EA022100B1 - Способ получения лекарственного средства, содержащего тадалафил - Google Patents
Способ получения лекарственного средства, содержащего тадалафил Download PDFInfo
- Publication number
- EA022100B1 EA022100B1 EA201070046A EA201070046A EA022100B1 EA 022100 B1 EA022100 B1 EA 022100B1 EA 201070046 A EA201070046 A EA 201070046A EA 201070046 A EA201070046 A EA 201070046A EA 022100 B1 EA022100 B1 EA 022100B1
- Authority
- EA
- Eurasian Patent Office
- Prior art keywords
- peg
- tadalafil
- drug
- solid
- polyethylene glycol
- Prior art date
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- 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
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/4985—Pyrazines or piperazines ortho- or peri-condensed with heterocyclic ring systems
-
- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
-
- 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
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
-
- 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
- A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/10—Drugs for genital or sexual disorders; Contraceptives for impotence
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Endocrinology (AREA)
- Reproductive Health (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Inorganic Chemistry (AREA)
- Gynecology & Obstetrics (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Nitrogen Condensed Heterocyclic Rings (AREA)
Abstract
Изобретение относится к способу получения лекарственного средства, содержащего тадалафил. В указанном способе тадалафил смешивают с одним или несколькими подходящими вспомогательными веществами, выбранными из полиэтиленгликоля, моностеарата полиоксиэтиленгликоля, глицерин-полиэтиленгликоль рицинолеата, поливинилпирролидона и/или сополимера винилпирролидона с винилацетатом, и нагревают до температуры от 100 до 200°С с образованием твердого или полутвердого раствора тадалафила.
Description
(57) Изобретение относится к способу получения лекарственного средства, содержащего тадалафил. В указанном способе тадалафил смешивают с одним или несколькими подходящими вспомогательными веществами, выбранными из полиэтиленгликоля, моностеарата полиоксиэтиленгликоля, глицерин-полиэтиленгликоль рицинолеата, поливинилпирролидона и/или сополимера винилпирролидона с винилацетатом, и нагревают до температуры от 100 до 200°С с образованием твердого или полутвердого раствора тадалафила.
022100 Β1
Claims (12)
1. Способ получения лекарственного средства, содержащего тадалафил, отличающийся тем, что тадалафил смешивают с одним или несколькими подходящими вспомогательными веществами, выбранными из полиэтиленгликоля (ПЭГ), моностеарата полиоксиэтиленгликоля, глицерин-полиэтиленгликоль рицинолеата, поливинилпирролидона и/или сополимера винилпирролидона с винилацетатом и нагревают до температуры от 100 до 200°С с образованием твердого или полутвердого раствора тадалафила.
2. Способ по п.1, отличающийся тем, что температура нагревания составляет от 150 до 200°С.
3. Способ по п.2, отличающийся тем, что температура нагревания составляет 200°С.
4. Способ по любому из пп.1-3, отличающийся тем, что ПЭГ выбирают из ПЭГ-200, ПЭГ-400, ПЭГ-600, ПЭГ-800, ПЭГ-1500, ПЭГ-4000, ПЭГ-6000, ПЭГ-8000, ПЭГ-1000 и/или ПЭГ-20000, в частности из ПЭГ-400, ПЭГ-4000, ПЭГ-6000 и/или ПЭГ-20000.
5. Способ по любому из пп.1-3, отличающийся тем, что поливинилпирролидон имеет молекулярный вес приблизительно 40000, а сополимер винилпирролидона с винилацетатом имеет молекулярный вес приблизительно 60000.
6. Способ по любому из пп.1-5, отличающийся тем, что нагревание проводят в экструдере или гомогенизаторе.
7. Способ по п.6, отличающийся тем, что при экструзии в качестве вспомогательного вещества применяют поливинилпирролидон и/или сополимер винилпирролидона с винилацетатом.
8. Способ по любому из пп.1-7, отличающийся тем, что содержание тадалафила в лекарственном средстве составляет от 2 до 15 вес.%.
9. Способ по п.8, отличающийся тем, что содержание тадалафила составляет от 3 до 10 вес.%.
10. Лекарственное средство, содержащее твердый или полутвердый раствор тадалафила, которое получено способом по любому из пп.1-9.
11. Лекарственное средство по п.10, отличающееся тем, что лекарственное средство находится в форме таблетки или в форме капсулы.
