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Process For The Preparation Of Donepezil Hydrochloride

Abstract: The present invention provides a process for preparing donepezii or a salt thereof the process comprising reducing a l-benzyl-4-[(5,6-diemexy-l-indanon-2-yl)methyiene]pyridonium halide of formula (II), wherein X is bromide or chloride, in the presence of an ionic compound, a solvent, a catalyst and a source of hydrogeo, to form donepezii and optionally converting the

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Notices, Deadlines & Correspondence

Patent Information

Application #
Filing Date
24 September 2010
Publication Number
06/2011
Publication Type
INA
Invention Field
PHARMACEUTICALS
Status
Email
Parent Application
Patent Number
Legal Status
Grant Date
2016-06-09
Renewal Date

Applicants

CIPLA LIMITED
289, BELLASIS ROAD, MUMBAI CENTRAL, MUMBAI - 400 008, MAHARASHTRA.

Inventors

1. RAO, DHARMARAJ RAMACHANDRA
4/403, GARDEN ENCLAVE, POKHARAN ROAD 2, THANE (WEST), 400 601, MAHARASHTRA, INDIA.
2. KANKAN, RAJENDRA NARAYANRAO
1204, HERITAGE, HIRANANDANI GARDENS, POWAI, MUMBAI - 400 076, MAHARASHTRA, INDIA
3. PATHI, SRINIVAS LAXMINARAYAN
2475/24, 7TH B MAIN, R P C LAYOUT, VIJAYNAGAR, BANGALORE 560 040, KARNATAKA, INDIA

Specification

FORM 2 THE PATENTS ACT, 1970 (39 OF 1970) & THE PATENTS RULES, 2003 COMPLETE SPECIFICATION (See Section 10; Rule 13) TITLE PROCESS FOR THE PREPARATION OF DONEPEZIL HYDROCHLORIDE APPLICANT CIPLA LIMITED AN INDIAN COMPANY OF 289 BELLASIS ROAD, MUMBAI CENTRAL, MUMBAI - 400 008, MAHARASHTRA INDIA The following specification particularly describes the nature of the invention and the manner in which it is to be performed. PROCESS FOR THE PREPARATION OF DONEPEZIL HYDROCHLORIDE Field of the Invention The present invention relates to an improved process for the preparation of highly pure donepezil hydrochloride. More, particularly, the present invention relates to an improved process for the preparation of donepezil hydrochloride using a novel reduction step carried out using at least one hydrogenation catalyst, in the presence of ionic compounds in organic solvents or an aqueous solvent or mixture thereof from 1-benzyM-[5,6-dimethoxy-1-indanon-2-yl)rnethylene] pyridonium bromide. More particularly the invention relates to an industrially suitable process for the preparation of donepezil hydrochloride. Backqround of the Invention Donepezil hydrochloride, which is chemically known as 1-benzyl-4-[(5,6-dimethoxy-1-indanon)-2-yl)methyl piperidine hydrochloride [formula l] is used in the treatment of Alzheimer's disease where it is used to increase cortical acetylcholine. It is available for oral administration in film-coated tablets containing 5 or 10 mg of donepezil hydrochloride. Donepezil hydrochloride is well known in the art and was first disclosed in US patent no. 4,895,841, hereinafter referred to as the '841 patent. As described therein donepezil hydrochloride is prepared by reacting 5,6-dimethoxy-1-indanone with 1- benzyl-4-formyipiperidine in the presence of a strong base such as lithium diisopropyl amide followed by a reduction step (Examples 3 and 4) with a palladium carbon catalyst in tetrahydrofuran

