HRP20220332T1 - Farmaceutski pripravak koji sadrži drospirenon za uporabu kao kontraceptiv - Google Patents
Farmaceutski pripravak koji sadrži drospirenon za uporabu kao kontraceptiv Download PDFInfo
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- HRP20220332T1 HRP20220332T1 HRP20220332TT HRP20220332T HRP20220332T1 HR P20220332 T1 HRP20220332 T1 HR P20220332T1 HR P20220332T T HRP20220332T T HR P20220332TT HR P20220332 T HRP20220332 T HR P20220332T HR P20220332 T1 HRP20220332 T1 HR P20220332T1
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- pharmaceutical preparation
- use according
- drospirenone
- dose unit
- active dose
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- METQSPRSQINEEU-UHFFFAOYSA-N dihydrospirorenone Natural products CC12CCC(C3(CCC(=O)C=C3C3CC33)C)C3C1C1CC1C21CCC(=O)O1 METQSPRSQINEEU-UHFFFAOYSA-N 0.000 title claims 12
- METQSPRSQINEEU-HXCATZOESA-N drospirenone Chemical compound C([C@]12[C@H]3C[C@H]3[C@H]3[C@H]4[C@@H]([C@]5(CCC(=O)C=C5[C@@H]5C[C@@H]54)C)CC[C@@]31C)CC(=O)O2 METQSPRSQINEEU-HXCATZOESA-N 0.000 title claims 12
- 229960004845 drospirenone Drugs 0.000 title claims 12
- 239000003433 contraceptive agent Substances 0.000 title claims 2
- 230000002254 contraceptive effect Effects 0.000 title claims 2
- 239000008194 pharmaceutical composition Substances 0.000 title claims 2
- 239000000825 pharmaceutical preparation Substances 0.000 claims 15
- 239000002245 particle Substances 0.000 claims 4
- 239000000546 pharmaceutical excipient Substances 0.000 claims 4
- 238000002360 preparation method Methods 0.000 claims 4
- 239000003826 tablet Substances 0.000 claims 4
- 238000000034 method Methods 0.000 claims 3
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims 2
- 239000003795 chemical substances by application Substances 0.000 claims 2
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims 2
- 238000007873 sieving Methods 0.000 claims 2
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 claims 1
- 239000001856 Ethyl cellulose Substances 0.000 claims 1
- ZZSNKZQZMQGXPY-UHFFFAOYSA-N Ethyl cellulose Chemical compound CCOCC1OC(OC)C(OCC)C(OCC)C1OC1C(O)C(O)C(OC)C(CO)O1 ZZSNKZQZMQGXPY-UHFFFAOYSA-N 0.000 claims 1
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims 1
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims 1
- 229960004977 anhydrous lactose Drugs 0.000 claims 1
- 239000002775 capsule Substances 0.000 claims 1
- 239000011248 coating agent Substances 0.000 claims 1
- 238000000576 coating method Methods 0.000 claims 1
- 239000003086 colorant Substances 0.000 claims 1
- 238000002425 crystallisation Methods 0.000 claims 1
- 230000008025 crystallization Effects 0.000 claims 1
- 238000004090 dissolution Methods 0.000 claims 1
- 238000007922 dissolution test Methods 0.000 claims 1
- 239000003974 emollient agent Substances 0.000 claims 1
- 229940011871 estrogen Drugs 0.000 claims 1
- 239000000262 estrogen Substances 0.000 claims 1
- 235000019325 ethyl cellulose Nutrition 0.000 claims 1
- 229920001249 ethyl cellulose Polymers 0.000 claims 1
- 239000000945 filler Substances 0.000 claims 1
- 239000008187 granular material Substances 0.000 claims 1
- 238000000227 grinding Methods 0.000 claims 1
- 239000001863 hydroxypropyl cellulose Substances 0.000 claims 1
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 claims 1
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims 1
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims 1
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims 1
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 claims 1
- 238000000338 in vitro Methods 0.000 claims 1
- 239000007788 liquid Substances 0.000 claims 1
- 235000019359 magnesium stearate Nutrition 0.000 claims 1
- 229940057948 magnesium stearate Drugs 0.000 claims 1
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims 1
- 239000008108 microcrystalline cellulose Substances 0.000 claims 1
- 229940016286 microcrystalline cellulose Drugs 0.000 claims 1
- 238000003801 milling Methods 0.000 claims 1
- 239000006187 pill Substances 0.000 claims 1
- 239000000902 placebo Substances 0.000 claims 1
- 229940068196 placebo Drugs 0.000 claims 1
- 239000000843 powder Substances 0.000 claims 1
- 238000001556 precipitation Methods 0.000 claims 1
- 239000000377 silicon dioxide Substances 0.000 claims 1
- 235000012239 silicon dioxide Nutrition 0.000 claims 1
