BR112022013746A2 - Formulação aquosa de cagrilintida, formulação aquosa de semaglutida, dispositivo médico, e, combinação de dose fixa - Google Patents

Formulação aquosa de cagrilintida, formulação aquosa de semaglutida, dispositivo médico, e, combinação de dose fixa

Info

Publication number
BR112022013746A2
BR112022013746A2 BR112022013746A BR112022013746A BR112022013746A2 BR 112022013746 A2 BR112022013746 A2 BR 112022013746A2 BR 112022013746 A BR112022013746 A BR 112022013746A BR 112022013746 A BR112022013746 A BR 112022013746A BR 112022013746 A2 BR112022013746 A2 BR 112022013746A2
Authority
BR
Brazil
Prior art keywords
aqueous formulation
cagrilintide
semaglutide
medical device
fixed dose
Prior art date
Application number
BR112022013746A
Other languages
English (en)
Inventor
Sander Tommy
Poulsen Christian
Rebecca Erritzøe Hansen Rosa
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=BR112022013746(A2) "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 BR112022013746A2 publication Critical patent/BR112022013746A2/pt

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22Hormones
    • A61K38/26Glucagons
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41Heterocyclic 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
    • A61K31/41641,3-Diazoles
    • A61K31/4172Imidazole-alkanecarboxylic acids, e.g. histidine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/1703Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/24Organic 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/19Syringes having more than one chamber, e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/04Anorexiants; Antiobesity agents

Abstract

FORMULAÇÃO AQUOSA DE CAGRILINTIDA, FORMULAÇÃO AQUOSA DE SEMAGLUTIDA, DISPOSITIVO MÉDICO, E, COMBINAÇÃO DE DOSE FIXA. São divulgadas, neste documento, uma formulação farmacêutica aquosa que compreende cagrilintida e uma formulação aquosa que compreende semaglutida. As composições dessas duas formulações farmacêuticas permitem sua apresentação e administração usando o dispositivo médico de câmara dupla divulgado neste documento. Indivíduos com doenças, tais como diabetes e/ou obesidade e/ou comorbidades relacionadas, podem se beneficiar da coadministração de semaglutida e cagrilintida, e/ou das duas formulações farmacêuticas líquidas divulgadas neste documento, usando o dispositivo médico divulgado neste documento.
BR112022013746A 2020-02-18 2021-02-17 Formulação aquosa de cagrilintida, formulação aquosa de semaglutida, dispositivo médico, e, combinação de dose fixa BR112022013746A2 (pt)

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
BR112022013746A2 true BR112022013746A2 (pt) 2022-10-11

Family

ID=74668840

Family Applications (2)

Application Number Title Priority Date Filing Date
BR112022013795A BR112022013795A2 (pt) 2020-02-18 2021-02-17 Composição farmacêutica líquida, e, kit
BR112022013746A BR112022013746A2 (pt) 2020-02-18 2021-02-17 Formulação aquosa de cagrilintida, formulação aquosa de semaglutida, dispositivo médico, e, combinação de dose fixa

Family Applications Before (1)

Application Number Title Priority Date Filing Date
BR112022013795A BR112022013795A2 (pt) 2020-02-18 2021-02-17 Composição farmacêutica líquida, e, kit

Country Status (15)

Country Link
US (3) US20230093542A1 (pt)
EP (2) EP4106727A1 (pt)
JP (3) JP2023512910A (pt)
KR (2) KR20220143037A (pt)
CN (2) CN115135304A (pt)
AU (2) AU2021208601A1 (pt)
BR (2) BR112022013795A2 (pt)
CA (2) CA3165355A1 (pt)
CL (1) CL2022002084A1 (pt)
CO (2) CO2022010915A2 (pt)
IL (2) IL294521A (pt)
MX (2) MX2022009844A (pt)
PE (2) PE20221575A1 (pt)
TW (2) TW202140063A (pt)
WO (2) WO2021144477A1 (pt)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20200044016A (ko) 2017-08-24 2020-04-28 노보 노르디스크 에이/에스 Glp-1 조성물 및 그 용도
US11478533B2 (en) 2020-04-27 2022-10-25 Novo Nordisk A/S Semaglutide for use in medicine
CN114249808A (zh) * 2021-12-27 2022-03-29 杭州诺泰澳赛诺医药技术开发有限公司 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
CN116763763A (zh) * 2022-12-05 2023-09-19 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

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US11318191B2 (en) 2022-05-03
CO2022010915A2 (es) 2022-11-08

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