HRP20240121T1 - Kontracepcija na bazi drospirenona za pacijenticu s viškom tjelesne težine - Google Patents
Kontracepcija na bazi drospirenona za pacijenticu s viškom tjelesne težine Download PDFInfo
- Publication number
- HRP20240121T1 HRP20240121T1 HRP20240121TT HRP20240121T HRP20240121T1 HR P20240121 T1 HRP20240121 T1 HR P20240121T1 HR P20240121T T HRP20240121T T HR P20240121TT HR P20240121 T HRP20240121 T HR P20240121T HR P20240121 T1 HRP20240121 T1 HR P20240121T1
- Authority
- HR
- Croatia
- Prior art keywords
- drospirenone
- use according
- daily
- dosage unit
- active dosage
- Prior art date
Links
- METQSPRSQINEEU-UHFFFAOYSA-N dihydrospirorenone Natural products CC12CCC(C3(CCC(=O)C=C3C3CC33)C)C3C1C1CC1C21CCC(=O)O1 METQSPRSQINEEU-UHFFFAOYSA-N 0.000 title claims 19
- 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 19
- 229960004845 drospirenone Drugs 0.000 title claims 19
- 239000003433 contraceptive agent Substances 0.000 title claims 4
- 230000002254 contraceptive effect Effects 0.000 title claims 4
- 239000004480 active ingredient Substances 0.000 claims 4
- 238000004806 packaging method and process Methods 0.000 claims 3
- 229940068196 placebo Drugs 0.000 claims 2
- 239000000902 placebo Substances 0.000 claims 2
- 208000008589 Obesity Diseases 0.000 claims 1
- 230000000740 bleeding effect Effects 0.000 claims 1
- 238000007922 dissolution test Methods 0.000 claims 1
- 229940011871 estrogen Drugs 0.000 claims 1
- 239000000262 estrogen Substances 0.000 claims 1
- 238000000338 in vitro Methods 0.000 claims 1
- 239000004615 ingredient Substances 0.000 claims 1
- 238000000034 method Methods 0.000 claims 1
- 235000020824 obesity Nutrition 0.000 claims 1
- 230000001225 therapeutic effect Effects 0.000 claims 1
- 238000002560 therapeutic procedure Methods 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
- A61K31/56—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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/18—Feminine contraceptives
Landscapes
- Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Reproductive Health (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Endocrinology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Gynecology & Obstetrics (AREA)
- Epidemiology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Claims (11)
1. Drospirenon kao jedini kontracepcijski sastojak sadržan u dnevnoj aktivnoj doznoj jedinici u količini od najmanje 3 mg za uporabu u terapiji kao kontracepcijsko sredstvo kod pacijentice koje pate od pretilosti, kao što je označeno sa BMI od 30 kg/m2 ili većim.
2. Drospirenon za uporabu prema zahtjevu 1, naznačen time što navedena uporaba u terapiji je smanjenje broja dana s pojavama krvarenja.
3. Drospirenon za uporabu prema bilo kojem od zahtjeva 1 ili 2, naznačen time što je navedena dnevna aktivna dozna jedinica sadržana u kontracepcijskom kompletu koji sadrži jednu ili više jedinica pakiranja pri čemu svaka jedinica pakiranja sadrži 21 do 28 dnevnih aktivnih doznih jedinica i naznačen time što:
a. količina drospirenona u svakoj dnevnoj aktivnoj doznoj jedinici je najmanje 3 mg bez estrogena, i
b. svaka dnevna aktivna dozna jedinica sadrži drospirenon u obliku tako da:
i. ne više od 50% drospirenona koji je inicijalno prisutan u navedenoj dnevnoj aktivnoj doznoj jedinici se otopi unutar 30 minuta i
ii. najmanje 50% navedenog drospirenona se otopi u vremenskom rasponu od 3 do 4 sata,
kada je dnevna aktivna dozna jedinica podvrgnuta in vitro testu otapanja prema USP XXIII Paddle metodi, postoci drospirenona su povezani s količinom drospirenona koja je inicijalno prisutna u navedenoj dnevnoj aktivnoj doznoj jedinici.
