ES2557805T3 - Liofilizacion de agente tensioactivo pulmonar liposomico sintetico - Google Patents

Liofilizacion de agente tensioactivo pulmonar liposomico sintetico Download PDF

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Publication number
ES2557805T3
ES2557805T3 ES13716655.9T ES13716655T ES2557805T3 ES 2557805 T3 ES2557805 T3 ES 2557805T3 ES 13716655 T ES13716655 T ES 13716655T ES 2557805 T3 ES2557805 T3 ES 2557805T3
Authority
ES
Spain
Prior art keywords
temperature
mixture
lyophilization
pulmonary surfactant
solidified
Prior art date
Legal status (The legal status 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 status listed.)
Active
Application number
ES13716655.9T
Other languages
English (en)
Spanish (es)
Inventor
Sergio Cesco-Cancian
Thomas HOY
Edward H. TRAPPLER
Michael S. Thomas
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Windtree Therapeutics Inc
Original Assignee
Discovery Laboratories 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 Discovery Laboratories Inc filed Critical Discovery Laboratories Inc
Application granted granted Critical
Publication of ES2557805T3 publication Critical patent/ES2557805T3/es
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • 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
    • A61K9/19—Particulate 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
    • 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
    • A61K31/20—Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids
    • 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
    • A61K31/66—Phosphorus compounds
    • A61K31/661—Phosphorus acids or esters thereof not having P—C bonds, e.g. fosfosal, dichlorvos, malathion or mevinphos
    • 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
    • A61K31/66—Phosphorus compounds
    • A61K31/683—Diesters of a phosphorus acid with two hydroxy compounds, e.g. phosphatidylinositols
    • 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
    • A61K31/66—Phosphorus compounds
    • A61K31/683—Diesters of a phosphorus acid with two hydroxy compounds, e.g. phosphatidylinositols
    • A61K31/685—Diesters of a phosphorus acid with two hydroxy compounds, e.g. phosphatidylinositols one of the hydroxy compounds having nitrogen atoms, e.g. phosphatidylserine, lecithin
    • 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
    • A61K38/395—Alveolar surfactant peptides; Pulmonary surfactant peptides
    • 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
    • A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
    • 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
    • A61K9/0082—Lung surfactant, artificial mucus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • 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
    • C07K14/785—Alveolar surfactant peptides; Pulmonary surfactant peptides
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F26—DRYING
    • F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
    • F26B5/00—Drying solid materials or objects by processes not involving the application of heat
    • F26B5/04—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum
    • F26B5/06—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum the process involving freezing

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Pulmonology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Molecular Biology (AREA)
  • Immunology (AREA)
  • Genetics & Genomics (AREA)
  • Toxicology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Peptides Or Proteins (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
ES13716655.9T 2012-03-28 2013-03-28 Liofilizacion de agente tensioactivo pulmonar liposomico sintetico Active ES2557805T3 (es)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201261616827P 2012-03-28 2012-03-28
US201261616827P 2012-03-28
PCT/US2013/034464 WO2013149074A1 (en) 2012-03-28 2013-03-28 Lyophilization of synthetic liposomal pulmonary surfactant

Publications (1)

Publication Number Publication Date
ES2557805T3 true ES2557805T3 (es) 2016-01-28

Family

ID=48096305

Family Applications (1)

Application Number Title Priority Date Filing Date
ES13716655.9T Active ES2557805T3 (es) 2012-03-28 2013-03-28 Liofilizacion de agente tensioactivo pulmonar liposomico sintetico

Country Status (35)

Country Link
US (3) US9554999B2 (OSRAM)
EP (2) EP2837377A1 (OSRAM)
JP (1) JP6178402B2 (OSRAM)
KR (1) KR102123129B1 (OSRAM)
CN (1) CN104271118B (OSRAM)
AU (2) AU2013237985B2 (OSRAM)
BR (1) BR112014024057A8 (OSRAM)
CA (1) CA2867649C (OSRAM)
CL (1) CL2014002553A1 (OSRAM)
CO (1) CO7081146A2 (OSRAM)
CR (1) CR20140449A (OSRAM)
CU (1) CU20140116A7 (OSRAM)
CY (1) CY1117380T1 (OSRAM)
DK (1) DK2723323T3 (OSRAM)
EC (1) ECSP14024363A (OSRAM)
ES (1) ES2557805T3 (OSRAM)
HK (1) HK1206979A1 (OSRAM)
HR (1) HRP20151392T1 (OSRAM)
HU (1) HUE026363T2 (OSRAM)
IL (1) IL234688B (OSRAM)
IN (1) IN2014DN08538A (OSRAM)
MA (1) MA37445B1 (OSRAM)
MX (1) MX359654B (OSRAM)
MY (1) MY164868A (OSRAM)
NZ (1) NZ630219A (OSRAM)
PE (1) PE20142302A1 (OSRAM)
PL (1) PL2723323T3 (OSRAM)
PT (1) PT2723323E (OSRAM)
RS (1) RS54513B1 (OSRAM)
RU (1) RU2671500C2 (OSRAM)
SG (1) SG11201405944PA (OSRAM)
SI (1) SI2723323T1 (OSRAM)
SM (1) SMT201500320B (OSRAM)
WO (2) WO2013149013A1 (OSRAM)
ZA (1) ZA201406982B (OSRAM)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DK2723323T3 (en) * 2012-03-28 2016-01-11 Discovery Lab Inc FREEZE DRYING OF SYNTHETIC liposomal pulmonary surfactant
EP3222273B1 (en) * 2014-11-18 2019-09-25 National Institute for Materials Science Method for producing porous particle
US10765753B2 (en) * 2014-12-30 2020-09-08 Samyang Biopharmaceuticals Corporation Polymer nanoparticle freeze-dried product, and preparation method therefor
HUE053799T2 (hu) * 2015-07-10 2021-07-28 Byondis Bv Antitest-duokarmicin gyógyszer-konjugátumokat tartalmazó készítmények
KR102716928B1 (ko) 2015-07-22 2024-10-11 닛토덴코 가부시키가이샤 나노 입자 동결건조물 형태를 위한 조성물 및 방법
JP7012512B2 (ja) * 2017-11-13 2022-01-28 清水建設株式会社 管理装置、製造システムおよび管理方法
WO2019126289A1 (en) * 2017-12-21 2019-06-27 Civitas Therapeutics, Inc. Surfactant formulations for inhalation
CN108853061A (zh) * 2018-10-09 2018-11-23 兆科药业(合肥)有限公司 一种人工合成肺表面活性剂药物组合物及与之的肠溶胶囊和其制备方法及用途
WO2020142420A1 (en) * 2018-12-31 2020-07-09 Novus Therapeutics, Inc. Novel surfactant-lipid alloy drug substance, methods of making the same, and pharmaceutical compositions comprising the same
US11287185B1 (en) 2020-09-09 2022-03-29 Stay Fresh Technology, LLC Freeze drying with constant-pressure and constant-temperature phases
KR102545292B1 (ko) * 2021-01-28 2023-06-16 인천대학교 산학협력단 마이크로캡슐 형성용 생체 적합 계면활성제 합성방법
EP4366691A1 (en) * 2021-07-05 2024-05-15 Chiesi Farmaceutici S.p.A. Process for the preparation of a pulmonary surfactant

