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MX2017000027A - Insulina micronizada, analogos de insulina micronizada y metodos para fabricarlos. - Google Patents

Insulina micronizada, analogos de insulina micronizada y metodos para fabricarlos.

Info

Publication number
MX2017000027A
MX2017000027A MX2017000027A MX2017000027A MX2017000027A MX 2017000027 A MX2017000027 A MX 2017000027A MX 2017000027 A MX2017000027 A MX 2017000027A MX 2017000027 A MX2017000027 A MX 2017000027A MX 2017000027 A MX2017000027 A MX 2017000027A
Authority
MX
Mexico
Prior art keywords
insulin
micronized insulin
micronized
manufacture
methods
Prior art date
Application number
MX2017000027A
Other languages
English (en)
Other versions
MX375021B (es
Inventor
DING Jeffrey
Bo Aili
Ziping Luo Mary
Yongfeng Zhang Jack
Original Assignee
Amphastar 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 Amphastar Pharmaceuticals Inc filed Critical Amphastar Pharmaceuticals Inc
Publication of MX2017000027A publication Critical patent/MX2017000027A/es
Publication of MX375021B publication Critical patent/MX375021B/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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • A61K9/1688—Processes resulting in pure drug agglomerate optionally containing up to 5% of excipient
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0075—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
    • 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
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/008—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy comprising drug dissolved or suspended in liquid propellant for inhalation via a pressurized metered dose inhaler [MDI]
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Diabetes (AREA)
  • Endocrinology (AREA)
  • Pulmonology (AREA)
  • Otolaryngology (AREA)
  • Zoology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Emergency Medicine (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)

Abstract

Un método para preparar una insulina inhalable adecuada para suministro pulmonar incluye: disolver la materia prima de la insulina en una solución ácida para formar una solución de insulina disuelta; titular la solución de insulina disuelta con una solución amortiguadora para formar una suspensión que comprende partículas de insulina micronizadas; y estabilizarlas partículas de insulina micronizadas.
MX2017000027A 2014-07-08 2015-07-08 Insulina micronizada, análogos de insulina micronizada y métodos para fabricarlos. MX375021B (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201462022026P 2014-07-08 2014-07-08
PCT/US2015/039625 WO2016007682A1 (en) 2014-07-08 2015-07-08 Micronized insulin, micronized insulin analogues, and methods of manufacturing the same

Publications (2)

Publication Number Publication Date
MX2017000027A true MX2017000027A (es) 2017-05-01
MX375021B MX375021B (es) 2025-03-06

Family

ID=53783921

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2017000027A MX375021B (es) 2014-07-08 2015-07-08 Insulina micronizada, análogos de insulina micronizada y métodos para fabricarlos.

Country Status (10)

Country Link
US (1) US10258573B2 (es)
EP (1) EP3166595B1 (es)
JP (1) JP6530480B2 (es)
CN (1) CN106794156B (es)
BR (1) BR112017000175B1 (es)
CA (1) CA2954287C (es)
DK (1) DK3166595T3 (es)
MX (1) MX375021B (es)
RU (1) RU2694063C2 (es)
WO (1) WO2016007682A1 (es)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2694063C2 (ru) 2014-07-08 2019-07-09 Эмфастар Фармасьютикалз, Инк. Тонкодисперсный инсулин, тонкодисперсные аналоги инсулина и способы их промышленного получения
US10322168B2 (en) 2016-01-07 2019-06-18 Amphastar Pharmaceuticals, Inc. High-purity inhalable particles of insulin and insulin analogues, and high-efficiency methods of manufacturing the same
US20210290733A1 (en) * 2018-07-16 2021-09-23 Arven Ilac Sanayi Ve Ticaret Anonim Sirketi Injectable micronized human insulin

