DK2432452T3 - Farmaceutisk telmisartan-drikkeopløsning - Google Patents
Farmaceutisk telmisartan-drikkeopløsning Download PDFInfo
- Publication number
- DK2432452T3 DK2432452T3 DK10723040.1T DK10723040T DK2432452T3 DK 2432452 T3 DK2432452 T3 DK 2432452T3 DK 10723040 T DK10723040 T DK 10723040T DK 2432452 T3 DK2432452 T3 DK 2432452T3
- Authority
- DK
- Denmark
- Prior art keywords
- telmisartan
- pharmaceutical solution
- solution
- solution according
- sugar
- Prior art date
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
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
-
- 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
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- 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
-
- 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
- A61K9/08—Solutions
-
- 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
- A61P13/12—Drugs for disorders of the urinary system of the kidneys
-
- 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)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Urology & Nephrology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Claims (18)
1. Farmaceutisk opløsning med en pH-værdi fra 10 eller højere indeholdende telmisartan, kendetegnet ved, at en eller flere sukkeralkoholer foreligger i en samlet koncentration fra 40 vægt-% til 70 vægt-%, fortrinsvist 60 vægt-% til 70 vægt-%, hvor sukkeralkoholen eller sukkeralkoholerne har et maximalt indhold af reducerende sukker på 1000 andele per million forud for tilsætning til opløsningen.
2. Farmaceutisk opløsning ifølge krav 1, kendetegnet ved, at opløsningen er en drikkeopløsning.
3. Farmaceutisk opløsning ifølge et af kravene 1 eller 2, kendetegnet ved, at den farmaceutiske opløsning har et maximalt indhold af reducerende sukre på 1000 andele per million.
4. Farmaceutisk opløsning ifølge et af kravene 1 til 3, kendetegnet ved, at den farmaceutiske opløsning har et minimalt indhold af reducerende sukre på 250 andele per million.
5. Farmaceutisk opløsning ifølge et af kravene 1 til 4, kendetegnet ved, at pH-værdien opnås gennem tilstedeværelsen af meglumin, natriumhydroxid, kaliumhydroxid eller en basisk aminosyre som arginin eller glutamin.
6. Farmaceutisk opløsning ifølge et af kravene 1 til 5, kendetegnet ved, at telmisartan foreligger i en koncentration fra 1 til 10 mg/ml fortrinsvist 1 til 5 mg/ml.
7. Farmaceutisk opløsning ifølge et af kravene ltil 6, kendetegnet ved, at andelen af reducerende sukre, hvor opløsningen baseret på mængden af det aktive stof af telmisartan, udgør mindre end 20 vægtprocent.
8. Farmaceutisk opløsning ifølge et af kravene 1 til 7, kendetegnet ved, at sukkeralkoholen eller sukkeralkoholerne er valgt fra gruppen af xylitol, maltitol, sorbitol, mannitol, erythrit og isomalt.
9. Farmaceutisk opløsning ifølge et af kravene 1 til 8, kendetegnet ved at opløsningen eventuelt yderligere indeholder formuleringshjælpestoffer. 10. farmaceutisk opløsning ifølge et af kravene 1 til 9, kendetegnet ved, at eventuelt o-kresol, m-kresol, p-kresol, eller benzalkoniumchlorid tilsættes som konserveringsmiddel alene eller i kombination.
11. Farmaceutisk opløsning ifølge et af kravene 1 til 10, k e n d e t e g n e t ved, at opløsningen i videst muligt omfang er fri, fortrinsvis fri af antioxidanter eller stabilisatorer.
12. Farmaceutisk opløsning ifølge et af kravene 1 til 11 til anvendelse ved behandling af hypertoni eller af nyrelidelse i mennesker, i særdeleshed børn, ældre mennesker eller mennesker med synkebesvær; eller i dyr, i særdeleshed hunde eller katte.
13. Fremgangsmåde til fremstilling af en farmaceutisk opløsning ifølge et af kravene 1 til 11, k e n d e t e g n e t ved a) at opløse telmisartan og en sukkeralkohol med et indhold af reducerende sukre på mindre end lOOOppm, fortrinsvist mindre end 300ppm, i et overskud af en farmaceutisk egnet base indtil en pH-værdi er justeret til mindst 10 eller højere; og b) at justere koncentrationen af telmisartan på 1 til 10 mg/ml.
