Sign In to Follow Application
View All Documents & Correspondence

Controlled Release Dosage Form With Improved Bioavailability

Abstract: The invention relates to oral controlled release dosage form comprising an atypical antipsychotic agent. More particularly, the invention relates to oral controlled release dosage form comprising paliperidone or its pharmaceutically acceptable salts thereof and the process for preparing the same, wherein said dosage form exhibits improved bioavailability of paliperidone as compared to the commercially available invega®

Get Free WhatsApp Updates!
Notices, Deadlines & Correspondence

Patent Information

Application #
Filing Date
18 February 2010
Publication Number
46/2011
Publication Type
INA
Invention Field
PHARMACEUTICALS
Status
Email
Parent Application
Patent Number
Legal Status
Grant Date
2019-03-12
Renewal Date

Applicants

MATRIX LABORATORIES LIMITED
1-1-151/1, IV FLOOR, SAIRAM TOWERS, ALEXANDER ROAD, SECUNDERABAD-500 003.

Inventors

1. REDDY, ANIL
1-1-151/1, IV FLOOR, SAIRAM TOWERS, ALEXANDER ROAD, SECUNDERABAD-500 003.
2. AMMINABAVI, NAGARAJ
1-1-151/1, IV FLOOR, SAIRAM TOWERS, ALEXANDER ROAD, SECUNDERABAD-500 003.
3. GORE, SUBHASH
1-1-151/1, IV FLOOR, SAIRAM TOWERS, ALEXANDER ROAD, SECUNDERABAD-500 003.
4. PANANCHUKUNNATH, MANOJ
1-1-151/1, IV FLOOR, SAIRAM TOWERS, ALEXANDER ROAD, SECUNDERABAD-500 003.
5. GUPTA, RAJESH
1-1-151/1, IV FLOOR, SAIRAM TOWERS, ALEXANDER ROAD, SECUNDERABAD-500 003.
6. BHUSHAN, INDU
1-1-151/1, IV FLOOR, SAIRAM TOWERS, ALEXANDER ROAD, SECUNDERABAD-500 003.

Specification

FIELD OF INVENTION The invention relates to controlled release dosage form comprising an atypical antipsychotic agent. More particularly, the invention relates to controlled release dosage form comprising paliperidone or its pharmaceutically acceptable salts thereof and the process for preparing the same. BACKGROUND OF THE INVENTION AND RELATED PRIOR ART Paliperidone is known as a major active metabolite of risperidone. It is chemically known as (±)-3-[2-[4- (6-fluoro-l, 2-benzisoxazol-3-yl)-l-piperidinyl] ethyl] -6, 7, 8, 9 -tetra hydro-9-hydroxy-2- methyl-4Hpyrido [1, 2-a] pyrimidin-4-one. It basically comprises a mixture of both (R) and (S) forms of risperidone and is disclosed in US 4,804,663 and 5,158,952. Paliperidone is marketed under the trade name Invega in the form of extended release tablet in the U.S. and Europe for the treatment of acute (short-term) as well as maintenance (long-term) treatment of schizophrenia. Paliperidone has a long half-life - about one day, so it is not a suitable drug for extended delivery. However, side effects such as anxiety, somnolence, dizziness, constipation, extra-pyramidal symptoms may be related to high blood plasma concentration levels restricting the ability to administer a single daily immediate release dose. Many efforts have been taken to control the release of the drug to provide extended release profile, while trying to control possible side-effects. A number of design options are available to control or modulate the drug release from a dosage form, but osmotic system of delivery is found to be most preferred design to control the release of drug from dosage form as it is independent of pH, presence of food and other physiological factors with respect to other conventional controlled release system. Commercially available Invega® is a capsule shaped tablet which consists of an osmotically active trilayer core surrounded by a subcoat and a semi¬permeable membrane. The trilayer core is composed of two drug layers containing the drug and excipients, and a push layer containing osmotically active components. There are two precision laser-drilled orifices on the drug-layer dome of the tablet. Patents / Patent applications, which disclose various osmotic controlled release compositions comprising paliperidone, are disclosed below: U.S. 2004/0092534, U.S. 2005/0208132, U.S.2005/0232995, U.S. 2006/0189635, U.S. 2009/0202631 and U.S. 2009/0227605 disclose an oral dosage form wherein said dosage form comprises a dose D of a benzisoxazole and an oral sustained release dosing structure adapted to sustainably release the benzisoxazole derivative at rates that provide (a) a mean, single dose, maximum plasma concentration Cmax of the benzisoxazole derivative and pharmacologically active metabolites thereof taken together and (b) a mean, single dose, area under a plasma concentration-time curve for AUQnf of the benzisoxazole derivative and pharmacologically active metabolites thereof taken together, which satisfy the relationship about 0.5 ng/mL/mg

