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“Process For Preparation Of Primidone”

Abstract: ABSTRACT The present invention relates to an improved process for the preparation of Primidone (1) with purity greater than 99.0% by HPLC.

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Notices, Deadlines & Correspondence

Patent Information

Application #
Filing Date
10 June 2019
Publication Number
50/2020
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 500033

Inventors

1. Manik Reddy Pullagurla
Plot#92; 1-98/2/92, Kavuri Hills – Phase II, Jubilee Hills, Hyderabad, Telangana India500033
2. Bhaskar Reddy Pitta
Plot#92; 1-98/2/92, Kavuri Hills – Phase II, Jubilee Hills, Hyderabad, Telangana India500033.
3. Jagadeesh Babu Rangisetty
Plot#92; 1-98/2/92, Kavuri Hills – Phase II, Jubilee Hills, Hyderabad, Telangana India500033

Specification

We claim:
1. A process for the preparation of Primidone (1) having purity greater than 99.0% comprising: a) reacting diethyl 2-ethyl-2-phenylmalonate (5)
with thiourea (4) and base to form sodium 5-ethyl-4,6-dioxo-5-phenyl-1,4,5,6-tetrahydropyrimidine~2-thiolate (3);
b) acidifying sodium 5-ethyl-4,6-dioxo-5-phenyl-l,4,5,6-tetrahydro pyrimidine-2-thiolate (3) with suitable acid to form 5-ethyl-5-phenyl-2-thioxodihydropyrimidine-4,6(lH,5H)-dione (2);
c) reducing 5-ethyl-5-phenyl-2-thioxodihydropyrimidine-4,6(lH,5H)-dione
using suitable reducing agent to form Primidone (1).
2. The process according to claim 1, where in the base used in step a) sodium
hydroxide, potassium hydroxide, sodium carbonate, sodium bicarbonate,
potassium carbonate, potassium bicarbonate, lithium hydroxide, aqueous
ammonia

3. The process according to claim 1, where in the acid used in step b)is selected from hydrochloric acid, hydrobromic acid, sulphuric acid, phosphoric acid.
4. The process according to claim 1, where in the reducing agent c) is selected from hydrogen, cobalt, nickel, lithium, zinc, iron.
5. The process as claimed in claim 1, wherein the suitable solvent is selected from water, methanol, ethanol, isopropyl alcohol (IPA), n-propanol, n-butanol, acetone, dichloromethane, tetrahydrofuran, ethyl acetate, acetonitrile, dimethyl formamide and dimethyl sulfoxide
6. Process for the purification of Primidone (1), which comprises of:
i. providing a solution of Primidone (1) in a suitable solvent;
ii. heating the reaction mixture to a suitable temperature; iii. cooling the reaction mixture to suitable temperature; iv. isolating the pure Primidone (1)
7. The process as claimed in claim 6, wherein the suitable solvents used is selected
from a group comprising of acetone, dichloromethane, toluene, ethyl acetate,
methanol, ethanol, isopropyl alcohol (IPA), n-propanol, n-butanol, water or
mixtures thereof.
8. The process, as claimed in claim 6, wherein the Primidone (1) obtained after
purification is having purity greater than 99.0 (%, w/w) purity by HPLC.

Documents

Application Documents

# Name Date
1 201941022910-PROVISIONAL SPECIFICATION [10-06-2019(online)].pdf 2019-06-10
2 201941022910-FORM 1 [10-06-2019(online)].pdf 2019-06-10
3 Correspondence by Applicant_ Form-1_17-06-2019.pdf 2019-06-17
4 201941022910-FORM 3 [10-06-2020(online)].pdf 2020-06-10
5 201941022910-ENDORSEMENT BY INVENTORS [10-06-2020(online)].pdf 2020-06-10
6 201941022910-DRAWING [10-06-2020(online)].pdf 2020-06-10
7 201941022910-COMPLETE SPECIFICATION [10-06-2020(online)].pdf 2020-06-10
8 201941022910-Specification_After Filing_21-07-2020.pdf 2020-07-21
9 201941022910-Form5_After Filing_21-07-2020.pdf 2020-07-21
10 201941022910-Form3_After Filing_21-07-2020.pdf 2020-07-21
11 201941022910-Correspondence_21-07-2020.pdf 2020-07-21
12 201941022910-FORM 18 [08-06-2023(online)].pdf 2023-06-08