4. Drospirenon za uporabu prema bilo kojem od zahtjeva 1 do 3, naznačen time što se količina drospirenona u svakoj dnevnoj aktivnoj doznoj jedinici kreće od oko 3.5 mg do 4.5 mg.
5. Drospirenon za uporabu prema bilo kojem od zahtjeva 2 ili 3, naznačen time što jedna ili više jedinica pakiranja dalje sadrže od 1 do 7 dnevnih doznih jedinica farmaceutski prihvatljivog placeba.
6. Drospirenon za uporabu prema bilo kojem od zahtjeva 3 do 5, naznačen time što svaka jedinica pakiranja sadrži 24 dnevne aktivne dozne jedinice.
7. Drospirenon za uporabu prema bilo kojem od zahtjeva 3 do 6, naznačen time što svaka jedinica pakiranja sadrži 4 dnevne placebo jedinice doze.
8. Drospirenon za uporabu prema bilo kojem od zahtjeva 1 do 7, naznačen time što je navedeni aktivni sastojak u kristalnom obliku.
9. Drospirenon za uporabu prema bilo kojem od zahtjeva 1 do 8, naznačen time što je navedeni aktivni sastojak u nemikroniziranom obliku.
10. Drospirenon za uporabu prema bilo kojem od zahtjeva 1 do 9, naznačen time što navedeni aktivni sastojak ima d50 manji od 70 µm
11. Drospirenon za uporabu prema bilo kojem od zahtjeva 1 do 10, naznačen time što navedeni aktivni sastojak u obliku čestica ima specifičnu površinu od oko 2,000 cm2/g do oko 8,500 cm2/g.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP15305965.4A EP3108889A1 (en) | 2015-06-23 | 2015-06-23 | Drospirenone-based contraceptive for a female patient affected with excess weight |
| CN201510348953.1A CN106265694A (zh) | 2015-06-23 | 2015-06-23 | 用于过重女性患者的基于屈螺酮的避孕药 |
| PCT/EP2016/064574 WO2016207298A1 (en) | 2015-06-23 | 2016-06-23 | Drospirenone-based contraceptive for a female patient affected with excess weight |
| EP16731177.8A EP3313408B1 (en) | 2015-06-23 | 2016-06-23 | Drospirenone-based contraceptive for a female patient affected with excess weight |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| HRP20240121T1 true HRP20240121T1 (hr) | 2024-04-12 |
| HRP20240121T8 HRP20240121T8 (hr) | 2024-05-10 |
Family
ID=56178376
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20240121TT HRP20240121T8 (hr) | 2015-06-23 | 2016-06-23 | Kontracepcija na bazi drospirenona za pacijenticu s viškom tjelesne težine |
Country Status (25)
| Country | Link |
|---|---|
| EP (1) | EP3313408B1 (hr) |
| JP (1) | JP6827962B2 (hr) |
| KR (1) | KR102217942B1 (hr) |
| CN (2) | CN108025014B (hr) |
| AU (1) | AU2016282863B2 (hr) |
| BR (1) | BR112017028048A2 (hr) |
| CA (1) | CA2989975C (hr) |
| DK (1) | DK3313408T3 (hr) |
| EA (1) | EA036497B1 (hr) |
| ES (1) | ES2970532T3 (hr) |
| FI (1) | FI3313408T3 (hr) |
| HK (1) | HK1255216A1 (hr) |
| HR (1) | HRP20240121T8 (hr) |
| HU (1) | HUE065350T2 (hr) |
| LT (1) | LT3313408T (hr) |
| MX (1) | MX2017016801A (hr) |
| MY (1) | MY187233A (hr) |
| NI (1) | NI201700173A (hr) |
| PH (1) | PH12017502379A1 (hr) |
| PL (1) | PL3313408T3 (hr) |
| RS (1) | RS65196B1 (hr) |
| SI (1) | SI3313408T1 (hr) |
| SV (1) | SV2017005602A (hr) |
| WO (1) | WO2016207298A1 (hr) |
| ZA (1) | ZA201800067B (hr) |
