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PE20221575A1 - Formulaciones farmaceuticas - Google Patents

Formulaciones farmaceuticas

Info

Publication number
PE20221575A1
PE20221575A1 PE2022001525A PE2022001525A PE20221575A1 PE 20221575 A1 PE20221575 A1 PE 20221575A1 PE 2022001525 A PE2022001525 A PE 2022001525A PE 2022001525 A PE2022001525 A PE 2022001525A PE 20221575 A1 PE20221575 A1 PE 20221575A1
Authority
PE
Peru
Prior art keywords
approximately
concentration
pharmaceutical formulations
acid
formulations
Prior art date
Application number
PE2022001525A
Other languages
English (en)
Inventor
Tommy Sander
Christian Poulsen
Rosa Rebecca Erritzøe Hansen
Original Assignee
Novo Nordisk As
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=74668840&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=PE20221575(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Novo Nordisk As filed Critical Novo Nordisk As
Publication of PE20221575A1 publication Critical patent/PE20221575A1/es

Links

Classifications

    • 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
    • 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
    • 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
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4164—1,3-Diazoles
    • A61K31/4172—Imidazole-alkanecarboxylic acids, e.g. histidine
    • 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
    • A61K38/1703—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/19—Syringes having more than one chamber, e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly
    • 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
    • A61P3/04—Anorexiants; Antiobesity agents

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Immunology (AREA)
  • Dermatology (AREA)
  • Inorganic Chemistry (AREA)
  • Endocrinology (AREA)
  • Hematology (AREA)
  • Molecular Biology (AREA)
  • Marine Sciences & Fisheries (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Diabetes (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Obesity (AREA)
  • Biophysics (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Biochemistry (AREA)
  • Child & Adolescent Psychology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

Esta referida a una formulacion farmaceutica acuosa que comprende cagrilintida; un tampon que es: acido glutamico/glutamato, en una concentracion de aproximadamente 2-10 mM; o acido lactico/lactato, en una concentracion de aproximadamente 2-35 mM; o acido acetico/acetato, en una concentracion de aproximadamente 2-10 mM; 90-99 % p/p de agua; y un pH de 3.5-4.5. Dicha composicion permite su presentacion y administracion mediante un dispositivo medico de doble camara. Las formulaciones son utiles en el tratamiento de enfermedades, tales como diabetes y/u obesidad y/o comorbilidades relacionadas.
PE2022001525A 2020-02-18 2021-02-17 Formulaciones farmaceuticas PE20221575A1 (es)

Applications Claiming Priority (8)

Application Number Priority Date Filing Date Title
EP20157963 2020-02-18
EP20171240 2020-04-24
EP20180645 2020-06-17
EP20180832 2020-06-18
EP21150056 2021-01-04
EP21151004 2021-01-11
EP21154657 2021-02-02
PCT/EP2021/053805 WO2021144476A1 (en) 2020-02-18 2021-02-17 Pharmaceutical formulations

Publications (1)

Publication Number Publication Date
PE20221575A1 true PE20221575A1 (es) 2022-10-06

Family

ID=74668840

Family Applications (2)

Application Number Title Priority Date Filing Date
PE2022001737A PE20230819A1 (es) 2020-02-18 2021-02-17 Composiciones y usos de glp-1
PE2022001525A PE20221575A1 (es) 2020-02-18 2021-02-17 Formulaciones farmaceuticas

Family Applications Before (1)

Application Number Title Priority Date Filing Date
PE2022001737A PE20230819A1 (es) 2020-02-18 2021-02-17 Composiciones y usos de glp-1

Country Status (15)

Country Link
US (4) US20230093542A1 (es)
EP (3) EP4537848A3 (es)
JP (3) JP2023512910A (es)
KR (2) KR20220143037A (es)
CN (2) CN115135304A (es)
AU (2) AU2021208601B2 (es)
BR (2) BR112022013795A2 (es)
CA (2) CA3165355A1 (es)
CL (1) CL2022002084A1 (es)
CO (2) CO2022010915A2 (es)
IL (2) IL294520A (es)
MX (2) MX2022009523A (es)
PE (2) PE20230819A1 (es)
TW (2) TWI878456B (es)
WO (2) WO2021144476A1 (es)

Families Citing this family (11)

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Publication number Priority date Publication date Assignee Title
EP4360651A3 (en) 2017-08-24 2024-07-17 Novo Nordisk A/S Glp-1 compositions and uses thereof
TWI878456B (zh) * 2020-02-18 2025-04-01 丹麥商諾佛 儂迪克股份有限公司 Glp-1組成物及其用途
US11478533B2 (en) 2020-04-27 2022-10-25 Novo Nordisk A/S Semaglutide for use in medicine
KR20240126450A (ko) 2021-11-10 2024-08-20 아이투오 테라퓨틱스, 인코포레이티드 이온성 액체 조성물
CN114249808B (zh) * 2021-12-27 2024-11-12 江苏诺泰澳赛诺生物制药股份有限公司 一种Cagrilintide的合成方法
CN114660214B (zh) * 2022-02-18 2024-04-05 兰州积石药业有限公司 一种司美格鲁肽的液相色谱检测方法及其应用
CN116763763B (zh) * 2022-12-05 2024-08-30 齐鲁制药有限公司 一种司美格鲁肽吸入喷雾剂及其制备方法
CN116159027A (zh) * 2022-12-29 2023-05-26 江苏诺泰澳赛诺生物制药股份有限公司 一种司美格鲁肽冻干药物组合物及其制备方法
WO2024148155A1 (en) 2023-01-06 2024-07-11 Nano Precision Medical, Inc. Formulations, devices and methods for a glp-1 agonist
WO2024248574A1 (ko) * 2023-06-02 2024-12-05 주식회사 지투지바이오 카그릴린타이드 또는 이의 약학적으로 허용가능한 염을 포함하는 서방성 미립구 제제 및 이의 제조방법
WO2024256632A1 (en) * 2023-06-15 2024-12-19 Novo Nordisk A/S Pharmaceutical formulations of an amylin receptor agonist and a glp-1 receptor agonist comprising a cyclodextrin

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