CN102985076A - 用于hrt的低剂量的固体口服剂型 - Google Patents

用于hrt的低剂量的固体口服剂型 Download PDF

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Publication number
CN102985076A
CN102985076A CN2011800283857A CN201180028385A CN102985076A CN 102985076 A CN102985076 A CN 102985076A CN 2011800283857 A CN2011800283857 A CN 2011800283857A CN 201180028385 A CN201180028385 A CN 201180028385A CN 102985076 A CN102985076 A CN 102985076A
Authority
CN
China
Prior art keywords
dosage form
women
present
dosage
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.)
Pending
Application number
CN2011800283857A
Other languages
English (en)
Chinese (zh)
Inventor
S·米尔兹克
R·舒曼恩
K·古德
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
Priority to CN201610391347.2A priority Critical patent/CN106038574A/zh
Publication of CN102985076A publication Critical patent/CN102985076A/zh
Pending legal-status Critical Current

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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
    • A61K31/565—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
    • 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
    • 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
    • A61K31/566—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 having an oxo group in position 17, e.g. estrone
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth 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
    • 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
    • A61K9/2853—Organic 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)
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • 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
    • A61P15/08—Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
    • 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
    • A61P15/12—Drugs for genital or sexual disorders; Contraceptives for climacteric disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/24—Drugs for disorders of the endocrine system of the sex hormones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • 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
    • A61K9/2059—Starch, 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)
CN2011800283857A 2010-04-15 2011-04-12 用于hrt的低剂量的固体口服剂型 Pending CN102985076A (zh)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN201610391347.2A CN106038574A (zh) 2010-04-15 2011-04-12 用于hrt的低剂量的固体口服剂型

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

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CN201610391347.2A Division CN106038574A (zh) 2010-04-15 2011-04-12 用于hrt的低剂量的固体口服剂型

Publications (1)

Publication Number Publication Date
CN102985076A true CN102985076A (zh) 2013-03-20

Family

ID=44625782

Family Applications (2)

Application Number Title Priority Date Filing Date
CN2011800283857A Pending CN102985076A (zh) 2010-04-15 2011-04-12 用于hrt的低剂量的固体口服剂型
CN201610391347.2A Pending CN106038574A (zh) 2010-04-15 2011-04-12 用于hrt的低剂量的固体口服剂型

Family Applications After (1)

Application Number Title Priority Date Filing Date
CN201610391347.2A Pending CN106038574A (zh) 2010-04-15 2011-04-12 用于hrt的低剂量的固体口服剂型

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

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020132801A1 (en) * 2001-01-11 2002-09-19 Schering Aktiengesellschaft Drospirenone for hormone replacement therapy
CN1395488A (zh) * 2000-01-18 2003-02-05 先灵公司 用于激素替代治疗的屈螺酮

Family Cites Families (14)

* 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
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

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1395488A (zh) * 2000-01-18 2003-02-05 先灵公司 用于激素替代治疗的屈螺酮
US20020132801A1 (en) * 2001-01-11 2002-09-19 Schering Aktiengesellschaft Drospirenone for hormone replacement therapy

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
ES2533584T3 (es) 2015-04-13
JP5852639B2 (ja) 2016-02-03
EP2558076B1 (en) 2014-12-24
JP2013523861A (ja) 2013-06-17
WO2011128337A3 (en) 2012-05-24

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