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.
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-EVIDENCE FOR REGISTRATION UNDER SSI [26-04-2025(online)].pdf | 2025-04-26 |
| 1 | 201941005485-PROVISIONAL SPECIFICATION [12-02-2019(online)].pdf | 2019-02-12 |
| 1 | 201941005485-Written submissions and relevant documents [15-02-2024(online)].pdf | 2024-02-15 |
| 2 | 201941005485-Correspondence to notify the Controller [27-01-2024(online)].pdf | 2024-01-27 |
| 2 | 201941005485-FORM 1 [12-02-2019(online)].pdf | 2019-02-12 |
| 2 | 201941005485-FORM FOR SMALL ENTITY [26-04-2025(online)].pdf | 2025-04-26 |
| 3 | 201941005485-DRAWINGS [12-02-2019(online)].pdf | 2019-02-12 |
| 3 | 201941005485-FORM-26 [26-04-2025(online)].pdf | 2025-04-26 |
| 3 | 201941005485-US(14)-HearingNotice-(HearingDate-01-02-2024).pdf | 2024-01-19 |
| 4 | Form 1_After Filing_20-02-2019.pdf | 2019-02-20 |
| 4 | 201941005485-Representation,including the statement and evidence [26-04-2025(online)].pdf | 2025-04-26 |
| 4 | 201941005485-ABSTRACT [16-08-2023(online)].pdf | 2023-08-16 |
| 5 | Correspondence by Applicant_Form 1_20-02-2019.pdf | 2019-02-20 |
| 5 | 201941005485-OTHERS [25-04-2025(online)].pdf | 2025-04-25 |
| 5 | 201941005485-CLAIMS [16-08-2023(online)].pdf | 2023-08-16 |
| 6 | 201941005485-PRE GRANT OPPOSITION DOCUMENT [25-04-2025(online)].pdf | 2025-04-25 |
| 6 | 201941005485-FORM 3 [12-02-2020(online)].pdf | 2020-02-12 |
| 6 | 201941005485-FER_SER_REPLY [16-08-2023(online)].pdf | 2023-08-16 |
| 7 | 201941005485-PRE GRANT OPPOSITION FORM [25-04-2025(online)].pdf | 2025-04-25 |
| 7 | 201941005485-OTHERS [16-08-2023(online)].pdf | 2023-08-16 |
| 7 | 201941005485-ENDORSEMENT BY INVENTORS [12-02-2020(online)].pdf | 2020-02-12 |
| 8 | 201941005485-DRAWING [12-02-2020(online)].pdf | 2020-02-12 |
| 8 | 201941005485-FER.pdf | 2023-02-16 |
| 8 | 201941005485-Written submissions and relevant documents [15-02-2024(online)].pdf | 2024-02-15 |
| 9 | 201941005485-COMPLETE SPECIFICATION [12-02-2020(online)].pdf | 2020-02-12 |
| 9 | 201941005485-Correspondence to notify the Controller [27-01-2024(online)].pdf | 2024-01-27 |
| 9 | 201941005485-FORM 18 [30-01-2023(online)].pdf | 2023-01-30 |
| 10 | 201941005485-FORM 3 [29-12-2021(online)].pdf | 2021-12-29 |
| 10 | 201941005485-Request Letter-Correspondence [13-02-2020(online)].pdf | 2020-02-13 |
| 10 | 201941005485-US(14)-HearingNotice-(HearingDate-01-02-2024).pdf | 2024-01-19 |
| 11 | 201941005485-ABSTRACT [16-08-2023(online)].pdf | 2023-08-16 |
| 11 | 201941005485-Correspondence_Form3_27-10-2020.pdf | 2020-10-27 |
| 11 | 201941005485-Form 1 (Submitted on date of filing) [13-02-2020(online)].pdf | 2020-02-13 |
| 12 | 201941005485-CLAIMS [16-08-2023(online)].pdf | 2023-08-16 |
| 12 | 201941005485-FORM 3 [06-10-2020(online)].pdf | 2020-10-06 |
| 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 |
| 13 | 201941005485-FER_SER_REPLY [16-08-2023(online)].pdf | 2023-08-16 |
| 13 | 201941005485-Correspondence_Form 2 Title Page, Form-1_04-03-2020.pdf | 2020-03-04 |
| 14 | 201941005485-CERTIFIED COPIES TRANSMISSION TO IB [14-02-2020(online)].pdf | 2020-02-14 |
| 14 | 201941005485-Correspondence_Form 3_04-03-2020.pdf | 2020-03-04 |
| 14 | 201941005485-OTHERS [16-08-2023(online)].pdf | 2023-08-16 |
| 15 | 201941005485-FER.pdf | 2023-02-16 |
| 15 | 201941005485-Form 1_After Filing_04-03-2020.pdf | 2020-03-04 |
