HRP20180103T1 - Farmaceutski oblici za oslobađanje aktivnih spojeva - Google Patents
Farmaceutski oblici za oslobađanje aktivnih spojeva Download PDFInfo
- Publication number
- HRP20180103T1 HRP20180103T1 HRP20180103TT HRP20180103T HRP20180103T1 HR P20180103 T1 HRP20180103 T1 HR P20180103T1 HR P20180103T T HRP20180103T T HR P20180103TT HR P20180103 T HRP20180103 T HR P20180103T HR P20180103 T1 HRP20180103 T1 HR P20180103T1
- Authority
- HR
- Croatia
- Prior art keywords
- pharmaceutical form
- pharmaceutical
- formulation
- ammonia
- proportion
- Prior art date
Links
- 150000001875 compounds Chemical class 0.000 title 1
- QGZKDVFQNNGYKY-UHFFFAOYSA-N Ammonia Chemical group N QGZKDVFQNNGYKY-UHFFFAOYSA-N 0.000 claims 14
- 239000008194 pharmaceutical composition Substances 0.000 claims 7
- 238000009472 formulation Methods 0.000 claims 6
- 239000000203 mixture Substances 0.000 claims 6
- 229910021529 ammonia Inorganic materials 0.000 claims 5
- 229920002683 Glycosaminoglycan Polymers 0.000 claims 4
- QGZKDVFQNNGYKY-UHFFFAOYSA-O ammonium group Chemical group [NH4+] QGZKDVFQNNGYKY-UHFFFAOYSA-O 0.000 claims 3
- 230000001419 dependent effect Effects 0.000 claims 3
- 239000000126 substance Substances 0.000 claims 3
- HTTJABKRGRZYRN-UHFFFAOYSA-N Heparin Chemical compound OC1C(NC(=O)C)C(O)OC(COS(O)(=O)=O)C1OC1C(OS(O)(=O)=O)C(O)C(OC2C(C(OS(O)(=O)=O)C(OC3C(C(O)C(O)C(O3)C(O)=O)OS(O)(=O)=O)C(CO)O2)NS(O)(=O)=O)C(C(O)=O)O1 HTTJABKRGRZYRN-UHFFFAOYSA-N 0.000 claims 2
- 239000000546 pharmaceutical excipient Substances 0.000 claims 2
- NIXOWILDQLNWCW-UHFFFAOYSA-N acrylic acid group Chemical group C(C=C)(=O)O NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 claims 1
- 229960003616 bemiparin Drugs 0.000 claims 1
- 239000000969 carrier Substances 0.000 claims 1
- 150000001768 cations Chemical class 0.000 claims 1
- 229920001577 copolymer Polymers 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 229960000610 enoxaparin Drugs 0.000 claims 1
- KANJSNBRCNMZMV-ABRZTLGGSA-N fondaparinux Chemical compound O[C@@H]1[C@@H](NS(O)(=O)=O)[C@@H](OC)O[C@H](COS(O)(=O)=O)[C@H]1O[C@H]1[C@H](OS(O)(=O)=O)[C@@H](O)[C@H](O[C@@H]2[C@@H]([C@@H](OS(O)(=O)=O)[C@H](O[C@H]3[C@@H]([C@@H](O)[C@H](O[C@@H]4[C@@H]([C@@H](O)[C@H](O)[C@@H](COS(O)(=O)=O)O4)NS(O)(=O)=O)[C@H](O3)C(O)=O)O)[C@@H](COS(O)(=O)=O)O2)NS(O)(=O)=O)[C@H](C(O)=O)O1 KANJSNBRCNMZMV-ABRZTLGGSA-N 0.000 claims 1
- 229960001318 fondaparinux Drugs 0.000 claims 1
- 239000008187 granular material Substances 0.000 claims 1
- 125000005397 methacrylic acid ester group Chemical group 0.000 claims 1
- 239000008185 minitablet Substances 0.000 claims 1
- 239000008188 pellet Substances 0.000 claims 1
- 229920000642 polymer Polymers 0.000 claims 1
- 230000002035 prolonged effect Effects 0.000 claims 1
- 150000003839 salts Chemical class 0.000 claims 1
- 239000003826 tablet Substances 0.000 claims 1
Classifications
-
- 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
-
- 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
- A61K9/2063—Proteins, e.g. gelatin
-
- 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
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Diabetes (AREA)
- Hematology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
Claims (14)
1. Farmaceutski oblik koji se sastoji od glikoziaminoglikana odabranog iz skupine koja se sastoji od: bemiparina, fondaparinuksa i enoksaparina i njihovih farmaceutski prihvatljivih soli; i tvari koja predstavlja neovisne ili ovisne o pH vrijednosti skupine kvaternog amonijaka čija je struktura polimera i kopolimera izvedena iz akrilnih i metakrilnih kiselih estera pri čemu:
- udio skupina amonijaka u farmaceutskom obliku je između 0,01 do 2,0 µmol amonijaka/mg farmaceutskog oblika,
- udio glikozaminoglikana u farmaceutskom obliku je između 15% do 50% masenog udjela, i
- farmaceutski oblik predstavlja postotak vlažnosti (maseni udio) niži od 10% pri čemu su naboji glikozaminoglikana samo djelomično neutralizirani odabranim kationima koji su ovisni ili neovisni o pH vrijednostima skupina kvaternog amonijaka.