14. Fremgangsmåde ifølge krav 13 indeholdende trinnene: a) at opsvulme et konsistensgivende middel med renset vand; b) at opløse det opsvulmede konsistensgivende middel ved en temperatur på > 50°C; c) at tilsætte en farmaceutisk egnet base ved en temperatur på > 50°C indtil en pH-værdi justeres til > 10,0; d) at tilsætte og at opløse telmisartanen og sukkeralkoholen ved en temperatur på > 50°C; e) at køle opløsningen ved stuetemperatur; og f) at påfylde den vandige opløsning med renset vand for at tilvejebringe den ønskede koncentration af telmisartan.
15. Fremgangsmåde ifølge krav 14, hvor trin b) til d) gennemføres ved en temperatur mellem 70°C og 80°C.
16. Fremgangsmåde ifølge et af kravene 14 eller 15, hvor fremgangsmåden omfatter de følgende yderligere trin: g) at tilsætte en eller flere syntetiske sødemidler, smagsstoffer og/eller konserveringsmiddel under omrøring ved stuetemperatur.
17. Fremgangsmåde ifølge krav 16, hvor det yderligere trin g) gennemføres mellem trin e) og f).
18. Fremgangsmåde ifølge krav 13, kendetegnet ved, at den farmaceutiske opløsning fremstilles til behandling af hypertoni eller nyrelidelse i mennesker eller dyr.
19. Glas- eller plastikbeholder med eller uden doseringshjælpemiddel indeholdende drikkeopløsningen ifølge et af kravene 1 til 12.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP09160771 | 2009-05-20 | ||
| PCT/EP2010/056895 WO2010133638A1 (de) | 2009-05-20 | 2010-05-19 | Pharmazeutische telmisartan-trinklösung |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK2432452T3 true DK2432452T3 (da) | 2016-10-10 |
Family
ID=42340411
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK10723040.1T DK2432452T3 (da) | 2009-05-20 | 2010-05-19 | Farmaceutisk telmisartan-drikkeopløsning |
Country Status (19)
| Country | Link |
|---|---|
| US (3) | US8871795B2 (da) |
| EP (1) | EP2432452B1 (da) |
| JP (1) | JP5612674B2 (da) |
| KR (1) | KR20120015325A (da) |
| CN (1) | CN102458363A (da) |
| AR (1) | AR076913A1 (da) |
| AU (1) | AU2010251194B2 (da) |
| BR (1) | BRPI1013037A2 (da) |
| CA (1) | CA2761576C (da) |
| CL (1) | CL2011002926A1 (da) |
| CO (1) | CO6470844A2 (da) |
| DK (1) | DK2432452T3 (da) |
| ES (1) | ES2598490T3 (da) |
| MX (1) | MX346039B (da) |
| NZ (1) | NZ597049A (da) |
| PL (1) | PL2432452T3 (da) |
| SG (1) | SG176585A1 (da) |
| TW (1) | TW201109040A (da) |
| WO (1) | WO2010133638A1 (da) |
Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1908469A1 (en) | 2006-10-06 | 2008-04-09 | Boehringer Ingelheim Vetmedica Gmbh | Angiotensin II receptor antagonist for the treatment of systemic diseases in cats |
| DK2432452T3 (da) * | 2009-05-20 | 2016-10-10 | Boehringer Ingelheim Vetmedica Gmbh | Farmaceutisk telmisartan-drikkeopløsning |
| JP6377426B2 (ja) * | 2013-06-21 | 2018-08-22 | わかもと製薬株式会社 | 水性医薬組成物 |
| JP6344678B2 (ja) * | 2013-09-27 | 2018-06-20 | キョーリンリメディオ株式会社 | テルミサルタン含有製剤及びその製造方法 |
| NZ759782A (en) * | 2017-07-07 | 2023-06-30 | Boehringer Ingelheim Vetmedica Gmbh | Angiotensin ii receptor antagonist for the prevention or treatment of systemic diseases in cats |
| US20230330100A1 (en) * | 2022-02-17 | 2023-10-19 | Woolsey Pharmaceuticals, Inc. | Taste-masking oral formulations of fasudil |
Family Cites Families (33)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE1023027B (de) | 1953-07-10 | 1958-01-23 | Hoffmann La Roche | Verfahren zur Herstellung von Polyendialdehyden |
