CA3083555A1 - Pharmaceutical formulation of 3.alpha.-ethynyl-3.beta.-hydroxyandrostan-17-one oxime - Google Patents

Pharmaceutical formulation of 3.alpha.-ethynyl-3.beta.-hydroxyandrostan-17-one oxime Download PDF

Info

Publication number
CA3083555A1
CA3083555A1 CA3083555A CA3083555A CA3083555A1 CA 3083555 A1 CA3083555 A1 CA 3083555A1 CA 3083555 A CA3083555 A CA 3083555A CA 3083555 A CA3083555 A CA 3083555A CA 3083555 A1 CA3083555 A1 CA 3083555A1
Authority
CA
Canada
Prior art keywords
pharmaceutical formulation
propylene glycol
glycerol
oxime
day
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
CA3083555A
Other languages
English (en)
French (fr)
Inventor
Paul Alhadeff
Magnus DOVERSKOG
Maja Johansson
Thomas MEIJER
Nicolaas Schipper
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.)
Umecrine Cognition AB
Original Assignee
Umecrine Cognition AB
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 Umecrine Cognition AB filed Critical Umecrine Cognition AB
Publication of CA3083555A1 publication Critical patent/CA3083555A1/en
Pending legal-status Critical Current

Links

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
    • A61K31/568—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 substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
    • 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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/4353—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/437—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a five-membered ring having nitrogen as a ring hetero atom, e.g. indolizine, beta-carboline
    • 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
    • A61K31/568—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 substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
    • A61K31/569—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 substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone substituted in position 17 alpha, e.g. ethisterone
    • 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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7016—Disaccharides, e.g. lactose, lactulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Psychiatry (AREA)
  • Hospice & Palliative Care (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Molecular Biology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Steroid Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
CA3083555A 2017-11-27 2018-11-27 Pharmaceutical formulation of 3.alpha.-ethynyl-3.beta.-hydroxyandrostan-17-one oxime Pending CA3083555A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201762590757P 2017-11-27 2017-11-27
US62/590,757 2017-11-27
PCT/EP2018/082727 WO2019102040A1 (en) 2017-11-27 2018-11-27 PHARMACEUTICAL FORMULATION OF 3α-ETHYNYL-3β-HYDROXYANDROSTAN-17-ONE OXIME

Publications (1)

Publication Number Publication Date
CA3083555A1 true CA3083555A1 (en) 2019-05-31

Family

ID=64556898

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3083555A Pending CA3083555A1 (en) 2017-11-27 2018-11-27 Pharmaceutical formulation of 3.alpha.-ethynyl-3.beta.-hydroxyandrostan-17-one oxime

Country Status (12)

Country Link
US (2) US10603326B2 (enExample)
EP (1) EP3716954A1 (enExample)
JP (1) JP7314459B2 (enExample)
KR (1) KR102771577B1 (enExample)
CN (1) CN111432805B (enExample)
AU (1) AU2018374029B2 (enExample)
BR (1) BR112020010519A2 (enExample)
CA (1) CA3083555A1 (enExample)
IL (1) IL274893B2 (enExample)
MX (1) MX391097B (enExample)
UA (1) UA128186C2 (enExample)
WO (1) WO2019102040A1 (enExample)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
UA128186C2 (uk) 2017-11-27 2024-05-01 Умекрайн Когнішн Аб ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ 3<font face="Symbol">a</font>-ЕТИНІЛ-3<font face="Symbol">b</font>-ГІДРОКСІАНДРОСТАН-17-ОНУ ОКСИМУ
EP4079307A1 (en) * 2021-04-20 2022-10-26 Umecrine Cognition AB New medical use
EP4389129A1 (en) 2022-12-22 2024-06-26 Umecrine Cognition AB 3a-ethynyl-3beta hydroxyandrostan 17-one oxime for treating parkinson's disease and l-dopa-induced dyskinesia
WO2025252725A1 (en) 2024-06-04 2025-12-11 Umecrine Cognition Ab Novel pharmaceutical formulation of golexanolone
WO2025252724A1 (en) 2024-06-04 2025-12-11 Umecrine Cognition Ab Novel pharmaceutical formulation of golexanolone

