JP2015527360A - トランス−クロミフェン製剤およびその使用 - Google Patents

トランス−クロミフェン製剤およびその使用 Download PDF

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Publication number
JP2015527360A
JP2015527360A JP2015528460A JP2015528460A JP2015527360A JP 2015527360 A JP2015527360 A JP 2015527360A JP 2015528460 A JP2015528460 A JP 2015528460A JP 2015528460 A JP2015528460 A JP 2015528460A JP 2015527360 A JP2015527360 A JP 2015527360A
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Prior art keywords
trans
clomiphene
pharmaceutical formulation
compound
particle size
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JP2015528460A
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Japanese (ja)
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JP2015527360A5 (enExample
Inventor
ジョセフ エス． ポドルスキ，
ジョセフ エス． ポドルスキ，
クアン シュー，
クアン シュー，
Original Assignee
レプロス セラピューティクス インコーポレイティド
レプロス セラピューティクス インコーポレイティド
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Application filed by レプロス セラピューティクス インコーポレイティド, レプロス セラピューティクス インコーポレイティド filed Critical レプロス セラピューティクス インコーポレイティド
Publication of JP2015527360A publication Critical patent/JP2015527360A/ja
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    • 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
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/138—Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine
    • 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
    • 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
    • A61K9/02—Suppositories; Bougies; Bases therefor; Ovules
    • 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
    • A61K9/10—Dispersions; Emulsions
    • 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
    • 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
    • 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
    • A61K9/4858—Organic 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • 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
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of 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
    • A61P15/02—Drugs for genital or sexual disorders; Contraceptives for disorders of the vagina
    • 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
    • A61P15/10—Drugs for genital or sexual disorders; Contraceptives for impotence
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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
    • A61P5/30—Oestrogens
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/29—Coated or structually defined flake, particle, cell, strand, strand portion, rod, filament, macroscopic fiber or mass thereof
    • Y10T428/2982—Particulate matter [e.g., sphere, flake, etc.]

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Endocrinology (AREA)
  • Reproductive Health (AREA)
  • Diabetes (AREA)
  • Gynecology & Obstetrics (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Emergency Medicine (AREA)
  • Pregnancy & Childbirth (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Rheumatology (AREA)
  • Dispersion Chemistry (AREA)
  • Neurology (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
JP2015528460A 2012-08-21 2013-03-15 トランス−クロミフェン製剤およびその使用 Withdrawn JP2015527360A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201261691722P 2012-08-21 2012-08-21
US61/691,722 2012-08-21
PCT/US2013/032659 WO2014031177A1 (en) 2012-08-21 2013-03-15 Trans-clomiphene formulations and uses thereof

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2017167061A Division JP2017206562A (ja) 2012-08-21 2017-08-31 トランス−クロミフェン製剤およびその使用

Publications (2)

Publication Number Publication Date
JP2015527360A true JP2015527360A (ja) 2015-09-17
JP2015527360A5 JP2015527360A5 (enExample) 2016-05-12

Family

ID=48014380

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2015528460A Withdrawn JP2015527360A (ja) 2012-08-21 2013-03-15 トランス−クロミフェン製剤およびその使用
JP2017167061A Pending JP2017206562A (ja) 2012-08-21 2017-08-31 トランス−クロミフェン製剤およびその使用

Family Applications After (1)

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JP2017167061A Pending JP2017206562A (ja) 2012-08-21 2017-08-31 トランス−クロミフェン製剤およびその使用

Country Status (22)

Country Link
US (1) US20150202167A1 (enExample)
EP (1) EP2887922A1 (enExample)
JP (2) JP2015527360A (enExample)
KR (1) KR20150041793A (enExample)
CN (1) CN104582686A (enExample)
AU (1) AU2013306393A1 (enExample)
BR (1) BR112015002288A2 (enExample)
CA (1) CA2880388A1 (enExample)
CL (1) CL2015000311A1 (enExample)
CR (1) CR20150096A (enExample)
EA (1) EA201590421A1 (enExample)
HK (1) HK1209636A1 (enExample)
IL (1) IL236911A0 (enExample)
IN (1) IN2015DN01698A (enExample)
MX (1) MX2015001912A (enExample)
NI (1) NI201500022A (enExample)
NZ (1) NZ704679A (enExample)
PH (1) PH12015500331A1 (enExample)
SG (2) SG10201704820SA (enExample)
UA (1) UA113324C2 (enExample)
WO (1) WO2014031177A1 (enExample)
ZA (1) ZA201501124B (enExample)