- 229960001866 silicon dioxide Drugs 0.000 claims 1
- 239000007787 solid Substances 0.000 claims 1
Classifications
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- 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
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
- A61K31/567—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in position 17 alpha, e.g. mestranol, norethandrolone
-
- 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
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
- A61K31/585—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin containing lactone rings, e.g. oxandrolone, bufalin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
-
- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1682—Processes
- A61K9/1688—Processes resulting in pure drug agglomerate optionally containing up to 5% of excipient
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- 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
- A61K9/2009—Inorganic compounds
-
- 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
-
- 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
-
- 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
- A61K9/4841—Filling excipients; Inactive ingredients
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/18—Feminine contraceptives
-
- 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
- A61K9/4816—Wall or shell material
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (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)
- Inorganic Chemistry (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Gynecology & Obstetrics (AREA)
- Endocrinology (AREA)
- Reproductive Health (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Claims (15)
1. Farmaceutski pripravak koji sadrži drospirenon za uporabu kao kontraceptiv za pacijenticu kojoj je to potrebno, pri čemu:
(a) dnevna jedinica aktivne doze navedenog pripravka sadrži količinu drospirenona od oko 2 mg do oko 6 mg drospirenona, jednog ili više farmaceutski prihvatljivih ekscipijenata, i ne sadrži nikakav estrogen, i pri čemu se navedena dnevna jedinica aktivne doze treba primijeniti prema režimu doziranja koji uključuje davanje navedene dnevne jedinice aktivne doze tijekom 24 uzastopna dana nakon čega slijede 4 uzastopna dana pri čemu se navedenom pacijentu ne daje nijedna jedinica aktivne doze; i pri čemu
(b) brzina otapanja navedene dnevne jedinice aktivne doze je takva da kada se podvrgne in vitro testu otapanja prema USP XXIII Paddle metodi,
(i) ne više od 50% drospirenona inicijalno prisutnog u navedenoj dnevnoj jedinici aktivne doze se otopi unutar 30 minuta, i
(ii) najmanje 50% drospirenona inicijalno prisutnog u navedenoj dnevnoj jedinici aktivne doze se otopi u vremenskom rasponu od 3 sata do 4 sata.
2. Farmaceutski pripravak prema zahtjevu 1, naznačen time što je navedeni pripravak nadalje naznačen time što se najmanje 70 % drospirenona otopi unutar 6 sati.
3. Farmaceutski pripravak za uporabu prema zahtjevu 1, naznačen time što se jedinica doze placeba treba primijeniti tijekom navedena 4 uzastopna dana pri čemu se navedenom pacijentu ne daje nijedna jedinica aktivne doze.
4. Farmaceutski pripravak za uporabu prema bilo kojem od zahtjeva 1 ili 3, naznačen time što je pripravak u jedinici aktivne doze formuliran u čvrstom obliku za oralnu primjenu odabran iz skupine koju čine tablete, ovalne tablete, granule, pilule, kapsule i prašci.
5. Farmaceutski pripravak za uporabu prema bilo kojem od zahtjeva 1 ili 3 do 4, naznačen time što je pripravak u jedinici aktivne doze formuliran kao tableta.
6. Farmaceutski pripravak za uporabu prema zahtjevu 5, naznačen time što tablete nadalje sadrže oblogu koja sadrži sredstvo za stvaranje filma i izborno prikladan ekscipijent.
7. Farmaceutski pripravak za uporabu prema zahtjevu 6, naznačen time što je navedeno sredstvo za stvaranje filma odabrano iz skupine koju čine hidroksipropilmetil celuloza, hidroksipropil celuloza, i etil celuloza.
8. Farmaceutski pripravak za uporabu prema zahtjevu 6, naznačen time što je navedeni prikladni ekscipijent odabran iz skupine koja se sastoji od omekšivača, punila i bojila.
9. Farmaceutski pripravak za uporabu prema bilo kojem od zahtjeva 1 ili 3 do 8, naznačen time što je navedeni drospirenon osiguran u obliku čestica koje imaju distribuciju veličine naznačenu (ii) d50 veličinom čestica u rasponu od oko 10 µm do oko 60 µm.