Documents

Application Documents

# Name Date
1 2025-MUMNP-2010-RELEVANT DOCUMENTS [23-03-2019(online)].pdf 2019-03-23
1 2025-MUMNP-2010-REPLY TO EXAMINATION REPORT-(10-03-2016).pdf 2016-03-10
2 2025-mumnp-2010-abstract.doc 2018-08-10
2 2025-MUMNP-2010-PETITION UNDER RULE 137--(10-03-2016).pdf 2016-03-10
3 2025-MUMNP-2010-PETITION UNDER RULE 137-(10-03-2016).pdf 2016-03-10
3 2025-mumnp-2010-abstract.pdf 2018-08-10
4 2025-MUMNP-2010-OTHERS-(10-03-2016).pdf 2016-03-10
4 2025-MUMNP-2010-ANNEXURE TO FORM 3(24-3-2011).pdf 2018-08-10
5 2025-MUMNP-2010-FORM 5-(10-03-2016).pdf 2016-03-10
6 2025-MUMNP-2010-CLAIMSAMENDED)-(10-03-2016).pdf 2016-03-10
6 2025-mumnp-2010-claims.pdf 2018-08-10
7 2025-MUMNP-2010-CORRESPONDENCE(21-2-2012).pdf 2018-08-10
7 2025-MUMNP-2010-CLAIMS(MARKED COPY)-(10-03-2016).pdf 2016-03-10
8 2025-MUMNP-2010-CORRESPONDENCE(24-3-2011).pdf 2018-08-10
8 2025-MUMNP-2010-ANNEXURE TO FORM 3-(10-03-2016).pdf 2016-03-10
9 2025-MUMNP-2010-CORRESPONDENCE(8-12-2010).pdf 2018-08-10
9 Form 27 [22-03-2017(online)].pdf 2017-03-22
10 2025-MUMNP-2010-CORRESPONDENCE(9-3-2011).pdf 2018-08-10
10 2025-MUMNP-2010-RELEVANT DOCUMENTS [22-03-2018(online)].pdf 2018-03-22
11 2025-MUMNP-2010-CORRESPONDENCE(IPO)-(9-6-2016).pdf 2018-08-10
11 abstract1.jpg 2018-08-10
12 2025-MUMNP-2010-CORRESPONDENCE(IPO)-(FER)-(18-3-2015).pdf 2018-08-10
12 27390 EP OA 02.pdf 2018-08-10
13 2025-MUMNP-2010-CORRESPONDENCE-011015.pdf 2018-08-10
13 27390 EP Intention to Grant (71(3) communication).pdf 2018-08-10
14 2025-mumnp-2010-correspondence.pdf 2018-08-10
14 27390 AU Response to OA 01.pdf 2018-08-10
15 2025-mumnp-2010-description(complete).pdf 2018-08-10
15 27390 AU Granted Specification.pdf 2018-08-10
16 27390 AU Grant Certificate.pdf 2018-08-10
16 2025-mumnp-2010-form 1.pdf 2018-08-10
17 27390 AU Allowed Claims.pdf 2018-08-10
17 2025-MUMNP-2010-Form 13-011015.pdf 2018-08-10
18 2025-MUMNP-2010-FORM 18(21-2-2012).pdf 2018-08-10
18 2025-MUMNP-2010_EXAMREPORT.pdf 2018-08-10
19 2025-mumnp-2010-form 2(title page).pdf 2018-08-10
19 2025-mumnp-2010-wo international publication report a8.pdf 2018-08-10
20 2025-MUMNP-2010-POWER OF AUTHORITY(8-12-2010).pdf 2018-08-10
21 2025-mumnp-2010-form 2.pdf 2018-08-10
21 2025-MUMNP-2010-MARKED COPY-011015.pdf 2018-08-10
22 2025-MUMNP-2010-FORM 3(9-3-2011).pdf 2018-08-10
22 2025-MUMNP-2010-GENERAL POWER OF AUTHORITY-011015.pdf 2018-08-10
23 2025-mumnp-2010-form pct-ib-308.pdf 2018-08-10
23 2025-mumnp-2010-form 3.pdf 2018-08-10
24 2025-mumnp-2010-form 5.pdf 2018-08-10
24 2025-mumnp-2010-form pct-ib-304.pdf 2018-08-10
25 2025-MUMNP-2010-FORM NO.INC-22 -011015.pdf 2018-08-10
26 2025-mumnp-2010-form 5.pdf 2018-08-10
26 2025-mumnp-2010-form pct-ib-304.pdf 2018-08-10
27 2025-mumnp-2010-form 3.pdf 2018-08-10
