AR044142A1 - Formulacion farmaceutica de la sal sodica del telmisartan - Google Patents

Formulacion farmaceutica de la sal sodica del telmisartan

Info

Publication number
AR044142A1
AR044142A1 ARP040101480A ARP040101480A AR044142A1 AR 044142 A1 AR044142 A1 AR 044142A1 AR P040101480 A ARP040101480 A AR P040101480A AR P040101480 A ARP040101480 A AR P040101480A AR 044142 A1 AR044142 A1 AR 044142A1
Authority
AR
Argentina
Prior art keywords
water
cellulose
mixture
sodium salt
hydroxypropyl
Prior art date
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.)
Pending
Application number
ARP040101480A
Other languages
English (en)
Inventor
Anja Kohlrausch
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.)
Boehringer Ingelheim Pharma GmbH Co KG
Original Assignee
Boehringer Ingelheim Pharma GmbH Co KG
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=33305059&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=AR044142(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Boehringer Ingelheim Pharma GmbH Co KG filed Critical Boehringer Ingelheim Pharma GmbH Co KG
Publication of AR044142A1 publication Critical patent/AR044142A1/es
Pending legal-status Critical Current

Links

Classifications

    • 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
    • A61K31/4164—1,3-Diazoles
    • A61K31/4184—1,3-Diazoles condensed with carbocyclic rings, e.g. benzimidazoles
    • 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
    • A61K31/38—Heterocyclic compounds having sulfur as a ring hetero atom
    • A61K31/39—Heterocyclic compounds having sulfur as a ring hetero atom having oxygen in the same ring
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/02—Drugs for disorders of the urinary system of urine or of the urinary tract, e.g. urine acidifiers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/10—Drugs for disorders of the urinary system of the bladder
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • A61P27/06—Antiglaucoma agents or miotics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/10—Antioedematous agents; Diuretics
    • 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
    • A61P9/04—Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
    • 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
    • A61P9/10—Drugs 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
    • 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)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Cardiology (AREA)
  • Epidemiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Urology & Nephrology (AREA)
  • Ophthalmology & Optometry (AREA)
  • Neurosurgery (AREA)
  • Hospice & Palliative Care (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Vascular Medicine (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Plural Heterocyclic Compounds (AREA)

Abstract

Formulación farmacéutica de la sal sódica cristalina del 4´-[[2-n-propil-4-metil-6-(1-metil-bencimidazol-2-il)-bencimidazol-1-ilmetil]-bifenil-2-carboxílico (telmisartan), así como procedimientos para su preparación. Reivindicación 1: Composición farmacéutica que contiene la sal sódica del telmisartan y un agente diurético. Reivindicación 2: La composición de la reivindicación 1, que contiene una o varias sustancias coadyuvantes de formulación seleccionadas entre el conjunto formado por manitol, sorbitol, xilita, sacarosa, carbonato de calcio, fosfato de calcio, lactosa, sal sódica de croscarmellosa, crospovidona, almidón glicolato de sodio, hidroxipropil-celulosa, almidón de maíz, poli(vinil-pirrolidona), copolímeros de vinil-pirrolidona con otros derivados vinílicos (copovidona), hidroxipropil-celulosa, hidroxipropil-metil-celulosa, celulosa microcristalina o almidón microcristalino, estearato de magnesio, estearil-fumarato de sodio, talco, hidroxipropil-metil celulosa, carboximetil-celulosa, acetato-ftalato de celulosa, poli (acetato de vinilo), agua, una mezcla de agua y etanol, una mezcla de agua y glicerol, una mezcla de agua y sorbita, una mezcla de agua y polietilen-glicol, propilen-glicol, alcohol cetil-estearílico, carboximetil-celulosa o sustancias que contienen grasas, tales como grasa dura o sus mezclas apropiadas. Reivindicación 3: Composición farmacéutica que contiene la sal sódica del telmisartan, eventualmente un agente diurético, y uno o varios agentes coadyuvantes de formulación seleccionados entre el conjunto formado por sorbitol, xilita, sacarosa, sal sódica de croscarmellosa, crospovidona, almidón glicolato de sodio, hidroxipropil-celulosa, almidón de maíz, poli(vinil-pirrolidona), copolímeros de vinil-pirrolidona con otros derivados vinílicos (copovidona), hidroxipropil-celulosa, hidroxipropil-metil-celulosa, celulosa microcristalina o estearil-fumarato de sodio, hidroxipropil-metil celulosa, agua, una mezcla de agua y etanol, una mezcla de agua y glicerol, una mezcla de agua y sorbita, una mezcla de agua y polietilen-glicol, propilen-glicol, alcohol cetil-estearílico, carboximetil-celulosa o sustancias que contienen grasas, tales como grasa dura o sus mezclas apropiadas. Reivindicación 4: La composición de las reivindicaciones 1 a 3, que contiene el agente diurético hidroclorotiazida (HCTZ). Reivindicación 13: La composición de la reivindicación 1 o la reivindicación 3, caracterizada porque junto a la sal sódica del telmisartan se incorporan otras sustancias activas farmacéuticas. Reivindicación 14: Procedimiento para la preparación de la composición farmacéutica de las reivindicaciones 1 a 3, caracterizada porque las sustancias activas se comprimen junto con las sustancias coadyuvantes para formar tabletas.
ARP040101480A 2003-04-30 2004-04-30 Formulacion farmaceutica de la sal sodica del telmisartan Pending AR044142A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
DE10319450A DE10319450A1 (de) 2003-04-30 2003-04-30 Pharmazeutische Formulierung des Telmisartan Natriumsalzes

