HRP20201808T1 - Tableta s enteričkim premazom - Google Patents
Tableta s enteričkim premazom Download PDFInfo
- Publication number
- HRP20201808T1 HRP20201808T1 HRP20201808TT HRP20201808T HRP20201808T1 HR P20201808 T1 HRP20201808 T1 HR P20201808T1 HR P20201808T T HRP20201808T T HR P20201808TT HR P20201808 T HRP20201808 T HR P20201808T HR P20201808 T1 HRP20201808 T1 HR P20201808T1
- Authority
- HR
- Croatia
- Prior art keywords
- enteric
- coated tablet
- coating
- tablet according
- polymer
- Prior art date
Links
- 239000002662 enteric coated tablet Substances 0.000 title claims 11
- 239000004615 ingredient Substances 0.000 claims 5
- 229920001688 coating polymer Polymers 0.000 claims 4
- 229920003169 water-soluble polymer Polymers 0.000 claims 4
- 239000011248 coating agent Substances 0.000 claims 3
- 239000011247 coating layer Substances 0.000 claims 3
- 238000000576 coating method Methods 0.000 claims 3
- 239000003826 tablet Substances 0.000 claims 3
- 239000003814 drug Substances 0.000 claims 2
- 239000002702 enteric coating Substances 0.000 claims 2
- 238000009505 enteric coating Methods 0.000 claims 2
- 229920000642 polymer Polymers 0.000 claims 2
- 229940124597 therapeutic agent Drugs 0.000 claims 2
- 208000019399 Colonic disease Diseases 0.000 claims 1
- 208000022559 Inflammatory bowel disease Diseases 0.000 claims 1
- 229920003086 cellulose ether Polymers 0.000 claims 1
- KBOPZPXVLCULAV-UHFFFAOYSA-N mesalamine Chemical group NC1=CC=C(O)C(C(O)=O)=C1 KBOPZPXVLCULAV-UHFFFAOYSA-N 0.000 claims 1
- 229960004963 mesalazine Drugs 0.000 claims 1
- 229920003145 methacrylic acid copolymer Polymers 0.000 claims 1
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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/196—Carboxylic acids, e.g. valproic acid having an amino group the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
-
- 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
- A61K31/60—Salicylic acid; Derivatives thereof
- A61K31/606—Salicylic acid; Derivatives thereof having amino groups
-
- 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
- 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
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
-
- 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
- A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
- A61K9/2846—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
- A61K9/28—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
- 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
- A61K9/2886—Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
-
- 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
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Inorganic Chemistry (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Claims (10)
1. Tableta s enteričkim premazom, naznačena time, da (A) jezgra tablete sadržava ljekoviti sastojak i ima težinu od 1 000 mg ili više; (B) sloj za oblaganje koji sadržava vodotopivi polimer nanesen na površinu jezgre tablete, pri čemu vodotopivi polimerni sloj za oblaganje (B) nema enteričku otpornost; i (C) enterički premaz koji se otapa pri pH 7 ili više, koji se nanosi na površinu sloja premaza koji sadržava polimer topiv u vodi, pri čemu je zbroj količine polimera premaza (B) i količine polimera premaza (C) 10 do 18 mg / cm2, količina polimera premaza (B) je 6 do 12 mg / cm2, a količina polimera premaza (C) je 3 do 6 mg / cm2.
2. Tableta s enteričkim premazom u skladu s patentnim zahtjevom 1, naznačena time, da jezgra tablete (A) ima težinu od 1 000 do 1 500 mg.
3. Tableta s enteričkim premazom u skladu s patentnim zahtjevom 1 ili 2, naznačena time, da sadržava ljekoviti sastojak od 700 do 1 300 mg.
4. Tableta s enteričkim premazom u skladu s bilo kojim od patentnih zahtjeva 1 do 3, naznačena time, da je polimer topiv u vodi jedan ili više elemenata odabranih iz skupine koja se sastoji od vodotopivih celuloznih etera.
5. Tableta s enteričkim premazom u skladu s bilo kojim od patentnih zahtjeva 1 do 4, naznačena time, da je enterički premaz koji se otapa pri pH 7 ili više premaz koji formira jedan ili više polimera odabranih iz skupine koja se sastoji od kopolimera metakrilne kiseline.
6. Tableta s enteričkim premazom u skladu s bilo kojim od patentnih zahtjeva 1 do 5, naznačena time, da ima ukupnu težinu od 1.200 do 1.600 mg.
7. Tableta s enteričkim premazom u skladu s bilo kojim od patentnih zahtjeva 1 do 6, naznačena time, da je ljekoviti sastojak terapijsko sredstvo za bolest debelog crijeva.
