PH12017501769A1 - Pharmaceutical complex formulation comprising amlodipine, losartan and chlorthalidone - Google Patents

Pharmaceutical complex formulation comprising amlodipine, losartan and chlorthalidone

Info

Publication number
PH12017501769A1
PH12017501769A1 PH12017501769A PH12017501769A PH12017501769A1 PH 12017501769 A1 PH12017501769 A1 PH 12017501769A1 PH 12017501769 A PH12017501769 A PH 12017501769A PH 12017501769 A PH12017501769 A PH 12017501769A PH 12017501769 A1 PH12017501769 A1 PH 12017501769A1
Authority
PH
Philippines
Prior art keywords
chlorthalidone
losartan
amlodipine
complex formulation
pharmaceutical complex
Prior art date
Application number
PH12017501769A
Other versions
PH12017501769B1 (en
Inventor
Yong Il Kim
Ho Taek Im
Leedong Roh
Youngsu Yoon
Jae Hyun Park
Jong Soo Woo
Original Assignee
Hanmi Pharm Ind Co 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.)
Filing date
Publication date
Application filed by Hanmi Pharm Ind Co Ltd filed Critical Hanmi Pharm Ind Co Ltd
Publication of PH12017501769A1 publication Critical patent/PH12017501769A1/en
Publication of PH12017501769B1 publication Critical patent/PH12017501769B1/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/403Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
    • A61K31/4035Isoindoles, e.g. phthalimide
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41Heterocyclic 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
    • A61K31/41641,3-Diazoles
    • A61K31/41781,3-Diazoles not condensed 1,3-diazoles and containing further heterocyclic rings, e.g. pilocarpine, nitrofurantoin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic 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
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/44221,4-Dihydropyridines, e.g. nifedipine, nicardipine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, 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
    • A61K9/2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, 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
    • A61K9/2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209Layered 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2095Tabletting 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/02Non-specific cardiovascular stimulants, e.g. drugs for syncope, antihypotensives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/04Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/10Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/12Antihypertensives

Abstract

The present invention provides a pharmaceutical complex formulation comprising a first mixture including amlodipine and chlorthalidone and a second mixture including losartan, which has an improved dissolution and stability. The complex formulation according to the present invention may achieve improved preventive or therapeutic effects for cardiovascular diseases by actuating different mechanism of amlodipine, losartan and chlorthalidone, and exhibits high dissolution rates of amlodipine, losartan and chlorthalidone and improved storage stability, due to the minimized drug interactions, and therefore, it is useful in the fields of pharmaceuticals and medicine.
PH12017501769A 2015-03-31 2017-09-26 Pharmaceutical complex formulation comprising amlodipine, losartan and chlorthalidone PH12017501769B1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR1020150045645A KR101914930B1 (en) 2015-03-31 2015-03-31 Pharmaceutical complex formulation comprising amlodipine, losartan and chlorthalidone
PCT/KR2016/002437 WO2016159535A1 (en) 2015-03-31 2016-03-11 Pharmaceutical complex formulation comprising amlodipine, losartan and chlorthalidone

Publications (2)

Publication Number Publication Date
PH12017501769A1 true PH12017501769A1 (en) 2018-03-19
PH12017501769B1 PH12017501769B1 (en) 2018-03-19

Family

ID=57007292

Family Applications (1)

Application Number Title Priority Date Filing Date
PH12017501769A PH12017501769B1 (en) 2015-03-31 2017-09-26 Pharmaceutical complex formulation comprising amlodipine, losartan and chlorthalidone

Country Status (11)

