure ferric carboxymaltose comprises ferric carboxymaltose of formula I.

### Claim 3 (depends on 1)

The process of claim 1, comprising:
oxidizing maltodextrin; and
reacting the oxidised maltodextrin further with a ferric source therewith providing the crude ferric carboxymaltose.

### Claim 4 (depends on 3)

The process of claim 3, comprising isolating the oxidizing maltodextrin and wherein the isolated maltodextrin is reacted with the ferric source.

### Claim 5 (depends on 3)

The process of claim 3, wherein the maltodextrin is oxidized with a sodium hypobromite solution in process water.

### Claim 6 (depends on 3)

The process of claim 3, wherein the ferric source comprises ferric chloride, and wherein reacting the oxidized maltodextrin in ferric chloride comprises reacting the oxidized maltodextrin in ferric chloride in process water solution, in the presence of sodium carbonate as a base.

### Claim 7 (depends on 6)

The process of claim 6, wherein oxidizing maltodextrin comprises providing a maltodextrin and water solution having a concentration of about 0.25 g/ml to about 0.50 g/ml; adding about 10% of the weight of water sodium hypobromite solution at a pH of about 9 to about 12 thereto; and stirring for sufficient time to yield oxidised maltodextrin.

### Claim 8 (depends on 7)

The process of claim 7, wherein charging the ferric carboxymaltose solution in a reaction vessel comprises charging in the reaction vessel a ferric chloride hexahydrate and process water solution having a concentration of about 0.4 g/ml to about 0.6 g/ml and wherein reacting the oxidised maltodextrin with the ferric source comprises charging the oxidised maltodextrin reaction mass into the ferric chloride solution at RT.

### Claim 9 (depends on 1)

The process of claim 1, wherein the first or second solvent comprises at least one of an acidic solvent and an organic solvent.

### Claim 10 (depends on 1)

The process of claim 1, wherein the first or second solvent comprises at least one of an alcoholic, a ketone solvent, or a mixture thereof.

### Claim 11 (depends on 1)

The process of claim 1, comprising preheating filtering equipment and filtering the crude ferric carboxymaltose and the first solvent solution.

### Claim 12 (depends on 1)

The process of claim 1, wherein the ferric carboxymaltose crude has an iron content of about 24% to about 32% weight/weight.

### Claim 13 (depends on 12)

The process of claim 12, wherein the ferric carboxymaltose crude has a molecular weight of about 120 kDa to about 200 kDa.

### Claim 14 (depends on 1)

The process of claim 1, comprising washing the isolated pure ferric carboxymaltose with a solvent and drying the washed ferric carboxymaltose.

### Claim 15 (depends on 1)

The process of claim 1, wherein the crude ferric carboxymaltose and first solvent solution has a concentration of about 0.20 g/ml to about 0.33 g/ml.

### Claim 16 (depends on 15)

The process of claim 15, comprising charging sodium chloride into the reaction vessel, heating the crude ferric carboxymaltose solution to between about 50° C. to about 60° C., filtering the reaction mass and removing therefore undissolved particulate, adding an alcoholic solvent to the filtrate and stirring for a sufficient amount of time and at a temperature of between about 15° C. to about 30° C., therewith precipitating the ferric carboxymaltose precipitate, and filtering, washing and drying the ferric carboxymaltose precipitate to yield ferric carboxymaltose API.

### Claim 17 (depends on 1)

Pure ferric carboxymaltose obtained with the process of claim 1.

### Claim 18 (depends on 1)

A pharmaceutical composition comprising pure ferric carboxymaltose obtained with the process of claim 1 and at least one pharmaceutically acceptable excipient.