12. Лекарственное средство по п.10, отличающееся тем, что 80% тадалафила высвобождается ίη νίίτο через 8-120 мин.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE102007028869A DE102007028869A1 (de) | 2007-06-22 | 2007-06-22 | Verfahren zur Herstellung eines Arzneimittels enthaltend Tadalafil |
PCT/EP2008/005066 WO2009000493A1 (de) | 2007-06-22 | 2008-06-23 | Verfahren zur herstellung eines arzneimittels enthaltend tadalafil |
Publications (2)
Publication Number | Publication Date |
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EA201070046A1 EA201070046A1 (ru) | 2010-06-30 |
EA022100B1 true EA022100B1 (ru) | 2015-11-30 |
Family
ID=39797930
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EA201070046A EA022100B1 (ru) | 2007-06-22 | 2008-06-23 | Способ получения лекарственного средства, содержащего тадалафил |
Country Status (14)
Country | Link |
---|---|
US (2) | US9238007B2 (ru) |
EP (1) | EP2170281A1 (ru) |
JP (1) | JP5443344B2 (ru) |
KR (1) | KR101525021B1 (ru) |
CN (1) | CN101720221A (ru) |
AU (1) | AU2008267431C1 (ru) |
BR (1) | BRPI0812807A2 (ru) |
CA (1) | CA2691667C (ru) |
DE (1) | DE102007028869A1 (ru) |
EA (1) | EA022100B1 (ru) |
IL (1) | IL202783A (ru) |
UA (1) | UA95374C2 (ru) |
WO (1) | WO2009000493A1 (ru) |
ZA (1) | ZA200908965B (ru) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
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EA028561B1 (ru) * | 2016-12-28 | 2017-11-30 | Тева Фармасьютикал Индастриз, Лтд. | Твердые лекарственные формы тадалафила |
Families Citing this family (22)
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DE102007028869A1 (de) | 2007-06-22 | 2008-12-24 | Ratiopharm Gmbh | Verfahren zur Herstellung eines Arzneimittels enthaltend Tadalafil |
US10610528B2 (en) | 2009-12-08 | 2020-04-07 | Intelgenx Corp. | Solid oral film dosage forms and methods for making same |
US20110136815A1 (en) | 2009-12-08 | 2011-06-09 | Horst Zerbe | Solid oral film dosage forms and methods for making same |
US20110263606A1 (en) * | 2010-04-26 | 2011-10-27 | Horst Zerbe | Solid oral dosage forms comprising tadalafil |
DE102010017463B4 (de) * | 2010-06-18 | 2014-02-20 | Eickhoff Antriebstechnik Gmbh | Planetenbolzen, Planetenträger, Planetengetriebe und Verfahren zur drehfesten Befestigung eines Planetenbolzens an einen Planetenträger |
WO2012107092A1 (en) | 2011-02-10 | 2012-08-16 | Synthon Bv | Pharmaceutical composition comprising tadalafil and a cyclodextrin |
WO2012107090A1 (en) | 2011-02-10 | 2012-08-16 | Synthon Bv | Granulated composition comprising tadalafil and a disintegrant |
WO2012107541A1 (en) | 2011-02-10 | 2012-08-16 | Synthon Bv | Pharmaceutical composition comprising tadalafil and a cyclodextrin |
WO2014003678A1 (en) * | 2012-06-28 | 2014-01-03 | Xspray Microparticles Ab | Pharmaceutical compositions comprising ambrisentan and solid dispersion particles containing tadalafil |
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2007
- 2007-06-22 DE DE102007028869A patent/DE102007028869A1/de not_active Withdrawn
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2008
- 2008-06-23 UA UAA201000594A patent/UA95374C2/ru unknown
- 2008-06-23 EA EA201070046A patent/EA022100B1/ru not_active IP Right Cessation
- 2008-06-23 EP EP08759325A patent/EP2170281A1/de not_active Withdrawn
- 2008-06-23 AU AU2008267431A patent/AU2008267431C1/en not_active Ceased
- 2008-06-23 JP JP2010512607A patent/JP5443344B2/ja not_active Expired - Fee Related
- 2008-06-23 BR BRPI0812807-3A2A patent/BRPI0812807A2/pt not_active Application Discontinuation
- 2008-06-23 US US12/665,309 patent/US9238007B2/en not_active Expired - Fee Related
- 2008-06-23 WO PCT/EP2008/005066 patent/WO2009000493A1/de active Application Filing
- 2008-06-23 CA CA2691667A patent/CA2691667C/en not_active Expired - Fee Related
- 2008-06-23 KR KR1020107000944A patent/KR101525021B1/ko active IP Right Grant
- 2008-06-23 CN CN200880021058A patent/CN101720221A/zh active Pending
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2009
- 2009-12-15 ZA ZA2009/08965A patent/ZA200908965B/en unknown
- 2009-12-17 IL IL202783A patent/IL202783A/en active IP Right Grant
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2015
- 2015-12-16 US US14/971,141 patent/US20160101103A1/en not_active Abandoned
Patent Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
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US6943166B1 (en) * | 1999-04-30 | 2005-09-13 | Lilly Icos Llc. | Compositions comprising phosphodiesterase inhabitors for the treatment of sexual disfunction |
WO2001008687A1 (en) * | 1999-08-03 | 2001-02-08 | Lilly Icos Llc | Beta-carboline pharmaceutical compositions |
US6841167B1 (en) * | 1999-08-03 | 2005-01-11 | Lilly Icos Llc. | β-carboline pharmaceutical compositions |
WO2003000343A2 (en) * | 2001-06-21 | 2003-01-03 | Vivus, Inc. | Administration of phosphodiesterase inhibitors for the treatment of premature ejaculation |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EA028561B1 (ru) * | 2016-12-28 | 2017-11-30 | Тева Фармасьютикал Индастриз, Лтд. | Твердые лекарственные формы тадалафила |
Also Published As
Publication number | Publication date |
---|---|
EA201070046A1 (ru) | 2010-06-30 |
IL202783A (en) | 2017-01-31 |
WO2009000493A1 (de) | 2008-12-31 |
AU2008267431A1 (en) | 2008-12-31 |
DE102007028869A1 (de) | 2008-12-24 |
CA2691667C (en) | 2014-10-28 |
US20160101103A1 (en) | 2016-04-14 |
JP2010530858A (ja) | 2010-09-16 |
AU2008267431B2 (en) | 2013-05-23 |
AU2008267431C1 (en) | 2013-09-26 |
IL202783A0 (en) | 2010-06-30 |
ZA200908965B (en) | 2012-06-27 |
CN101720221A (zh) | 2010-06-02 |
JP5443344B2 (ja) | 2014-03-19 |
KR101525021B1 (ko) | 2015-06-04 |
EP2170281A1 (de) | 2010-04-07 |
KR20100052453A (ko) | 2010-05-19 |
CA2691667A1 (en) | 2008-12-31 |
BRPI0812807A2 (pt) | 2014-12-02 |
UA95374C2 (ru) | 2011-07-25 |
US9238007B2 (en) | 2016-01-19 |
US20100179159A1 (en) | 2010-07-15 |
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