10. Farmaceutski pripravak za uporabu prema zahtjevu 9, naznačen time što se navedene čestice drospirenona dobivaju postupkom koji se sastoji od mljevenja izborno kombiniranog s prosijavanjem.
11. Farmaceutski pripravak za uporabu prema zahtjevu 10, naznačen time što se navedeni proces mljevenja provodi u mlinu odabranom iz skupine koju čine: mlin tekuće energije, mlin s kuglicama, mlin s šipkama, mlin s čekićem, mlin za rezanje, i oscilirajući granulator.
12. Farmaceutski pripravak za uporabu prema zahtjevu 9, naznačen time što se navedene čestice drospirenona dobivaju postupkom koji se sastoji od kristalizacije ili taloženja izborno kombiniranog s korakom prosijavanja.
13. Farmaceutski pripravak za uporabu prema bilo kojem od zahtjeva 1 ili 3 do 12, naznačen time što je navedeni drospirenon ne-mikronizirani i bitno kristalizirani oblik.
14. Farmaceutski pripravak za uporabu prema bilo kojem od zahtjeva 1 ili 3 do 13, naznačen time što navedeni farmaceutski pripravak kao farmaceutski prihvatljive ekscipijente sadrži: mikrokristalnu celulozu, bezvodnu laktozu, silicij dioksid, i magnezijev stearat.
15. Farmaceutski pripravak za uporabu prema bilo kojem od zahtjeva 1 ili 3 do 14, naznačen time što se navedeni drospirenon daje u količini od oko 4 mg.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP10305708 | 2010-06-29 | ||
| US36839610P | 2010-07-28 | 2010-07-28 | |
| EP19209672.5A EP3632448B1 (en) | 2010-06-29 | 2011-06-28 | Pharmaceutical composition comprising drospirenone for use as a contraceptive |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20220332T1 true HRP20220332T1 (hr) | 2022-05-13 |
Family
ID=42671710
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20220332TT HRP20220332T1 (hr) | 2010-06-29 | 2011-06-28 | Farmaceutski pripravak koji sadrži drospirenon za uporabu kao kontraceptiv |
Country Status (23)
| Country | Link |
|---|---|
| US (6) | US11452695B2 (hr) |
| EP (3) | EP3632448B1 (hr) |
| JP (1) | JP5810159B2 (hr) |
| KR (3) | KR20130048227A (hr) |
| AR (1) | AR081670A1 (hr) |
| BR (1) | BR112012033391B1 (hr) |
| CA (3) | CA3061421C (hr) |
| CY (2) | CY1122544T1 (hr) |
| DK (1) | DK3632448T3 (hr) |
| EA (1) | EA028680B1 (hr) |
| ES (1) | ES2908657T3 (hr) |
| FR (2) | FR20C1020I1 (hr) |
| HR (1) | HRP20220332T1 (hr) |
| HU (3) | HUE058176T2 (hr) |
| LT (2) | LT3632448T (hr) |
| NO (1) | NO2020015I1 (hr) |
| NZ (1) | NZ605176A (hr) |
| PE (2) | PE20130780A1 (hr) |
| PL (2) | PL2588114T3 (hr) |
| PT (1) | PT3632448T (hr) |
| RS (2) | RS59826B1 (hr) |
| SI (2) | SI2588114T1 (hr) |
| WO (1) | WO2012000981A1 (hr) |
Families Citing this family (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US10849857B2 (en) | 2010-07-28 | 2020-12-01 | Laboratorios Leon Farma Sa | Pharmaceutical compositions comprising active drugs, contraceptive kits comprising active drugs, and methods of administering the same |
| US11351122B1 (en) | 2010-07-28 | 2022-06-07 | Laboratorios Leon Farma Sa | Synthetic progestogens and pharmaceutical compositions comprising the same |
| AR081670A1 (es) | 2010-06-29 | 2012-10-10 | Leon Farma Sa Lab | Composicion farmaceutica que comprende drospirenona y kit anticonceptivo |
| US9603860B2 (en) | 2010-07-28 | 2017-03-28 | Laboratorios Leon Farma Sa | Pharmaceutical compositions comprising active drugs, contraceptive kits comprising active drugs, and methods of administering the same |