| US4448778A (en) * | 1981-08-03 | 1984-05-15 | Ici Americas Inc. | Maltitol containing gel base systems |
| US4880804A (en) | 1988-01-07 | 1989-11-14 | E. I. Du Pont De Nemours And Company | Angiotensin II receptor blocking benzimidazoles |
| US6028091A (en) | 1990-12-14 | 2000-02-22 | Smithkline Beecham Plc | Medicament |
| US5591762A (en) * | 1991-02-06 | 1997-01-07 | Dr. Karl Thomae Gmbh | Benzimidazoles useful as angiotensin-11 antagonists |
| JP3862295B2 (ja) | 1993-09-30 | 2006-12-27 | 独立行政法人理化学研究所 | 抗肥満剤 |
| MX9707683A (es) | 1995-04-07 | 1997-12-31 | Novartis Ag | Composiciones de combinacion que contienen benazepril o benazeprilat y valsartan. |
| EP0910375B1 (en) | 1996-06-24 | 2002-05-02 | Merck & Co., Inc. | A composition of enalapril and losartan |
| JPH11315034A (ja) | 1998-03-04 | 1999-11-16 | Takeda Chem Ind Ltd | アンギオテンシンｉｉ拮抗作用を有する化合物の徐放性製剤、その製造法および用途 |
| PL342684A1 (en) | 1998-03-04 | 2001-07-02 | Takeda Chemical Industries Ltd | Preperation featured by reterded release of aii antagonist, production and application of such preparation |
| US6204281B1 (en) | 1998-07-10 | 2001-03-20 | Novartis Ag | Method of treatment and pharmaceutical composition |
| DE19901921C2 (de) | 1999-01-19 | 2001-01-04 | Boehringer Ingelheim Pharma | Polymorphe von Telmisartan, Verfahren zu deren Herstellung und deren Verwendung zur Herstellung eines Arzneimittels |
| US6358986B1 (en) | 1999-01-19 | 2002-03-19 | Boehringer Ingelheim Pharma Kg | Polymorphs of telmisartan |
| DE10018401A1 (de) | 2000-04-13 | 2001-10-25 | Boehringer Ingelheim Pharma | Verwendung von Bradycardica bei der Behandlung von mit Hypertrophie einhergehenden Myocarderkrankungen und neue Arzneimittelkombinationen |
| WO2002030400A1 (fr) * | 2000-10-06 | 2002-04-18 | Takeda Chemical Industries, Ltd. | Preparations solides |
| EP1413315A4 (en) | 2001-08-03 | 2006-08-16 | Takeda Pharmaceutical | DRUGS WITH CONTINUOUS RELEASE |
| 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 |
| US6737432B2 (en) | 2001-10-31 | 2004-05-18 | Boehringer Ingelheim Pharma Kg | Crystalline form of telmisartan sodium |
| US7232828B2 (en) | 2002-08-10 | 2007-06-19 | Bethesda Pharmaceuticals, Inc. | PPAR Ligands that do not cause fluid retention, edema or congestive heart failure |
| AU2003268219B2 (en) | 2002-08-28 | 2009-09-24 | Barnes-Jewish Hospital | Conjoint administration of morphogens and ACE inhibitors in treatment of chronic renal failure |
| US8980870B2 (en) * | 2002-09-24 | 2015-03-17 | Boehringer Ingelheim International Gmbh | Solid telmisartan pharmaceutical formulations |
| DE10244681A1 (de) * | 2002-09-24 | 2004-04-08 | Boehringer Ingelheim International Gmbh | Neue feste Telmisartan enthaltende pharmazeutische Formulierungen und deren Herstellung |
| DE10335027A1 (de) | 2003-07-31 | 2005-02-17 | Boehringer Ingelheim Pharma Gmbh & Co. Kg | Verwendung von Angiotensin II Rezeptor Antagonisten |
| US20050187262A1 (en) | 2004-01-12 | 2005-08-25 | Grogan Donna R. | Compositions comprising (S)-amlodipine and an angiotensin receptor blocker and methods of their use |
| DE102004008804A1 (de) | 2004-02-20 | 2005-09-08 | Boehringer Ingelheim Pharma Gmbh & Co. Kg | Mehrschichttablette |
| EP1579862A1 (en) | 2004-03-25 | 2005-09-28 | Boehringer Ingelheim Vetmedica Gmbh | Use of PDE III inhibitors for the reduction of heart size in mammals suffering from heart failure |
| WO2005123070A1 (en) | 2004-06-09 | 2005-12-29 | Fibrogen, Inc. | Dual blockade of renin-angiotensin system reduces connective tissue growth factor levels in diabetic nephropathy |
