DK3442586T3 - Stabil parenteral nimopidinformulering - Google Patents

Stabil parenteral nimopidinformulering Download PDF

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Publication number
DK3442586T3
DK3442586T3 DK17783039.5T DK17783039T DK3442586T3 DK 3442586 T3 DK3442586 T3 DK 3442586T3 DK 17783039 T DK17783039 T DK 17783039T DK 3442586 T3 DK3442586 T3 DK 3442586T3
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DK
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Prior art keywords
nimopide
informulation
stable parenteral
parenteral
stable
Prior art date
Application number
DK17783039.5T
Other languages
English (en)
Inventor
S George Kottayil
Amresh Kumar
Prasanna Sunthankar
Vimal Kavuru
Original Assignee
Acasti Pharma U S Inc
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 Acasti Pharma U S Inc filed Critical Acasti Pharma U S Inc
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Publication of DK3442586T3 publication Critical patent/DK3442586T3/da

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    • 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
    • A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
    • A61K9/1075—Microemulsions or submicron emulsions; Preconcentrates or solids thereof; Micelles, e.g. made of phospholipids or block copolymers
    • 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
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/455—Nicotinic acids, e.g. niacin; Derivatives thereof, e.g. esters, amides
    • 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
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4422—1,4-Dihydropyridines, e.g. nifedipine, nicardipine
    • 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
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/24—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
    • 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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
    • 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
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • 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
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/04—Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
    • 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
    • A61P9/06—Antiarrhythmics
    • 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
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • 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
    • A61P9/12—Antihypertensives
DK17783039.5T 2016-04-13 2017-04-12 Stabil parenteral nimopidinformulering DK3442586T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201662322008P 2016-04-13 2016-04-13
PCT/US2017/027164 WO2017180718A1 (en) 2016-04-13 2017-04-12 Stable nimopidine parenteral formulation

Publications (1)

Publication Number Publication Date
DK3442586T3 true DK3442586T3 (da) 2022-09-12

Family

ID=60039305

Family Applications (1)

Application Number Title Priority Date Filing Date
DK17783039.5T DK3442586T3 (da) 2016-04-13 2017-04-12 Stabil parenteral nimopidinformulering

Country Status (18)

Country Link
US (3) US10092557B2 (da)
EP (2) EP4032527A1 (da)
JP (3) JP2019511522A (da)
KR (1) KR20190005871A (da)
CN (2) CN109069651A (da)
AU (2) AU2017249396A1 (da)
BR (1) BR112018070960A2 (da)
CA (1) CA3021237A1 (da)
DK (1) DK3442586T3 (da)
EA (1) EA201891977A1 (da)
ES (1) ES2927490T3 (da)
HR (1) HRP20221100T1 (da)
HU (1) HUE059921T2 (da)
IL (1) IL262335A (da)
PL (1) PL3442586T3 (da)
PT (1) PT3442586T (da)
SI (1) SI3442586T1 (da)
WO (1) WO2017180718A1 (da)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018132728A1 (en) * 2017-01-12 2018-07-19 Duke University Compositions and methods for the treatment of demyelinating conditions
US10342787B1 (en) 2018-01-25 2019-07-09 Arbor Pharmaceuticals, Llc Non-aqueous liquid nimodipine compositions
US11517563B2 (en) 2018-01-25 2022-12-06 Azurity Pharmaceuticals, Inc. Liquid nimodipine compositions
US20190255033A1 (en) * 2018-02-22 2019-08-22 Nortic Holdings Inc. Stable Nimodipine Parenteral Formulation
US11278575B2 (en) 2018-07-12 2022-03-22 Duke University Compositions and methods for the treatment of demyelinating conditions
US20210338649A1 (en) * 2018-09-08 2021-11-04 Jiangsu Jiuxu Haitian Pharmaceutical Co., Ltd. Nimodipine injection composition and preparation method therefor
US20200163947A1 (en) * 2018-11-02 2020-05-28 Nortic Holdings Inc. Methods of treatment using nimodipine parenteral formulations
US20240091147A1 (en) * 2019-11-25 2024-03-21 Fordoz Pharma Corp. Oral liquid formulations of lipid-lowering and blood pressure-lowering drugs
CN112137956A (zh) * 2020-10-26 2020-12-29 辰欣药业股份有限公司 一种尼莫地平缓释乳注射液的制备方法
CN113509434A (zh) * 2021-04-26 2021-10-19 广东金城金素制药有限公司 尼莫地平口服溶液、其制备方法和应用
WO2023140582A1 (ko) * 2022-01-24 2023-07-27 주식회사 엘지화학 이소옥사졸린 유도체를 포함하는 주사용 제제
US20230364068A1 (en) * 2022-05-16 2023-11-16 Acasti Pharma U.S., Inc. Nimodipine Parenteral Administration
CN115990262A (zh) * 2022-06-27 2023-04-21 北京德立福瑞医药科技有限公司 不含乙醇和磷脂的湿热灭菌的尼莫地平组合物及其制备方法
CN116350586B (zh) * 2023-04-19 2024-02-20 山东泰合医药科技有限公司 一种尼莫地平胶束注射液及其制备方法