Family Cites Families (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB9405304D0 (en) 1994-03-16 1994-04-27 Scherer Ltd R P Delivery systems for hydrophobic drugs
GB9608719D0 (en) 1996-04-26 1996-07-03 Scherer Ltd R P Pharmaceutical compositions
SE511313C2 (sv) 1997-01-13 1999-09-06 Gs Dev Ab Komposition med reglerad frisättning innefattande fettsyraester av diacylglycerol
GB9907715D0 (en) 1999-04-01 1999-05-26 Scherer Corp R P Pharmaceutical compositions
KR20010100194A (ko) * 2000-03-13 2001-11-14 박호군 여러 가지 물질의 가용화용 조성물과 제형 및 그들의제조방법
US20040191207A1 (en) 2003-03-31 2004-09-30 Lipari John M. Alpha-hydroxy acid ester drug delivery compositions and methods of use
JP2010502703A (ja) 2006-09-06 2010-01-28 メルク エンド カムパニー インコーポレーテッド 置換アミドの経口投与のための液体及び半固体の医薬製剤
EP2711372A1 (en) 2006-11-21 2014-03-26 Umecrine AB The use of pregnane and androstane steroids for the manufacture of a pharmaceutical composition for the treatment of CNS disorders
JP5687287B2 (ja) 2010-01-14 2015-03-18 ウメクライン ムード エービー 改善された保存性及び溶解特性を有する3−ベータ−ヒドロキシ−5−アルファ−プレグナン−20−オンを含有する薬学的組成物
US9034858B2 (en) 2010-11-30 2015-05-19 Lipocine Inc. High-strength testosterone undecanoate compositions
US8951996B2 (en) 2011-07-28 2015-02-10 Lipocine Inc. 17-hydroxyprogesterone ester-containing oral compositions and related methods
US9801819B2 (en) 2012-06-28 2017-10-31 Johnson & Johnson Consumer Inc. Racecadotril compositions
HK1223300A1 (zh) 2013-06-03 2017-07-28 Tolmar, Inc. 皮质类固醇组合物
CN106163528A (zh) * 2014-01-29 2016-11-23 梅克芳识别有限公司 用于治疗肝脑病的甾族化合物
WO2015193224A1 (en) 2014-06-17 2015-12-23 Merck Sharp & Dohme B.V. Stable formulations of testosterone undecanoate
US9498485B2 (en) * 2014-08-28 2016-11-22 Lipocine Inc. Bioavailable solid state (17-β)-hydroxy-4-androsten-3-one esters
KR101679992B1 (ko) 2015-12-31 2016-11-28 주식회사 유유제약 프로필렌글리콜 모노라우레이트를 포함하는 두타스테리드의 약학적 조성물 및 이의 제조 방법
KR101716878B1 (ko) 2016-05-12 2017-03-15 주식회사 유유제약 글리세롤 지방산에스테르유도체 또는 프로필렌글리콜 지방산에스테르유도체를 함유한 두타스테리드와 타다라필의 복합 캡슐제제 조성물 및 이의 제조방법
US10278977B2 (en) 2016-06-06 2019-05-07 Umecrine Cognition Ab Methods for treating hypersomnolence
UA128186C2 (uk) 2017-11-27 2024-05-01 Умекрайн Когнішн Аб ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ 3<font face="Symbol">a</font>-ЕТИНІЛ-3<font face="Symbol">b</font>-ГІДРОКСІАНДРОСТАН-17-ОНУ ОКСИМУ

Also Published As

Publication number Publication date
US11123351B2 (en) 2021-09-21
AU2018374029B2 (en) 2024-01-11
JP7314459B2 (ja) 2023-07-26
JP2021504468A (ja) 2021-02-15
IL274893B1 (en) 2024-04-01
US20200297737A1 (en) 2020-09-24
KR20200093008A (ko) 2020-08-04
US10603326B2 (en) 2020-03-31
EP3716954A1 (en) 2020-10-07
UA128186C2 (uk) 2024-05-01
BR112020010519A2 (pt) 2020-10-20
IL274893B2 (en) 2024-08-01
MX2020005442A (es) 2022-03-30
RU2020121142A3 (enExample) 2022-03-28
CN111432805A (zh) 2020-07-17
MX391097B (es) 2025-03-21
AU2018374029A1 (en) 2020-06-18
US20190358244A1 (en) 2019-11-28
NZ764901A (en) 2025-05-02
WO2019102040A1 (en) 2019-05-31
CN111432805B (zh) 2023-02-17
RU2020121142A (ru) 2021-12-29
KR102771577B1 (ko) 2025-02-20
IL274893A (en) 2020-07-30

