MA50068B1 - Formulations de copanlisib - Google Patents

Formulations de copanlisib

Info

Publication number
MA50068B1
MA50068B1 MA50068A MA50068A MA50068B1 MA 50068 B1 MA50068 B1 MA 50068B1 MA 50068 A MA50068 A MA 50068A MA 50068 A MA50068 A MA 50068A MA 50068 B1 MA50068 B1 MA 50068B1
Authority
MA
Morocco
Prior art keywords
copanlisib
stable
solution containing
stock solution
lyophilization
Prior art date
Application number
MA50068A
Other languages
English (en)
Other versions
MA50068A (fr
Inventor
Julia FREUNDLIEB
Tia JACOBS
Original Assignee
Bayer Pharma Aktiengesellschaft
Bayer Consumer Care Ag
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=63407234&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=MA50068(B1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority claimed from EP17207771.1A external-priority patent/EP3498266A1/fr
Application filed by Bayer Pharma Aktiengesellschaft, Bayer Consumer Care Ag filed Critical Bayer Pharma Aktiengesellschaft
Publication of MA50068A publication Critical patent/MA50068A/fr
Publication of MA50068B1 publication Critical patent/MA50068B1/fr

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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • A61K31/5355—Non-condensed oxazines and containing further heterocyclic rings
    • 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
    • A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • A61K31/5375—1,4-Oxazines, e.g. morpholine
    • A61K31/5377—1,4-Oxazines, e.g. morpholine not condensed and containing further heterocyclic rings, e.g. timolol
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • 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
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • 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
    • A61P35/00—Antineoplastic agents
    • A61P35/02—Antineoplastic agents specific for leukemia

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Inorganic Chemistry (AREA)
  • Dermatology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Oncology (AREA)
  • Hematology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Road Signs Or Road Markings (AREA)
  • Luminescent Compositions (AREA)

Abstract

La présente invention concerne : un procédé de préparation d'une solution mère aqueuse stable contenant du copanlisib, appropriée pour la lyophilisation et pour des applications thérapeutiques ; une solution mère stable contenant du copanlisib, dotée d'une solubilité accrue et directement appropriée pour la lyophilisation ; un procédé de lyophilisation d'une telle solution mère aqueuse contenant du copanlisib ; un solide stable et lyophilisé contenant du copanlisib, en particulier une poudre ou un gâteau, contenant en particulier une dose thérapeutique de copanlisib dans un ou deux contenants, en particulier un contenant scellé ; un procédé de reconstitution de tels lyophilisats ; et une solution reconstituée stable contenant du copanlisib, dotée d'une solubilité accrue, appropriée pour une dilution supplémentaire et pour des applications thérapeutiques.
MA50068A 2017-09-08 2018-09-06 Formulations de copanlisib MA50068B1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
EP17190117 2017-09-08
EP17207771.1A EP3498266A1 (fr) 2017-12-15 2017-12-15 Formulations de copanlisib
PCT/EP2018/073965 WO2019048527A1 (fr) 2017-09-08 2018-09-06 Formulations de copanlisib
EP18762107.3A EP3678644B1 (fr) 2017-09-08 2018-09-06 Formulations de copanlisib

Publications (2)

Publication Number Publication Date
MA50068A MA50068A (fr) 2021-06-02
MA50068B1 true MA50068B1 (fr) 2024-07-31

Family

ID=63407234

Family Applications (1)

Application Number Title Priority Date Filing Date
MA50068A MA50068B1 (fr) 2017-09-08 2018-09-06 Formulations de copanlisib

Country Status (36)