| EP2383279A1 (en) | 2011-07-19 | 2011-11-02 | Pantarhei Bioscience B.V. | Process for the preparation of estetrol |
| ES2877186T3 (es) | 2015-06-18 | 2021-11-16 | Estetra Sprl | Comprimido orodispersable que contiene estetrol |
| PL3106148T3 (pl) | 2015-06-18 | 2018-08-31 | Mithra Pharmaceuticals S A | Jednostka dawkowania ulegająca rozpadowi w jamie ustnej zawierająca składnik estetrolowy |
| PL3310333T3 (pl) | 2015-06-18 | 2020-07-13 | Estetra Sprl | Ulegająca rozpadowi w jamie ustnej jednostka dawkowana zawierająca składnik estetrolowy |
| ES2877476T3 (es) | 2015-06-18 | 2021-11-16 | Estetra Sprl | Comprimido orodispersable que contiene estetrol |
| EP3108889A1 (en) | 2015-06-23 | 2016-12-28 | Philippe Perrin | Drospirenone-based contraceptive for a female patient affected with excess weight |
| HRP20240121T8 (hr) * | 2015-06-23 | 2024-05-10 | Laboratorios Leon Farma Sa | Kontracepcija na bazi drospirenona za pacijenticu s viškom tjelesne težine |
| KR20220144885A (ko) | 2016-08-05 | 2022-10-27 | 에스테트라, 소시에떼 아 레스폰서빌리떼 리미떼 | 월경통 및 생리통의 관리방법 |
| JOP20200260A1 (ar) | 2018-04-19 | 2019-10-19 | Estetra Sprl | مركبات واستخداماتها للتخفيف من الأعراض المصاحبة لانقطاع الطمث |
| TWI801561B (zh) | 2018-04-19 | 2023-05-11 | 比利時商依思特拉私人有限責任公司 | 化合物及其用於緩解絕經相關症狀的用途 |
| EP4134082A1 (en) | 2021-08-12 | 2023-02-15 | Chemo Research, S.L. | Method for treating endometriosis and providing effective contraception |
| WO2023152658A1 (en) | 2022-02-10 | 2023-08-17 | Lupin Limited | Slow release drospirenone tablet composition |
| WO2023165988A1 (en) | 2022-03-01 | 2023-09-07 | Chemo Research, S.L. | Chewable oral contraceptive |
Family Cites Families (33)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE2652761C2 (de) | 1976-11-16 | 1985-11-21 | Schering AG, 1000 Berlin und 4709 Bergkamen | 15,16-Methylen-Spirolactone, Verfahren zu deren Herstellung und diese enthaltende Arzneimittel |
| DE3022337A1 (de) | 1980-06-11 | 1982-01-07 | Schering Ag Berlin Und Bergkamen, 1000 Berlin | Praeparate zur kontrazeption und zur behandlung gynaekologischer stoerungen |
| DE69112917T2 (de) | 1990-06-15 | 1996-05-15 | Merck & Co Inc | Kristallisationsverfahren zur Verbesserung der Kristallstruktur und -grösse. |
| GB2256648B (en) | 1991-05-29 | 1995-08-30 | Colorcon Ltd | Wax polish composition |
| DE19633685C1 (de) | 1996-08-12 | 1997-10-09 | Schering Ag | Verfahren zur Herstellung von Drospirenon (6beta,7beta;15 beta,16beta-Dimethyl-en-3-oxo-17alpha-pregn-4-en-21,17-carbolacton, DRSP) sowie 7alpha-(3-Hydroxy-1-propyl)-6beta,7beta;15beta, 16beta-dimethylen-5beta-androstan-3beta,5,17beta-triol (ZK 92836) und 6beta,7beta;15beta,16beta-dimethylen-5beta-hydroxy-3-oxo-17alpha-androstan-21,17-carbolacton (90965) als Zwischenprodukte des Verfahrens |
| US6787531B1 (en) | 1999-08-31 | 2004-09-07 | Schering Ag | Pharmaceutical composition for use as a contraceptive |
| JP4354667B2 (ja) | 1999-08-31 | 2009-10-28 | バイエル・シエーリング・ファーマ・アクチエンゲゼルシャフト | 避妊薬としての使用へのエチニルエストラジオールとドロスピレノンの医薬用組合せ |
| WO2001052857A1 (en) | 2000-01-18 | 2001-07-26 | Schering Aktiengesellschaft | Drospirenone for hormone replacement therapy |
| US20020132801A1 (en) | 2001-01-11 | 2002-09-19 | Schering Aktiengesellschaft | Drospirenone for hormone replacement therapy |
| US7786101B2 (en) | 2002-11-05 | 2010-08-31 | Bayer Schering Pharma Ag | Cardiovascular protection using anti-aldosteronic progestins |
