DK1808438T3 - Rensning og stabilisering af peptid og proteiner i lægemidler - Google Patents

Rensning og stabilisering af peptid og proteiner i lægemidler

Info

Publication number: DK1808438T3
Authority: DK; Denmark
Prior art keywords: peptide; insulin; complexing agent; impurity; patient
Prior art date: 1999-06-29

Application number

DK07075344.7T

Other languages

English (en)

Inventor

Solomon S Steiner

Joseph W Sulner

Rodney J Woods

Original Assignee

Mannkind Corp

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.)

1999-06-29

Filing date

2000-06-29

Publication date

2014-10-27

2000-06-29 Application filed by Mannkind Corp filed Critical Mannkind Corp

2014-10-27 Application granted granted Critical

2014-10-27 Publication of DK1808438T3 publication Critical patent/DK1808438T3/da

Links

108090000765 processed proteins & peptides Proteins 0.000 title abstract 4
239000003814 drug Substances 0.000 title abstract 3
102000004169 proteins and genes Human genes 0.000 title abstract 3
108090000623 proteins and genes Proteins 0.000 title abstract 3
229940079593 drug Drugs 0.000 title 1
238000000746 purification Methods 0.000 title 1
230000006641 stabilisation Effects 0.000 title 1
238000011105 stabilization Methods 0.000 title 1
NOESYZHRGYRDHS-UHFFFAOYSA-N insulin Chemical compound N1C(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(NC(=O)CN)C(C)CC)CSSCC(C(NC(CO)C(=O)NC(CC(C)C)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CCC(N)=O)C(=O)NC(CC(C)C)C(=O)NC(CCC(O)=O)C(=O)NC(CC(N)=O)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CSSCC(NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2C=CC(O)=CC=2)NC(=O)C(CC(C)C)NC(=O)C(C)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2NC=NC=2)NC(=O)C(CO)NC(=O)CNC2=O)C(=O)NCC(=O)NC(CCC(O)=O)C(=O)NC(CCCNC(N)=N)C(=O)NCC(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC(O)=CC=3)C(=O)NC(C(C)O)C(=O)N3C(CCC3)C(=O)NC(CCCCN)C(=O)NC(C)C(O)=O)C(=O)NC(CC(N)=O)C(O)=O)=O)NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C1CSSCC2NC(=O)C(CC(C)C)NC(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)CC=1C=CC=CC=1)C(C)C)CC1=CN=CN1 NOESYZHRGYRDHS-UHFFFAOYSA-N 0.000 abstract 10
102000004877 Insulin Human genes 0.000 abstract 5
108090001061 Insulin Proteins 0.000 abstract 5
229940125396 insulin Drugs 0.000 abstract 5
239000008139 complexing agent Substances 0.000 abstract 4
239000000203 mixture Substances 0.000 abstract 4
239000012535 impurity Substances 0.000 abstract 3
238000009472 formulation Methods 0.000 abstract 2
HCHKCACWOHOZIP-UHFFFAOYSA-N Zinc Chemical compound [Zn] HCHKCACWOHOZIP-UHFFFAOYSA-N 0.000 abstract 1
239000013543 active substance Substances 0.000 abstract 1
239000008280 blood Substances 0.000 abstract 1
210000004369 blood Anatomy 0.000 abstract 1
238000001990 intravenous administration Methods 0.000 abstract 1
238000000034 method Methods 0.000 abstract 1
239000011859 microparticle Substances 0.000 abstract 1
239000011701 zinc Substances 0.000 abstract 1
229910052725 zinc Inorganic materials 0.000 abstract 1