Country Link
US (1) US20200281932A1 (fr)
EP (1) EP3678644B1 (fr)
JP (2) JP2020533292A (fr)
KR (1) KR20200052326A (fr)
CN (1) CN111278430A (fr)
AU (1) AU2018328812A1 (fr)
BR (1) BR112020004545A2 (fr)
CA (1) CA3074890A1 (fr)
CL (1) CL2020000584A1 (fr)
CO (1) CO2020002628A2 (fr)
CR (1) CR20200111A (fr)
CU (1) CU24607B1 (fr)
DK (1) DK3678644T3 (fr)
DO (1) DOP2020000054A (fr)
ES (1) ES2950663T3 (fr)
FI (1) FI3678644T3 (fr)
GE (2) GEP20237486B (fr)
HR (1) HRP20230612T1 (fr)
HU (1) HUE063178T2 (fr)
IL (1) IL272857B2 (fr)
JO (1) JOP20200053A1 (fr)
LT (1) LT3678644T (fr)
MA (1) MA50068B1 (fr)
MX (1) MX2020002633A (fr)
NI (1) NI202000019A (fr)
PE (1) PE20200958A1 (fr)
PH (1) PH12020500448A1 (fr)
PL (1) PL3678644T3 (fr)
RS (1) RS64316B1 (fr)
SG (1) SG11202001696QA (fr)
SI (1) SI3678644T1 (fr)
TW (1) TWI794288B (fr)
UA (1) UA126817C2 (fr)
UY (1) UY37868A (fr)
WO (1) WO2019048527A1 (fr)
ZA (1) ZA202002378B (fr)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA3134943A1 (fr) 2019-03-26 2020-10-01 Pocket Naloxone Corp. Dispositifs et procedes d'administration de compositions pharmaceutiques
US11278709B1 (en) 2021-03-12 2022-03-22 Pocket Naloxone Corp. Drug delivery device and methods for using same
EP4070785B1 (fr) * 2021-04-06 2023-11-08 Synthon B.V. Composition lyophilisée d'un sel de copanlisib
CN115252613B (zh) * 2022-08-09 2024-01-12 北京清华长庚医院 药物组合物及其在逆转仑伐替尼耐药性中的用途
WO2024069239A1 (fr) * 2022-09-28 2024-04-04 Urogen Pharma Ltd. Compositions comprenant un hydrogel thermoréversible et ayant une période d'utilisation étendue

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004029055A1 (fr) 2002-09-30 2004-04-08 Bayer Pharmaceuticals Corporation Derives d'azole-pyrimidines fondues
AR064106A1 (es) 2006-12-05 2009-03-11 Bayer Schering Pharma Ag Derivados de 2,3-dihidroimidazo [1,2-c] quinazolina sustituida utiles para el tratamiento de enfermedades y trastornos hiper-proliferativos asociados con la angiogenesis
EP2508525A1 (fr) 2011-04-05 2012-10-10 Bayer Pharma Aktiengesellschaft Sels de 2,3-dihydroimidazo[1,2-C]quinazoline substitutés
EP3018127A1 (fr) 2014-11-07 2016-05-11 Bayer Pharma Aktiengesellschaft Synthèse de copanlisib et son sel de dichlorhydrate
TN2018000271A1 (en) * 2016-02-01 2020-01-16 Bayer Pharma AG Copanlisib biomarkers.
TN2018000272A1 (en) * 2016-02-01 2020-01-16 Bayer Pharma AG Copanlisib biomarkers

Also Published As

Publication number Publication date
US20200281932A1 (en) 2020-09-10
LT3678644T (lt) 2023-06-26
NI202000019A (es) 2020-08-28
SG11202001696QA (en) 2020-03-30
HRP20230612T1 (hr) 2023-09-29
JP2020533292A (ja) 2020-11-19
KR20200052326A (ko) 2020-05-14
UA126817C2 (uk) 2023-02-08
JOP20200053A1 (ar) 2020-03-08
PH12020500448A1 (en) 2021-02-08
EP3678644A1 (fr) 2020-07-15
HUE063178T2 (hu) 2023-12-28
CL2020000584A1 (es) 2020-08-21
FI3678644T3 (fi) 2023-07-28
TWI794288B (zh) 2023-03-01
MX2020002633A (es) 2020-07-13
JP2023071917A (ja) 2023-05-23
UY37868A (es) 2019-04-30
CO2020002628A2 (es) 2020-04-01
AU2018328812A1 (en) 2020-03-12
DK3678644T3 (da) 2023-07-31
CA3074890A1 (fr) 2019-03-14
ZA202002378B (en) 2023-10-25
PE20200958A1 (es) 2020-09-24
DOP2020000054A (es) 2020-09-30
PL3678644T3 (pl) 2023-09-11
WO2019048527A1 (fr) 2019-03-14
CN111278430A (zh) 2020-06-12
EP3678644B1 (fr) 2023-05-03
RS64316B1 (sr) 2023-08-31
IL272857A (en) 2020-04-30
CU20200017A7 (es) 2020-11-30
MA50068A (fr) 2021-06-02
GEP20237486B (en) 2023-03-27
GEAP202215306A (en) 2022-10-25
CU24607B1 (es) 2022-06-06
CR20200111A (es) 2020-07-24
BR112020004545A2 (pt) 2020-09-08
IL272857B2 (en) 2024-03-01
ES2950663T3 (es) 2023-10-11
SI3678644T1 (sl) 2023-08-31
IL272857B1 (en) 2023-11-01
TW201919636A (zh) 2019-06-01

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