8. Tableta s enteričkim premazom u skladu s bilo kojim od patentnih zahtjeva 1 do 6, naznačena time, da je ljekoviti sastojak terapijsko sredstvo za upalnu bolest crijeva.
9. Tableta s enteričkim premazom u skladu s bilo kojim od patentnih zahtjeva 1 do 6, naznačena time, da je ljekoviti sastojak 5-aminosalicilna kiselina.
10. Tableta s enteričkim premazom u skladu s bilo kojim od patentnih zahtjeva 1 do 9, naznačena time, da je omjer polimerne mase (B / C) premaza (B) i premaza (C) od 1,0 do 2,5.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2013032759 | 2013-02-22 | ||
| EP14754975.2A EP2959892B1 (en) | 2013-02-22 | 2014-02-21 | Enteric coated tablet |
| PCT/JP2014/054104 WO2014129568A1 (ja) | 2013-02-22 | 2014-02-21 | 腸溶錠 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20201808T1 true HRP20201808T1 (hr) | 2021-01-08 |
Family
ID=51391349
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20201808TT HRP20201808T1 (hr) | 2013-02-22 | 2020-11-12 | Tableta s enteričkim premazom |
Country Status (25)
| Country | Link |
|---|---|
| US (4) | US20150374632A1 (hr) |
| EP (1) | EP2959892B1 (hr) |
| JP (1) | JP6237760B2 (hr) |
| KR (1) | KR102167265B1 (hr) |
| CN (1) | CN105025888B (hr) |
| AU (1) | AU2014219726B2 (hr) |
| BR (1) | BR112015020237B1 (hr) |
| CA (1) | CA2901166C (hr) |
| CY (1) | CY1123908T1 (hr) |
| DK (1) | DK2959892T3 (hr) |
| ES (1) | ES2821766T3 (hr) |
| HR (1) | HRP20201808T1 (hr) |
| HU (1) | HUE052167T2 (hr) |
| IL (1) | IL240575B (hr) |
| LT (1) | LT2959892T (hr) |
| MX (1) | MX369967B (hr) |
| NZ (1) | NZ711201A (hr) |
| PT (1) | PT2959892T (hr) |
| RS (1) | RS61099B1 (hr) |
| RU (1) | RU2675844C2 (hr) |
| SG (1) | SG11201506653WA (hr) |
| SI (1) | SI2959892T1 (hr) |
| TW (1) | TWI688411B (hr) |
| WO (1) | WO2014129568A1 (hr) |
| ZA (1) | ZA201506585B (hr) |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CA2990578C (en) | 2015-06-30 | 2023-09-26 | National University Corporation Okayama University | Drug for preventing or treating inflammatory bowel disease |
| EP3162362A1 (de) * | 2015-10-30 | 2017-05-03 | Dr. Falk Pharma Gmbh | Optimierte mesalazinhaltige hochdosistablette |
| CN106511277A (zh) * | 2016-11-22 | 2017-03-22 | 吉林省博大伟业制药有限公司 | 一种聚普瑞锌颗粒剂及其制备方法 |
| US10098898B1 (en) | 2017-12-04 | 2018-10-16 | Handa Pharmaceuticals, Llc | Release stable mesalamine dosage forms |
| EP3662898A1 (en) * | 2018-12-07 | 2020-06-10 | Tillotts Pharma AG | Solid composition comprising mesalazine |
Family Cites Families (18)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS58109413A (ja) * | 1981-12-23 | 1983-06-29 | Eisai Co Ltd | 耐衝撃性腸溶錠 |
| US5914132A (en) | 1993-02-26 | 1999-06-22 | The Procter & Gamble Company | Pharmaceutical dosage form with multiple enteric polymer coatings for colonic delivery |
| ITMI991316A1 (it) * | 1999-06-14 | 2000-12-14 | Cip Ninety Two 92 S A | Composizioni farmaceutiche orali a rilascio modificato di mesalazina |
| DE10013029A1 (de) * | 2000-03-17 | 2001-09-20 | Roehm Gmbh | Mehrschichtige Arzneiform für die Colonfreigabe |
| US20020028240A1 (en) * | 2000-04-17 | 2002-03-07 | Toyohiro Sawada | Timed-release compression-coated solid composition for oral administration |
| BRPI0117180B8 (pt) | 2001-11-23 | 2021-05-25 | Procter & Gamble | composição farmacêutica em uma forma de unidade sólida de dosagem para a administração oral a um ser humano ou animal inferior |