Classifications

- 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
- 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
- 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
- A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/69—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
- A61K47/6949—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes
- 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
- A61K9/0012—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
- A61K9/0075—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
- A61K9/14—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
- A61K9/141—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
- A61K9/145—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 organic compounds
- 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
- 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
- A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
- A61K9/1676—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
- 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
- B—PERFORMING OPERATIONS; TRANSPORTING
- B82—NANOTECHNOLOGY
- B82Y—SPECIFIC USES OR APPLICATIONS OF NANOSTRUCTURES; MEASUREMENT OR ANALYSIS OF NANOSTRUCTURES; MANUFACTURE OR TREATMENT OF NANOSTRUCTURES
- B82Y5/00—Nanobiotechnology or nanomedicine, e.g. protein engineering or drug delivery
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D241/00—Heterocyclic compounds containing 1,4-diazine or hydrogenated 1,4-diazine rings
- C07D241/02—Heterocyclic compounds containing 1,4-diazine or hydrogenated 1,4-diazine rings not condensed with other rings
- C07D241/06—Heterocyclic compounds containing 1,4-diazine or hydrogenated 1,4-diazine rings not condensed with other rings having one or two double bonds between ring members or between ring members and non-ring members
- C07D241/08—Heterocyclic compounds containing 1,4-diazine or hydrogenated 1,4-diazine rings not condensed with other rings having one or two double bonds between ring members or between ring members and non-ring members with oxygen atoms directly attached to ring carbon atoms
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
- C07K1/14—Extraction; Separation; Purification
- C07K1/30—Extraction; Separation; Purification by precipitation
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
- C07K1/14—Extraction; Separation; Purification
- C07K1/30—Extraction; Separation; Purification by precipitation
- C07K1/32—Extraction; Separation; Purification by precipitation as complexes
- 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
- C07K14/605—Glucagons
- 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)
Chemical & Material Sciences (AREA)
Life Sciences & Earth Sciences (AREA)
Engineering & Computer Science (AREA)
Bioinformatics & Cheminformatics (AREA)
General Health & Medical Sciences (AREA)
Medicinal Chemistry (AREA)
Organic Chemistry (AREA)
Pharmacology & Pharmacy (AREA)
Veterinary Medicine (AREA)
Public Health (AREA)
Animal Behavior & Ethology (AREA)
Epidemiology (AREA)
Biophysics (AREA)
Molecular Biology (AREA)
Proteomics, Peptides & Aminoacids (AREA)
Genetics & Genomics (AREA)
Biochemistry (AREA)
Endocrinology (AREA)
Diabetes (AREA)
Zoology (AREA)
Gastroenterology & Hepatology (AREA)
Toxicology (AREA)
Analytical Chemistry (AREA)
Nanotechnology (AREA)
Pulmonology (AREA)
Otolaryngology (AREA)
Immunology (AREA)
Chemical Kinetics & Catalysis (AREA)
General Chemical & Material Sciences (AREA)
Crystallography & Structural Chemistry (AREA)
Biotechnology (AREA)
General Engineering & Computer Science (AREA)
Medical Informatics (AREA)
Dermatology (AREA)
Oil, Petroleum & Natural Gas (AREA)
Emergency Medicine (AREA)
Hematology (AREA)
Obesity (AREA)
Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)

DK07075344.7T 1999-06-29 2000-06-29 Rensning og stabilisering af peptid og proteiner i lægemidler DK1808438T3 (da)

Applications Claiming Priority (2)

Application Number	Priority Date	Filing Date	Title
US14143399P	1999-06-29	1999-06-29
EP00945009A EP1196430B1 (en)	1999-06-29	2000-06-29	Purification and stabilization of peptide and protein pharmaceutical agents

Publications (1)

Publication Number	Publication Date
DK1808438T3 true DK1808438T3 (da)	2014-10-27

Family

ID=22495668

Family Applications (4)

Application Number	Title	Priority Date	Filing Date
DK07075344.7T DK1808438T3 (da)	1999-06-29	2000-06-29	Rensning og stabilisering af peptid og proteiner i lægemidler
DK00945009.9T DK1196430T3 (da)	1999-06-29	2000-06-29	Rensning og stabilisering af peptider og proteiner i farmaceutiske midler
DK10075474.6T DK2280020T3 (da)	1999-06-29	2000-06-29	Farmaceutiske formuleringer omfattende et peptid kompleksbundet til et diketopiperazin
DK10075475.3T DK2280021T3 (da)	1999-06-29	2000-06-29	Farmaceutiske formuleringer omfattende insulin kompleksbundet til et diketopiperazin

