HRP20130033T1 - Kruti farmaceutski pripravak koji sadrži valsartan - Google Patents

Kruti farmaceutski pripravak koji sadrži valsartan Download PDF

Info

Publication number
HRP20130033T1
HRP20130033T1 HRP20130033TT HRP20130033T HRP20130033T1 HR P20130033 T1 HRP20130033 T1 HR P20130033T1 HR P20130033T T HRP20130033T T HR P20130033TT HR P20130033 T HRP20130033 T HR P20130033T HR P20130033 T1 HRP20130033 T1 HR P20130033T1
Authority
HR
Croatia
Prior art keywords
valsartan
mixture
compressing
pharmaceutical composition
particles
Prior art date
Application number
HRP20130033TT
Other languages
English (en)
Inventor
Miha Vrbinc
Janika Slanc Vovk
Marija Rangus
Silvo Zupancic
Franci Bevec
Lidija Cernosa
Original Assignee
Krka, Tovarna Zdravil D.D., Novo Mesto
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=35966966&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HRP20130033(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority claimed from EP04030782A external-priority patent/EP1674080A1/en
Application filed by Krka, Tovarna Zdravil D.D., Novo Mesto filed Critical Krka, Tovarna Zdravil D.D., Novo Mesto
Publication of HRP20130033T1 publication Critical patent/HRP20130033T1/hr

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
    • 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
    • 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
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/2072—Pills, 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
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • 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
    • A61K9/2072—Pills, 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
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Cardiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Claims (5)

1. Postupak priprave farmaceutskog pripravka koji sadrži valsartan, naznačen time, da obuhvaća sljedeće korake: - dobava čestica valsartana najvećeg promjera 1 100 pm - granuliranje smjese valsartana i ekscipijensa uporabom vode ili vodene disperzije kao tekućine za granuliranje kako bi se dobio granulat - dodavanje daljnjih ekscipijensa u navedeni granulat kako bi se dobila smjesa za komprimiranje - komprimiranje smjese za komprimiranje u željeni oblik te - po izboru, nanošenje premaza, pri čemu smjesa sadrži umreženu natrijevu karboksimetil celulozu s ekscipijensom.
2. Postupak u skladu s patentnim zahtjevom 1, naznačen time, da je tlak kompresije u fazi kompresije 25 kN ili manji.
3. Postupak u skladu s patentnim zahtjevom 1 or 2, naznačen time, da je vrijednost D5o čestica valsartana 150 pm ili manja.
4. Postupak u skladu s patentnim zahtjevom 3, naznačen time, da najmanje 20 % čestica valsartana ima promjer u rasponu od 0,02 do 50 pm.
5. Farmaceutski pripravak koji sadrži valsartan, naznačen time, da se dobiva postupkom u skladu s jednim od patentnih zahtjeva 1-4.
HRP20130033TT 2004-12-24 2013-01-16 Kruti farmaceutski pripravak koji sadrži valsartan HRP20130033T1 (hr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP04030782A EP1674080A1 (en) 2004-12-24 2004-12-24 Solid pharmaceutical composition comprising valsartan
EP05004433 2005-03-01

Publications (1)

Publication Number Publication Date
HRP20130033T1 true HRP20130033T1 (hr) 2013-02-28

Family

ID=35966966

Family Applications (1)

Application Number Title Priority Date Filing Date
HRP20130033TT HRP20130033T1 (hr) 2004-12-24 2013-01-16 Kruti farmaceutski pripravak koji sadrži valsartan

Country Status (16)

Country Link
US (1) US20080102120A1 (hr)
EP (2) EP2033629B1 (hr)
CN (1) CN101087589B (hr)
AU (1) AU2005318365B2 (hr)
CA (1) CA2592091A1 (hr)
DK (1) DK2033629T3 (hr)
EA (2) EA012392B1 (hr)
ES (1) ES2397552T3 (hr)
HR (1) HRP20130033T1 (hr)
ME (1) ME01453B (hr)
NO (1) NO20073889L (hr)
PL (1) PL2033629T3 (hr)
PT (1) PT2033629E (hr)
RS (1) RS52607B (hr)
SI (1) SI2033629T1 (hr)
WO (1) WO2006066961A1 (hr)

