Abstract: The present invention relates to an improved process for the preparation of pharmaceutical grade of Sucroferric oxyhydroxide (1). More particularly, the present invention relates to a process for the preparation of Sucroferric oxyhydroxide (1) specific surface area of more than 16 m2/gm.
1. A process for the preparation of pharmaceutical grade Sucroferric Oxyhydroxide (1), comprising: a) mixing aqueous ferric chloride hexahydrate (3) and an aqueous solution of suitable base or mixture of bases to form ferric oxyhydroxide (2); b) isolating ferric oxyhydroxide (2) and washing solid ferric oxyhydroxide (2) with water; c) adding a suitable protic solvent to the solid ferric oxyhydroxide (2) at a suitable temperature; d) adding suitable carbohydrates to the reaction mixture at 25-30 °C; and e) isolating Sucroferric oxyhydroxide (1) using water immiscible solvents.
2. The process as claimed in claim 1, wherein the base used is selected from a group comprising of sodium bicarbonate, potassium bicarbonate, lithium bicarbonate, sodium hydroxide, potassium hydroxide, calcium hydroxide or mixtures thereof.
3. The process as claimed in claim 1, wherein the protic solvent used in step c) may be selected from a group comprising of methanol, ethanol, isopropyl alcohol, n-propanol, n-butanol, water or mixture thereof.
4. The process as claimed in claim 1, wherein the suitable carbohydrate is selected from glucose, sucrose, fructose, corn starch, wheat starch, rice starch, maize starch, potato starch, or mixture thereof.
5. The process as claimed in claim 1, wherein the water immiscible solvent is selected from a group comprising of dichloromethane, ethyl acetate, diethyl ether, methyl tert-butyl ether, toluene, hexane, cyclohexane, heptane, carbon tetrachloride or mixture thereof.
6. The process as claimed in claim 1, wherein Sucroferric oxyhydroxide (1) is having ferrous ion content less than 0.5(% w/w) and chloride content less than 0.3% (w/w).
7. The process as claimed in claim 1, wherein Sucroferric oxyhydroxide (1) is having starch content in the range of 26% to 34(% w/w) and sucrose content in the range of 26% to 32 (% w/w).
8. The process as claimed in claim 1, wherein the Sucroferric oxyhydroxide (1) is having particle size more than 100 urn.
9. The process as claimed in claim 1, wherein the Sucroferric oxyhydroxide (1) is having specific surface area more than 16 m2/gm.
10. The process as claimed in claim 1, wherein the Sucroferric oxyhydroxide (1) is having phosphate binding capacity by Ion Chromatography (IC) is at least 2.6 meq. of phosphate per 500 mg Iron and at least 0.2 mg P/mg of Iron.
We Claim:
1. A process for the preparation of pharmaceutical grade Sucroferric Oxyhydroxide
(1), comprising:
a) mixing aqueous ferric chloride hexahydrate (3) and an aqueous solution of suitable base or mixture of bases to form ferric oxyhydroxide (2);
b) isolating ferric oxyhydroxide (2) and washing solid ferric oxyhydroxide (2) with water;
c) adding a suitable protic solvent to the solid ferric oxyhydroxide (2) at a suitable temperature;
d) adding suitable carbohydrates to the reaction mixture at 25-30 °C; and
e) isolating Sucroferric oxyhydroxide (1) using water immiscible solvents.
2. The process as claimed in claim 1, wherein the base used is selected from a group comprising of sodium bicarbonate, potassium bicarbonate, lithium bicarbonate, sodium hydroxide, potassium hydroxide, calcium hydroxide or mixtures thereof.
3. The process as claimed in claim 1, wherein the protic solvent used in step c) may be selected from a group comprising of methanol, ethanol, isopropyl alcohol, n-propanol, n-butanol, water or mixture thereof.
4. The process as claimed in claim 1, wherein the suitable carbohydrate is selected from glucose, sucrose, fructose, corn starch, wheat starch, rice starch, maize starch, potato starch, or mixture thereof.
5. The process as claimed in claim 1, wherein the water immiscible solvent is selected from a group comprising of dichloromethane, ethyl acetate, diethyl ether, methyl tert-butyl ether, toluene, hexane, cyclohexane, heptane, carbon tetrachloride or mixture thereof.
6. The process as claimed in claim 1, wherein Sucroferric oxyhydroxide (1) is having ferrous ion content less than 0.5(% w/w) and chloride content less than 0.3% (w/w).
7. The process as claimed in claim 1, wherein Sucroferric oxyhydroxide (1) is having starch content in the range of 26% to 34(% w/w) and sucrose content in the range of 26% to 32 (% w/w).
8. The process as claimed in claim 1, wherein the Sucroferric oxyhydroxide (1) is having particle size more than 100 urn.
9. The process as claimed in claim 1, wherein the Sucroferric oxyhydroxide (1) is having specific surface area more than 16 m2/gm.