Documents

Application Documents

# Name Date
1 0417-che-2010 form-2 18-02-2010.pdf 2010-02-18
1 417-CHE-2010-RELEVANT DOCUMENTS [28-07-2023(online)].pdf 2023-07-28
2 0417-che-2010 form-1 18-02-2010.pdf 2010-02-18
2 417-CHE-2010-RELEVANT DOCUMENTS [05-09-2022(online)].pdf 2022-09-05
3 417-CHE-2010-RELEVANT DOCUMENTS [29-09-2021(online)].pdf 2021-09-29
3 0417-che-2010 drawings 18-02-2010.pdf 2010-02-18
4 417-CHE-2010-FORM 4 [12-05-2021(online)].pdf 2021-05-12
4 0417-che-2010 description(provisional) 18-02-2010.pdf 2010-02-18
5 417-CHE-2010-RELEVANT DOCUMENTS [30-03-2020(online)].pdf 2020-03-30
5 0417-che-2010 correspondence others 18-02-2010.pdf 2010-02-18
6 417-CHE-2010-IntimationOfGrant12-03-2019.pdf 2019-03-12
6 417-che-2010 form-1 23-03-2010.pdf 2010-03-23
7 417-CHE-2010-PatentCertificate12-03-2019.pdf 2019-03-12
7 417-CHE-2010 FORM-3 23-03-2010.pdf 2010-03-23
8 417-CHE-2010-Written submissions and relevant documents (MANDATORY) [12-03-2019(online)].pdf 2019-03-12
8 417-CHE-2010 FORM-5 17-02-2011.pdf 2011-02-17
9 417-CHE-2010 FORM-2 17-02-2011.pdf 2011-02-17
9 Abstract_Granted 309060_12-03-2019.pdf 2019-03-12
10 417-CHE-2010 FORM-1 17-02-2011.pdf 2011-02-17
10 Claims_Granted 309060_12-03-2019.pdf 2019-03-12
11 417-CHE-2010 DRAWINGS 17-02-2011.pdf 2011-02-17
11 Description_Granted 309060_12-03-2019.pdf 2019-03-12
12 417-CHE-2010 DESCRIPTION(COMPLETE) 17-02-2011.pdf 2011-02-17
12 Drawings_Granted 309060_12-03-2019.pdf 2019-03-12
13 417-CHE-2010 CORRESPONDENCE 17-02-2011.pdf 2011-02-17
13 Marked up Claims_Granted 309060_12-03-2019.pdf 2019-03-12
14 417-CHE-2010 CLAIMS 17-02-2011.pdf 2011-02-17
14 417-CHE-2010-COMPLETE SPECIFICATION [11-09-2017(online)].pdf 2017-09-11
15 417-CHE-2010 ABSTRACT 17-02-2011.pdf 2011-02-17
15 417-CHE-2010-FER_SER_REPLY [11-09-2017(online)].pdf 2017-09-11
16 417-CHE-2010- FORM-13 13-05-2011.pdf 2011-05-13
16 417-CHE-2010-FER.pdf 2017-03-22
17 417-CHE-2010- CORRESPONDENCE OTHERS 13-05-2011.pdf 2011-05-13
17 417-CHE-2010 FORM-13 16-11-2011.pdf 2011-11-16
18 417-CHE-2010 FORM-18 13-05-2011.pdf 2011-05-13
19 417-CHE-2010 FORM-13 16-11-2011.pdf 2011-11-16
19 417-CHE-2010- CORRESPONDENCE OTHERS 13-05-2011.pdf 2011-05-13
20 417-CHE-2010- FORM-13 13-05-2011.pdf 2011-05-13
20 417-CHE-2010-FER.pdf 2017-03-22
21 417-CHE-2010 ABSTRACT 17-02-2011.pdf 2011-02-17
21 417-CHE-2010-FER_SER_REPLY [11-09-2017(online)].pdf 2017-09-11
22 417-CHE-2010 CLAIMS 17-02-2011.pdf 2011-02-17