27 2025-mumnp-2010-form pct-ib-308.pdf 2018-08-10
28 2025-MUMNP-2010-FORM 3(9-3-2011).pdf 2018-08-10
28 2025-MUMNP-2010-GENERAL POWER OF AUTHORITY-011015.pdf 2018-08-10
29 2025-mumnp-2010-form 2.pdf 2018-08-10
29 2025-MUMNP-2010-MARKED COPY-011015.pdf 2018-08-10
30 2025-MUMNP-2010-POWER OF AUTHORITY(8-12-2010).pdf 2018-08-10
31 2025-mumnp-2010-form 2(title page).pdf 2018-08-10
31 2025-mumnp-2010-wo international publication report a8.pdf 2018-08-10
32 2025-MUMNP-2010-FORM 18(21-2-2012).pdf 2018-08-10
32 2025-MUMNP-2010_EXAMREPORT.pdf 2018-08-10
33 2025-MUMNP-2010-Form 13-011015.pdf 2018-08-10
33 27390 AU Allowed Claims.pdf 2018-08-10
34 2025-mumnp-2010-form 1.pdf 2018-08-10
34 27390 AU Grant Certificate.pdf 2018-08-10
35 27390 AU Granted Specification.pdf 2018-08-10
35 2025-mumnp-2010-description(complete).pdf 2018-08-10
36 2025-mumnp-2010-correspondence.pdf 2018-08-10
36 27390 AU Response to OA 01.pdf 2018-08-10
37 2025-MUMNP-2010-CORRESPONDENCE-011015.pdf 2018-08-10
37 27390 EP Intention to Grant (71(3) communication).pdf 2018-08-10
38 2025-MUMNP-2010-CORRESPONDENCE(IPO)-(FER)-(18-3-2015).pdf 2018-08-10
38 27390 EP OA 02.pdf 2018-08-10
39 2025-MUMNP-2010-CORRESPONDENCE(IPO)-(9-6-2016).pdf 2018-08-10
39 abstract1.jpg 2018-08-10
40 2025-MUMNP-2010-CORRESPONDENCE(9-3-2011).pdf 2018-08-10
40 2025-MUMNP-2010-RELEVANT DOCUMENTS [22-03-2018(online)].pdf 2018-03-22
41 2025-MUMNP-2010-CORRESPONDENCE(8-12-2010).pdf 2018-08-10
41 Form 27 [22-03-2017(online)].pdf 2017-03-22
42 2025-MUMNP-2010-ANNEXURE TO FORM 3-(10-03-2016).pdf 2016-03-10
42 2025-MUMNP-2010-CORRESPONDENCE(24-3-2011).pdf 2018-08-10
43 2025-MUMNP-2010-CLAIMS(MARKED COPY)-(10-03-2016).pdf 2016-03-10
43 2025-MUMNP-2010-CORRESPONDENCE(21-2-2012).pdf 2018-08-10
44 2025-mumnp-2010-claims.pdf 2018-08-10
44 2025-MUMNP-2010-CLAIMSAMENDED)-(10-03-2016).pdf 2016-03-10
45 2025-MUMNP-2010-FORM 5-(10-03-2016).pdf 2016-03-10
46 2025-MUMNP-2010-OTHERS-(10-03-2016).pdf 2016-03-10
46 2025-MUMNP-2010-ANNEXURE TO FORM 3(24-3-2011).pdf 2018-08-10
47 2025-MUMNP-2010-PETITION UNDER RULE 137-(10-03-2016).pdf 2016-03-10
47 2025-mumnp-2010-abstract.pdf 2018-08-10
48 2025-MUMNP-2010-PETITION UNDER RULE 137--(10-03-2016).pdf 2016-03-10
49 2025-MUMNP-2010-REPLY TO EXAMINATION REPORT-(10-03-2016).pdf 2016-03-10
49 2025-MUMNP-2010-RELEVANT DOCUMENTS [23-03-2019(online)].pdf 2019-03-23

ERegister / Renewals

3rd: 25 Aug 2016

From 24/03/2011 - To 24/03/2012

4th: 25 Aug 2016

From 24/03/2012 - To 24/03/2013

5th: 25 Aug 2016

From 24/03/2013 - To 24/03/2014

6th: 25 Aug 2016

From 24/03/2014 - To 24/03/2015

7th: 25 Aug 2016

From 24/03/2015 - To 24/03/2016

8th: 25 Aug 2016

From 24/03/2016 - To 24/03/2017

9th: 15 Feb 2017

From 24/03/2017 - To 24/03/2018

10th: 12 Mar 2018

From 24/03/2018 - To 24/03/2019