HRP20161153T1 - Farmaceutski pripravak koji sadrži aspirin i bisoprolol - Google Patents
Farmaceutski pripravak koji sadrži aspirin i bisoprolol Download PDFInfo
- Publication number
- HRP20161153T1 HRP20161153T1 HRP20161153TT HRP20161153T HRP20161153T1 HR P20161153 T1 HRP20161153 T1 HR P20161153T1 HR P20161153T T HRP20161153T T HR P20161153TT HR P20161153 T HRP20161153 T HR P20161153T HR P20161153 T1 HRP20161153 T1 HR P20161153T1
- Authority
- HR
- Croatia
- Prior art keywords
- capsule
- aspirin
- pharmaceutical
- months
- bisoprolol
- Prior art date
Links
- BSYNRYMUTXBXSQ-UHFFFAOYSA-N Aspirin Chemical compound CC(=O)OC1=CC=CC=C1C(O)=O BSYNRYMUTXBXSQ-UHFFFAOYSA-N 0.000 title claims 12
- 229960001138 acetylsalicylic acid Drugs 0.000 title claims 12
- 229960002781 bisoprolol Drugs 0.000 title claims 4
- VHYCDWMUTMEGQY-UHFFFAOYSA-N bisoprolol Chemical compound CC(C)NCC(O)COC1=CC=C(COCCOC(C)C)C=C1 VHYCDWMUTMEGQY-UHFFFAOYSA-N 0.000 title claims 4
- 239000008194 pharmaceutical composition Substances 0.000 title 1
- 239000002775 capsule Substances 0.000 claims 27
- RZPZLFIUFMNCLY-WLHGVMLRSA-N (e)-but-2-enedioic acid;1-(propan-2-ylamino)-3-[4-(2-propan-2-yloxyethoxymethyl)phenoxy]propan-2-ol Chemical compound OC(=O)\C=C\C(O)=O.CC(C)NCC(O)COC1=CC=C(COCCOC(C)C)C=C1 RZPZLFIUFMNCLY-WLHGVMLRSA-N 0.000 claims 8
- 229960005400 bisoprolol fumarate Drugs 0.000 claims 8
- 239000007963 capsule composition Substances 0.000 claims 4
- 239000012535 impurity Substances 0.000 claims 4
- 239000004480 active ingredient Substances 0.000 claims 3
- 230000003993 interaction Effects 0.000 claims 2
- 230000004888 barrier function Effects 0.000 claims 1
- 239000013060 biological fluid Substances 0.000 claims 1
- 239000002245 particle Substances 0.000 claims 1
- 239000000546 pharmaceutical excipient Substances 0.000 claims 1
- 239000000126 substance Substances 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
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/138—Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine
-
- 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
- A61K31/612—Salicylic acid; Derivatives thereof having the hydroxy group in position 2 esterified, e.g. salicylsulfuric acid
- A61K31/616—Salicylic acid; Derivatives thereof having the hydroxy group in position 2 esterified, e.g. salicylsulfuric acid by carboxylic acids, e.g. acetylsalicylic acid
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
-
- 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)
- Public Health (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Heart & Thoracic Surgery (AREA)
- Cardiology (AREA)
- Diabetes (AREA)
- Hematology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Claims (16)
1. Farmaceutska kapsula koja sadrži samo dva farmaceutski aktivna sastojka, naznačena time što kapsula sadrži:
tabletu koja sadrži aspirin kao prvi farmaceutski aktivni sastojak; i
bisoprolol fumarat sa veličinom čestica kontroliranom do 90% < 425 µm, kao drugi farmaceutski aktivni sastojak, koji je pomiješan sa inertnim ekscipijensima i koji okružuje tabletu;
pri čemu kapsula sadrži od 50 mg do 125 mg aspirina i od 1.25 mg do 15 mg bisoprolol fumarata;
pri čemu je tableta aspirina obložena slojem barijere da se spriječi kemijska interakcija između aspirina i bisoprolol fumarata i da se spriječi interakcija između aspirina i vlage u kapsuli; i
pri čemu se aspirin može oslobađati iz kapsule u biološke tekućine da se osigura maksimalna koncentracija prije maksimalne koncentracije bisoprolola.