22 417-CHE-2010-COMPLETE SPECIFICATION [11-09-2017(online)].pdf 2017-09-11
23 417-CHE-2010 CORRESPONDENCE 17-02-2011.pdf 2011-02-17
23 Marked up Claims_Granted 309060_12-03-2019.pdf 2019-03-12
24 Drawings_Granted 309060_12-03-2019.pdf 2019-03-12
24 417-CHE-2010 DESCRIPTION(COMPLETE) 17-02-2011.pdf 2011-02-17
25 417-CHE-2010 DRAWINGS 17-02-2011.pdf 2011-02-17
25 Description_Granted 309060_12-03-2019.pdf 2019-03-12
26 417-CHE-2010 FORM-1 17-02-2011.pdf 2011-02-17
26 Claims_Granted 309060_12-03-2019.pdf 2019-03-12
27 417-CHE-2010 FORM-2 17-02-2011.pdf 2011-02-17
27 Abstract_Granted 309060_12-03-2019.pdf 2019-03-12
28 417-CHE-2010 FORM-5 17-02-2011.pdf 2011-02-17
28 417-CHE-2010-Written submissions and relevant documents (MANDATORY) [12-03-2019(online)].pdf 2019-03-12
29 417-CHE-2010 FORM-3 23-03-2010.pdf 2010-03-23
29 417-CHE-2010-PatentCertificate12-03-2019.pdf 2019-03-12
30 417-che-2010 form-1 23-03-2010.pdf 2010-03-23
30 417-CHE-2010-IntimationOfGrant12-03-2019.pdf 2019-03-12
31 417-CHE-2010-RELEVANT DOCUMENTS [30-03-2020(online)].pdf 2020-03-30
31 0417-che-2010 correspondence others 18-02-2010.pdf 2010-02-18
32 417-CHE-2010-FORM 4 [12-05-2021(online)].pdf 2021-05-12
32 0417-che-2010 description(provisional) 18-02-2010.pdf 2010-02-18
33 417-CHE-2010-RELEVANT DOCUMENTS [29-09-2021(online)].pdf 2021-09-29
33 0417-che-2010 drawings 18-02-2010.pdf 2010-02-18
34 417-CHE-2010-RELEVANT DOCUMENTS [05-09-2022(online)].pdf 2022-09-05
34 0417-che-2010 form-1 18-02-2010.pdf 2010-02-18
35 417-CHE-2010-RELEVANT DOCUMENTS [28-07-2023(online)].pdf 2023-07-28
35 0417-che-2010 form-2 18-02-2010.pdf 2010-02-18

Search Strategy

1 417che2010searchpdf_07-03-2017.pdf

ERegister / Renewals

3rd: 21 Mar 2019

From 18/02/2012 - To 18/02/2013

4th: 21 Mar 2019

From 18/02/2013 - To 18/02/2014

5th: 21 Mar 2019

From 18/02/2014 - To 18/02/2015

6th: 21 Mar 2019

From 18/02/2015 - To 18/02/2016

7th: 21 Mar 2019

From 18/02/2016 - To 18/02/2017

8th: 21 Mar 2019

From 18/02/2017 - To 18/02/2018

9th: 21 Mar 2019

From 18/02/2018 - To 18/02/2019

10th: 21 Mar 2019

From 18/02/2019 - To 18/02/2020

11th: 05 Feb 2020

From 18/02/2020 - To 18/02/2021

12th: 12 May 2021

From 18/02/2021 - To 18/02/2022

13th: 11 Feb 2022

From 18/02/2022 - To 18/02/2023

14th: 16 Feb 2023

From 18/02/2023 - To 18/02/2024

15th: 13 Feb 2024

From 18/02/2024 - To 18/02/2025

16th: 06 Feb 2025

From 18/02/2025 - To 18/02/2026