MX2021014614A - Composiciones terapeuticas estables en solventes polares aproticos y metodos de elaboracion de las mismas. - Google Patents

Composiciones terapeuticas estables en solventes polares aproticos y metodos de elaboracion de las mismas.

Info

Publication number
MX2021014614A
MX2021014614A MX2021014614A MX2021014614A MX2021014614A MX 2021014614 A MX2021014614 A MX 2021014614A MX 2021014614 A MX2021014614 A MX 2021014614A MX 2021014614 A MX2021014614 A MX 2021014614A MX 2021014614 A MX2021014614 A MX 2021014614A
Authority
MX
Mexico
Prior art keywords
aprotic polar
methods
formulations
polar solvents
manufacturing
Prior art date
Application number
MX2021014614A
Other languages
English (en)
Inventor
Martin Donovan
Wendy Hu
Original Assignee
Xeris Pharmaceuticals 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 Xeris Pharmaceuticals Inc filed Critical Xeris Pharmaceuticals Inc
Publication of MX2021014614A publication Critical patent/MX2021014614A/es

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/26—Glucagons
    • 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
    • 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
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • 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
    • A61K51/00—Preparations containing radioactive substances for use in therapy or testing in vivo
    • A61K51/12—Preparations containing radioactive substances for use in therapy or testing in vivo characterised by a special physical form, e.g. emulsion, microcapsules, liposomes, characterized by a special physical form, e.g. emulsions, dispersions, microcapsules
    • A61K51/121—Solutions, i.e. homogeneous liquid formulation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Diabetes (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Endocrinology (AREA)
  • Immunology (AREA)
  • Inorganic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Hematology (AREA)
  • Organic Chemistry (AREA)
  • Obesity (AREA)
  • Emergency Medicine (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Dermatology (AREA)
  • Dispersion Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Optics & Photonics (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

La presente invención se refiere al uso de solventes polares apróticos, agua, y un agente estabilizador de ionización para preparar formulaciones terapéuticas estables compatibles con el dispositivo al disolver un agente terapéutico (ingrediente activo) en un sistema de solvente polar aprótico que luego se puede usar con diversos dispositivos (por ejemplo, bombas, equipos de infusión) para administración de la formulación. En ciertas formas de realización, la invención se dirige a formulaciones que comprenden uno o más agentes terapéuticos, así como métodos para hacer tales formulaciones, que comprenden al menos un agente terapéutico disuelto en un sistema de solvente polar aprótico, tal como una mezcla de DMSO/agua, que comprende al menos un excipiente estabilizador de ionización en una concentración suficiente para impartir estabilidad física y química al agente terapéutico.
MX2021014614A 2019-05-31 2020-05-29 Composiciones terapeuticas estables en solventes polares aproticos y metodos de elaboracion de las mismas. MX2021014614A (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201962855134P 2019-05-31 2019-05-31
PCT/US2020/035172 WO2020243464A1 (en) 2019-05-31 2020-05-29 Stable therapeutic compositions in aprotic polar solvents and methods of manufacturing the same

Publications (1)

Publication Number Publication Date
MX2021014614A true MX2021014614A (es) 2022-01-06

Family

ID=71094894

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2021014614A MX2021014614A (es) 2019-05-31 2020-05-29 Composiciones terapeuticas estables en solventes polares aproticos y metodos de elaboracion de las mismas.

Country Status (12)

Country Link
US (2) US11576951B2 (es)
EP (1) EP3975993A1 (es)
JP (1) JP2022534291A (es)
KR (1) KR20220024061A (es)
CN (1) CN114144170B (es)
AU (1) AU2020284104A1 (es)
BR (1) BR112021023549A2 (es)
CA (1) CA3141872A1 (es)
CO (1) CO2021016449A2 (es)
IL (1) IL288453A (es)
MX (1) MX2021014614A (es)
WO (1) WO2020243464A1 (es)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024086699A1 (en) * 2022-10-19 2024-04-25 Xeris Pharmaceuticals, Inc. Sustained release injectable formulations using aprotic polar solvents
US20240148680A1 (en) * 2022-10-19 2024-05-09 Xeris Pharmaceuticals, Inc. Stable levothyroxine compositions in aprotic polar solvents

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4727041A (en) 1986-04-16 1988-02-23 Chaovanee Aroonsakul Method of diagnosing Alzheimer's disease
US5065747A (en) 1989-11-21 1991-11-19 University Of South Florida Method for improving the accuracy of diagnosis of growth hormone deficiency
GB0716385D0 (en) * 2007-08-22 2007-10-03 Camurus Ab Formulations
CN105853348B (zh) 2011-03-10 2019-08-30 Xeris药物公司 肠胃外注射用稳定溶液
WO2013067022A1 (en) 2011-10-31 2013-05-10 Xeris Pharmaceuticals, Inc. Formulations for the treatment of diabetes
US9649364B2 (en) * 2015-09-25 2017-05-16 Xeris Pharmaceuticals, Inc. Methods for producing stable therapeutic formulations in aprotic polar solvents
WO2016196976A1 (en) * 2015-06-04 2016-12-08 Xeris Pharmaceuticals, Inc. Glucagon delivery apparatuses and related methods
WO2016201248A1 (en) 2015-06-10 2016-12-15 Xeris Pharmaceuticals, Inc. Use of low dose glucagon
CN111565740A (zh) 2017-12-22 2020-08-21 Xeris药物公司 治疗1型糖尿病和使用胰岛素的2型糖尿病中由运动引起的低血糖

Also Published As

Publication number Publication date
US20230346891A1 (en) 2023-11-02
US11576951B2 (en) 2023-02-14
CA3141872A1 (en) 2020-12-03
US11957736B2 (en) 2024-04-16
WO2020243464A1 (en) 2020-12-03
AU2020284104A1 (en) 2021-12-16
BR112021023549A2 (pt) 2022-01-04
CN114144170A (zh) 2022-03-04
CO2021016449A2 (es) 2021-12-10
JP2022534291A (ja) 2022-07-28
KR20220024061A (ko) 2022-03-03
IL288453A (en) 2022-01-01
CN114144170B (zh) 2024-04-05
EP3975993A1 (en) 2022-04-06
US20200376083A1 (en) 2020-12-03

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