2. Farmaceutska kapsula parema patentnom zahtjevu 1, naznačena time što se aspirin neposredno oslobađa iz kapsule tako da osigurava maksimalnu koncentraciju u roku od 2 sata.
3. Farmaceutska kapsula prema patentnom zahtjevu 1 ili 2, naznačena time što se bisoprolol neposredno oslobađa iz kapsule tako da osigurava maksimalnu koncentraciju bisoprolola u roku od 4 sata.
4. Farmaceutska formulacija kapsule prema bilo kojem od patentnih zahtjeva 1 do 3, naznačena time što kada je kapsula čuvana na 25°C i 60% relativne vlažnosti u trajanju od 1 mjesec, koncentracija svake pojedinačne nečistoće nije veća od 0.3% tež./tež.
5. Farmaceutska formulacija kapsule prema patentnom zahtjevu 4, naznačena time što se kapsula čuva na 25°C i 60% relativne vlažnosti u trajanju od 3 mjeseca, ili 6 mjeseci, ili 12 mjeseci, ili do 24 mjeseca, koncentracija svake pojedinačne nečistoće nije veća od 0.3% tež./tež.
6. Farmaceutska formulacija kapsule prema bilo kojem od patentnih zahtjeva 1 do 5, naznačena time što, kada se kapsula čuva na 25°C i 60% relativne vlažnosti u trajanju od 1 mjeseca, koncentracija bilo koje pojedinačne nečistoće nije veća od 0.2% tež/tež.
7. Farmaceutska formulacija kapsule prema patentnom zahtjevu 6, naznačena time što, kada se kapsula čuva na 25°C i 60% relativne vlažnosti u trajanju od 3 mjeseca, ili 6 mjeseci, ili 12 mjeseci, ili do 24 mjeseca, koncentracija bilo koje pojedinačne nečistoće nije veća od 0.2% tež./tež.
8. Farmaceutska kapsula prema bilo kojem od patentnih zahtjeva 1 do 7, naznačena time što tableta sadrži od 75 do 110 mg aspirina.
9. Kapsula prema bilo kojem od patentnih zahtjeva 1 do 8, naznačena time što tableta sadrži približno 75 mg aspirina.
10. Kapsula prema bilo kojem od patentnih zahtjeva 1 do 8, naznačena time što tableta sadrži približno 100 mg aspirina.
11. Kapsula prema bilo kojem od patentnih zahtjeva 1 do 8, naznačena time što tableta sadrži približno 82 mg aspirina.
12. Kapsula prema bilo kojem od patentnih zahtjeva 1 do 11, naznačena time što kapsula sadrži približno 5 mg bisoprolol fumarata.
13. Kapsula prema bilo kojem od patentnih zahtjeva 1 do 11, naznačena time što kapsula sadrži približno 10 mg bisoprolol fumarata.
14. Kapsula prema bilo kojem od patentnih zahtjeva 1 do 11, naznačena time što kapsula sadrži približno 1.25 mg bisoprolol fumarata.
15. Kapsula prema bilo kojem od patentnih zahtjeva 1 do 11, naznačena time što kapsula sadrži približno 3.75 mg bisoprolol fumarata.