| CN100364532C (zh) | 2004-09-30 | 2008-01-30 | 江苏恒瑞医药股份有限公司 | 包含氨氯地平和血管紧张素ⅱ受体抑制剂的组合物 |
| UA89065C2 (ru) | 2004-11-05 | 2009-12-25 | Бёрингэр Ингэльхайм Интэрнациональ Гмбх | Двухслойная таблетка, которая содержит телмисартан и амлодипин |
| US20070026026A1 (en) * | 2005-08-01 | 2007-02-01 | David Delmarre | Oral liquid losartan compositions |
| EP1908469A1 (en) | 2006-10-06 | 2008-04-09 | Boehringer Ingelheim Vetmedica Gmbh | Angiotensin II receptor antagonist for the treatment of systemic diseases in cats |
| EP1970053A1 (en) * | 2007-03-14 | 2008-09-17 | Boehringer Ingelheim Pharma GmbH & Co. KG | Pharmaceutical composition |
| DK2432452T3 (da) * | 2009-05-20 | 2016-10-10 | Boehringer Ingelheim Vetmedica Gmbh | Farmaceutisk telmisartan-drikkeopløsning |
-
2010
- 2010-05-19 DK DK10723040.1T patent/DK2432452T3/da active
- 2010-05-19 NZ NZ597049A patent/NZ597049A/en not_active IP Right Cessation
- 2010-05-19 AR ARP100101742A patent/AR076913A1/es active Pending
- 2010-05-19 SG SG2011085883A patent/SG176585A1/en unknown
- 2010-05-19 KR KR1020117027620A patent/KR20120015325A/ko not_active Application Discontinuation
- 2010-05-19 MX MX2011012114A patent/MX346039B/es active IP Right Grant
- 2010-05-19 CA CA2761576A patent/CA2761576C/en not_active Expired - Fee Related
- 2010-05-19 PL PL10723040T patent/PL2432452T3/pl unknown
- 2010-05-19 TW TW099115966A patent/TW201109040A/zh unknown
- 2010-05-19 AU AU2010251194A patent/AU2010251194B2/en active Active
- 2010-05-19 JP JP2012511281A patent/JP5612674B2/ja active Active
- 2010-05-19 WO PCT/EP2010/056895 patent/WO2010133638A1/de active Application Filing
- 2010-05-19 CN CN2010800319074A patent/CN102458363A/zh active Pending
- 2010-05-19 BR BRPI1013037A patent/BRPI1013037A2/pt not_active IP Right Cessation
- 2010-05-19 ES ES10723040.1T patent/ES2598490T3/es active Active
- 2010-05-19 US US13/321,216 patent/US8871795B2/en active Active
- 2010-05-19 EP EP10723040.1A patent/EP2432452B1/de active Active
-
2011
- 2011-11-18 CL CL2011002926A patent/CL2011002926A1/es unknown
- 2011-11-30 CO CO11165084A patent/CO6470844A2/es not_active Application Discontinuation
-
2014
- 2014-08-27 US US14/469,750 patent/US10314782B2/en active Active
-
2019
- 2019-04-25 US US16/394,610 patent/US10537523B2/en active Active
Also Published As
| Publication number | Publication date |
|---|---|
| KR20120015325A (ko) | 2012-02-21 |
| CL2011002926A1 (es) | 2012-06-22 |
| JP2012526856A (ja) | 2012-11-01 |
| WO2010133638A1 (de) | 2010-11-25 |
| NZ597049A (en) | 2014-01-31 |
| SG176585A1 (en) | 2012-01-30 |
| EP2432452B1 (de) | 2016-07-27 |
| AR076913A1 (es) | 2011-07-20 |
| US10537523B2 (en) | 2020-01-21 |
| AU2010251194A1 (en) | 2012-01-19 |
| CA2761576A1 (en) | 2010-11-25 |
| AU2010251194B2 (en) | 2016-02-25 |
| US20190247305A1 (en) | 2019-08-15 |
| EP2432452A1 (de) | 2012-03-28 |
| TW201109040A (en) | 2011-03-16 |
| JP5612674B2 (ja) | 2014-10-22 |
| CA2761576C (en) | 2017-08-22 |
| PL2432452T3 (pl) | 2017-07-31 |
| US20120095069A1 (en) | 2012-04-19 |
| BRPI1013037A2 (pt) | 2019-09-24 |
| CO6470844A2 (es) | 2012-06-29 |
| US20140364473A1 (en) | 2014-12-11 |
| US8871795B2 (en) | 2014-10-28 |
| MX346039B (es) | 2017-03-03 |
| US10314782B2 (en) | 2019-06-11 |
| CN102458363A (zh) | 2012-05-16 |
| MX2011012114A (es) | 2011-12-16 |
| ES2598490T3 (es) | 2017-01-27 |
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