Similar Documents

Publication Publication Date Title
US11123351B2 (en) Pharmaceutical formulation of 3-alpha-ethynyl-3-beta-hydroxyandrostan-17-one oxime
ES2863500T3 (es) Formulaciones lipídicas de acetato de abiraterona
ES2983643T3 (es) Terapia oral con tridecanoato de testosterona
TW201521719A (zh) 含有脂質化合物、三酸甘油酯及界面活性劑之組成物與使用該組成物之方法
US20220071983A1 (en) Pharmaceutical Composition
AU2015270187A1 (en) Oral pharmaceutical composition of isotretinoin
CN113473974A (zh) 药物组合物
CN114344309A (zh) 一种别孕烷醇酮衍生物自乳化制剂及其制备方法
JP6618488B2 (ja) テストステロンウンデカノエートの安定な製剤
RU2639482C2 (ru) Фармацевтические композиции
AU2006222117A1 (en) Microemulsions of cannabinoid receptor binding compounds
RU2779262C2 (ru) ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ 3α-ЭТИНИЛ-3β-ГИДРОКСИАНДРОСТАН-17-ОНА ОКСИМА
WO2016066611A1 (en) Pharmaceutical compositions containing cinacalcet and methods for their preparation and use
RU2397759C2 (ru) Микроэмульсионные композиции, включающие антагонисты вещества р
BRPI0720489A2 (pt) Cápsulas de gelatina compreendendo um ácido
JP6887520B2 (ja) 経口医薬組成物
CN115804753A (zh) 阿戈美拉汀自微乳组合物、胶囊剂及其应用
WO2025252725A1 (en) Novel pharmaceutical formulation of golexanolone

Legal Events

Date Code Title Description
EEER Examination request

Effective date: 20231123

MFA Maintenance fee for application paid

Free format text: FEE DESCRIPTION TEXT: MF (APPLICATION, 6TH ANNIV.) - STANDARD

Year of fee payment: 6

U00 Fee paid

Free format text: ST27 STATUS EVENT CODE: A-2-2-U10-U00-U101 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE REQUEST RECEIVED

Effective date: 20241017

U11 Full renewal or maintenance fee paid

Free format text: ST27 STATUS EVENT CODE: A-2-2-U10-U11-U102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE PAYMENT DETERMINED COMPLIANT

Effective date: 20241017

Free format text: ST27 STATUS EVENT CODE: A-2-2-U10-U11-U102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE PAYMENT PAID IN FULL

Effective date: 20241017

D15 Examination report completed

Free format text: ST27 STATUS EVENT CODE: A-2-2-D10-D15-D126 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: EXAMINER'S REPORT

Effective date: 20241206

P11 Amendment of application requested

Free format text: ST27 STATUS EVENT CODE: A-2-2-P10-P11-P100 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: AMENDMENT RECEIVED - RESPONSE TO EXAMINER'S REQUISITION

Effective date: 20250325

W00 Other event occurred

Free format text: ST27 STATUS EVENT CODE: A-2-2-W10-W00-W111 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: CORRESPONDENT DETERMINED COMPLIANT

Effective date: 20250402

P11 Amendment of application requested

Free format text: ST27 STATUS EVENT CODE: A-2-2-P10-P11-P102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: AMENDMENT DETERMINED COMPLIANT

Effective date: 20250716

P13 Application amended

Free format text: ST27 STATUS EVENT CODE: A-2-2-P10-P13-X000 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: APPLICATION AMENDED

Effective date: 20250716

MFA Maintenance fee for application paid

Free format text: FEE DESCRIPTION TEXT: MF (APPLICATION, 7TH ANNIV.) - STANDARD

Year of fee payment: 7

U00 Fee paid

Free format text: ST27 STATUS EVENT CODE: A-2-2-U10-U00-U101 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE REQUEST RECEIVED

Effective date: 20251020

U11 Full renewal or maintenance fee paid

Free format text: ST27 STATUS EVENT CODE: A-2-2-U10-U11-U102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE PAYMENT PAID IN FULL

Effective date: 20251020

D22 Grant of ip right intended

Free format text: ST27 STATUS EVENT CODE: A-2-2-D10-D22-D128 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: ALLOWANCE REQUIREMENTS DETERMINED COMPLIANT

Effective date: 20260525

W00 Other event occurred

Free format text: ST27 STATUS EVENT CODE: A-2-2-W10-W00-W100 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: LETTER SENT

Effective date: 20260526