EP2648730A4 - Complex formulation comprising lercanidipine hydrochloride and valsartan and method for the preparation thereof - Google Patents

Complex formulation comprising lercanidipine hydrochloride and valsartan and method for the preparation thereof

Info

Publication number: EP2648730A4
Authority: EP; European Patent Office
Prior art keywords: valsartan; preparation; lercanidipine hydrochloride; complex formulation; formulation
Prior art date: 2010-12-09
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.): Withdrawn

Application number

EP11847739.7A

Other languages

German (de)

French (fr)

Other versions

EP2648730A2 (en

Inventor

Young Sik Chung

Soo Ah Park

Ree Sun Kim

Sung Il Kim

Jae Hyeon Juhn

Dong Kyu Kim

Yoo Rin Kim

Hee Dong Park

Seong Jae Park

Sung Hack Lee

Ju Hyun Kim

Min Young Jung

Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)

LG Chem Ltd

Original Assignee

LG Life Sciences Ltd

Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)

2010-12-09

Filing date

2011-12-07

Publication date

2014-08-06

Family has litigation

First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=46207595&utm_source=***_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=EP2648730(A4) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.

2011-12-07 Application filed by LG Life Sciences Ltd filed Critical LG Life Sciences Ltd

2013-10-16 Publication of EP2648730A2 publication Critical patent/EP2648730A2/en

2014-08-06 Publication of EP2648730A4 publication Critical patent/EP2648730A4/en

Status Withdrawn legal-status Critical Current

Links

Classifications

- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4422—1,4-Dihydropyridines, e.g. nifedipine, nicardipine
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
- A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/12—Antihypertensives

Landscapes

Health & Medical Sciences (AREA)
Life Sciences & Earth Sciences (AREA)
Pharmacology & Pharmacy (AREA)
Chemical & Material Sciences (AREA)
Veterinary Medicine (AREA)
Medicinal Chemistry (AREA)
Public Health (AREA)
General Health & Medical Sciences (AREA)
Animal Behavior & Ethology (AREA)
Engineering & Computer Science (AREA)
Epidemiology (AREA)
Bioinformatics & Cheminformatics (AREA)
Chemical Kinetics & Catalysis (AREA)
Heart & Thoracic Surgery (AREA)
Cardiology (AREA)
General Chemical & Material Sciences (AREA)
Organic Chemistry (AREA)
Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

EP11847739.7A 2010-12-09 2011-12-07 Complex formulation comprising lercanidipine hydrochloride and valsartan and method for the preparation thereof Withdrawn EP2648730A4 (en)

Applications Claiming Priority (2)

Application Number	Priority Date	Filing Date	Title
KR20100125804		2010-12-09
PCT/KR2011/009413 WO2012077968A2 (en)	2010-12-09	2011-12-07	Complex formulation comprising lercanidipine hydrochloride and valsartan and method for the preparation thereof

Publications (2)

Publication Number	Publication Date
EP2648730A2 EP2648730A2 (en)	2013-10-16
EP2648730A4 true EP2648730A4 (en)	2014-08-06

Family

ID=46207595

Family Applications (1)

Application Number	Title	Priority Date	Filing Date
EP11847739.7A Withdrawn EP2648730A4 (en)	2010-12-09	2011-12-07	Complex formulation comprising lercanidipine hydrochloride and valsartan and method for the preparation thereof

Country Status (17)

Country	Link
EP (1)	EP2648730A4 (en)
KR (1)	KR101414814B1 (en)
CN (1)	CN103249415B (en)
AR (1)	AR084195A1 (en)
AU (1)	AU2011339150B2 (en)
BR (1)	BR112013013415A2 (en)
CL (1)	CL2013001626A1 (en)
CO (1)	CO6721030A2 (en)
DO (1)	DOP2013000115A (en)
EA (1)	EA201390844A1 (en)
IL (1)	IL226449A0 (en)
MX (1)	MX2013005716A (en)
PE (1)	PE20140699A1 (en)
SG (1)	SG190326A1 (en)
UA (1)	UA108277C2 (en)
UY (1)	UY33772A (en)
WO (1)	WO2012077968A2 (en)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
CN102755322B (en) *	2012-07-24	2013-12-11	兆科药业（广州）有限公司	Compound preparation of lercanidipine and atorvastatin
KR20140111982A (en) *	2013-03-12	2014-09-22	주식회사 엘지생명과학	Complex formulation comprising valsartan and rosuvastatin calcium and method for the preparation thereof
US11382866B2 (en) *	2017-07-06	2022-07-12	Mankind Pharma Ltd.	Fixed dose pharmaceutical composition of valsartan and sacubitril
KR102233986B1 (en) *	2019-06-25	2021-03-30	경남과학기술대학교 산학협력단	Solid pharmaceutical composition comprising lafutidine and irsogladin and process for producing thereof

Citations (1)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
WO2007001067A2 (en) *	2005-06-27	2007-01-04	Daiichi Sankyo Company, Limited	Solid dosage form comprising an angiotensin ii receptor antagonist and a calcium channel blocker

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
US20040198789A1 (en) *	2003-02-28	2004-10-07	Recordati Ireland Limited	Lercanidipine/ARB/diuretic therapeutic combinations
CA2547657A1 (en) *	2003-12-01	2005-06-16	Lifecycle Pharma A/S	Pharmaceutical compositions comprising lercanidipine
KR100888131B1 (en) *	2006-10-10	2009-03-11	한올제약주식회사	Combination preparation for Cardiovascular disease therapy by Chronotherapy theory.