Families Citing this family (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1897537A1 (en) * 2006-09-04 2008-03-12 Novartis AG Composition comprising an angiotensin II receptor antagonist
PE20081364A1 (es) * 2006-09-04 2008-12-04 Novartis Ag Composicion farmaceutica que comprende valsartan
US20080152717A1 (en) * 2006-12-14 2008-06-26 Isp Investments, Inc. Amorphous valsartan and the production thereof
TR200703568A1 (tr) * 2007-05-24 2008-07-21 Sanovel �La� Sanay� Ve T�Caret Anon�M ��Rket� Valsartan formülasyonları
GB0715628D0 (en) * 2007-08-10 2007-09-19 Generics Uk Ltd Solid valsartan composition
WO2009113091A2 (en) * 2008-01-24 2009-09-17 Usv Limited Pharmaceutical compositions comprising valsartan
EP2405899A2 (en) * 2009-03-11 2012-01-18 Sanovel Ilaç Sanayi Ve Ticaret Anonim Sirketi Valsartan formulations
SI2536396T1 (sl) 2010-02-16 2017-01-31 KRKA, tovarna zdravil, d.d.,Novo mesto Postopek za pripravo oralnih trdnih odmernih oblik, ki obsegajo valsartan
CN102119912A (zh) * 2011-01-25 2011-07-13 南京白敬宇制药有限责任公司 一种非水溶性药物缓释制剂的制备方法
CN102204907A (zh) * 2011-03-31 2011-10-05 北京赛科药业有限责任公司 一种含缬沙坦的药物组合物及其制备方法
WO2013098578A1 (en) 2011-12-31 2013-07-04 Abdi Ibrahim Ilac Sanayi Ve Ticaret Anonim Sirketi Immediate release pharmaceutical composition of valsartan hydrochlorothiazide
WO2013098576A1 (en) 2011-12-31 2013-07-04 Abdi Ibrahim Ilac Sanayi Ve Ticaret Anonim Sirketi Immediate release pharmaceutical composition of valsartan
CN103599084B (zh) * 2013-11-22 2018-10-30 威海迪素制药有限公司 一种降压组合物
KR101545268B1 (ko) * 2015-02-05 2015-08-20 보령제약 주식회사 정제 및 이의 제조방법
CN104887640B (zh) * 2015-06-30 2017-12-19 昆明医科大学 一种含有缬沙坦的固体药物组合物
US20210267908A1 (en) * 2020-03-02 2021-09-02 Mankind Pharma Ltd. Pharmaceutical compositions of rivaroxaban
CN112098408B (zh) * 2020-09-14 2022-12-09 湖北亿纬动力有限公司 一种羧甲基纤维素钠溶解效果的检测方法及应用

Family Cites Families (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE59107440D1 (de) * 1990-02-19 1996-04-04 Ciba Geigy Ag Acylverbindungen
GB9613470D0 (en) 1996-06-27 1996-08-28 Ciba Geigy Ag Small solid oral dosage form
TR200805275T2 (tr) 1998-12-23 2008-09-22 Novartis Ag AT-1 veya AT-2 reseptörlerindeki artışın neden olduğu hastalıkların tedavisi için AT-1 reseptör antagonisti veya AT-2 reseptör modülatörünün kullanımı@
US6294192B1 (en) * 1999-02-26 2001-09-25 Lipocine, Inc. Triglyceride-free compositions and methods for improved delivery of hydrophobic therapeutic agents
US6211217B1 (en) * 1999-03-16 2001-04-03 Novartis Ag Method for reducing pericardial fibrosis and adhesion formation
US20030236236A1 (en) * 1999-06-30 2003-12-25 Feng-Jing Chen Pharmaceutical compositions and dosage forms for administration of hydrophobic drugs
JP2003530343A (ja) * 2000-04-12 2003-10-14 ノバルティス アクチエンゲゼルシャフト アルドステロンシンターゼインヒビター単体またはａｔ１−レセプターアンタゴニストとの組み合わせの新規医薬使用
US6499984B1 (en) 2000-05-22 2002-12-31 Warner-Lambert Company Continuous production of pharmaceutical granulation
CA2411882C (en) 2000-06-22 2011-09-06 Novartis Ag Solid valsartan pharmaceutical compositions
PE20020613A1 (es) * 2000-07-19 2002-08-07 Novartis Ag Sales de (s)-n-(1-carboxi-2-metil-prop-1-il)-n-pentanoil-n-[2'-(1h-tetrazol-5-il)-bifenil-4-ilmetil]-amina como antagonista del receptor at1
US20030152622A1 (en) * 2001-10-25 2003-08-14 Jenny Louie-Helm Formulation of an erodible, gastric retentive oral diuretic
NZ533968A (en) * 2002-01-17 2006-10-27 Novartis Ag Pharmaceutical compositions comprising valsartan and nep inhibitors
AU2003294883A1 (en) 2002-12-18 2004-07-09 Novartis Ag Combinations of valsartan with cox-2 inhibitors
DE602004013405T2 (de) 2003-03-17 2009-05-07 Teva Pharmaceutical Industries Ltd. Polymorphe formen von valsartan
WO2004094391A2 (en) 2003-04-21 2004-11-04 Teva Pharmaceutical Industries Ltd. Process for the preparation of valsartan and intermediates thereof
US7378531B2 (en) * 2003-04-21 2008-05-27 Teva Pharmaceutical Industries Ltd Process for the preparation of valsartan
US7915247B1 (en) * 2006-08-21 2011-03-29 Mutual Pharmaceutical Company, Inc. Methods of use of fenofibric acid

