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1. WO2022002905 - PARENTERAL PHARMACEUTICAL COMPOSITION COMPRISING AZACITIDINE IN DMSO

Publication Number WO/2022/002905
Publication Date 06.01.2022
International Application No. PCT/EP2021/067796
International Filing Date 29.06.2021
IPC
A61K 31/706 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
70Carbohydrates; Sugars; Derivatives thereof
7042Compounds having saccharide radicals and heterocyclic rings
7052having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
706containing six-membered rings with nitrogen as a ring hetero atom
A61K 9/00 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
A61K 47/20 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
20containing sulfur, e.g. dimethyl sulfoxide , docusate, sodium lauryl sulfate or aminosulfonic acids
A61P 35/02 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
35Antineoplastic agents
02specific for leukemia
A61K 9/08 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
08Solutions
CPC
A61K 31/706
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
70Carbohydrates; Sugars; Derivatives thereof
7042Compounds having saccharide radicals and heterocyclic rings
7052having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
706containing six-membered rings with nitrogen as a ring hetero atom
A61K 41/17
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
41Medicinal preparations obtained by treating materials with wave energy or particle radiation ; ; Therapies using these preparations
10Inactivation or decontamination of a medicinal preparation prior to administration to an animal or a person
17by ultraviolet [UV] or infrared [IR] light, X-rays or gamma rays
A61K 47/20
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
20containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
A61K 9/0019
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
0012Galenical forms characterised by the site of application
0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
A61K 9/08
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
08Solutions
A61P 35/02
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
35Antineoplastic agents
02specific for leukemia
Applicants
  • SANDOZ AG [CH]/[CH]
Inventors
  • TOLDY, Arpad
  • LITTRINGER, Eva
  • OBERER, Katri Rouvali
Agents
  • TER MEER STEINMEISTER & PARTNER PATENTANWÄLTE MBB
Priority Data
20183501.401.07.2020EP
Publication Language English (en)
Filing Language English (EN)
Designated States
Title
(EN) PARENTERAL PHARMACEUTICAL COMPOSITION COMPRISING AZACITIDINE IN DMSO
(FR) COMPOSITION PHARMACEUTIQUE PARENTÉRALE COMPRENANT DE L'AZACITIDINE DANS DU DMSO
Abstract
(EN) A parenteral pharmaceutical composition comprising azacitidine and dimethyl sulfoxide, wherein the pharmaceutical composition comprises azacitidine at a concentration of from 40 mg/mL to 340 mg/mL. An injection syringe, a cartridge, a container or a vial containing the pharmaceutical composition for single or multiple dosing. The pharmaceutical composition for use in the treatment of myelodysplastic syndrome, acute myelomonocytic leukemia or chronic myelomonocytic leukemia. A kit of parts comprising the pharmaceutical composition in a vial, cartridge or container and an injection device. A method for preparing the pharmaceutical composition comprising the steps of (a) providing azacitidine or decitabine; and (b) mixing the azacitidine or the decitabine with dimethyl sulfoxide to provide the pharmaceutical composition. An infusion composition obtainable by mixing the pharmaceutical composition and an infusion solution.
(FR) L'invention concerne une composition pharmaceutique parentérale comprenant de l'azacitidine et du diméthylsulfoxyde, la composition pharmaceutique comprenant de l'azacitidine à une concentration de 40 mg/mL à 340 mg/mL. L'invention concerne une seringue d'injection, une cartouche, un récipient ou un flacon contenant la composition pharmaceutique pour un dosage simple ou multiple. L'invention concerne la composition pharmaceutique destinée à être utilisée dans le traitement du syndrome myélodysplasique, de la leucémie myélomonocytaire aiguë ou de la leucémie myélomonocytaire chronique. L'invention concerne également un kit de pièces comprenant la composition pharmaceutique dans un flacon, une cartouche ou un récipient et un dispositif d'injection. L'invention concerne également une méthode de préparation de la composition pharmaceutique comprenant les étapes consistant à (a) fournir de l'azacitidine ou de la decitabine; et (b) mélanger l'azacitidine ou la decitabine avec du diméthylsulfoxyde pour obtenir la composition pharmaceutique. L'invention concerne également une composition de perfusion pouvant être obtenue par mélange de la composition pharmaceutique et d'une solution de perfusion.
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