2011
- 2011-12-06 UY UY0001033772A patent/UY33772A/en not_active Application Discontinuation
- 2011-12-07 WO PCT/KR2011/009413 patent/WO2012077968A2/en active Application Filing
- 2011-12-07 CN CN201180058951.9A patent/CN103249415B/en active Active
- 2011-12-07 AR ARP110104583A patent/AR084195A1/en unknown
- 2011-12-07 SG SG2013038211A patent/SG190326A1/en unknown
- 2011-12-07 UA UAA201307936A patent/UA108277C2/en unknown
- 2011-12-07 KR KR1020110130400A patent/KR101414814B1/en active IP Right Grant
- 2011-12-07 MX MX2013005716A patent/MX2013005716A/en unknown
- 2011-12-07 EA EA201390844A patent/EA201390844A1/en unknown
- 2011-12-07 PE PE2013001346A patent/PE20140699A1/en not_active Application Discontinuation
- 2011-12-07 BR BR112013013415A patent/BR112013013415A2/en not_active IP Right Cessation
- 2011-12-07 AU AU2011339150A patent/AU2011339150B2/en active Active
- 2011-12-07 EP EP11847739.7A patent/EP2648730A4/en not_active Withdrawn
2013
- 2013-05-20 IL IL226449A patent/IL226449A0/en unknown
- 2013-05-21 DO DO2013000115A patent/DOP2013000115A/en unknown
- 2013-06-06 CL CL2013001626A patent/CL2013001626A1/en unknown
- 2013-06-21 CO CO13147794A patent/CO6721030A2/en unknown

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
WO2007001067A2 (en) *	2005-06-27	2007-01-04	Daiichi Sankyo Company, Limited	Solid dosage form comprising an angiotensin ii receptor antagonist and a calcium channel blocker

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
FDA: "Guidance for Industry Fixed Dose Combination and Co-Packaged Drug Products for Treatment of HIV", INTERNET CITATION, May 2004 (2004-05-01), XP002417855, Retrieved from the Internet <URL:http://www.fda.gov/oc/initiatives/hiv/hivguidance.html> [retrieved on 20070131] *
PUJARI S ET AL: "Safety and long-term effectiveness of generic fixed-dose formulations of nevirapine-based HAART amongst antiretroviral-naive HIV-infected patients in India", INTERNET CITATION, 16 December 2003 (2003-12-16), XP002417803, Retrieved from the Internet <URL:http://libdoc.who.int/publications/2003/a86263.pdf> [retrieved on 20070131] *
See also references of WO2012077968A2 *

Also Published As

Publication number	Publication date
CO6721030A2 (en)	2013-07-31
UA108277C2 (en)	2015-04-10
AR084195A1 (en)	2013-04-24
IL226449A0 (en)	2013-07-31
DOP2013000115A (en)	2014-07-31
UY33772A (en)	2012-07-31
WO2012077968A3 (en)	2012-07-26
SG190326A1 (en)	2013-06-28
CN103249415A (en)	2013-08-14
WO2012077968A2 (en)	2012-06-14
KR101414814B1 (en)	2014-07-21
AU2011339150A1 (en)	2013-06-06
CL2013001626A1 (en)	2013-10-04
AU2011339150B2 (en)	2015-09-10
BR112013013415A2 (en)	2019-09-24
MX2013005716A (en)	2013-06-12
KR20120089787A (en)	2012-08-13
PE20140699A1 (en)	2014-06-13
CN103249415B (en)	2017-12-12
EA201390844A1 (en)	2013-11-29
EP2648730A2 (en)	2013-10-16

Legal Events

Date	Code	Title	Description
2013-09-13	PUAI	Public reference made under article 153(3) epc to a published international application that has entered the european phase	Free format text: ORIGINAL CODE: 0009012
2013-10-16	17P	Request for examination filed	Effective date: 20130621
2013-10-16	AK	Designated contracting states	Kind code of ref document: A2 Designated state(s): AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR
2014-03-19	DAX	Request for extension of the european patent (deleted)
2014-08-06	A4	Supplementary search report drawn up and despatched	Effective date: 20140707
2014-08-06	RIC1	Information provided on ipc code assigned before grant	Ipc: A61K 9/50 20060101ALI20140701BHEP Ipc: A61K 31/4422 20060101AFI20140701BHEP Ipc: A61K 9/16 20060101ALI20140701BHEP Ipc: A61K 31/41 20060101ALI20140701BHEP Ipc: A61P 9/00 20060101ALI20140701BHEP
2016-07-20	17Q	First examination report despatched	Effective date: 20160620
2017-03-03	STAA	Information on the status of an ep patent application or granted ep patent	Free format text: STATUS: THE APPLICATION IS DEEMED TO BE WITHDRAWN
2017-04-05	18D	Application deemed to be withdrawn	Effective date: 20161101

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