JP2018527305A5 - - Google Patents
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- JP2018527305A5 JP2018527305A5 JP2017567465A JP2017567465A JP2018527305A5 JP 2018527305 A5 JP2018527305 A5 JP 2018527305A5 JP 2017567465 A JP2017567465 A JP 2017567465A JP 2017567465 A JP2017567465 A JP 2017567465A JP 2018527305 A5 JP2018527305 A5 JP 2018527305A5
- Authority
- JP
- Japan
- Prior art keywords
- pharmaceutical composition
- composition according
- drospirenone
- daily
- contraceptive
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
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- 239000008194 pharmaceutical composition Substances 0.000 claims 12
- 230000002254 contraceptive Effects 0.000 claims 8
- 239000003433 contraceptive agent Substances 0.000 claims 8
- METQSPRSQINEEU-HXCATZOESA-N (1R,2R,4R,10R,11S,14S,15S,16S,18S,19S)-10,14-dimethylspiro[hexacyclo[9.8.0.0^{2,4}.0^{5,10}.0^{14,19}.0^{16,18}]nonadecane-15,2'-oxolan]-5-ene-5',7-dione 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 claims 7
- 229960004845 drospirenone Drugs 0.000 claims 7
- 238000004806 packaging method and process Methods 0.000 claims 5
- 239000000902 placebo Substances 0.000 claims 2
- 229940068196 placebo Drugs 0.000 claims 2
- 208000008589 Obesity Diseases 0.000 claims 1
- 238000007922 dissolution test Methods 0.000 claims 1
- 230000000694 effects Effects 0.000 claims 1
- 239000000262 estrogen Substances 0.000 claims 1
- 238000000338 in vitro Methods 0.000 claims 1
- 235000020824 obesity Nutrition 0.000 claims 1
- 239000002245 particle Substances 0.000 claims 1
Claims (11)
- 肥満に影響される女性患者のための避妊薬として使用するための医薬組成物であって、一日活性投与量単位における唯一の避妊成分としてドロスピレノンを３ｍｇ以上の量で含む医薬組成物。
- ＢＭＩが３０ｋｇ／ｍ２以上の女性患者のための避妊薬として使用するための、請求項１に記載の医薬組成物。
- 前記一日活性投与量単位が、１以上の包装単位を含む避妊薬キットに含まれており、各包装単位が２１〜２８の一日活性投与量単位を含んでおり、
（ａ）各一日活性投与量単位におけるドロスピレノンの量が、エストロゲンなしで、３ｍｇ以上であり、かつ
（ｂ）各一日活性投与量単位が、一日活性投与量単位をＵＳＰ ＸＸＩＩＩパドル法に準拠したインビトロ溶解試験に付したときに、
（ｉ）前記一日活性投与量単位に当初存在するドロスピレノンの５０％以下が３０分間以内に溶解し、かつ
（ｉｉ）該ドロスピレノンの５０％以上が３〜４時間の時間範囲で溶解する
形態でドロスピレノンを含んでおり、前記ドロスピレノンのパーセンテージが、前記一日活性投与量単位に当初存在するドロスピレノンの量に対する、請求項１又は請求項２に記載の医薬組成物。 - 前記一日活性投与量単位におけるドロスピレノンの量が３．５ｍｇ〜４．５ｍｇである、請求項３に記載の医薬組成物。
- 前記１以上の包装単位が、さらに、薬学的に許容されるプラセボの１〜７の一日投与量単位を含む、請求項３又は請求項４に記載の医薬組成物。
- 各包装単位が、２４の一日活性投与量単位を含む、請求項３に記載の医薬組成物。
- 各包装単位が、４の一日プラセボ投与量単位を含む、請求項３に記載の医薬組成物。
- 前記避妊成分が結晶質の形態である、請求項１乃至請求項７のいずれか１項に記載の医薬組成物。
- 前記避妊成分が、微粒子化されていない形態である、請求項１乃至請求項８のいずれか１項に記載の医薬組成物。
- 前記避妊成分が７０μｍ未満のｄ５０を有する、請求項１乃至請求項９のいずれか１項に記載の医薬組成物。
- 粒子の形態の前記避妊成分が、２０００ｃｍ２／ｇ〜８５００ｃｍ２／ｇの比表面積を有する、請求項１乃至請求項１０のいずれか１項に記載の医薬組成物。
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| 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 |
| EP15305965.4A EP3108889A1 (en) | 2015-06-23 | 2015-06-23 | Drospirenone-based contraceptive for a female patient affected with excess weight |