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DE3316510A1 (de) 1983-05-06 1984-11-08 Bayer Ag Parenterale formulierung von nimodipin, ein verfahren zu ihrer herstellung sowie ihre verwendung bei der bekaempfung von erkrankungen
US4879308A (en) 1987-08-11 1989-11-07 Lyphomed, Inc. Aqueous nitroglycerin injection and manufacturing process
DE4440337A1 (de) * 1994-11-11 1996-05-15 Dds Drug Delivery Services Ges Pharmazeutische Nanosuspensionen zur Arzneistoffapplikation als Systeme mit erhöhter Sättigungslöslichkeit und Lösungsgeschwindigkeit
US6363471B1 (en) 2000-01-03 2002-03-26 Advanced Micro Devices, Inc. Mechanism for handling 16-bit addressing in a processor
EP1425311A4 (en) 2001-01-11 2004-12-01 Eastman Chem Co CYCLODEXTRINSULFONATES, GUEST INCLUDING COMPLEXES, METHOD FOR THEIR PRODUCTION AND RELATED MATERIALS
DE10124952A1 (de) * 2001-05-21 2002-12-12 Bayer Ag Verfahren zur Herstellung von Nanodispersionen
US6566347B1 (en) 2001-08-22 2003-05-20 Duquesne University Of The Holy Ghost Controlled release pharmaceutical
US20040247624A1 (en) * 2003-06-05 2004-12-09 Unger Evan Charles Methods of making pharmaceutical formulations for the delivery of drugs having low aqueous solubility
CN1183908C (zh) * 2003-08-08 2005-01-12 北京四环科宝制药有限公司 一种尼莫地平的注射用药物组合物及其制备方法
CN1589795A (zh) * 2003-09-04 2005-03-09 范敏华 尼莫地平冻干组合物及其制备方法
EP1933837A4 (en) * 2005-10-14 2009-07-15 Transform Pharmaceuticals Inc PHARMACEUTICAL LIQUID COMPOSITIONS OF NIMODIPIN
CN101129366A (zh) * 2007-08-23 2008-02-27 沈阳万爱普利德医药科技有限公司 一种尼莫地平药物组合物及其制备方法
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Also Published As

Publication number Publication date
CA3021237A1 (en) 2017-10-19
KR20190005871A (ko) 2019-01-16
CN109069651A (zh) 2018-12-21
BR112018070960A2 (pt) 2019-01-29
HUE059921T2 (hu) 2023-01-28
EA201891977A1 (ru) 2019-09-30
US20180325886A1 (en) 2018-11-15
EP3442586B1 (en) 2022-06-08
ES2927490T3 (es) 2022-11-07
PL3442586T3 (pl) 2023-01-30
EP3442586A1 (en) 2019-02-20
EP4032527A1 (en) 2022-07-27
AU2017249396A1 (en) 2018-10-18
US20170296527A1 (en) 2017-10-19
WO2017180718A1 (en) 2017-10-19
JP2021011488A (ja) 2021-02-04
JP2022009013A (ja) 2022-01-14
SI3442586T1 (sl) 2023-01-31
IL262335A (en) 2018-11-29
US10092557B2 (en) 2018-10-09
CN114886850A (zh) 2022-08-12
US20200397773A1 (en) 2020-12-24
US11433062B2 (en) 2022-09-06
AU2020201863B2 (en) 2022-04-28
JP7196373B2 (ja) 2022-12-27
EP3442586A4 (en) 2019-11-20
US10765671B2 (en) 2020-09-08
AU2020201863A1 (en) 2020-04-02
HRP20221100T1 (hr) 2022-11-25
PT3442586T (pt) 2022-09-28
JP2019511522A (ja) 2019-04-25

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