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
UA113291C2 (xx) 2011-08-04 2017-01-10 Метаболіти транскломіфену і їх застосування
CN104994877A (zh) 2012-11-02 2015-10-21 利普生物药剂公司 用于癌症治疗的反式-克罗米芬
EP3015453B1 (en) 2014-10-28 2016-10-12 F.I.S.- Fabbrica Italiana Sintetici S.p.A. Process for the preparation of Clomiphene
EP3015454A1 (en) 2014-10-28 2016-05-04 F.I.S.- Fabbrica Italiana Sintetici S.p.A. Stable solid form of trans-Clomiphene citrate
US11737934B2 (en) 2015-10-14 2023-08-29 Qfix Systems, Llc MRI compatible patient trolley
CN108463453A (zh) * 2016-04-22 2018-08-28 意大利合成制造有限公司 用于制备具有针状晶体习性的柠檬酸恩氯米芬的方法
CA3098552A1 (en) 2019-11-14 2021-05-14 Apotex Inc. Processes for the preparation of zuclomiphene and intermediates thereof
CA3098725A1 (en) 2019-11-14 2021-05-14 Apotex Inc. Zuclpomiphene salts and crystalline forms thereof
CA3105944A1 (en) 2020-01-22 2021-07-22 Apotex Inc. Crystalline forms of zuclomiphene citrate
EP3907213A1 (en) 2020-05-04 2021-11-10 Pcas Processes for the production of isomerically pure or enriched cis-clomiphene
US11578025B2 (en) 2020-10-19 2023-02-14 Apotex Inc. Processes for the preparation of zuclomiphene intermediates

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070202166A1 (en) * 2006-02-23 2007-08-30 Marvin Heuer Method for increasing the rate and consistency of bioavailability of supplemental dietary ingredients
JP2007530974A (ja) * 2004-03-31 2007-11-01 トロフォゲン，インコーポレイテッド ヒト糖タンパク質ホルモンのスーパーアゴニストおよびその使用
WO2010054248A1 (en) * 2008-11-07 2010-05-14 Repros Therapeutics Inc. Trans-clomiphene for metabolic syndrome and diabetes mellitus type 2

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Publication number Priority date Publication date Assignee Title
US2914563A (en) 1957-08-06 1959-11-24 Wm S Merrell Co Therapeutic composition
IT951631B (it) 1971-03-18 1973-07-10 Richardson Merrell Spa Composti utili per la separazione di isomeri ottici geometrici e strutturali e relativo procedimen to di sintesi
CN1289075C (zh) * 2001-07-09 2006-12-13 佐纳根有限公司 富含反式克罗米酚的克罗米酚组合物的用途
EP1776098A1 (en) 2004-07-14 2007-04-25 Repros Therapeutics Inc. Trans-clomiphene for the treatment of benign prostate hypertrophy, prostate cancer, hypogonadism, elevated triglycerides and high cholesterol
MX2010004195A (es) 2007-10-16 2010-06-02 Repros Therapeutics Inc Trans-clomifeno para el sindrome metabolico.

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2007530974A (ja) * 2004-03-31 2007-11-01 トロフォゲン，インコーポレイテッド ヒト糖タンパク質ホルモンのスーパーアゴニストおよびその使用
US20070202166A1 (en) * 2006-02-23 2007-08-30 Marvin Heuer Method for increasing the rate and consistency of bioavailability of supplemental dietary ingredients
WO2010054248A1 (en) * 2008-11-07 2010-05-14 Repros Therapeutics Inc. Trans-clomiphene for metabolic syndrome and diabetes mellitus type 2

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
BIOCHEMICAL PHARMACOLOGY, vol. 55(6), JPN6016046175, 1998, pages 841 - 851, ISSN: 0003451801 *
DRUG DEVELOPMENT AND INDUSTRIAL PHARMACY, vol. 15(6&7), JPN6017015236, 1989, pages 1021 - 1028, ISSN: 0003548407 *

Also Published As

Publication number Publication date
IL236911A0 (en) 2015-03-31
EA201590421A1 (ru) 2015-06-30
WO2014031177A1 (en) 2014-02-27
KR20150041793A (ko) 2015-04-17
PH12015500331A1 (en) 2015-04-20
CR20150096A (es) 2015-05-04
NI201500022A (es) 2016-02-01
US20150202167A1 (en) 2015-07-23
NZ704679A (en) 2016-02-26
SG10201704820SA (en) 2017-07-28
AU2013306393A1 (en) 2015-02-19
ZA201501124B (en) 2016-04-28
BR112015002288A2 (pt) 2017-07-04
SG11201500641TA (en) 2015-04-29
IN2015DN01698A (enExample) 2015-07-03
CA2880388A1 (en) 2014-02-27
HK1209636A1 (en) 2016-04-08
UA113324C2 (xx) 2017-01-10
CN104582686A (zh) 2015-04-29
EP2887922A1 (en) 2015-07-01
CL2015000311A1 (es) 2015-08-14
MX2015001912A (es) 2015-06-05
JP2017206562A (ja) 2017-11-24

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