| CA2514879C (en) * | 2003-01-03 | 2014-09-16 | Shire Laboratories Inc. | Two or more enteric materials to regulate drug release |
| RU2375048C2 (ru) * | 2003-07-17 | 2009-12-10 | Д-Р Редди'С Лабораторис Инк. | Фармацевтическая композиция с набухающим покрытием |
| MY147202A (en) | 2003-11-26 | 2012-11-14 | Novartis Ag | Compositions comprising organic compounds |
| DE102006035549A1 (de) * | 2006-07-27 | 2008-01-31 | Evonik Röhm Gmbh | Arzneiform mit mindestens zweischichtiger Trennschicht |
| WO2008135090A1 (en) * | 2007-05-07 | 2008-11-13 | Evonik Röhm Gmbh | Solid dosage forms comprising an enteric coating with accelerated drug release |
| JP2011500553A (ja) * | 2007-10-10 | 2011-01-06 | ルピン・リミテッド | ５−アミノサリチル酸またはその塩もしくは代謝産物の新規な結腸を標的とする調節放出性生体接着性製剤 |
| US20090162434A1 (en) | 2007-12-21 | 2009-06-25 | Disphar International Bv | Mesalazine tablet |
| US8329208B2 (en) * | 2009-07-28 | 2012-12-11 | Methylation Sciences International Srl | Pharmacokinetics of S-adenosylmethionine formulations |
| CN101732280B (zh) * | 2009-10-23 | 2012-04-18 | 天津力生制药股份有限公司 | 一种结肠定位释药的口服制剂 |
| EP2425826A1 (en) | 2010-09-01 | 2012-03-07 | Disphar International B.V. | Mesalazine tablet having improved dissolution |
| EP2468264A1 (en) * | 2010-12-27 | 2012-06-27 | Laboratorios Liconsa, S.A. | Oral pharmaceutical tablet for controled release of mesalazine and process for obtaining it |
| ES2655622T3 (es) * | 2012-04-30 | 2018-02-20 | Tillotts Pharma Ag | Una formulación de fármaco de liberación retardada |
-
2014
- 2014-02-21 US US14/769,660 patent/US20150374632A1/en not_active Abandoned
- 2014-02-21 AU AU2014219726A patent/AU2014219726B2/en active Active
- 2014-02-21 WO PCT/JP2014/054104 patent/WO2014129568A1/ja active Application Filing
- 2014-02-21 HU HUE14754975A patent/HUE052167T2/hu unknown
- 2014-02-21 SG SG11201506653WA patent/SG11201506653WA/en unknown
- 2014-02-21 CA CA2901166A patent/CA2901166C/en active Active
- 2014-02-21 NZ NZ71120114A patent/NZ711201A/en unknown
- 2014-02-21 SI SI201431710T patent/SI2959892T1/sl unknown
- 2014-02-21 KR KR1020157022571A patent/KR102167265B1/ko active IP Right Grant
- 2014-02-21 BR BR112015020237-3A patent/BR112015020237B1/pt not_active IP Right Cessation
- 2014-02-21 JP JP2015501510A patent/JP6237760B2/ja active Active
- 2014-02-21 ES ES14754975T patent/ES2821766T3/es active Active
- 2014-02-21 MX MX2015010871A patent/MX369967B/es active IP Right Grant
- 2014-02-21 LT LTEP14754975.2T patent/LT2959892T/lt unknown
- 2014-02-21 PT PT147549752T patent/PT2959892T/pt unknown
- 2014-02-21 CN CN201480009951.3A patent/CN105025888B/zh active Active
- 2014-02-21 EP EP14754975.2A patent/EP2959892B1/en active Active
- 2014-02-21 RU RU2015140119A patent/RU2675844C2/ru active
- 2014-02-21 DK DK14754975.2T patent/DK2959892T3/da active
- 2014-02-21 RS RS20201388A patent/RS61099B1/sr unknown
- 2014-02-21 TW TW103105940A patent/TWI688411B/zh active
-
2015
- 2015-08-13 IL IL240575A patent/IL240575B/en active IP Right Grant
- 2015-09-07 ZA ZA2015/06585A patent/ZA201506585B/en unknown
-
2018
- 2018-09-20 US US16/136,377 patent/US20190015345A1/en not_active Abandoned
-
2020
- 2020-11-12 HR HRP20201808TT patent/HRP20201808T1/hr unknown
- 2020-12-08 CY CY20201101162T patent/CY1123908T1/el unknown
- 2020-12-11 US US17/118,824 patent/US20210093577A1/en not_active Abandoned
-
2023
- 2023-08-01 US US18/363,001 patent/US20230372250A1/en active Pending
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