Country Link
KR (1) KR101914930B1 (en)
CN (1) CN108289850B (en)
AR (1) AR105758A1 (en)
JO (1) JO3461B1 (en)
MX (1) MX2017012459A (en)
MY (1) MY190016A (en)
PH (1) PH12017501769B1 (en)
RU (1) RU2713883C2 (en)
TW (1) TWI714560B (en)
UY (1) UY36595A (en)
WO (1) WO2016159535A1 (en)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR101910902B1 (en) * 2016-11-03 2018-10-24 한미약품 주식회사 Pharmaceutical complex formulation comprising amlodipine, losartan and chlorthalidone
KR20180053044A (en) * 2016-11-11 2018-05-21 주식회사유한양행 A pharmaceutical composition in a monolithic matrix tablet form comprising chlorthalidone or its salt and amlodipine or its salt and a process for preparing the same
KR20200143914A (en) * 2019-06-17 2020-12-28 주식회사유한양행 A pharmaceutical composition in a multi-layered tablet form comprising amlodipine or its salt and chlorthalidone its salt
KR20210074428A (en) 2019-12-11 2021-06-22 한미약품 주식회사 Pharmaceutical complex formulation comprising amlodipine, losartan and chlorthalidone
CN115666564A (en) * 2020-06-09 2023-01-31 韩美药品株式会社 Pharmaceutical combination preparation for preventing or treating cardiovascular system diseases comprising amlodipine, losartan and chlorthalidone in a single-layered tablet

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5138069A (en) 1986-07-11 1992-08-11 E. I. Du Pont De Nemours And Company Angiotensin II receptor blocking imidazoles
CA2179067A1 (en) 1993-12-23 1995-06-29 Gordon Creston Campbell, Jr. Polymorphs of losartan and the process for the preparation of form ii of losartan
KR100452491B1 (en) 2001-03-29 2004-10-12 한미약품 주식회사 A novel crystalline amlodipine camsylate and a preparing method thereof
US20030152622A1 (en) * 2001-10-25 2003-08-14 Jenny Louie-Helm Formulation of an erodible, gastric retentive oral diuretic
EG24716A (en) * 2002-05-17 2010-06-07 Novartis Ag Combination of organic compounds
CA2532450C (en) * 2003-07-16 2012-09-11 Boehringer Ingelheim International Gmbh Chlorthalidone combinations
US20070237815A1 (en) * 2006-04-06 2007-10-11 Lawrence Solomon Dosage forms and methods comprising amlodipine and chlorthalidone
KR101247583B1 (en) * 2006-12-08 2013-03-26 한미사이언스 주식회사 Pharmaceutical composition comprising amlodipine or a pharmaceutically acceptable salt thereof and losartan or a pharmaceutically acceptable salt thereof
KR20090057538A (en) * 2007-12-03 2009-06-08 박사룡 A composition for treating hypertension comprising angiotensin ii antagonist, calsium andtagonist and diuretics
WO2009084040A1 (en) * 2007-12-28 2009-07-09 Rubicon Research Private Limited Once a day formulation of angiotensin receptor blockers
AU2009338267B2 (en) 2009-01-23 2014-09-18 Hanmi Science Co., Ltd. Solid pharmaceutical composition comprising amlodipine and losartan and process for producing same
KR101907881B1 (en) * 2011-12-30 2018-12-11 한미약품 주식회사 Fixed dose combination formulation comprising losartan, amlodipine and hydrochlorothiazide
KR101392364B1 (en) * 2012-04-17 2014-05-07 한국유나이티드제약 주식회사 Pharmaceutical composition comprising amlodipine and losartan having an improved stability

Also Published As

Publication number Publication date
JO3461B1 (en) 2020-07-05
KR101914930B1 (en) 2018-11-05
AR105758A1 (en) 2017-11-08
TW201639563A (en) 2016-11-16
WO2016159535A1 (en) 2016-10-06
CN108289850B (en) 2021-04-09
PH12017501769B1 (en) 2018-03-19
MX2017012459A (en) 2018-01-30
RU2017134562A (en) 2019-04-04
TWI714560B (en) 2021-01-01
RU2713883C2 (en) 2020-02-10
RU2017134562A3 (en) 2019-08-15
MY190016A (en) 2022-03-22
UY36595A (en) 2016-10-31
CN108289850A (en) 2018-07-17
KR20160117055A (en) 2016-10-10

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