RU96118271A - COMPOSITIONS CONTAINING FINE-CREATED NEBIVOL - Google Patents

COMPOSITIONS CONTAINING FINE-CREATED NEBIVOL

Info

Publication number
RU96118271A
RU96118271A RU96118271/14A RU96118271A RU96118271A RU 96118271 A RU96118271 A RU 96118271A RU 96118271/14 A RU96118271/14 A RU 96118271/14A RU 96118271 A RU96118271 A RU 96118271A RU 96118271 A RU96118271 A RU 96118271A
Authority
RU
Russia
Prior art keywords
pharmaceutical composition
composition according
finely divided
nebivolol hydrochloride
nebivolol
Prior art date
Application number
RU96118271/14A
Other languages
Russian (ru)
Other versions
RU2137473C1 (en
Inventor
Янс Еген
Францискус Сманс Гуидо
Мари Виктор Гилис Поль
Original Assignee
Жансен Фармасетика Н.В.
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 Жансен Фармасетика Н.В. filed Critical Жансен Фармасетика Н.В.
Priority claimed from PCT/EP1995/000489 external-priority patent/WO1995022325A1/en
Publication of RU96118271A publication Critical patent/RU96118271A/en
Application granted granted Critical
Publication of RU2137473C1 publication Critical patent/RU2137473C1/en

Links

Claims (1)

1. Фармацевтическая композиция, включающая фармацевтически приемлемый носитель и в качестве активного ингредиента небиволол или фармацевтически приемлемую его соль, отличающаяся тем, что активный ингредиент находится в тонкоизмельченной твердой форме.1. A pharmaceutical composition comprising a pharmaceutically acceptable carrier and, as an active ingredient, nebivolol or a pharmaceutically acceptable salt thereof, characterized in that the active ingredient is in finely divided solid form. 2. Фармацевтическая композиция по п.1, в которой фармацевтическая композиция представляет собой твердую фармацевтическую композицию. 2. The pharmaceutical composition according to claim 1, in which the pharmaceutical composition is a solid pharmaceutical composition. 3. Фармацевтическая композиция по п.1 или 2, в которой активный ингредиент представляет тонкоизмельченную форму небиволол гидрохлорида. 3. The pharmaceutical composition according to claim 1 or 2, in which the active ingredient is a finely divided form of nebivolol hydrochloride. 4. Фармацевтическая композиция по п.3, в которой тонкоизмельченная форма небиволол гидрохлорида имеет удельную поверхность по крайней мере 23 х 103 см2/мг (2,3 х 103 м2/кг).4. The pharmaceutical composition according to claim 3, in which the finely divided form of nebivolol hydrochloride has a specific surface area of at least 23 x 10 3 cm 2 / mg (2.3 x 10 3 m 2 / kg). 5. Фармацевтическая композиция по п.3, в которой указанная фармацевтическая композиция включает 1 - 4% тонкоизмельченной формы небиволол гидрохлорида. 5. The pharmaceutical composition according to claim 3, wherein said pharmaceutical composition comprises 1 to 4% finely divided form of nebivolol hydrochloride. 6. Фармацевтическая композиция по п.3, в которой фармацевтическая композиция дополнительно включает полисорбат в качестве смачивающего средства и в которой отношение (вес/вес) полисорбат/небиволол гидрохлорид находится в пределах от 0,025 до 0,5. 6. The pharmaceutical composition according to claim 3, in which the pharmaceutical composition further comprises polysorbate as a wetting agent and in which the ratio (weight / weight) of polysorbate / nebivolol hydrochloride is in the range from 0.025 to 0.5. 7. Фармацевтическая композиция по п.2, в которой указанная фармацевтическая композиция представляет таблетку. 7. The pharmaceutical composition according to claim 2, wherein said pharmaceutical composition is a tablet. 8. Фармацевтическая композиция по п.3, в которой указанная фармацевтическая композиция представляет таблетку, в основном, имеющую следующий состав (рецептуру), %:
Небиволол гидрохлорид - 2,40
Лактоза - 61,6
Рисовый крахмал - 20,0
Натрий кроскармелоза - 6,00
Коллоидальный безводный кремнезем - 0,26
Стеарат магния - 0,50
Hypromellose 2910 спз - 2,00
Полисорбат 80 - 0,20
Микрокристаллическая целлюлоза - 7,00
9. Таблетка по п.7, отличающаяся тем, что она имеет растворение 75% через 45 мин.8. The pharmaceutical composition according to claim 3, in which the pharmaceutical composition is a tablet, basically having the following composition (formulation),%:
Nebivolol hydrochloride - 2.40
Lactose - 61.6
Rice Starch - 20.0
Croscarmellose sodium - 6.00
Colloidal Anhydrous Silica - 0.26
Magnesium Stearate - 0.50
Hypromellose 2910 SPR - 2.00
Polysorbate 80 - 0.20
Microcrystalline cellulose - 7.00
9. The tablet according to claim 7, characterized in that it has a dissolution of 75% after 45 minutes. 10. Тонкоизмельченная форма небиволол гидрохлорида, имеющая удельную поверхность по крайней мере 23 х 103 см2/г.10. A finely divided form of nebivolol hydrochloride having a specific surface area of at least 23 x 10 3 cm 2 / g.
RU96118271A 1994-02-17 1995-02-10 Compositions containing finely ground nebivolol RU2137473C1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US19798894A 1994-02-17 1994-02-17
US197,988 1994-02-17
PCT/EP1995/000489 WO1995022325A1 (en) 1994-02-17 1995-02-10 Compositions containing micronized nebivolol

