HRP20191477T1 - Farmaceutski sastav s-ketamin hidroklorida - Google Patents

Farmaceutski sastav s-ketamin hidroklorida Download PDF

Info

Publication number
HRP20191477T1
HRP20191477T1 HRP20191477T HRP20191477T1 HR P20191477 T1 HRP20191477 T1 HR P20191477T1 HR P20191477 T HRP20191477 T HR P20191477T HR P20191477 T1 HRP20191477 T1 HR P20191477T1
Authority
HR
Croatia
Prior art keywords
pharmaceutical composition
depression
composition according
present
pharmaceutical
Prior art date
Application number
Other languages
English (en)
Inventor
Esther D G Basstanie
Johanna Bentz
Roger C A Embrechts
Nico Rudolph Niemeiijer
Original Assignee
Janssen Pharmaceutica Nv
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=50549465&utm_source=***_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HRP20191477(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Janssen Pharmaceutica Nv filed Critical Janssen Pharmaceutica Nv
Publication of HRP20191477T1 publication Critical patent/HRP20191477T1/hr

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/135Amines having aromatic rings, e.g. ketamine, nortriptyline
    • 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
    • A61K47/02Inorganic compounds
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K9/0043Nose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/24Antidepressants
    • YGENERAL 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
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Otolaryngology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pain & Pain Management (AREA)
  • Psychiatry (AREA)
  • Organic Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Inorganic Chemistry (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)

Claims (15)

1. Farmaceutski sastav koji obuhvaća S-ketamin hidroklorid i vodu; pri čemu farmaceutski sastav ne obuhvaća antimikrobni konzervans; pri čemu S-ketamin hidroklorid se nalazi u koncentraciji od najmanje ekv. 120 mg/mL, na temelju ukupnog volumena sastava.
2. Farmaceutski sastav prema zahtjevu 1, koji (i) dodatno sadrži pufer; i/ili (ii) ima pH vrijednost u opsegu od 4.0 do 6.5.
3. Farmaceutski sastav prema zahtjevu 1, pri čemu S-ketamin hidroklorid se nalazi u koncentraciji u opsegu od ekv. 125 mg/mL do ekv. 150 mg/mL, na temelju ukupnog volumena sastava; ili pri čemu S-ketamin hidroklorid se nalazi u koncentraciji u opsegu od 126 mg / mL do 162 mg/mL, na temelju ukupnog volumena sastava.
4. Farmaceutski sastav prema zahtjevu 1, pri čemu je farmaceutski sastav formuliran za nazalnu primjenu.
5. Farmaceutski sastav prema zahtjevu 1, pri čemu farmaceutski sastav dalje sadrži pufer.
6. Farmaceutski sastav prema zahtjevu 5, pri čemu je pufer 1N NaOH.
7. Farmaceutski sastav prema zahtjevu 5, pri čemu se pufer nalazi u količini koja je dovoljna da se podesi pH farmaceutskog sastava do pH u opsegu od pH 3.5 do pH 6.5; ili pri čemu se pufer nalazi u količini koja je dovoljna da se podesi pH sastava do pH u opsegu od pH 4.5 do pH 5.5.
8. Farmaceutski sastav prema zahtjevu 1, pri čemu farmaceutski sastav pokazuje vrijeme trajanja pod ubrzanim uvjetima skladištenja od najmanje 3 mjeseca.
9. Farmaceutski oblik doziranja koji obuhvaća farmaceutski sastav prema bilo kojem od zahtjeva 1-8.
10. Oblik doziranja prema zahtjevu 9, koji je prilagođen za nazalnu primjenu.
11. Farmaceutski sastav prema zahtjevu 1 ili farmaceutski oblik doziranja prema zahtjevu 9 za upotrebu u liječenju depresije.
12. Farmaceutski sastav ili farmaceutski oblik doziranja za upotrebu prema zahtjevu 11, pri čemu je depresija odabrana iz grupe koja obuhvaća veliki depresivni poremećaj, unipolarnu depresiju, liječenje refraktorne depresije, rezistentnu depresiju, anksioznu depresiju i bipolarnu depresiju.
13. Farmaceutski sastav ili farmaceutski oblik doziranja za upotrebu prema zahtjevu 11, pri čemu je depresija odabrana iz grupe koja obuhvaća rezistentnu depresiju ili liječenje refraktorne depresije.
14. Farmaceutski sastav prema zahtjevu 1, koji obuhvaća S-ketamin HCl; limunsku kiselinu; dinatrijev edetat; natrijev hidroksid; i vodu.
15. Farmaceutski sastav prema zahtjevu 1, koji obuhvaća (a) S-ketamin HCl; pri čemu se S-Ketamin HCl nalazi u količini od oko 161.4 mg/ml; (b) limunsku kiselinu 1 vodu; pri čemu se limunska kiselina nalazi u količini od oko 1.5 mg/ml; (c) dinatrijev edetat; pri čemu se dinatrijev edetat nalazi u količini od oko 0.12 mg/ml; (d) natrijev hidroksid; pri čemu se natrijev hidroksid nalazi u količini koja je dovoljna da se podesi pH farmaceutskog sastava do pH od oko 4.5; i (e) vodu.
HRP20191477 2013-03-15 2019-08-14 Farmaceutski sastav s-ketamin hidroklorida HRP20191477T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201361791505P 2013-03-15 2013-03-15
EP14719471.6A EP2968221B1 (en) 2013-03-15 2014-03-14 Pharmaceutical composition of s-ketamine hydrochloride
PCT/US2014/027074 WO2014143646A1 (en) 2013-03-15 2014-03-14 Pharmaceutical composition of s-ketamine hydrochloride