16. Kapsula prema bilo kojem od patentnih zahtjeva 1 do 11, naznačena time što kapsula sadrži približno 2. 5 mg bisoprolol fumarata.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US33191610P | 2010-05-06 | 2010-05-06 | |
| EP14199791.6A EP2857014B1 (en) | 2010-05-06 | 2011-05-05 | A pharmaceutical composition comprising aspirin and bisoprolol |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20161153T1 true HRP20161153T1 (hr) | 2016-11-18 |
Family
ID=44246384
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20150125AT HRP20150125T1 (hr) | 2010-05-06 | 2015-02-02 | Farmaceutski oblik koji sadrži aspirin i bisoprolol |
| HRP20161153TT HRP20161153T1 (hr) | 2010-05-06 | 2016-09-07 | Farmaceutski pripravak koji sadrži aspirin i bisoprolol |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20150125AT HRP20150125T1 (hr) | 2010-05-06 | 2015-02-02 | Farmaceutski oblik koji sadrži aspirin i bisoprolol |
Country Status (11)
| Country | Link |
|---|---|
| EP (2) | EP2857014B1 (hr) |
| EA (2) | EA026163B1 (hr) |
| ES (2) | ES2528119T3 (hr) |
| HR (2) | HRP20150125T1 (hr) |
| HU (1) | HUE029647T2 (hr) |
| PL (2) | PL2566472T3 (hr) |
| PT (1) | PT2566472E (hr) |
| RS (2) | RS55064B1 (hr) |
| SI (2) | SI2566472T1 (hr) |
| UA (1) | UA109895C2 (hr) |
| WO (1) | WO2011138772A1 (hr) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FR3027803B1 (fr) | 2014-11-05 | 2018-02-09 | Les Laboratoires Servier | Composition pharmaceutique comprenant un betabloquant et un inhibiteur de l'enzyme de conversion |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| PL2120878T3 (pl) * | 2007-02-09 | 2015-01-30 | Alphapharm Pty Ltd | Postać dawkowania zawierająca dwa czynne składniki farmaceutyczne o różnych postaciach fizycznych |
-
2011
- 2011-05-05 UA UAA201210668A patent/UA109895C2/uk unknown
- 2011-05-05 WO PCT/IE2011/000027 patent/WO2011138772A1/en active Application Filing
- 2011-05-05 EP EP14199791.6A patent/EP2857014B1/en active Active
- 2011-05-05 EA EA201290776A patent/EA026163B1/ru not_active IP Right Cessation
- 2011-05-05 RS RS20160698A patent/RS55064B1/sr unknown
- 2011-05-05 PL PL11720589T patent/PL2566472T3/pl unknown
- 2011-05-05 EA EA201691986A patent/EA201691986A1/ru unknown
- 2011-05-05 PL PL14199791.6T patent/PL2857014T3/pl unknown
- 2011-05-05 SI SI201130407T patent/SI2566472T1/sl unknown
- 2011-05-05 RS RS20150136A patent/RS53846B1/en unknown
- 2011-05-05 PT PT11720589T patent/PT2566472E/pt unknown
- 2011-05-05 ES ES11720589.8T patent/ES2528119T3/es active Active
- 2011-05-05 ES ES14199791.6T patent/ES2581158T3/es active Active
- 2011-05-05 SI SI201130911A patent/SI2857014T1/sl unknown
- 2011-05-05 HU HUE14199791A patent/HUE029647T2/en unknown
- 2011-05-05 EP EP11720589.8A patent/EP2566472B1/en active Active
-
2015
- 2015-02-02 HR HRP20150125AT patent/HRP20150125T1/hr unknown
-
2016
- 2016-09-07 HR HRP20161153TT patent/HRP20161153T1/hr unknown
Also Published As
| Publication number | Publication date |
|---|---|
| UA109895C2 (uk) | 2015-10-26 |
| WO2011138772A1 (en) | 2011-11-10 |
| EP2857014A1 (en) | 2015-04-08 |
| SI2566472T1 (sl) | 2015-04-30 |
| EP2857014B1 (en) | 2016-06-22 |
| PL2857014T3 (pl) | 2016-12-30 |
| EA201691986A1 (ru) | 2017-03-31 |
| PL2566472T3 (pl) | 2015-06-30 |
| EP2566472A1 (en) | 2013-03-13 |
| ES2528119T3 (es) | 2015-02-04 |
| RS53846B1 (en) | 2015-08-31 |
| RS55064B1 (sr) | 2016-12-30 |
| SI2857014T1 (sl) | 2016-09-30 |
| HRP20150125T1 (hr) | 2015-03-27 |
| HUE029647T2 (en) | 2017-03-28 |
| EA026163B1 (ru) | 2017-03-31 |
| EP2566472B1 (en) | 2015-01-07 |
| ES2581158T3 (es) | 2016-09-01 |
| PT2566472E (pt) | 2015-03-04 |
| EA201290776A1 (ru) | 2013-04-30 |
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| HRP20161153T1 (hr) | Farmaceutski pripravak koji sadrži aspirin i bisoprolol |