MX2018008265A - Particulas de insulina y analogos de insulina inhalables de pureza elevada y metodos de fabricacion de los mismos de eficiencia elevada. - Google Patents
Particulas de insulina y analogos de insulina inhalables de pureza elevada y metodos de fabricacion de los mismos de eficiencia elevada.Info
- Publication number
- MX2018008265A MX2018008265A MX2018008265A MX2018008265A MX2018008265A MX 2018008265 A MX2018008265 A MX 2018008265A MX 2018008265 A MX2018008265 A MX 2018008265A MX 2018008265 A MX2018008265 A MX 2018008265A MX 2018008265 A MX2018008265 A MX 2018008265A
- Authority
- MX
- Mexico
- Prior art keywords
- insulin
- purity
- manufacturing
- same
- particles
- Prior art date
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
- 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
-
- 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
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/143—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with inorganic compounds
-
- 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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- C07K14/575—Hormones
- C07K14/62—Insulins
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Diabetes (AREA)
- Endocrinology (AREA)
- Organic Chemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Gastroenterology & Hepatology (AREA)
- Zoology (AREA)
- Otolaryngology (AREA)
- Pulmonology (AREA)
- Immunology (AREA)
- Toxicology (AREA)
- Molecular Biology (AREA)
- Inorganic Chemistry (AREA)
- Genetics & Genomics (AREA)
- Biophysics (AREA)
- Biochemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Emergency Medicine (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Obesity (AREA)
- Hematology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
Abstract
Un material de insulina inhalable de pureza elevada, utilizado para preparar un producto farmacéutico pulmonar, incluye partículas de insulina que tienen un tamaño de partícula a nivel micrométrico y que tienen las siguientes características: (i) la pureza de la insulina no es menor que 96 % sobre la base seca; (ii) la cantidad total de impurezas relacionadas con la insulina no es mayor que 2 %; (iii) la cantidad total de impurezas del disolvente, que no es un componente de la formulación del co-disolvente para un producto pulmonar, no es mayor que 0.03 %; y (iv) la cantidad total de impurezas no relacionadas con el disolvente no es mayor que 0.3 %. Hasta 99 % en volumen de las partículas de insulina en la insulina inhalable tienen un tamaño de partícula menor que 5 µm, basado en el volumen total de las partículas de insulina. Un método de eficiencia elevada prepara un material de insulina inhalable de pureza elevada. La tasa de rendimiento para el método de eficiencia elevada es de 75 a 85 % o más.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US14/990,787 US10322168B2 (en) | 2016-01-07 | 2016-01-07 | High-purity inhalable particles of insulin and insulin analogues, and high-efficiency methods of manufacturing the same |
PCT/US2016/012715 WO2017119906A1 (en) | 2016-01-07 | 2016-01-08 | High-purity inhalable particles of insulin and insulin analogues, and high-efficiency methods of manufacturing the same |
Publications (1)
Publication Number | Publication Date |
---|---|
MX2018008265A true MX2018008265A (es) | 2018-09-18 |
Family
ID=55590120
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
MX2018008265A MX2018008265A (es) | 2016-01-07 | 2016-01-08 | Particulas de insulina y analogos de insulina inhalables de pureza elevada y metodos de fabricacion de los mismos de eficiencia elevada. |
Country Status (8)
Country | Link |
---|---|
US (3) | US10322168B2 (es) |
EP (1) | EP3399961A1 (es) |
JP (2) | JP2019505519A (es) |
CN (1) | CN108778246B (es) |
AU (3) | AU2016385386A1 (es) |
CA (1) | CA3010211C (es) |
MX (1) | MX2018008265A (es) |
WO (1) | WO2017119906A1 (es) |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN114306577B (zh) * | 2020-10-10 | 2024-04-09 | 南京汉欣医药科技有限公司 | 一种门冬胰岛素30混悬液的制备方法 |