2. Farmaceutski oblik u skladu s jednih od patentnih zahtjeva 1 naznačen time što tvar koja predstavlja ovisne ili neovisne pH skupine kvaternog amonijaka nije tvar topiva u vodi.
3. Farmaceutski oblik u skladu s bilo kojim od patentnih zahtjeva 1 do 2 naznačen time što je udio amonijevih skupina u farmaceutskom obliku između 0,05 i 1,7 µmol amonijaka/mg farmaceutskog oblika.
4. Farmaceutski oblik u skladu s patentnim zahtjevom 3 naznačen time što je udio amonijevih skupina u farmaceutskom obliku između 0,21 i 0,4 µmol amonijaka/mg farmaceutskog oblika.
5. Farmaceutski oblik u skladu s jednim od patentnih zahtjeva 1 do 4 naznačen time što je udio glikozaminoglikana u farmaceutskom obliku između 25 i 50% masenog udjela.
6. Farmaceutski oblik u skladu s patentnim zahtjevom 5, naznačen time što je udio glikoaminoglikozana u farmaceutskom obliku između 33 i 50% masenog udjela.
7. Farmaceutski oblik u skladu s bilo kojim od patentnih zahtjeva 1 do 6 naznačen time što farmaceutski oblik prikazuje postotak vlažnosti (maseni udio) niži od 8%.
8. Farmaceutski oblik u skladu s bilo kojim od patentnih zahtjeva 1 do 2 naznačen time što,
- udio amonijevih skupina u farmaceutskom obliku je otprilike od 0,16 do 1,7 µmol amonijaka/mg farmaceutskog sastava, i
- udio glikozaminoglikana u farmaceutskom sastavu je od 20% do 50% masenog udjela.
9. Farmaceutski oblik u skladu s bilo kojim od patentnih zahtjeva 1 do 8 naznačen time što se sastoji od farmaceutski prihvatljivih pomoćnih tvari pri čemu je postotak (maseni udio) pomoćnih tvari ili nositelja u formulaciji jednak ili niži od 10%.
10. Farmaceutska formulacija koja se sastoji od farmaceutskog oblika definiranog u patentnom zahtjevu 9 naznačena time se komponenta prikazuje kao skupine kvaternog amonijaka koje čine dio površine navedene formulacije.
11. Farmaceutska formulacija u skladu s bilo kojim od patentnih zahtjeva 9 do 10 naznačena time što je navedena formulacija pelet, granula, tableta ili mini tableta.
12. Farmaceutska formulacija u skladu s bilo kojim od patentnih zahtjeva 9 do 11 naznačena time što navedenu formulaciju treba primijeniti oralno.
13. Farmaceutska formulacija u skladu s patentnim zahtjevom 12 naznačena time što navedena formulacija predstavlja formulaciju s neproduljenim oslobađanjem.
14. Farmaceutski oblik definiran prema bilo kojem od patentnih zahtjeva 1 do 8 ili farmaceutska formulacija definirana prema bilo kojoj od patentnih zahtjeva 9 do 13 za uporabu kao lijek.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP09382014A EP2213282A1 (en) | 2009-01-30 | 2009-01-30 | Pharmaceutical forms for the release of active compounds |
| PCT/EP2010/051127 WO2010086425A1 (en) | 2009-01-30 | 2010-01-29 | Pharmaceutical forms for the release of active compounds |
| EP10702287.3A EP2391352B1 (en) | 2009-01-30 | 2010-01-29 | Pharmaceutical forms for the release of active compounds |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20180103T1 true HRP20180103T1 (hr) | 2018-04-20 |
Family
ID=40602343
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20180103TT HRP20180103T1 (hr) | 2009-01-30 | 2018-01-19 | Farmaceutski oblici za oslobađanje aktivnih spojeva |
Country Status (11)
| Country | Link |
|---|---|
| EP (2) | EP2213282A1 (hr) |
| CY (1) | CY1120050T1 (hr) |
| DK (1) | DK2391352T3 (hr) |
| ES (1) | ES2655689T3 (hr) |
| HR (1) | HRP20180103T1 (hr) |
| HU (1) | HUE037915T2 (hr) |
| LT (1) | LT2391352T (hr) |
| PL (1) | PL2391352T3 (hr) |
| PT (1) | PT2391352T (hr) |
| SI (1) | SI2391352T1 (hr) |
| WO (2) | WO2010086425A1 (hr) |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102120781B (zh) * | 2011-03-16 | 2013-07-17 | 中国药科大学 | 一种新型胰岛素口服纳米粒的制备及应用 |