Publications (1)

Publication Number Publication Date
HRP20191477T1 true HRP20191477T1 (hr) 2019-12-13

Family

ID=50549465

Family Applications (1)

Application Number Title Priority Date Filing Date
HRP20191477 HRP20191477T1 (hr) 2013-03-15 2019-08-14 Farmaceutski sastav s-ketamin hidroklorida

Country Status (25)

Country Link
US (2) US20140275276A1 (hr)
EP (3) EP2968221B1 (hr)
KR (3) KR20230156807A (hr)
CN (3) CN111297803A (hr)
AU (6) AU2014228324B2 (hr)
CL (1) CL2015002733A1 (hr)
CR (1) CR20150480A (hr)
CY (1) CY1121928T1 (hr)
DK (1) DK2968221T3 (hr)
ES (1) ES2745024T3 (hr)
HR (1) HRP20191477T1 (hr)
HU (1) HUE045982T2 (hr)
LT (1) LT2968221T (hr)
ME (1) ME03465B (hr)
MX (1) MX2015012342A (hr)
MY (1) MY191332A (hr)
NZ (1) NZ712270A (hr)
PE (2) PE20191796A1 (hr)
PH (1) PH12015501957A1 (hr)
PL (1) PL2968221T3 (hr)
PT (1) PT2968221T (hr)
RS (1) RS59130B1 (hr)
SG (3) SG11201507358VA (hr)
SI (1) SI2968221T1 (hr)
WO (1) WO2014143646A1 (hr)