10. The process as claimed in claim 1, wherein the Sucroferric oxyhydroxide (1) is having phosphate binding capacity by Ion Chromatography (IC) is at least 2.6 meq. of phosphate per 500 mg Iron and at least 0.2 mg P/mg of Iron.
| # | Name | Date |
|---|---|---|
| 1 | 201941005485-PROVISIONAL SPECIFICATION [12-02-2019(online)].pdf | 2019-02-12 |
| 2 | 201941005485-FORM 1 [12-02-2019(online)].pdf | 2019-02-12 |
| 3 | 201941005485-DRAWINGS [12-02-2019(online)].pdf | 2019-02-12 |
| 4 | Form 1_After Filing_20-02-2019.pdf | 2019-02-20 |
| 5 | Correspondence by Applicant_Form 1_20-02-2019.pdf | 2019-02-20 |
| 6 | 201941005485-FORM 3 [12-02-2020(online)].pdf | 2020-02-12 |
| 7 | 201941005485-ENDORSEMENT BY INVENTORS [12-02-2020(online)].pdf | 2020-02-12 |
| 8 | 201941005485-DRAWING [12-02-2020(online)].pdf | 2020-02-12 |
| 9 | 201941005485-COMPLETE SPECIFICATION [12-02-2020(online)].pdf | 2020-02-12 |
| 10 | 201941005485-Request Letter-Correspondence [13-02-2020(online)].pdf | 2020-02-13 |
| 11 | 201941005485-Form 1 (Submitted on date of filing) [13-02-2020(online)].pdf | 2020-02-13 |
| 12 | 201941005485-Request Letter-Correspondence [14-02-2020(online)].pdf | 2020-02-14 |
| 13 | 201941005485-Form 1 (Submitted on date of filing) [14-02-2020(online)].pdf | 2020-02-14 |
| 14 | 201941005485-CERTIFIED COPIES TRANSMISSION TO IB [14-02-2020(online)].pdf | 2020-02-14 |
| 15 | 201941005485-Request Letter-Correspondence [18-02-2020(online)].pdf | 2020-02-18 |
| 16 | 201941005485-Form 1 (Submitted on date of filing) [18-02-2020(online)].pdf | 2020-02-18 |
| 17 | 201941005485-CERTIFIED COPIES TRANSMISSION TO IB [18-02-2020(online)].pdf | 2020-02-18 |
| 18 | 201941005485-Request Letter-Correspondence [19-02-2020(online)].pdf | 2020-02-19 |
| 19 | 201941005485-Form 1 (Submitted on date of filing) [19-02-2020(online)].pdf | 2020-02-19 |
| 20 | 201941005485-CERTIFIED COPIES TRANSMISSION TO IB [19-02-2020(online)].pdf | 2020-02-19 |
| 21 | 201941005485-Form-5-After Filing_20-02-2020.pdf | 2020-02-20 |
| 22 | 201941005485-Form-3-After Filing_20-02-2020.pdf | 2020-02-20 |
| 23 | 201941005485-Form-1-After Filing_20-02-2020.pdf | 2020-02-20 |
| 24 | 201941005485-Correspondence_20-02-2020.pdf | 2020-02-20 |
| 25 | 201941005485--Form2 (Title Page)_Complete_20-02-2020.pdf | 2020-02-20 |
| 26 | 201941005485-FORM 3 [22-02-2020(online)].pdf | 2020-02-22 |
| 27 | 201941005485-Form 1_After Filing_04-03-2020.pdf | 2020-03-04 |
| 28 | 201941005485-Correspondence_Form 3_04-03-2020.pdf | 2020-03-04 |
| 29 | 201941005485-Correspondence_Form 2 Title Page, Form-1_04-03-2020.pdf | 2020-03-04 |
| 30 | 201941005485-FORM 3 [06-10-2020(online)].pdf | 2020-10-06 |
| 31 | 201941005485-Correspondence_Form3_27-10-2020.pdf | 2020-10-27 |
| 32 | 201941005485-FORM 3 [29-12-2021(online)].pdf | 2021-12-29 |
| 33 | 201941005485-FORM 18 [30-01-2023(online)].pdf | 2023-01-30 |
| 34 | 201941005485-FER.pdf | 2023-02-16 |
| 35 | 201941005485-OTHERS [16-08-2023(online)].pdf | 2023-08-16 |
| 36 | 201941005485-FER_SER_REPLY [16-08-2023(online)].pdf | 2023-08-16 |
| 37 | 201941005485-CLAIMS [16-08-2023(online)].pdf | 2023-08-16 |
| 38 | 201941005485-ABSTRACT [16-08-2023(online)].pdf | 2023-08-16 |
| 39 | 201941005485-US(14)-HearingNotice-(HearingDate-01-02-2024).pdf | 2024-01-19 |
| 40 | 201941005485-Correspondence to notify the Controller [27-01-2024(online)].pdf | 2024-01-27 |
| 41 | 201941005485-Written submissions and relevant documents [15-02-2024(online)].pdf | 2024-02-15 |
| 42 | 201941005485-PRE GRANT OPPOSITION FORM [25-04-2025(online)].pdf | 2025-04-25 |
| 43 | 201941005485-PRE GRANT OPPOSITION DOCUMENT [25-04-2025(online)].pdf | 2025-04-25 |
| 44 | 201941005485-OTHERS [25-04-2025(online)].pdf | 2025-04-25 |
| 45 | 201941005485-Representation,including the statement and evidence [26-04-2025(online)].pdf | 2025-04-26 |
| 46 | 201941005485-FORM-26 [26-04-2025(online)].pdf | 2025-04-26 |
| 47 | 201941005485-FORM FOR SMALL ENTITY [26-04-2025(online)].pdf | 2025-04-26 |
| 48 | 201941005485-EVIDENCE FOR REGISTRATION UNDER SSI [26-04-2025(online)].pdf | 2025-04-26 |
| 49 | 201941005485-Request for hearing [03-05-2025(online)].pdf | 2025-05-03 |
| 1 | searchE_09-02-2023.pdf |
| 2 | SCREENSHOTAE_19-01-2024.pdf |