Family Cites Families (25)
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 |
US6051256A (en) | 1994-03-07 | 2000-04-18 | Inhale Therapeutic Systems | Dispersible macromolecule compositions and methods for their preparation and use |
KR100419037B1 (ko) | 1994-03-07 | 2004-06-12 | 넥타르 테라퓨틱스 | 폐를통한인슐린의전달방법및그조성물 |
US5597893A (en) | 1994-10-31 | 1997-01-28 | Eli Lilly And Company | Preparation of stable insulin analog crystals |
AR002976A1 (es) | 1995-03-31 | 1998-05-27 | Lilly Co Eli | Formulaciones farmaceuticas parenterales de efecto prolongado de insulina; cristales de dichos analogos aplicables en dichas formulaciones yprocedimiento de las formulaciones mencionadas |
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 |
HUP0000547A3 (en) | 1997-03-20 | 2002-11-28 | Novo Nordisk As | Zinc free insulin crystals for use in pulmonary compositions |
US6310038B1 (en) | 1997-03-20 | 2001-10-30 | Novo Nordisk A/S | Pulmonary insulin crystals |
AU5453300A (en) | 1999-06-29 | 2001-01-31 | Eli Lilly And Company | Insulin crystals for pulmonary administration |
DK2280020T3 (en) | 1999-06-29 | 2016-05-02 | Mannkind Corp | Pharmaceutical formulations comprising a peptide complexed with a diketopiperazine |
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 |
CN1826170B (zh) | 2003-07-18 | 2010-12-08 | 巴克斯特国际公司 | 通过受控相分离制备的小球形颗粒的制造方法、其用途和成分 |
CA2540771A1 (en) | 2003-09-30 | 2005-04-14 | Spherics, Inc. | Nanoparticulate therapeutic biologically active agents |
EP1734938B1 (en) | 2004-03-26 | 2012-06-20 | Universita' Degli Studi Di Parma | Insulin highly respirable microparticles |
WO2009020434A1 (en) | 2007-08-07 | 2009-02-12 | Nanomaterials Technology Pte Ltd | A process for making micro-sized protein particles |
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 |
CN101721375B (zh) * | 2009-12-30 | 2012-05-30 | 上海交通大学 | 胰岛素缓释微米球组合物及其制备方法 |
US20130202659A1 (en) | 2012-01-31 | 2013-08-08 | Cerulean Pharma Inc. | Polymer-agent conjugates, particles, compositions, and related methods of use |
BR112017000175B1 (pt) * | 2014-07-08 | 2023-11-21 | Amphastar Pharmaceuticals,Inc. | Método de preparação de uma insulina inalável adequada para a liberação pulmonar e partículas de insulina micronizadas |
-
2016
- 2016-01-07 US US14/990,787 patent/US10322168B2/en active Active
- 2016-01-08 JP JP2018535397A patent/JP2019505519A/ja not_active Withdrawn
- 2016-01-08 CN CN201680083267.9A patent/CN108778246B/zh active Active
- 2016-01-08 EP EP16711707.6A patent/EP3399961A1/en not_active Ceased
- 2016-01-08 CA CA3010211A patent/CA3010211C/en active Active
- 2016-01-08 WO PCT/US2016/012715 patent/WO2017119906A1/en active Application Filing
- 2016-01-08 MX MX2018008265A patent/MX2018008265A/es unknown
- 2016-01-08 AU AU2016385386A patent/AU2016385386A1/en not_active Abandoned
- 2016-09-29 US US15/280,508 patent/US10406210B2/en active Active
-
2019
- 2019-08-28 US US16/553,681 patent/US11446360B2/en active Active
-
2020
- 2020-02-12 AU AU2020201000A patent/AU2020201000A1/en not_active Abandoned
-
2021
- 2021-02-15 JP JP2021021986A patent/JP7194208B2/ja active Active
- 2021-07-23 AU AU2021206890A patent/AU2021206890B2/en active Active
Also Published As
Publication number | Publication date |
---|---|
CN108778246A (zh) | 2018-11-09 |
CA3010211A1 (en) | 2017-07-13 |
US20170196942A1 (en) | 2017-07-13 |
US20170196941A1 (en) | 2017-07-13 |
WO2017119906A1 (en) | 2017-07-13 |
JP7194208B2 (ja) | 2022-12-21 |
AU2016385386A1 (en) | 2018-07-19 |
AU2020201000A1 (en) | 2020-02-27 |
AU2021206890B2 (en) | 2023-04-13 |
US10406210B2 (en) | 2019-09-10 |
CN108778246B (zh) | 2023-04-18 |
US10322168B2 (en) | 2019-06-18 |
US20190388514A1 (en) | 2019-12-26 |
CA3010211C (en) | 2020-10-13 |
EP3399961A1 (en) | 2018-11-14 |
AU2021206890A1 (en) | 2021-08-12 |
JP2019505519A (ja) | 2019-02-28 |
JP2021091693A (ja) | 2021-06-17 |
US11446360B2 (en) | 2022-09-20 |
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