| CN201510348953.1 | 2015-06-23 | ||
| EP15305965.4 | 2015-06-23 | ||
| PCT/EP2016/064574 WO2016207298A1 (en) | 2015-06-23 | 2016-06-23 | Drospirenone-based contraceptive for a female patient affected with excess weight |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2018527305A JP2018527305A (ja) | 2018-09-20 |
| JP2018527305A5 true JP2018527305A5 (ja) | 2019-07-18 |
| JP6827962B2 JP6827962B2 (ja) | 2021-02-10 |
Family
ID=56178376
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2017567465A Active JP6827962B2 (ja) | 2015-06-23 | 2016-06-23 | 過剰体重に影響される女性患者のためのドロスピレノン系避妊薬 |
Country Status (26)
| Country | Link |
|---|---|
| EP (1) | EP3313408B1 (ja) |
| JP (1) | JP6827962B2 (ja) |
| KR (1) | KR102217942B1 (ja) |
| CN (2) | CN113750108A (ja) |
| AU (1) | AU2016282863B2 (ja) |
| BR (1) | BR112017028048A2 (ja) |
| CA (1) | CA2989975C (ja) |
| DK (1) | DK3313408T3 (ja) |
| EA (1) | EA036497B1 (ja) |
| ES (1) | ES2970532T3 (ja) |
| FI (1) | FI3313408T3 (ja) |
| HK (1) | HK1255216A1 (ja) |
| HR (1) | HRP20240121T8 (ja) |
| HU (1) | HUE065350T2 (ja) |
| LT (1) | LT3313408T (ja) |
| MX (1) | MX2017016801A (ja) |
| MY (1) | MY187233A (ja) |
| NI (1) | NI201700173A (ja) |
| PH (1) | PH12017502379A1 (ja) |
| PL (1) | PL3313408T3 (ja) |
| RS (1) | RS65196B1 (ja) |
| SI (1) | SI3313408T1 (ja) |
| SV (1) | SV2017005602A (ja) |
| UA (1) | UA122873C2 (ja) |
| WO (1) | WO2016207298A1 (ja) |
| ZA (1) | ZA201800067B (ja) |
Families Citing this family (10)
| 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 |
| CA2988485A1 (en) | 2015-06-18 | 2016-12-22 | Mithra Pharmaceuticals S.A. | Orodispersible tablet containing estetrol |
| SI3310333T1 (sl) | 2015-06-18 | 2020-08-31 | Estetra Sprl | Orodisperzibilna enota odmerka, ki vsebuje komponento estetrola |
| EP3310346B1 (en) | 2015-06-18 | 2021-03-24 | Estetra SPRL | Orodispersible tablet containing estetrol |
| KR102664563B1 (ko) | 2015-06-18 | 2024-05-09 | 에스테트라, 소시에떼 아 레스폰서빌리떼 리미떼 | 에스테트롤 성분을 함유하는 구강분해성 투여 단위 |
| AU2016282863B2 (en) | 2015-06-23 | 2021-05-27 | Laboratorios Leon Farma Sa | Drospirenone-based contraceptive for a female patient affected with excess weight |
| CA3178291A1 (en) | 2016-08-05 | 2018-04-12 | Estetra Srl | Method for the management of dysmenorrhea and menstrual pain |
| 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 |
Family Cites Families (13)
| 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 |
| MY151322A (en) * | 2004-04-30 | 2014-05-15 | Bayer Ip Gmbh | Management of breakthrough bleeding in extended hormonal contraceptive regimens |
| UA91190C2 (ru) * | 2004-04-30 | 2010-07-12 | Шерінг Акцієнгезельшафт | Контроль прорывных кровотечений при пролонгированном режиме приема гормональных контрацептивов |
