JP5852639B2 - Hrtのための低用量固体経口投与形態 - Google Patents

Hrtのための低用量固体経口投与形態 Download PDF

Info

Publication number
JP5852639B2
JP5852639B2 JP2013504243A JP2013504243A JP5852639B2 JP 5852639 B2 JP5852639 B2 JP 5852639B2 JP 2013504243 A JP2013504243 A JP 2013504243A JP 2013504243 A JP2013504243 A JP 2013504243A JP 5852639 B2 JP5852639 B2 JP 5852639B2
Authority
JP
Japan
Prior art keywords
oral administration
solid preparation
women
drsp
starch
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.)
Expired - Fee Related
Application number
JP2013504243A
Other languages
English (en)
Japanese (ja)
Other versions
JP2013523861A5 (https=
JP2013523861A (ja
Inventor
シュテファン・ムレツコ
ロルフ・シュルマン
ケルスティン・グーデ
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Bayer Intellectual Property GmbH
Original Assignee
Bayer Intellectual Property GmbH
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Bayer Intellectual Property GmbH filed Critical Bayer Intellectual Property GmbH
Publication of JP2013523861A publication Critical patent/JP2013523861A/ja
Publication of JP2013523861A5 publication Critical patent/JP2013523861A5/ja
Application granted granted Critical
Publication of JP5852639B2 publication Critical patent/JP5852639B2/ja
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/565Compounds 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/565Compounds 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
    • A61K31/566Compounds 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 having an oxo group in position 17, e.g. estrone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/58Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
    • A61K31/585Compounds 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/2853Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/286Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • A61P15/08Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • A61P15/12Drugs for genital or sexual disorders; Contraceptives for climacteric disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/24Drugs for disorders of the endocrine system of the sex hormones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Endocrinology (AREA)
  • Reproductive Health (AREA)
  • Gynecology & Obstetrics (AREA)
  • Cardiology (AREA)
  • Diabetes (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pregnancy & Childbirth (AREA)
  • Inorganic Chemistry (AREA)
  • Zoology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
JP2013504243A 2010-04-15 2011-04-12 Hrtのための低用量固体経口投与形態 Expired - Fee Related JP5852639B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP10160069.0 2010-04-15
EP10160069 2010-04-15
PCT/EP2011/055717 WO2011128337A2 (en) 2010-04-15 2011-04-12 Low-dosed solid oral dosage forms for hrt

Publications (3)

Publication Number Publication Date
JP2013523861A JP2013523861A (ja) 2013-06-17
JP2013523861A5 JP2013523861A5 (https=) 2014-05-29
JP5852639B2 true JP5852639B2 (ja) 2016-02-03

Family

ID=44625782

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2013504243A Expired - Fee Related JP5852639B2 (ja) 2010-04-15 2011-04-12 Hrtのための低用量固体経口投与形態

Country Status (7)

Country Link
US (1) US20130140210A1 (https=)
EP (1) EP2558076B1 (https=)
JP (1) JP5852639B2 (https=)
CN (2) CN102985076A (https=)
CA (1) CA2796139A1 (https=)
ES (1) ES2533584T3 (https=)
WO (1) WO2011128337A2 (https=)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2025132539A1 (en) 2023-12-19 2025-06-26 Qbdc Gmbh Predicting the quality of a bioprocess and product