Families Citing this family (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015037248A1 (en) 2013-09-13 2015-03-19 National University Corporation Chiba University Application of r-ketamine and salt thereof as pharmaceuticals
CA2936809A1 (en) 2014-01-14 2015-07-23 Children's Hospital Medical Center Compositions comprising ketamine for treating an autism spectrum disorder
US9844551B2 (en) 2015-01-14 2017-12-19 Children's Hospital Medical Center Compositions and methods for treatment of fragile X syndrome
US20160332962A1 (en) 2015-05-13 2016-11-17 Janssen Pharmaceutica Nv (s)-csa salt of s-ketamine, (r)-csa salt of s-ketamine and processes for the preparation of s-ketamine
CN106562952B (zh) * 2015-10-09 2020-06-09 江阴安博生物医药有限公司 ***在治疗重性抑郁障碍中的应用
WO2018191482A2 (en) * 2017-04-13 2018-10-18 Ovid Therapeutics Inc. Methods of treating developmental encephalopathies
EP3505157B1 (en) 2017-12-29 2021-12-08 Celon Pharma S.A. Dry powder ketamine composition for pulmonary administration in treatment-resistant depression
JPWO2019160057A1 (ja) 2018-02-15 2021-02-04 国立大学法人千葉大学 炎症性疾患若しくは骨疾患の予防又は治療剤及び医薬組成物
AU2019262197A1 (en) 2018-05-04 2020-11-26 Perception Neuroscience, Inc. Methods of treating substance abuse
EP3628313A1 (en) 2018-09-28 2020-04-01 Celon Pharma S.A. Ketamine composition for use in a method of treatment of depression by pulmonary administration
CA3140035A1 (en) 2019-05-31 2020-12-03 Celon Pharma S.A. An inhaler for electronically supervised parenteral administration of a pharmaceutical composition
JP2022542746A (ja) 2019-05-31 2022-10-07 セロン ファーマ エス.アー. 医薬組成物の電子的に監督された投与
JP2022548233A (ja) * 2019-09-13 2022-11-17 ヤンセン ファーマシューティカルズ,インコーポレーテッド エスケタミンの鼻腔内投与
US11160799B2 (en) * 2019-10-22 2021-11-02 Cessatech A/S Pediatric combination
AR120816A1 (es) * 2019-12-20 2022-03-23 Alar Pharmaceuticals Inc Formulaciones inyectables de larga duración de sales de pamoato de ketamina
CN114903840A (zh) * 2021-02-08 2022-08-16 四川普锐特药业有限公司 一种治疗抑郁症的低剂量r-***经鼻药物
CN113813250B (zh) * 2021-07-21 2023-05-05 广州新济药业科技有限公司 含***的药物组合物及其制备方法和应用
CN116942647A (zh) * 2022-04-26 2023-10-27 宜昌人福药业有限责任公司 艾司***液体制剂及其用途
US12005035B1 (en) * 2023-08-14 2024-06-11 Daniel C. Javitt Compositions and methods for treatment of chronic pain and depression

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE4312016A1 (de) 1993-04-13 1994-10-20 Goedecke Ag Stabile Ketamin-Lösungen
US6572849B2 (en) * 2000-09-20 2003-06-03 Lee Shahinian, Jr. Self-preserved antibacterial nasal, inhalable, and topical ophthalmic preparations and medications
US6881731B1 (en) 2000-10-23 2005-04-19 Shanbrom Technologies, Llc Enhancers for microbiological disinfection
US8785500B2 (en) * 2006-03-22 2014-07-22 Icahn School Of Medicine At Mount Sinai Intranasal administration of ketamine to treat depression
DE102007009888A1 (de) * 2007-02-28 2008-09-04 Hermann, Holger Lars, Dr. Verwendung von S-(+)-Ketamin zur Behandlung von Depressionen
JP6722453B2 (ja) * 2012-08-23 2020-07-15 スチュアート エル ウェグ 抗不安薬組成物、製剤および使用方法