Families Citing this family (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2383279A1 (en) | 2011-07-19 | 2011-11-02 | Pantarhei Bioscience B.V. | Process for the preparation of estetrol |
| DK3310346T3 (da) | 2015-06-18 | 2021-05-25 | Estetra Sprl | Orodispersibel tablet indeholdende estetrol |
| PL3310333T3 (pl) | 2015-06-18 | 2020-07-13 | Estetra Sprl | Ulegająca rozpadowi w jamie ustnej jednostka dawkowana zawierająca składnik estetrolowy |
| MA44205B1 (fr) | 2015-06-18 | 2021-04-30 | Estetra Sprl | Comprimé orodispersible comprenant estetrol |
| GEP20217308B (en) | 2015-06-18 | 2021-10-25 | Estetra Sprl | Orodispersible dosage unit containing an estetrol component |
| CA3178291A1 (en) | 2016-08-05 | 2018-04-12 | Estetra Srl | Method for the management of dysmenorrhea and menstrual pain |
| 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 |
| JOP20200260A1 (ar) | 2018-04-19 | 2019-10-19 | Estetra Sprl | مركبات واستخداماتها للتخفيف من الأعراض المصاحبة لانقطاع الطمث |
| EP4134082A1 (en) | 2021-08-12 | 2023-02-15 | Chemo Research, S.L. | Method for treating endometriosis and providing effective contraception |
Family Cites Families (12)
| 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 |
| DE19525017A1 (de) * | 1995-06-28 | 1997-01-02 | Schering Ag | Pharmazeutisches Kombinatonspräparat, Kit und Methode zur hormonalen Kontrazeption |
| 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 |
| GT200500099A (es) * | 2004-04-30 | 2006-05-05 | Tratamiento de la hemorragia de disrupcion en regimenes anticonceptivos extendidos | |
| MY151322A (en) * | 2004-04-30 | 2014-05-15 | Bayer Ip Gmbh | Management of breakthrough bleeding in extended hormonal contraceptive regimens |
| ITMI20042338A1 (it) | 2004-12-06 | 2005-03-06 | Ind Chimica Srl | Processo per la preparazione di drospirenone |
| DK1746101T4 (da) | 2005-07-21 | 2014-08-11 | Bayer Pharma AG | Fremgangsmåde til fremstilling af 3-oxo-pregn-4-en-21,17-carbolactoner ved metalfri oxidation af 17-(3-hydroxypropyl)-3,17-dihydroxyandrostaner |
| MX2009010763A (es) * | 2007-04-05 | 2009-10-28 | Bayer Schering Pharma Ag | NUEVO REGIMEN DE DROSPIRENONA/17ß-ESTRADIOL, PRODUCTO FARMACEUTICO COMBINADO Y CONJUNTO DE ELEMENTOS (KIT) PARA SU APLICACION. |
| WO2011113196A1 (zh) * | 2010-03-16 | 2011-09-22 | 台州太法药业有限公司 | 屈螺酮制备方法 |
| AR081670A1 (es) * | 2010-06-29 | 2012-10-10 | Leon Farma Sa Lab | Composicion farmaceutica que comprende drospirenona y kit anticonceptivo |
| CN103372015A (zh) * | 2012-04-19 | 2013-10-30 | 国家人口计生委科学技术研究所 | 包含屈螺酮或屈螺酮和雌激素的阴道环制剂 |
| RU2527357C1 (ru) * | 2013-08-02 | 2014-08-27 | Государственное бюджетное образовательное Учреждение высшего профессионального образования "Московский государственный медико-стоматологический университет имени А.И. Евдокимова" Министерства здравоохранения Российской Федерации (МГМСУ имени А.И. Евдокимова" Минздрава России) | Способ персонифицированной профилактики эстрогензависимых заболеваний у здоровых женщин и женщин с факторами сердечно-сосудистого риска в возрасте 45-60 лет |
