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MX2019003611A - Formulaciones novedosas. - Google Patents

Formulaciones novedosas.

Info

Publication number
MX2019003611A
MX2019003611A MX2019003611A MX2019003611A MX2019003611A MX 2019003611 A MX2019003611 A MX 2019003611A MX 2019003611 A MX2019003611 A MX 2019003611A MX 2019003611 A MX2019003611 A MX 2019003611A MX 2019003611 A MX2019003611 A MX 2019003611A
Authority
MX
Mexico
Prior art keywords
zinc
species
binding
logk
respect
Prior art date
Application number
MX2019003611A
Other languages
English (en)
Inventor
Gerring David
Howell Sarah
Jezek Jan
ZAKRZEWSKI Leon
Original Assignee
Arecor Ltd
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
Priority claimed from GBGB1616509.4A external-priority patent/GB201616509D0/en
Priority claimed from GBGB1617866.7A external-priority patent/GB201617866D0/en
Priority claimed from GBGB1707190.3A external-priority patent/GB201707190D0/en
Application filed by Arecor Ltd filed Critical Arecor Ltd
Publication of MX2019003611A publication Critical patent/MX2019003611A/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
    • A61K38/28—Insulins
    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/194—Carboxylic acids, e.g. valproic acid having two or more carboxyl groups, e.g. succinic, maleic or phthalic acid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/24—Heavy metals; Compounds thereof
    • A61K33/30—Zinc; Compounds thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/06—Tripeptides
    • A61K38/063—Glutathione
    • 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
    • A61K47/16—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
    • 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
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • 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
    • 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
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • 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
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/3159—Dose expelling manners
    • A61M5/31591—Single dose, i.e. individually set dose administered only once from the same medicament reservoir, e.g. including single stroke limiting means
    • 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
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/3159—Dose expelling manners
    • A61M5/31593—Multi-dose, i.e. individually set dose repeatedly administered from the same medicament reservoir
    • 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
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/48—Drugs for disorders of the endocrine system of the pancreatic hormones
    • A61P5/50—Drugs for disorders of the endocrine system of the pancreatic hormones for increasing or potentiating the activity of insulin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Diabetes (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Hematology (AREA)
  • Inorganic Chemistry (AREA)
  • Endocrinology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Zoology (AREA)
  • Dermatology (AREA)
  • Emergency Medicine (AREA)
  • Obesity (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)

Abstract

Se proporciona, entre otros, una formulación farmacéutica liquida acuosa que comprende (i) un compuesto de insulina, (ii) zinc iónico, (iii) una especie de unión de zinc a una concentración de 1 mM o mas seleccionada de especies que tienen un logK con respecto a la unión de ion de zinc en el intervalo de 4.5-12.3 a 25°C, y (iv) un agente tensoactivo no ionico que es un glicosido de alquilo; y en donde la formulación esta sustancialmente libre de EDTA y cualquier otra especie de unión de zinc que tenga un logK con respecto a la unión de iones de zinc de mas de 12.3 a 25°C.
MX2019003611A 2016-09-29 2017-09-29 Formulaciones novedosas. MX2019003611A (es)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
GBGB1616509.4A GB201616509D0 (en) 2016-09-29 2016-09-29 Novel formulations
GBGB1617866.7A GB201617866D0 (en) 2016-10-21 2016-10-21 Novel formulations
GBGB1707190.3A GB201707190D0 (en) 2017-05-05 2017-05-05 Novel Formulations
PCT/GB2017/052940 WO2018060735A1 (en) 2016-09-29 2017-09-29 Novel formulations

Publications (1)

Publication Number Publication Date
MX2019003611A true MX2019003611A (es) 2019-06-17

Family

ID=60037644

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2019003611A MX2019003611A (es) 2016-09-29 2017-09-29 Formulaciones novedosas.

Country Status (13)

Country Link
US (2) US20190290737A1 (es)
EP (3) EP3518893A1 (es)
JP (5) JP2019529506A (es)
KR (1) KR102482664B1 (es)
CN (2) CN109789088A (es)
AU (2) AU2017334289B2 (es)
CA (2) CA3034972C (es)
DK (1) DK3518892T5 (es)
ES (1) ES2954180T3 (es)
IL (1) IL265609B2 (es)
MX (1) MX2019003611A (es)
PL (1) PL3518892T3 (es)
WO (2) WO2018060736A1 (es)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB201607918D0 (en) 2016-05-06 2016-06-22 Arecor Ltd Novel formulations
EP3518893A1 (en) * 2016-09-29 2019-08-07 Arecor Limited Novel formulations
GB201707188D0 (en) * 2017-05-05 2017-06-21 Arecor Ltd Novel formulations
WO2019193353A1 (en) * 2018-04-04 2019-10-10 Arecor Limited Medical infusion pump system for the delivery of an insulin compound
CN112004521A (zh) * 2018-04-04 2020-11-27 艾瑞克有限公司 用于递送胰岛素化合物的医用输注泵系统
US20210113763A1 (en) * 2018-04-04 2021-04-22 Arecor Limited Medical infusion pump system for the delivery of an insulin compound
FR3084586B1 (fr) * 2018-08-03 2020-11-06 Adocia Compositions sous forme d'une solution aqueuse injectable comprenant de l'amyline, un agoniste au recepteur de l'amyline ou un analogue d'amyline et un compose amphiphile porteur de radicaux hydrophobes
WO2020190591A1 (en) * 2019-03-15 2020-09-24 Eli Lilly And Company Preserved formulations
JP7518149B2 (ja) * 2019-07-12 2024-07-17 ノヴォ ノルディスク アー／エス 高濃度インスリン製剤
GB201911461D0 (en) * 2019-08-09 2019-09-25 Arecor Ltd Novel composition
GB202004814D0 (en) 2020-04-01 2020-05-13 Arecor Ltd Novel formulations
EP4281039A2 (en) * 2021-01-25 2023-11-29 Mylan Ireland Limited Pharmaceutical glp peptide compositions and methods of preparation thereof