Also Published As

Publication number Publication date
RS59130B1 (sr) 2019-09-30
AU2014228324B2 (en) 2019-01-31
US20140275277A1 (en) 2014-09-18
SG10201912735TA (en) 2020-02-27
KR20210028278A (ko) 2021-03-11
PH12015501957A1 (en) 2016-01-11
ES2745024T3 (es) 2020-02-27
KR20230156807A (ko) 2023-11-14
CL2015002733A1 (es) 2016-03-04
NZ712270A (en) 2020-02-28
AU2014228324A1 (en) 2015-09-17
KR20150129023A (ko) 2015-11-18
EP4309735A2 (en) 2024-01-24
DK2968221T3 (da) 2019-08-05
EP2968221B1 (en) 2019-06-19
AU2023200976A1 (en) 2023-03-23
CR20150480A (es) 2015-10-26
CY1121928T1 (el) 2020-10-14
EP3498268A1 (en) 2019-06-19
AU2019200705B2 (en) 2020-10-08
BR112015022970A8 (pt) 2019-11-26
US20140275276A1 (en) 2014-09-18
ME03465B (me) 2020-01-20
MX2015012342A (es) 2016-06-06
CN105073103A (zh) 2015-11-18
AU2019200705A1 (en) 2019-02-21
AU2019200696B2 (en) 2020-10-08
PT2968221T (pt) 2019-09-13
SI2968221T1 (sl) 2019-08-30
AU2019200702A1 (en) 2019-02-21
PE20160052A1 (es) 2016-01-28
SG11201507358VA (en) 2015-10-29
WO2014143646A1 (en) 2014-09-18
SG10201802106TA (en) 2018-04-27
CN116251084A (zh) 2023-06-13
AU2019200696A1 (en) 2019-02-21
BR112015022970A2 (pt) 2017-07-18
LT2968221T (lt) 2019-07-25
AU2019200702B2 (en) 2020-10-08
AU2021200072A1 (en) 2021-03-18
MY191332A (en) 2022-06-16
PL2968221T3 (pl) 2020-01-31
EP2968221A1 (en) 2016-01-20
HUE045982T2 (hu) 2020-01-28
PE20191796A1 (es) 2019-12-24
CN111297803A (zh) 2020-06-19
EP4309735A3 (en) 2024-04-17

Similar Documents

Publication Publication Date Title
HRP20191477T1 (hr) Farmaceutski sastav s-ketamin hidroklorida
HRP20171256T1 (hr) Farmaceutski pripravci karbetocina
HRP20200434T1 (hr) Stabilne vodene formulacije adalimumaba
HRP20191957T1 (hr) Policiklični-karbamoilpiridonski spojevi i njihova farmaceutska upotreba
BR112018000592A2 (pt) composição de desbloqueio de nariz congestionado tendo atividade antiviral
BR112017010551A2 (pt) composto, métodos para ativação de guanilato ciclase solúvel, para tratamento de uma ou mais condições selecionadas a partir de uma doença em um paciente e para tratamento de uma doença ou condição, composição farmacêutica, uso de um composto, e, medicamento.
JP2015527402A5 (hr)
BR112015029512A2 (pt) derivados de pirazolopirrolidina e seu uso no tratamento de doenças
JP2015534562A5 (hr)
BR112015022972A2 (pt) composição farmacêutica de cloridrato de s-cetamina
HRP20171092T1 (hr) Stabilna tekuća formulacija amg 416 (velkalcetid)
EA201291410A1 (ru) Фармацевтические композиции, содержащие 4-амино-5-фтор-3-[6-(4-метилпиперазин-1-ил)-1h-бензимидазол-2-ил]-1h-хинолин-2-она лактат моногидрат
BR112015029401A8 (pt) derivados de pirazolo-pirrolidin-4-ona, seus usos, e composição e combinação farmacêuticas
SI2889033T1 (en) Treatment of negative symptoms of schizophrenia with (R) -7-chloro-N- (chonylidin-3-yl) benzo (B) thiophene-2-carboxamide and pharmaceutically acceptable salts thereof
RS54711B1 (en) PARENTERAL TAPENTADOL ADMINISTRATION
JP2018532806A5 (hr)
BR112012030641A2 (pt) métodos e composições para terapia farmacêutica oral
RS54632B1 (en) LIQUID PHARMACEUTICAL COMPOSITION CONTAINING NITIZINON
HRP20240166T1 (hr) Postupak liječenja prader-willijevog sindroma
HRP20210010T1 (hr) Injekcijske farmaceutske formulacije lefamulina
MX2019003698A (es) Composicion que comprende al menos una sal farmaceuticamente aceptable de elafibranor soluble en medio acuoso que muestra una absorcion intestinal mejorada.
HRP20201598T1 (hr) Pripravci
HRP20211308T1 (hr) Veterinarski postupak za izazivanje emeze
EA201992382A2 (ru) Пероральная таблетированная фармацевтическая композиция двойного применения на основе сульфатных солей и способы ее применения
BR112015025058A2 (pt) composição farmacêutica capaz de controlar facilmente o padrão de dissolução de lacosamida ou de um sal farmaceuticamente aceitável da mesma