-
2016
- 2016-06-23 EP EP16731177.8A patent/EP3313408B1/en active Active
- 2016-06-23 WO PCT/EP2016/064574 patent/WO2016207298A1/en active Application Filing
- 2016-06-23 MX MX2017016801A patent/MX2017016801A/es unknown
- 2016-06-23 FI FIEP16731177.8T patent/FI3313408T3/fi active
- 2016-06-23 PL PL16731177.8T patent/PL3313408T3/pl unknown
- 2016-06-23 ES ES16731177T patent/ES2970532T3/es active Active
- 2016-06-23 CN CN201680045547.0A patent/CN108025014B/zh active Active
- 2016-06-23 EA EA201792595A patent/EA036497B1/ru unknown
- 2016-06-23 JP JP2017567465A patent/JP6827962B2/ja active Active
- 2016-06-23 AU AU2016282863A patent/AU2016282863B2/en active Active
- 2016-06-23 MY MYPI2017704873A patent/MY187233A/en unknown
- 2016-06-23 HU HUE16731177A patent/HUE065350T2/hu unknown
- 2016-06-23 RS RS20240118A patent/RS65196B1/sr unknown
- 2016-06-23 SI SI201631799T patent/SI3313408T1/sl unknown
- 2016-06-23 HR HRP20240121TT patent/HRP20240121T8/hr unknown
- 2016-06-23 BR BR112017028048A patent/BR112017028048A2/pt not_active Application Discontinuation
- 2016-06-23 DK DK16731177.8T patent/DK3313408T3/da active
- 2016-06-23 CN CN202111154721.4A patent/CN113750108A/zh active Pending
- 2016-06-23 LT LTEPPCT/EP2016/064574T patent/LT3313408T/lt unknown
- 2016-06-23 CA CA2989975A patent/CA2989975C/en active Active
- 2016-06-23 KR KR1020187001303A patent/KR102217942B1/ko active IP Right Grant
-
2017
- 2017-12-20 PH PH12017502379A patent/PH12017502379A1/en unknown
- 2017-12-21 NI NI201700173A patent/NI201700173A/es unknown
- 2017-12-21 SV SV2017005602A patent/SV2017005602A/es unknown
-
2018
- 2018-01-04 ZA ZA2018/00067A patent/ZA201800067B/en unknown
- 2018-11-09 HK HK18114345.3A patent/HK1255216A1/zh unknown
Also Published As
| Publication number | Publication date |
|---|---|
| MY187233A (en) | 2021-09-13 |
| ES2970532T3 (es) | 2024-05-29 |
| EA201792595A1 (ru) | 2018-06-29 |
| HUE065350T2 (hu) | 2024-05-28 |
| LT3313408T (lt) | 2024-03-12 |
| CN113750108A (zh) | 2021-12-07 |
| PH12017502379A1 (en) | 2018-06-25 |
| HK1255216A1 (zh) | 2019-08-09 |
| KR20180019173A (ko) | 2018-02-23 |
| RS65196B1 (sr) | 2024-03-29 |
| JP6827962B2 (ja) | 2021-02-10 |
| WO2016207298A1 (en) | 2016-12-29 |
| EP3313408A1 (en) | 2018-05-02 |
| KR102217942B1 (ko) | 2021-02-19 |
| CN108025014A (zh) | 2018-05-11 |
| EP3313408B1 (en) | 2023-12-06 |
| SI3313408T1 (sl) | 2024-04-30 |
| CA2989975A1 (en) | 2016-12-29 |
| MX2017016801A (es) | 2018-05-11 |
| ZA201800067B (en) | 2019-07-31 |
| JP2018527305A (ja) | 2018-09-20 |
| CN108025014B (zh) | 2021-10-22 |
| PL3313408T3 (pl) | 2024-04-15 |
| BR112017028048A2 (pt) | 2018-09-04 |
| SV2017005602A (es) | 2018-08-14 |
| AU2016282863B2 (en) | 2021-05-27 |
| NI201700173A (es) | 2018-04-02 |
| FI3313408T3 (fi) | 2024-01-25 |
| HRP20240121T8 (hr) | 2024-05-10 |
| CA2989975C (en) | 2021-10-12 |
| DK3313408T3 (da) | 2024-01-29 |
| EA036497B1 (ru) | 2020-11-17 |
| AU2016282863A1 (en) | 2018-02-08 |
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