Publications (1)

Publication Number Publication Date
AR044142A1 true AR044142A1 (es) 2005-08-24

Family

ID=33305059

Family Applications (2)

Application Number Title Priority Date Filing Date
ARP040101480A Pending AR044142A1 (es) 2003-04-30 2004-04-30 Formulacion farmaceutica de la sal sodica del telmisartan
ARP120102583A AR087210A2 (es) 2003-04-30 2012-07-17 Formulacion farmaceutica de la sal sodica del telmisartan

Family Applications After (1)

Application Number Title Priority Date Filing Date
ARP120102583A AR087210A2 (es) 2003-04-30 2012-07-17 Formulacion farmaceutica de la sal sodica del telmisartan

Country Status (22)

Country Link
EP (1) EP1622612B9 (es)
JP (2) JP5156231B2 (es)
KR (1) KR20060008943A (es)
CN (1) CN100589802C (es)
AR (2) AR044142A1 (es)
AT (1) ATE388703T1 (es)
AU (1) AU2004233581B2 (es)
BR (1) BRPI0409809A (es)
CA (1) CA2524091C (es)
CL (1) CL2004000899A1 (es)
DE (2) DE10319450A1 (es)
DK (1) DK1622612T3 (es)
ES (1) ES2303634T4 (es)
IL (1) IL171465A (es)
MX (1) MXPA05011647A (es)
NZ (1) NZ543775A (es)
PE (1) PE20050464A1 (es)
RU (1) RU2372918C2 (es)
TW (1) TWI364278B (es)
UY (1) UY28293A1 (es)
WO (1) WO2004096215A1 (es)
ZA (1) ZA200507223B (es)

Families Citing this family (23)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE10319450A1 (de) * 2003-04-30 2004-11-18 Boehringer Ingelheim Pharma Gmbh & Co. Kg Pharmazeutische Formulierung des Telmisartan Natriumsalzes
DE10319592A1 (de) * 2003-05-02 2004-11-18 Boehringer Ingelheim Pharma Gmbh & Co. Kg Behandlung von diabetischer Retinopathie mit Angiotensin II-Rezeptorblockern
WO2006044754A2 (en) * 2004-10-18 2006-04-27 Dr. Reddy's Laboratories Ltd. Process for preparing telmisartan
US8637078B2 (en) 2005-11-24 2014-01-28 Boehringer Ingelheim International Gmbh Bilayer tablet comprising telmisartan and diuretic
SI2269583T1 (sl) 2006-06-16 2014-12-31 Lek Pharmaceuticals D.D. Farmacevtski pripravek, ki vsebuje hidroklorotiazid in telmisartan
TWI482772B (zh) 2006-08-21 2015-05-01 Astrazeneca Ab 適合口服且包含三唑并[4,5-d]嘧啶衍生物之組合物
US20100247649A1 (en) * 2007-10-30 2010-09-30 Dr. Reddy's Laboratories Ltd. Pharmaceutical formulations comprising telmisartan and hydrochlorothiazide
DE102008047910A1 (de) 2008-09-19 2010-03-25 Molkerei Meggle Wasserburg Gmbh & Co. Kg Tablettierhilfsstoff auf Laktose- und Cellulosebasis
CZ301299B6 (cs) 2008-11-24 2010-01-06 Zentiva, A.S. Pevná farmaceutická kompozice s úcinnými látkami atorvastatinem a telmisartanem
PL2443094T3 (pl) 2009-06-19 2013-08-30 Krka Tovarna Zdravil D D Novo Mesto Sposób wytwarzania telmisartanu
EP2448575A2 (en) * 2009-07-02 2012-05-09 Bilgic Mahmut Pharmaceutical composition increasing solubility and stability
JP2011136908A (ja) * 2009-12-25 2011-07-14 Kyowa Yakuhin Kogyo Kk アンギオテンシンｉｉ受容体拮抗剤を含む固形製剤および固形製剤におけるアンギオテンシンｉｉ受容体拮抗剤の保存安定性向上方法
CA2706292A1 (en) * 2010-05-28 2011-11-28 Pharmascience Inc. A stable pharmaceutical formulation comprising telmisartan and hydrochlorothiazide
WO2011161123A2 (en) 2010-06-21 2011-12-29 Krka, Tovarna Zdravil, D.D., Novo Mesto Multilayer pharmaceutical tablet comprising telmisartan and a diuretic
ES2777890T3 (es) * 2010-11-15 2020-08-06 Boehringer Ingelheim Int Terapia antidiabética vasoprotectora y cardioprotectora
CA2846387C (en) * 2011-08-26 2016-02-09 Wockhardt Limited Methods for treating cardiovascular disorders
CN102526037B (zh) * 2012-02-10 2014-08-27 重庆康刻尔制药有限公司 一种替米沙坦药物组合、片剂及其制备方法
EP2649996A1 (en) * 2012-04-11 2013-10-16 Laboratorios Del. Dr. Esteve, S.A. Crystalline forms of sartans like telmisartan with beta blockers
JP6018420B2 (ja) * 2012-06-05 2016-11-02 ニプロ株式会社 アンジオテンシンｉｉ受容体拮抗薬およびサイアザイド系利尿薬を含む医薬組成物
JP6428340B2 (ja) * 2014-05-23 2018-11-28 ニプロ株式会社 テルミサルタンを含む医薬組成物の造粒方法
JP5956034B1 (ja) * 2015-07-27 2016-07-20 エルメッド エーザイ株式会社 テルミサルタン含有医薬組成物
CN107501192A (zh) * 2017-08-15 2017-12-22 中国科学院上海药物研究所 替米沙坦与氢氯噻嗪的共晶
KR20200043618A (ko) * 2018-10-18 2020-04-28 주식회사유한양행 아미노피리미딘 유도체 또는 이의 염을 포함하는 경구투여용 약학 조성물