| ITMI20042338A1 (it) | 2004-12-06 | 2005-03-06 | Ind Chimica Srl | Processo per la preparazione di drospirenone |
| PL1746101T5 (pl) | 2005-07-21 | 2014-11-28 | Bayer Pharma AG | Sposób wytwarzania 3-oksopreg-4-eno-21,17-karbolaktonów drogą bezmetalowego utleniania 17-(3-hydroksypropylo-3,17-dihydroksyandrostanu |
| UY31010A1 (es) * | 2007-04-05 | 2008-11-28 | Bayer Schering Pharma Ag | Nuevo régimen de drospirenona/17b-estradiol, producto farmacéutico combinado y conjunto de elementos (kit) para su aplicacion |
| EP2548881B1 (en) * | 2010-03-16 | 2014-12-17 | Taizhou Taifa Pharmaceuticals Co., Ltd | Preparation method of drospirenone |
| 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 |
| AU2016282863B2 (en) | 2015-06-23 | 2021-05-27 | Laboratorios Leon Farma Sa | Drospirenone-based contraceptive for a female patient affected with excess weight |
-
2016
- 2016-06-23 AU AU2016282863A patent/AU2016282863B2/en active Active
- 2016-06-23 MY MYPI2017704873A patent/MY187233A/en unknown
- 2016-06-23 ES ES16731177T patent/ES2970532T3/es active Active
- 2016-06-23 BR BR112017028048A patent/BR112017028048A2/pt not_active Application Discontinuation
- 2016-06-23 CN CN202111154721.4A patent/CN113750108A/zh active Pending
- 2016-06-23 MX MX2017016801A patent/MX2017016801A/es unknown
- 2016-06-23 HR HRP20240121TT patent/HRP20240121T8/hr unknown
- 2016-06-23 RS RS20240118A patent/RS65196B1/sr unknown
- 2016-06-23 DK DK16731177.8T patent/DK3313408T3/da active
- 2016-06-23 PL PL16731177.8T patent/PL3313408T3/pl unknown
- 2016-06-23 CN CN201680045547.0A patent/CN108025014B/zh active Active
- 2016-06-23 CA CA2989975A patent/CA2989975C/en active Active
- 2016-06-23 LT LTEPPCT/EP2016/064574T patent/LT3313408T/lt unknown
- 2016-06-23 WO PCT/EP2016/064574 patent/WO2016207298A1/en active Application Filing
- 2016-06-23 SI SI201631799T patent/SI3313408T1/sl unknown
- 2016-06-23 KR KR1020187001303A patent/KR102217942B1/ko active IP Right Grant
- 2016-06-23 FI FIEP16731177.8T patent/FI3313408T3/fi active
- 2016-06-23 EP EP16731177.8A patent/EP3313408B1/en active Active
- 2016-06-23 JP JP2017567465A patent/JP6827962B2/ja active Active
- 2016-06-23 UA UAA201712722A patent/UA122873C2/uk unknown
- 2016-06-23 HU HUE16731177A patent/HUE065350T2/hu unknown
- 2016-06-23 EA EA201792595A patent/EA036497B1/ru unknown
-
2017
- 2017-12-20 PH PH12017502379A patent/PH12017502379A1/en unknown
- 2017-12-21 SV SV2017005602A patent/SV2017005602A/es unknown
- 2017-12-21 NI NI201700173A patent/NI201700173A/es unknown
-
2018
- 2018-01-04 ZA ZA2018/00067A patent/ZA201800067B/en unknown
- 2018-11-09 HK HK18114345.3A patent/HK1255216A1/zh unknown
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