PL2868315T3 - Udoskonalone preparaty i sposoby liofilizacji oraz uzyskiwane liofilizaty - Google Patents

Udoskonalone preparaty i sposoby liofilizacji oraz uzyskiwane liofilizaty

Info

Publication number
PL2868315T3
PL2868315T3 PL14188334T PL14188334T PL2868315T3 PL 2868315 T3 PL2868315 T3 PL 2868315T3 PL 14188334 T PL14188334 T PL 14188334T PL 14188334 T PL14188334 T PL 14188334T PL 2868315 T3 PL2868315 T3 PL 2868315T3
Authority
PL
Poland
Prior art keywords
lyophilates
lyophilization
methods
improved formulations
formulations
Prior art date
Application number
PL14188334T
Other languages
English (en)
Polish (pl)
Inventor
Martin Sven Jacobson
Original Assignee
Biogen Chesapeake Llc
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 Biogen Chesapeake Llc filed Critical Biogen Chesapeake Llc
Publication of PL2868315T3 publication Critical patent/PL2868315T3/pl

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682Processes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/16Amides, e.g. hydroxamic acids
    • A61K31/17Amides, e.g. hydroxamic acids having the group >N—C(O)—N< or >N—C(S)—N<, e.g. urea, thiourea, carmustine
    • A61K31/175Amides, e.g. hydroxamic acids having the group >N—C(O)—N< or >N—C(S)—N<, e.g. urea, thiourea, carmustine having the group, >N—C(O)—N=N— or, e.g. carbonohydrazides, carbazones, semicarbazides, semicarbazones; Thioanalogues thereof
    • 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
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445Non condensed piperidines, e.g. piperocaine
    • A61K31/451Non condensed piperidines, e.g. piperocaine having a carbocyclic group directly attached to the heterocyclic ring, e.g. glutethimide, meperidine, loperamide, phencyclidine, piminodine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/64Sulfonylureas, e.g. glibenclamide, tolbutamide, chlorpropamide
    • 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
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1611Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • A61K9/1623Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/14Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A61P25/16Anti-Parkinson drugs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/10Antioedematous agents; Diuretics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/10Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/12Antihypertensives

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)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Diabetes (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Cardiology (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Dermatology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Inorganic Chemistry (AREA)
  • Communicable Diseases (AREA)
  • Obesity (AREA)
  • Oncology (AREA)
  • Vascular Medicine (AREA)
  • Urology & Nephrology (AREA)
  • Psychology (AREA)
  • Emergency Medicine (AREA)
  • Endocrinology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
  • Nitrogen Condensed Heterocyclic Rings (AREA)
PL14188334T 2007-12-04 2008-12-03 Udoskonalone preparaty i sposoby liofilizacji oraz uzyskiwane liofilizaty PL2868315T3 (pl)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US99224107P 2007-12-04 2007-12-04
EP08857974.3A EP2224913B1 (en) 2007-12-04 2008-12-03 Improved formulations and methods for lyophilization and lyophilates provided thereby
EP14188334.8A EP2868315B1 (en) 2007-12-04 2008-12-03 Improved formulations and methods for lyophilization and lyophilates provided thereby

Publications (1)

Publication Number Publication Date
PL2868315T3 true PL2868315T3 (pl) 2018-06-29

Family

ID=40718143

Family Applications (1)

Application Number Title Priority Date Filing Date
PL14188334T PL2868315T3 (pl) 2007-12-04 2008-12-03 Udoskonalone preparaty i sposoby liofilizacji oraz uzyskiwane liofilizaty

Country Status (14)

Country Link
US (6) US8277845B2 (cg-RX-API-DMAC7.html)
EP (2) EP2224913B1 (cg-RX-API-DMAC7.html)
JP (5) JP5812318B2 (cg-RX-API-DMAC7.html)
CN (1) CN101932308B (cg-RX-API-DMAC7.html)
CA (3) CA3123813C (cg-RX-API-DMAC7.html)
CY (1) CY1119256T1 (cg-RX-API-DMAC7.html)
DK (1) DK2868315T3 (cg-RX-API-DMAC7.html)
ES (1) ES2638977T3 (cg-RX-API-DMAC7.html)
HR (1) HRP20171223T1 (cg-RX-API-DMAC7.html)
LT (1) LT2868315T (cg-RX-API-DMAC7.html)
PL (1) PL2868315T3 (cg-RX-API-DMAC7.html)
PT (1) PT2868315T (cg-RX-API-DMAC7.html)
SI (1) SI2868315T1 (cg-RX-API-DMAC7.html)
WO (1) WO2009073711A1 (cg-RX-API-DMAC7.html)

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KR102336425B1 (ko) 2017-06-30 2021-12-07 무라다기카이가부시끼가이샤 반송 시스템 및 반송 방법
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US20220280537A1 (en) * 2021-03-04 2022-09-08 Biogen Chesapeake Llc Low-sorbing glyburide formulation and methods
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CN113274361B (zh) * 2021-06-08 2022-05-06 吉林津升制药有限公司 一种烟酰胺冻干粉针剂及其制备方法
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Also Published As

Publication number Publication date
EP2868315A1 (en) 2015-05-06
JP2015134763A (ja) 2015-07-27
LT2868315T (lt) 2017-09-25
EP2868315B1 (en) 2017-05-31
US20150141516A1 (en) 2015-05-21
EP2224913A1 (en) 2010-09-08
US20210244669A1 (en) 2021-08-12
CA3240562A1 (en) 2009-06-11
SI2868315T1 (sl) 2017-10-30
JP5812318B2 (ja) 2015-11-11
CA2707484A1 (en) 2009-06-11
JP6377189B2 (ja) 2018-08-22
PT2868315T (pt) 2017-09-04
JP6603762B2 (ja) 2019-11-06
DK2868315T3 (en) 2017-09-04
US8858997B2 (en) 2014-10-14
US20100273886A1 (en) 2010-10-28
JP6866438B2 (ja) 2021-04-28
EP2224913A4 (en) 2013-04-24
EP2224913B1 (en) 2014-10-15
US20190099372A1 (en) 2019-04-04
WO2009073711A1 (en) 2009-06-11
JP6084639B2 (ja) 2017-02-22
ES2638977T3 (es) 2017-10-24
HRP20171223T1 (hr) 2017-11-03
CN101932308B (zh) 2014-11-05
JP2018197244A (ja) 2018-12-13
US10426729B2 (en) 2019-10-01
CN101932308A (zh) 2010-12-29
US8277845B2 (en) 2012-10-02
US10869835B2 (en) 2020-12-22
US10117834B2 (en) 2018-11-06
JP2020007334A (ja) 2020-01-16
JP2011505424A (ja) 2011-02-24
CA3123813A1 (en) 2009-06-11
CA3123813C (en) 2024-10-08
US20200093747A1 (en) 2020-03-26
CY1119256T1 (el) 2018-02-14
JP2017128569A (ja) 2017-07-27
US20130245069A1 (en) 2013-09-19
CA2707484C (en) 2021-08-10

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