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SI9210098B (sl) * 1991-02-06 2000-06-30 Dr. Karl Thomae Benzimidazoli, zdravila, ki te spojine vsebujejo, in postopek za njihovo pripravo
JP4107831B2 (ja) * 2000-11-21 2008-06-25 第一三共株式会社 医薬組成物
US20040242891A1 (en) * 2001-10-26 2004-12-02 Jonathan Campbell Production of keto acids
DE10153737A1 (de) * 2001-10-31 2003-05-28 Boehringer Ingelheim Pharma Kristallines Natriumsalz des Telmisartans, Verfahren zu dessen Herstellung und dessen Verwendung zur Herstellung eines Arzneimittels
DE60224096T3 (de) * 2002-01-16 2012-01-12 Boehringer Ingelheim Pharma Gmbh & Co. Kg Verfahren zur herstellung einer zweischichtigen pharmazeutischen tablette enthaltend telmisartan und hydrochlorothiazid
DE10244681A1 (de) * 2002-09-24 2004-04-08 Boehringer Ingelheim International Gmbh Neue feste Telmisartan enthaltende pharmazeutische Formulierungen und deren Herstellung
DE10301371A1 (de) * 2003-01-16 2004-08-05 Boehringer Ingelheim Pharma Gmbh & Co. Kg Pharmazeutische Kombination zur Prophylaxe oder Therapie von kardiovaskulären, kardiopulmonalen, pulmonalen oder renalen Krankheiten
DE10319450A1 (de) * 2003-04-30 2004-11-18 Boehringer Ingelheim Pharma Gmbh & Co. Kg Pharmazeutische Formulierung des Telmisartan Natriumsalzes

Also Published As

Publication number Publication date
AU2004233581A1 (en) 2004-11-11
DE502004006500D1 (de) 2008-04-24
NZ543775A (en) 2009-03-31
ATE388703T1 (de) 2008-03-15
MXPA05011647A (es) 2005-12-15
AR087210A2 (es) 2014-02-26
RU2005137031A (ru) 2007-06-10
PE20050464A1 (es) 2005-07-04
BRPI0409809A (pt) 2006-05-09
CN1780618A (zh) 2006-05-31
WO2004096215A1 (de) 2004-11-11
UY28293A1 (es) 2004-11-30
IL171465A (en) 2010-06-30
ZA200507223B (en) 2006-05-31
JP2006524635A (ja) 2006-11-02
AU2004233581B2 (en) 2010-04-22
EP1622612B1 (de) 2008-03-12
JP5254268B2 (ja) 2013-08-07
TWI364278B (en) 2012-05-21
DK1622612T3 (da) 2008-05-26
DE10319450A1 (de) 2004-11-18
CN100589802C (zh) 2010-02-17
RU2372918C2 (ru) 2009-11-20
CL2004000899A1 (es) 2005-03-04
JP2010138207A (ja) 2010-06-24
EP1622612A1 (de) 2006-02-08
EP1622612B9 (de) 2008-11-05
CA2524091A1 (en) 2004-11-11
ES2303634T3 (es) 2008-08-16
ES2303634T4 (es) 2009-04-01
JP5156231B2 (ja) 2013-03-06
KR20060008943A (ko) 2006-01-27
TW200509914A (en) 2005-03-16
CA2524091C (en) 2012-02-21

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