Family Cites Families (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE4426709A1 (de) 1994-07-20 1996-01-25 Schering Ag Steroidale Sexualhormone enthaltende feste Arzneiformen
DE19651000A1 (de) * 1996-12-01 1998-06-04 Schering Ag Oxyiminopregnancarbolactone
US5891868A (en) * 1997-11-21 1999-04-06 Kaiser Foundation Health Plan, Inc. Methods for treating postmenopausal women using ultra-low doses of estrogen
US6787531B1 (en) * 1999-08-31 2004-09-07 Schering Ag Pharmaceutical composition for use as a contraceptive
ATE442147T1 (de) * 2000-01-18 2009-09-15 Bayer Schering Pharma Ag Pharmazeutische zubereitung enthaltend drospirenon
US20020132801A1 (en) * 2001-01-11 2002-09-19 Schering Aktiengesellschaft Drospirenone for hormone replacement therapy
WO2002036144A1 (en) * 2000-10-30 2002-05-10 University Of Zurich Gnrh analogues for treatment of urinary incontinence
EP1216712A1 (en) 2000-12-20 2002-06-26 Schering Aktiengesellschaft Cyclodextrin-drospirenone inclusion complexes
EP1216713A1 (en) * 2000-12-20 2002-06-26 Schering Aktiengesellschaft Compositions of estrogen-cyclodextrin complexes
JP2004521951A (ja) * 2001-07-13 2004-07-22 シエーリング アクチエンゲゼルシャフト Hrtのためのドロスピレノン及びエストロゲンスルファメートの組み合わせ
US8022053B2 (en) * 2004-11-02 2011-09-20 Bayer Schering Pharma Aktiengesellschaft Oral solid dosage forms containing a low dose of estradiol
GT200500315A (es) 2004-11-02 2006-06-06 Formas de dosificacion oral solidas que contienen una dosis baja de estradiol
US8475838B2 (en) 2005-06-03 2013-07-02 Sandoz Ag Rapidly-dissolving pharmaceutical composition for inhibiting ovulation
US20080066739A1 (en) * 2006-09-20 2008-03-20 Lemahieu Edward Methods and systems of delivering medication via inhalation
US20090023693A1 (en) * 2007-04-05 2009-01-22 Vladimir Hanes New drospirenone/17beta-estradiol regimen, pharmaceutical combination product and kit for performing this regimen
WO2009138224A1 (en) 2008-05-14 2009-11-19 Helm Ag Pharmaceutical composition comprising drospirenone

Also Published As

Publication number Publication date
US20130140210A1 (en) 2013-06-06
CN106038574A (zh) 2016-10-26
EP2558076A2 (en) 2013-02-20
CA2796139A1 (en) 2011-10-20
WO2011128337A2 (en) 2011-10-20
CN102985076A (zh) 2013-03-20
ES2533584T3 (es) 2015-04-13
EP2558076B1 (en) 2014-12-24
JP2013523861A (ja) 2013-06-17
WO2011128337A3 (en) 2012-05-24

Similar Documents

Publication Publication Date Title
JP5820465B2 (ja) Hrtのための極低用量固体経口投与形態
JP7140355B2 (ja) エステトロール成分を含有する口腔内崩壊性投与単位
CA2988362C (en) Orodispersible tablet containing estetrol
KR102539030B1 (ko) 드로스피레논을 포함하는 약학적 조성물 및 피임용 키트
MD3310345T2 (ro) Comprimată orodispersabilă ce conține estetrol
CN101484143A (zh) 包含四氢叶酸的药物组合物
JP5852639B2 (ja) Hrtのための低用量固体経口投与形態
EA013262B1 (ru) Пероральные твёрдые лекарственные формы, содержащие низкую дозу эстрадиола
HK1183437A (en) Low-dosed solid oral dosage forms for hrt
HK1183438A (en) Very low-dosed solid oral dosage forms for hrt
CN101623287B (zh) 一种屈螺酮类似物的治疗更年期综合症的药物组合物
HK1179165A (en) Pharmaceutical composition containing a tetrahydrofolic acid

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20140408

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20140408

RD04 Notification of resignation of power of attorney

Free format text: JAPANESE INTERMEDIATE CODE: A7424

Effective date: 20141215

RD03 Notification of appointment of power of attorney

Free format text: JAPANESE INTERMEDIATE CODE: A7423

Effective date: 20150227

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20150310

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20150605

RD04 Notification of resignation of power of attorney

Free format text: JAPANESE INTERMEDIATE CODE: A7424

Effective date: 20150602

TRDD Decision of grant or rejection written
A01 Written decision to grant a patent or to grant a registration (utility model)

Free format text: JAPANESE INTERMEDIATE CODE: A01

Effective date: 20151110

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20151204

R150 Certificate of patent or registration of utility model

Ref document number: 5852639

Country of ref document: JP

Free format text: JAPANESE INTERMEDIATE CODE: R150

LAPS Cancellation because of no payment of annual fees