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“Improved Process For The Preparation Of Sucroferric Oxyhydroxide”

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.

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Notices, Deadlines & Correspondence

Patent Information

Application #
Filing Date
12 February 2019
Publication Number
33/2020
Publication Type
INA
Invention Field
CHEMICAL
Status
Email
radha@biophore.com
Parent Application

Applicants

Biophore India Pharmaceuticals Pvt. Ltd
Plot#92, 1-98/2/92, Kavuri Hills–Phase II, Jubilee Hills, Hyderabad, Telangana India, Pin Code-500 033.

Inventors

1. Manik Reddy Pullagurla
Plot#92, 1-98/2/92, Kavuri Hills–Phase II, Jubilee Hills, Hyderabad, Telangana India, Pin Code-500 033.
2. Bhaskar Reddy Pitta
Plot#92, 1-98/2/92, Kavuri Hills–Phase II, Jubilee Hills, Hyderabad, Telangana India, Pin Code-500 033.
3. Rajesh Bhudeti
Plot#92, 1-98/2/92, Kavuri Hills–Phase II, Jubilee Hills, Hyderabad, Telangana India, Pin Code-500 033.
4. Jagadeesh Babu Rangisetty
Plot#92, 1-98/2/92, Kavuri Hills–Phase II, Jubilee Hills, Hyderabad, Telangana India, Pin Code-500 033.

Specification

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.

Documents

Application Documents

# 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

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