Also Published As

Publication number Publication date
RS52607B (en) 2013-04-30
AU2005318365A1 (en) 2006-06-29
CN101087589B (zh) 2013-01-30
EP2033629B1 (en) 2012-11-14
CA2592091A1 (en) 2006-06-29
EP2033629A1 (en) 2009-03-11
WO2006066961A1 (en) 2006-06-29
EA012392B1 (ru) 2009-10-30
US20080102120A1 (en) 2008-05-01
PT2033629E (pt) 2013-01-24
ME01453B (me) 2014-04-20
CN101087589A (zh) 2007-12-12
ES2397552T3 (es) 2013-03-07
PL2033629T3 (pl) 2013-04-30
EA015108B1 (ru) 2011-06-30
EP1833464A1 (en) 2007-09-19
EA200701107A1 (ru) 2008-04-28
AU2005318365B2 (en) 2011-02-03
DK2033629T3 (da) 2013-02-04
EA200900646A1 (ru) 2009-10-30
NO20073889L (no) 2007-09-24
SI2033629T1 (sl) 2013-01-31

Similar Documents

Publication Publication Date Title
HRP20130033T1 (hr) Kruti farmaceutski pripravak koji sadrži valsartan
CN1208048C (zh) 纳米中药饮片及其制备方法
HK1072359A1 (en) Pharmaceutical composition comprising N-((1-N-butyl-4-piperidinyl)menthyl)-3,4-dihydro-2H-(1,3)oxazino(3,2-A)indole-10carboxamide or salt and process for preparing thereof comprising dry granulation
EP2210591A3 (en) Wet granulation tableting method using aqueous dispersion of low-substituted hydroxypropyl cellulose
CN104523791B (zh) 一种鲜人参活性提取物口崩片及其制备方法
JP2011229440A5 (hr)
RU2010101797A (ru) Фармацевтический твердый препарат, содержащий бензазепины и способ его получения
CN103205329A (zh) 一种金钗石斛香皂
CN104306415B (zh) 一种白芷破壁饮片的制备方法
CN103536538B (zh) 一种有效掩味的膨胀性微丸及其制备方法
ATE329582T1 (de) Herstellung von tabletten von pharmazeutisch aktiven substanzen mit ungünstigen tablettierungseigenschaften mit einer mikrokristalline zellulose enthaltenden granulierflüssigkeit
CA2648667A1 (en) Sustained-release tablet production process
CN106342929A (zh) 花卉杀虫剂及其制备方法
CN101732555A (zh) 一种治疗感冒咳嗽及慢性支气管炎的药
CN108904455A (zh) 一种含有高剂量油酯成分的片剂的制备方法
CN105813822B (zh) 用于连接管的水溶性支撑件、其制备方法及用途
CN106478419B (zh) 从异叶青兰中分离制备迷迭香酸的方法及其应用
CN104523638A (zh) 含有草酸艾司西酞普兰的片剂及其制备方法
KR101462367B1 (ko) 알코올이 포함되지 않은 홍삼 타브렛
KR101832697B1 (ko) 합성 계면활성제를 포함하지 않는 머드 샴푸 조성물
CN102188546B (zh) 一种治疗风热感冒的中药组合物片剂的制备方法
CN106727391A (zh) 一种奥卡西平缓释片及其制备方法
EP2341925A4 (en) THROMBOLYTIC AND ANTI-THROMBOTIC AGENT COMPOSITION AND PRODUCTION METHOD THEREOF
CN101757475A (zh) 一种新雪制剂的制备方法
CN104958695A (zh) 一种解郁顺心片的制备方法