| EP3451730B1 (en) | 2011-04-01 | 2024-03-27 | Mitsubishi Electric Corporation | User equipment performing radio communication and base station used in a communication system |
| EP3273239A1 (en) | 2016-07-19 | 2018-01-24 | Laboratorios Farmacéuticos Rovi, S.A. | Procedure of analysis of glycosaminoglycans, heparins and their derivatives by nuclear magnetic resonance |
Family Cites Families (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3482014A (en) | 1966-06-29 | 1969-12-02 | Canada Packers Ltd | Orally active heparin and method for making and using same |
| US4703042A (en) | 1984-05-21 | 1987-10-27 | Bodor Nicholas S | Orally active heparin salts containing multivalent cationic units |
| US4925677A (en) * | 1988-08-31 | 1990-05-15 | Theratech, Inc. | Biodegradable hydrogel matrices for the controlled release of pharmacologically active agents |
| US6582728B1 (en) | 1992-07-08 | 2003-06-24 | Inhale Therapeutic Systems, Inc. | Spray drying of macromolecules to produce inhaleable dry powders |
| FR2811227A1 (fr) * | 2000-07-07 | 2002-01-11 | Philippe Maincent | Vecteurs particulaires destines a ameliorer l'absorption orale de principes actifs |
| ITMI20012599A1 (it) | 2001-12-11 | 2003-06-11 | Cosmo Spa | Composizioni farmaceutiche per la somministrazione orale di eparina osuoi derivati, utili per la terapia di malattie infiammatorie dell'int |
| KR100508911B1 (ko) * | 2002-05-09 | 2005-08-18 | 주식회사 펩트론 | 서방성 단백질 약물 제형 및 이의 제조방법 |
| GB0310919D0 (en) * | 2003-05-13 | 2003-06-18 | West Pharm Serv Drug Res Ltd | Pharmaceutical compositions |
| ES2222822B1 (es) | 2003-07-28 | 2005-12-16 | Laboratorios Farmaceuticos Rovi, S.A. | Diamidas de aminoacidos en posicion no alfa utiles como adyuvantes para la administracion de agentes biologicos activos. |
| BRPI0414982A (pt) * | 2003-10-01 | 2006-11-21 | Debio Rech Pharma Sa | dispositivo e método para produção de partìculas |
| US7556826B2 (en) * | 2005-01-04 | 2009-07-07 | Gp Medical, Inc. | Nanoparticles for protein drug delivery |
| US20070154546A1 (en) | 2005-12-30 | 2007-07-05 | Zhang Jack Y | Sustained release pharmaceutical compositions |
| ES2296529B1 (es) | 2006-08-07 | 2009-04-01 | Laboratorios Farmaceuticos Rovi, S.A. | Composicion farmaceutica con promotores de absorcion. |
-
2009
- 2009-01-30 EP EP09382014A patent/EP2213282A1/en not_active Withdrawn
-
2010
- 2010-01-29 SI SI201031619T patent/SI2391352T1/en unknown
- 2010-01-29 DK DK10702287.3T patent/DK2391352T3/da active
- 2010-01-29 PT PT107022873T patent/PT2391352T/pt unknown
- 2010-01-29 PL PL10702287T patent/PL2391352T3/pl unknown
- 2010-01-29 LT LTEP10702287.3T patent/LT2391352T/lt unknown
- 2010-01-29 HU HUE10702287A patent/HUE037915T2/hu unknown
- 2010-01-29 WO PCT/EP2010/051127 patent/WO2010086425A1/en active Application Filing
- 2010-01-29 ES ES10702287.3T patent/ES2655689T3/es active Active
- 2010-01-29 WO PCT/EP2010/051129 patent/WO2010086427A1/en active Application Filing
- 2010-01-29 EP EP10702287.3A patent/EP2391352B1/en active Active
-
2018
- 2018-01-16 CY CY20181100045T patent/CY1120050T1/el unknown
- 2018-01-19 HR HRP20180103TT patent/HRP20180103T1/hr unknown
Also Published As
| Publication number | Publication date |
|---|---|
| EP2213282A1 (en) | 2010-08-04 |
| WO2010086425A1 (en) | 2010-08-05 |
| PL2391352T3 (pl) | 2018-05-30 |
| HUE037915T2 (hu) | 2018-09-28 |
| PT2391352T (pt) | 2018-01-19 |
| ES2655689T3 (es) | 2018-02-21 |
| LT2391352T (lt) | 2018-05-25 |
| EP2391352B1 (en) | 2017-11-01 |
| WO2010086427A1 (en) | 2010-08-05 |
| EP2391352A1 (en) | 2011-12-07 |
| DK2391352T3 (da) | 2018-01-29 |
| CY1120050T1 (el) | 2018-12-12 |
| SI2391352T1 (en) | 2018-04-30 |
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