| 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 |
| 16 | 201941005485-FORM 18 [30-01-2023(online)].pdf | 2023-01-30 |
| 16 | 201941005485-FORM 3 [22-02-2020(online)].pdf | 2020-02-22 |
| 17 | 201941005485--Form2 (Title Page)_Complete_20-02-2020.pdf | 2020-02-20 |
| 17 | 201941005485-CERTIFIED COPIES TRANSMISSION TO IB [18-02-2020(online)].pdf | 2020-02-18 |
| 17 | 201941005485-FORM 3 [29-12-2021(online)].pdf | 2021-12-29 |
| 18 | 201941005485-Correspondence_20-02-2020.pdf | 2020-02-20 |
| 18 | 201941005485-Correspondence_Form3_27-10-2020.pdf | 2020-10-27 |
| 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 |
| 19 | 201941005485-FORM 3 [06-10-2020(online)].pdf | 2020-10-06 |
| 19 | 201941005485-Form-1-After Filing_20-02-2020.pdf | 2020-02-20 |
| 20 | 201941005485-CERTIFIED COPIES TRANSMISSION TO IB [19-02-2020(online)].pdf | 2020-02-19 |
| 20 | 201941005485-Correspondence_Form 2 Title Page, Form-1_04-03-2020.pdf | 2020-03-04 |
| 20 | 201941005485-Form-3-After Filing_20-02-2020.pdf | 2020-02-20 |
| 21 | 201941005485-Form-5-After Filing_20-02-2020.pdf | 2020-02-20 |
| 21 | 201941005485-Correspondence_Form 3_04-03-2020.pdf | 2020-03-04 |
| 22 | 201941005485-CERTIFIED COPIES TRANSMISSION TO IB [19-02-2020(online)].pdf | 2020-02-19 |
| 22 | 201941005485-Form 1_After Filing_04-03-2020.pdf | 2020-03-04 |
| 22 | 201941005485-Form-3-After Filing_20-02-2020.pdf | 2020-02-20 |
| 23 | 201941005485-Form 1 (Submitted on date of filing) [19-02-2020(online)].pdf | 2020-02-19 |
| 23 | 201941005485-FORM 3 [22-02-2020(online)].pdf | 2020-02-22 |
| 23 | 201941005485-Form-1-After Filing_20-02-2020.pdf | 2020-02-20 |
| 24 | 201941005485-Request Letter-Correspondence [19-02-2020(online)].pdf | 2020-02-19 |
| 24 | 201941005485-Correspondence_20-02-2020.pdf | 2020-02-20 |
| 24 | 201941005485--Form2 (Title Page)_Complete_20-02-2020.pdf | 2020-02-20 |
| 25 | 201941005485-CERTIFIED COPIES TRANSMISSION TO IB [18-02-2020(online)].pdf | 2020-02-18 |
| 25 | 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 1 (Submitted on date of filing) [18-02-2020(online)].pdf | 2020-02-18 |
| 26 | 201941005485-FORM 3 [22-02-2020(online)].pdf | 2020-02-22 |
| 26 | 201941005485-Form-1-After Filing_20-02-2020.pdf | 2020-02-20 |
| 27 | 201941005485-Form 1_After Filing_04-03-2020.pdf | 2020-03-04 |
| 27 | 201941005485-Form-3-After Filing_20-02-2020.pdf | 2020-02-20 |
| 27 | 201941005485-Request Letter-Correspondence [18-02-2020(online)].pdf | 2020-02-18 |
| 28 | 201941005485-Form-5-After Filing_20-02-2020.pdf | 2020-02-20 |
| 28 | 201941005485-Correspondence_Form 3_04-03-2020.pdf | 2020-03-04 |
| 28 | 201941005485-CERTIFIED COPIES TRANSMISSION TO IB [14-02-2020(online)].pdf | 2020-02-14 |
| 29 | 201941005485-CERTIFIED COPIES TRANSMISSION TO IB [19-02-2020(online)].pdf | 2020-02-19 |
| 29 | 201941005485-Correspondence_Form 2 Title Page, Form-1_04-03-2020.pdf | 2020-03-04 |
| 29 | 201941005485-Form 1 (Submitted on date of filing) [14-02-2020(online)].pdf | 2020-02-14 |
| 30 | 201941005485-Form 1 (Submitted on date of filing) [19-02-2020(online)].pdf | 2020-02-19 |
| 30 | 201941005485-FORM 3 [06-10-2020(online)].pdf | 2020-10-06 |
| 30 | 201941005485-Request Letter-Correspondence [14-02-2020(online)].pdf | 2020-02-14 |
| 31 | 201941005485-Correspondence_Form3_27-10-2020.pdf | 2020-10-27 |
| 31 | 201941005485-Form 1 (Submitted on date of filing) [13-02-2020(online)].pdf | 2020-02-13 |