Family Cites Families (23)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6582728B1 (en) 1992-07-08 2003-06-24 Inhale Therapeutic Systems, Inc. Spray drying of macromolecules to produce inhaleable dry powders
US6090925A (en) 1993-03-09 2000-07-18 Epic Therapeutics, Inc. Macromolecular microparticles and methods of production and use
CA2183577C (en) * 1994-03-07 2007-10-30 John S. Patton Methods and compositions for pulmonary delivery of insulin
US6051256A (en) 1994-03-07 2000-04-18 Inhale Therapeutic Systems Dispersible macromolecule compositions and methods for their preparation and use
US5597893A (en) * 1994-10-31 1997-01-28 Eli Lilly And Company Preparation of stable insulin analog crystals
YU18596A (sh) * 1995-03-31 1998-07-10 Eli Lilly And Company Analogne formulacije monomernog insulina
SE9501384D0 (sv) * 1995-04-13 1995-04-13 Astra Ab Process for the preparation of respirable particles
US5985309A (en) 1996-05-24 1999-11-16 Massachusetts Institute Of Technology Preparation of particles for inhalation
US6310038B1 (en) 1997-03-20 2001-10-30 Novo Nordisk A/S Pulmonary insulin crystals
IL131796A0 (en) * 1997-03-20 2001-03-19 Novo Nordisk As Zinc free insulin crystals for use in pulmonary compositions
AU5453300A (en) 1999-06-29 2001-01-31 Eli Lilly And Company Insulin crystals for pulmonary administration
PT1196430E (pt) 1999-06-29 2012-04-18 Mannkind Corp Purificação e estabilização de péptidos e proteínas em agentes farmacêuticos
WO2002000207A1 (en) 2000-06-27 2002-01-03 Mi Tech Company Limited The controlled release preparation of insulin and its method
ES2326209T3 (es) 2000-10-27 2009-10-05 Baxter Healthcare S.A. Produccion de microesferas.
US20080026068A1 (en) * 2001-08-16 2008-01-31 Baxter Healthcare S.A. Pulmonary delivery of spherical insulin microparticles
DE10235168A1 (de) * 2002-08-01 2004-02-12 Aventis Pharma Deutschland Gmbh Verfahren zur Reinigung von Preproinsulin
GB0300427D0 (en) * 2003-01-09 2003-02-05 Univ Strathclyde Pharmaceutical composition
US20050147687A1 (en) * 2003-07-18 2005-07-07 Julia Rashba-Step Methods for fabrication, uses and compositions of small spherical particles of AAT prepared by controlled phase separation
JP2007507527A (ja) * 2003-09-30 2007-03-29 スフェリックス， インコーポレイテッド 生物学的に活性なナノ粒子治療用因子
WO2005092301A1 (en) 2004-03-26 2005-10-06 Universita' Degli Studi Di Parma Insulin highly respirable microparticles
EP2036572A1 (en) * 2007-09-04 2009-03-18 Novo Nordisk A/S Process for drying a protein, a protein particle and a pharmaceutical composition comprising the protein particle
EP2811980A4 (en) * 2012-01-31 2015-12-23 Cerulean Pharma Inc POLYMER-AGENT CONJUGATES, PARTICLES, COMPOSITIONS AND METHODS OF USE THEREOF
RU2694063C2 (ru) 2014-07-08 2019-07-09 Эмфастар Фармасьютикалз, Инк. Тонкодисперсный инсулин, тонкодисперсные аналоги инсулина и способы их промышленного получения

Also Published As

Publication number Publication date
RU2694063C2 (ru) 2019-07-09
CA2954287A1 (en) 2016-01-14
RU2017103751A (ru) 2018-08-08
JP6530480B2 (ja) 2019-06-12
BR112017000175B1 (pt) 2023-11-21
DK3166595T3 (da) 2019-08-05
JP2017520593A (ja) 2017-07-27
CA2954287C (en) 2020-12-22
RU2017103751A3 (es) 2018-08-08
CN106794156A (zh) 2017-05-31
EP3166595A1 (en) 2017-05-17
WO2016007682A1 (en) 2016-01-14
CN106794156B (zh) 2021-03-09
US20160008287A1 (en) 2016-01-14
EP3166595B1 (en) 2019-05-15
MX375021B (es) 2025-03-06
US10258573B2 (en) 2019-04-16
BR112017000175A2 (pt) 2017-10-31

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