| US20040087563A1 (en) | 2002-11-05 | 2004-05-06 | Siegfried Mayerhofer | Hormone replacement therapy with cardiovascular protection using antialdosteronic progestins |
| US20050220825A1 (en) | 2004-03-10 | 2005-10-06 | Adrian Funke | Molecular dispersions of drospirenone |
| MY142989A (en) | 2004-03-10 | 2011-02-14 | Bayer Schering Pharma Ag | Stabilised supersaturated solids of lipophilic drugs |
| EP1980242B1 (en) | 2004-03-10 | 2010-08-11 | Bayer Schering Pharma Aktiengesellschaft | Liquid compositions as a micro-emulsion pre-concentrate comprising drospirenone moleculary dispersed |
| MY151322A (en) | 2004-04-30 | 2014-05-15 | Bayer Ip Gmbh | Management of breakthrough bleeding in extended hormonal contraceptive regimens |
| JP5288796B2 (ja) | 2004-07-07 | 2013-09-11 | ワイス・エルエルシー | 周期的プロゲスチンレジメン及びキット |
| EP1625849A1 (en) | 2004-08-09 | 2006-02-15 | Liconsa, Liberacion Controlada de Sustancias Activas, S.A. | Pharmaceutical composition comprising drospirenone and ethynylestradiol |
| ITMI20042338A1 (it) | 2004-12-06 | 2005-03-06 | Ind Chimica Srl | Processo per la preparazione di drospirenone |
| US20060293295A1 (en) | 2005-05-13 | 2006-12-28 | Kai Strothmann | Pharmaceutical composition comprising progestogens and/or estrogens and 5-methyl- (6S)-tetrahydrofolate |
| US8475838B2 (en) | 2005-06-03 | 2013-07-02 | Sandoz Ag | Rapidly-dissolving pharmaceutical composition for inhibiting ovulation |
| TW200727920A (en) | 2005-06-21 | 2007-08-01 | Organon Nv | New regimens for oral monophasic contraceptives |
| ATE403668T1 (de) | 2005-07-21 | 2008-08-15 | Bayer Schering Pharma Ag | Verfahren zur herstellung von 3-oxo-pregn-4-en-21,17-carbolactonen durch die metallfreie oxidation von 17-(3-hydroxypropyl)-3,17- dihydroxyandrostanen |
| CN101489563A (zh) | 2006-07-06 | 2009-07-22 | 拜耳先灵医药股份有限公司 | 用于避孕和预防先天性畸形风险的药物制剂 |
| JP2010503632A (ja) * | 2006-09-16 | 2010-02-04 | バイエル・シエーリング・ファーマ アクチエンゲゼルシャフト | 経口改良放出製剤 |
| US8741329B2 (en) | 2007-09-21 | 2014-06-03 | Merck Sharp & Dohme B.V. | Drug delivery system |
| MX2010008945A (es) | 2008-02-13 | 2010-09-07 | Bayer Schering Pharma Ag | Sistema de administracion de drogas con efecto estabilizante. |
| WO2009138224A1 (en) | 2008-05-14 | 2009-11-19 | Helm Ag | Pharmaceutical composition comprising drospirenone |
| TW201008569A (en) * | 2008-08-08 | 2010-03-01 | Bayer Schering Pharma Ag | Progestin-containing drug delivery system |
| DE102008037025C5 (de) | 2008-08-08 | 2016-07-07 | Jesalis Pharma Gmbh | Verfahren zur Herstellung kristalliner Wirkstoff-Mikropartikel bzw. einer Wirkstoffpartikel-Festkörperform |
| US10849857B2 (en) | 2010-07-28 | 2020-12-01 | Laboratorios Leon Farma Sa | Pharmaceutical compositions comprising active drugs, contraceptive kits comprising active drugs, and methods of administering the same |
| US11351122B1 (en) | 2010-07-28 | 2022-06-07 | Laboratorios Leon Farma Sa | Synthetic progestogens and pharmaceutical compositions comprising the same |
| AR081670A1 (es) | 2010-06-29 | 2012-10-10 | Leon Farma Sa Lab | Composicion farmaceutica que comprende drospirenona y kit anticonceptivo |
| US9603860B2 (en) | 2010-07-28 | 2017-03-28 | Laboratorios Leon Farma Sa | Pharmaceutical compositions comprising active drugs, contraceptive kits comprising active drugs, and methods of administering the same |
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