| 31 | 201941005485-Request Letter-Correspondence [19-02-2020(online)].pdf | 2020-02-19 |
| 32 | 201941005485-CERTIFIED COPIES TRANSMISSION TO IB [18-02-2020(online)].pdf | 2020-02-18 |
| 32 | 201941005485-FORM 3 [29-12-2021(online)].pdf | 2021-12-29 |
| 32 | 201941005485-Request Letter-Correspondence [13-02-2020(online)].pdf | 2020-02-13 |
| 33 | 201941005485-COMPLETE SPECIFICATION [12-02-2020(online)].pdf | 2020-02-12 |
| 33 | 201941005485-Form 1 (Submitted on date of filing) [18-02-2020(online)].pdf | 2020-02-18 |
| 33 | 201941005485-FORM 18 [30-01-2023(online)].pdf | 2023-01-30 |
| 34 | 201941005485-DRAWING [12-02-2020(online)].pdf | 2020-02-12 |
| 34 | 201941005485-FER.pdf | 2023-02-16 |
| 34 | 201941005485-Request Letter-Correspondence [18-02-2020(online)].pdf | 2020-02-18 |
| 35 | 201941005485-OTHERS [16-08-2023(online)].pdf | 2023-08-16 |
| 35 | 201941005485-ENDORSEMENT BY INVENTORS [12-02-2020(online)].pdf | 2020-02-12 |
| 35 | 201941005485-CERTIFIED COPIES TRANSMISSION TO IB [14-02-2020(online)].pdf | 2020-02-14 |
| 36 | 201941005485-FER_SER_REPLY [16-08-2023(online)].pdf | 2023-08-16 |
| 36 | 201941005485-Form 1 (Submitted on date of filing) [14-02-2020(online)].pdf | 2020-02-14 |
| 36 | 201941005485-FORM 3 [12-02-2020(online)].pdf | 2020-02-12 |
| 37 | 201941005485-CLAIMS [16-08-2023(online)].pdf | 2023-08-16 |
| 37 | 201941005485-Request Letter-Correspondence [14-02-2020(online)].pdf | 2020-02-14 |
| 37 | Correspondence by Applicant_Form 1_20-02-2019.pdf | 2019-02-20 |
| 38 | 201941005485-ABSTRACT [16-08-2023(online)].pdf | 2023-08-16 |
| 38 | 201941005485-Form 1 (Submitted on date of filing) [13-02-2020(online)].pdf | 2020-02-13 |
| 38 | Form 1_After Filing_20-02-2019.pdf | 2019-02-20 |
| 39 | 201941005485-DRAWINGS [12-02-2019(online)].pdf | 2019-02-12 |
| 39 | 201941005485-Request Letter-Correspondence [13-02-2020(online)].pdf | 2020-02-13 |
| 39 | 201941005485-US(14)-HearingNotice-(HearingDate-01-02-2024).pdf | 2024-01-19 |
| 40 | 201941005485-COMPLETE SPECIFICATION [12-02-2020(online)].pdf | 2020-02-12 |
| 40 | 201941005485-Correspondence to notify the Controller [27-01-2024(online)].pdf | 2024-01-27 |
| 40 | 201941005485-FORM 1 [12-02-2019(online)].pdf | 2019-02-12 |
| 41 | 201941005485-DRAWING [12-02-2020(online)].pdf | 2020-02-12 |
| 41 | 201941005485-PROVISIONAL SPECIFICATION [12-02-2019(online)].pdf | 2019-02-12 |
| 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 |
| 42 | 201941005485-ENDORSEMENT BY INVENTORS [12-02-2020(online)].pdf | 2020-02-12 |
| 43 | 201941005485-PRE GRANT OPPOSITION DOCUMENT [25-04-2025(online)].pdf | 2025-04-25 |
| 43 | 201941005485-FORM 3 [12-02-2020(online)].pdf | 2020-02-12 |
| 44 | Correspondence by Applicant_Form 1_20-02-2019.pdf | 2019-02-20 |
| 44 | 201941005485-OTHERS [25-04-2025(online)].pdf | 2025-04-25 |
| 45 | Form 1_After Filing_20-02-2019.pdf | 2019-02-20 |
| 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 |
| 46 | 201941005485-DRAWINGS [12-02-2019(online)].pdf | 2019-02-12 |
| 47 | 201941005485-FORM FOR SMALL ENTITY [26-04-2025(online)].pdf | 2025-04-26 |
| 47 | 201941005485-FORM 1 [12-02-2019(online)].pdf | 2019-02-12 |
| 48 | 201941005485-PROVISIONAL SPECIFICATION [12-02-2019(online)].pdf | 2019-02-12 |
| 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 | SCREENSHOTAE_19-01-2024.pdf |
| 1 | searchE_09-02-2023.pdf |
| 2 | SCREENSHOTAE_19-01-2024.pdf |
| 2 | searchE_09-02-2023.pdf |