Publications (2)

Publication Number Publication Date
RU96118271A true RU96118271A (en) 1999-01-20
RU2137473C1 RU2137473C1 (en) 1999-09-20

Family

ID=22731545

Family Applications (1)

Application Number Title Priority Date Filing Date
RU96118271A RU2137473C1 (en) 1994-02-17 1995-02-10 Compositions containing finely ground nebivolol

Country Status (30)

Country Link
US (1) US5759580A (en)
EP (1) EP0744946B1 (en)
JP (1) JP3810079B2 (en)
KR (1) KR100361636B1 (en)
CN (1) CN1112921C (en)
AT (1) ATE212547T1 (en)
AU (1) AU688860B2 (en)
BR (1) BR9506828A (en)
CA (1) CA2182582C (en)
CY (1) CY2329B1 (en)
CZ (1) CZ290844B6 (en)
DE (1) DE69525241T2 (en)
DK (1) DK0744946T3 (en)
ES (1) ES2171533T3 (en)
FI (1) FI117888B (en)
HU (1) HU221848B1 (en)
IL (1) IL112659A (en)
MX (1) MX9603314A (en)
MY (1) MY115339A (en)
NO (1) NO314712B1 (en)
NZ (1) NZ279822A (en)
PL (1) PL178505B1 (en)
PT (1) PT744946E (en)
RU (1) RU2137473C1 (en)
SG (1) SG47487A1 (en)
SI (1) SI0744946T1 (en)
SK (1) SK283250B6 (en)
TW (1) TW355683B (en)
WO (1) WO1995022325A1 (en)
ZA (1) ZA951294B (en)