Family Applications After (3)

Application Number	Title	Priority Date	Filing Date
DK00945009.9T DK1196430T3 (da)	1999-06-29	2000-06-29	Rensning og stabilisering af peptider og proteiner i farmaceutiske midler
DK10075474.6T DK2280020T3 (da)	1999-06-29	2000-06-29	Farmaceutiske formuleringer omfattende et peptid kompleksbundet til et diketopiperazin
DK10075475.3T DK2280021T3 (da)	1999-06-29	2000-06-29	Farmaceutiske formuleringer omfattende insulin kompleksbundet til et diketopiperazin

Country Status (11)

Country	Link
US (7)	US6444226B1 (da)
EP (5)	EP1196430B1 (da)
JP (5)	JP4713798B2 (da)
AT (1)	ATE545652T1 (da)
AU (3)	AU779986B2 (da)
CA (1)	CA2377204C (da)
CY (3)	CY1112441T1 (da)
DK (4)	DK1808438T3 (da)
ES (4)	ES2395096T3 (da)
PT (2)	PT1196430E (da)
WO (1)	WO2001000654A2 (da)

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2000
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Publication number	Publication date
JP2016117722A (ja)	2016-06-30
CA2377204C (en)	2015-01-20
US6652885B2 (en)	2003-11-25
WO2001000654A3 (en)	2001-07-05
EP1196430A2 (en)	2002-04-17
EP2280020B1 (en)	2016-02-17
EP2280004B1 (en)	2016-04-20
EP2280021B1 (en)	2016-02-17
AU2008229952A1 (en)	2008-11-06
US6444226B1 (en)	2002-09-03
EP1808438A2 (en)	2007-07-18
AU779986B2 (en)	2005-02-24
US8389470B2 (en)	2013-03-05
HK1154253A1 (en)	2012-04-13
DK2280021T3 (da)	2016-05-02
AU2008229952B2 (en)	2012-01-19
JP5774828B2 (ja)	2015-09-09
HK1107103A1 (en)	2008-03-28
US7943178B2 (en)	2011-05-17
US20150031609A1 (en)	2015-01-29
US7648960B2 (en)	2010-01-19
WO2001000654A2 (en)	2001-01-04
US8889099B2 (en)	2014-11-18
US20110105391A1 (en)	2011-05-05
CY1117668T1 (el)	2017-05-17
US20100086609A1 (en)	2010-04-08
US20030013641A1 (en)	2003-01-16
JP2014221794A (ja)	2014-11-27
JP2011026330A (ja)	2011-02-10
PT1808438E (pt)	2015-01-14
DK2280020T3 (da)	2016-05-02
EP1196430B1 (en)	2012-02-15
JP2003503420A (ja)	2003-01-28
EP2280021A1 (en)	2011-02-02
WO2001000654A9 (en)	2002-07-25
AU2005202230A1 (en)	2005-06-16
AU5901000A (en)	2001-01-31
JP5798999B2 (ja)	2015-10-21
EP1808438A3 (en)	2008-12-24
ES2395096T3 (es)	2013-02-08
US20130143801A1 (en)	2013-06-06
JP4713798B2 (ja)	2011-06-29
US20040077528A1 (en)	2004-04-22
EP2280004A1 (en)	2011-02-02
ES2569949T3 (es)	2016-05-13
DK1196430T3 (da)	2012-05-21
ES2526707T3 (es)	2015-01-14
CY1112441T1 (el)	2015-12-09
AU2005202230B2 (en)	2008-07-17
JP2013049684A (ja)	2013-03-14
ATE545652T1 (de)	2012-03-15
CA2377204A1 (en)	2001-01-04
CY1115766T1 (el)	2017-01-25
EP1808438B1 (en)	2014-10-01
EP2280020A1 (en)	2011-02-02
PT1196430E (pt)	2012-04-18
ES2569916T3 (es)	2016-05-13

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