Family Cites Families (29)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FI78616C (fi) * 1982-02-05 1989-09-11 Novo Industri As Foerfarande foer framstaellning av en foer infusionsaendamaol avsedd stabiliserad insulinloesning, som har en foerhoejd zinkhalt.
PH25772A (en) 1985-08-30 1991-10-18 Novo Industri As Insulin analogues, process for their preparation
JPH04502465A (ja) 1988-12-23 1992-05-07 ノボ　ノルディスク　アクティーゼルスカブ ヒトインシュリン類似物質
NZ232375A (en) 1989-02-09 1992-04-28 Lilly Co Eli Insulin analogues modified at b29
DE69019534T2 (de) 1989-12-21 1995-09-21 Novonordisk As Insulinzubereitungen, die nikotinsäure oder nikotinamid enthalten.
US5866538A (en) 1996-06-20 1999-02-02 Novo Nordisk A/S Insulin preparations containing NaCl
DE10114178A1 (de) 2001-03-23 2002-10-10 Aventis Pharma Gmbh Zinkfreie und zinkarme Insulinzubereitungen mit verbesserter Stabilität
CN101340893B (zh) * 2005-10-20 2012-03-21 玛瑞纳生物技术有限公司 速效胰岛素的鼻内施用
EP2158898A1 (en) * 2006-06-23 2010-03-03 Aegis Therapeutics LLC Stabilizing alkylglycoside compositions and method thereof
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WO2015104311A1 (en) * 2014-01-09 2015-07-16 Sanofi Stabilized glycerol free pharmaceutical formulations of insulin analogues and/or insulin derivatives
KR20160101195A (ko) * 2014-01-09 2016-08-24 사노피 인슐린 아스파트의 안정화된 약제학적 제형
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EP3006045B3 (en) 2014-10-07 2021-03-17 Cyprumed GmbH Pharmaceutical formulations for the oral delivery of peptide or protein drugs
AR102869A1 (es) * 2014-12-16 2017-03-29 Lilly Co Eli Composiciones de insulina de rápida acción
GB201607918D0 (en) * 2016-05-06 2016-06-22 Arecor Ltd Novel formulations
EP3518893A1 (en) * 2016-09-29 2019-08-07 Arecor Limited Novel formulations

Also Published As

Publication number Publication date
WO2018060736A1 (en) 2018-04-05
DK3518892T5 (da) 2024-09-02
IL265609B1 (en) 2023-10-01
EP3518892B1 (en) 2023-06-21
DK3518892T3 (da) 2023-07-31
EP3518893A1 (en) 2019-08-07
CN109803639B (zh) 2024-01-02
JP2019533656A (ja) 2019-11-21
JP2024153677A (ja) 2024-10-29
JP2019529506A (ja) 2019-10-17
PL3518892T3 (pl) 2023-11-27
IL265609A (en) 2019-05-30
CA3034972C (en) 2024-04-09
WO2018060735A1 (en) 2018-04-05
US20190282667A1 (en) 2019-09-19
EP4265296A3 (en) 2023-12-20
AU2017334289B2 (en) 2023-04-20
ES2954180T3 (es) 2023-11-20
AU2017334290A1 (en) 2019-03-21
JP7145849B2 (ja) 2022-10-03
CA3034971A1 (en) 2018-04-05
AU2017334289A1 (en) 2019-03-21
JP2022180499A (ja) 2022-12-06
EP4265296A2 (en) 2023-10-25
JP2022176989A (ja) 2022-11-30
EP3518892A1 (en) 2019-08-07
CA3034972A1 (en) 2018-04-05
CN109803639A (zh) 2019-05-24
CN109789088A (zh) 2019-05-21
US20190290737A1 (en) 2019-09-26
AU2017334290B2 (en) 2023-04-20
IL265609B2 (en) 2024-02-01
KR20190060788A (ko) 2019-06-03
KR102482664B1 (ko) 2022-12-29

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