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AR016827A1 (en) 1997-08-22 2001-08-01 Smithkline Beecham Corp PROCEDURE FOR THE PREPARATION OF A PHARMACEUTICAL TABLET
AR017512A1 (en) * 1997-08-22 2001-09-12 Smithkline Beecham Corp TABLETS OF QUICKLY DISPOSABLE METILCELLULOSE FOR ORAL ROUTE ADMINISTRATION AND PROCEDURE TO PREPARE THEM
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JP2004528337A (en) * 2001-05-02 2004-09-16 ニトロメド インコーポレーテッド Nitrosated and nitrosylated nebivolol, and metabolites, compositions, and methods of use
US7803838B2 (en) * 2004-06-04 2010-09-28 Forest Laboratories Holdings Limited Compositions comprising nebivolol
EP1737847B1 (en) 2004-07-30 2008-06-04 Torrent Pharmaceuticals Ltd Nebivolol and its pharmaceutically acceptable salts, process for preparation and pharmaceutical compositions of nebivolol
EP1776354B1 (en) * 2004-08-11 2010-04-21 Hetero Drugs Limited A novel process for preparation of nebivolol intermediates
US7344907B2 (en) * 2004-11-19 2008-03-18 International Business Machines Corporation Apparatus and methods for encapsulating microelectromechanical (MEM) devices on a wafer scale
NZ560386A (en) * 2005-01-31 2009-12-24 Mylan Lab Inc Pharmaceutical composition comprising hydroxylated nebivolol
WO2006084684A1 (en) * 2005-02-11 2006-08-17 Stada Arzneimittel Ag Pharmaceutical compositions comprising nebivolol and a hydrophilic polymer
US7560575B2 (en) * 2005-12-28 2009-07-14 Acino Pharma Ag Process for preparation of racemic Nebivolol
EP1803716B1 (en) * 2005-12-28 2012-07-25 Acino Pharma AG A process for preparation of racemic nebivolol
EP1973895A1 (en) * 2006-01-18 2008-10-01 Hetero Drugs Limited Process for isolation of desired isomers of nebivolol intermediates
EP1839658A1 (en) * 2006-03-30 2007-10-03 Hexal A/S Pharmaceutical composition comprising micronized nebivolol
DE102006036579A1 (en) * 2006-08-04 2008-02-07 Alfred E. Tiefenbacher Gmbh & Co.Kg Composition, useful to treat hypertension, comprises nebivolol as active agent and a polymer carrier material, where the active agent is present in micronized form in a polymer carrier matrix and is essentially free of wetting agent
EP1886674B1 (en) * 2006-08-04 2010-03-31 Alfred, E. Tiefenbacher Gmbh & Co. Kg Pharmaceutical composition comprising nebivolol
UA97813C2 (en) * 2006-12-05 2012-03-26 Янссен Фармацевтика Н.В. Fumarate salt of (alpha s, beta r)-6-bromo-alpha-[2-(dimethylamino)ethyl]-2-methoxy-alpha-1-naphthalenyl-beta-phenyl-3-quinolineethanol
US20100137424A1 (en) * 2007-01-22 2010-06-03 Mostafa Akbarieh Pharmaceutical compositions comprising nebivolol or a nebivolol analogue
WO2009004649A2 (en) * 2007-05-21 2009-01-08 Sun Pharmaceutical Industries Limited Enteric coated pharmaceutical compositions
US20090030071A1 (en) * 2007-07-26 2009-01-29 Shaw Andrew A Treatment of Cardiovascular Disease in Mexican Americans Using Nebivolol
CN101463024B (en) 2007-12-21 2011-06-08 上海现代制药股份有限公司 Method for preparing RRRS and SSSR type nebivolol intermediate mixture
US20090181975A1 (en) * 2008-01-15 2009-07-16 Forest Laboratories Holdings Limited Nebivolol in the treatment of sexual dysfunction
ATE533752T1 (en) 2008-09-08 2011-12-15 Cadila Pharmaceuticals Ltd IMPROVED MANUFACTURING PROCESS FOR NEBIVOLOL HYDROCHOLORIDE
IT1395354B1 (en) 2009-07-23 2012-09-14 Zach System Spa NEBIVOLOL PREPARATION PROCESS
IT1397962B1 (en) 2010-02-11 2013-02-04 Menarini Int Operations Lu Sa PROCESS FOR NEBIVOLOL PREPARATION.
KR20110130872A (en) * 2010-05-28 2011-12-06 현대약품 주식회사 Pharmaceutical composition comprising crystalline nebivolol hydrochloride and method for manufacturing the same
WO2012003181A2 (en) * 2010-07-02 2012-01-05 Fmc Corporation Solid forms
CN105085499B (en) * 2015-08-07 2018-09-25 上海现代制药海门有限公司 The Crystallization Separation method of nebivolol hydrochloric acid intermediate mixture
JP7525264B2 (en) * 2017-04-28 2024-07-30 リベルタス バイオ，インコーポレイティド Formulations, methods, kits, and dosage forms for treating atopic dermatitis and improving the stability of drug substances
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