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BE751108R (fr) 1969-06-06 1970-11-03 Berliet Automobiles Dispositif pour la mesure precise de la consommation specifiquedes moteurs a combustion
JPS59164724A (ja) * 1983-03-10 1984-09-17 Tokyo Tanabe Co Ltd サ−フアクタント及びそれを含有する呼吸窮迫症候群治療剤
US5260273A (en) * 1988-01-06 1993-11-09 The Scripps Research Institute Pulmonary surfactant protein and related polypeptide
US6315983B1 (en) 1996-01-24 2001-11-13 Byk Gulden Lomberg Chemische Fabrik Gmbh Process for the production of powdered pulmonary surfactant preparations
AU2322097A (en) * 1996-03-27 1997-10-17 Ortho Pharmaceutical Corporation Lyophilized pulmonary surfactant peptide compositions
US6652837B1 (en) 1996-05-24 2003-11-25 Massachusetts Institute Of Technology Preparation of novel particles for inhalation
US5855913A (en) 1997-01-16 1999-01-05 Massachusetts Instite Of Technology Particles incorporating surfactants for pulmonary drug delivery
US5874064A (en) 1996-05-24 1999-02-23 Massachusetts Institute Of Technology Aerodynamically light particles for pulmonary drug delivery
JPWO2005105111A1 (ja) 2004-04-29 2008-07-31 相男 李 人工肺サーファクタント組成物およびその使用方法
US7582312B2 (en) * 2004-11-15 2009-09-01 Discovery Laboratories, Inc. Methods to produce lung surfactant formulations via lyophilization and formulations and uses thereof
EP2377554A1 (en) 2005-07-22 2011-10-19 Amgen, Inc Concentrated protein lyophilates, methods and uses
EP1997502A1 (en) 2007-06-01 2008-12-03 CHIESI FARMACEUTICI S.p.A. Reconstituted surfactants having improved properties
DK2723323T3 (en) * 2012-03-28 2016-01-11 Discovery Lab Inc FREEZE DRYING OF SYNTHETIC liposomal pulmonary surfactant

Also Published As

Publication number Publication date
MA37445B1 (fr) 2017-01-31
MA37445A1 (fr) 2016-04-29
ECSP14024363A (es) 2015-09-30
SMT201500320B (it) 2016-02-25
HK1205685A1 (en) 2015-12-24
MX359654B (es) 2018-10-05
US9554999B2 (en) 2017-01-31
SG11201405944PA (en) 2014-10-30
NZ630219A (en) 2016-09-30
MY164868A (en) 2018-01-30
EP2837377A1 (en) 2015-02-18
US8748396B2 (en) 2014-06-10
CN104271118B (zh) 2017-02-08
HK1197174A1 (zh) 2015-01-09
AU2013237985B2 (en) 2017-07-06
CO7081146A2 (es) 2014-10-10
CL2014002553A1 (es) 2015-04-06
KR20140137453A (ko) 2014-12-02
CY1117380T1 (el) 2017-04-26
AU2017239624A1 (en) 2017-10-26
CA2867649A1 (en) 2013-10-03
CR20140449A (es) 2015-05-04
SI2723323T1 (sl) 2016-04-29
IL234688A0 (en) 2014-11-30
BR112014024057A8 (pt) 2018-01-16
IN2014DN08538A (OSRAM) 2015-05-15
WO2013149074A1 (en) 2013-10-03
KR102123129B1 (ko) 2020-06-15
EP2723323B1 (en) 2015-09-23
JP6178402B2 (ja) 2017-08-09
CU20140116A7 (es) 2015-01-29
PL2723323T3 (pl) 2016-05-31
RS54513B1 (sr) 2016-06-30
ZA201406982B (en) 2016-05-25
HUE026363T2 (en) 2016-06-28
HRP20151392T1 (hr) 2016-03-25
EP2723323A1 (en) 2014-04-30
RU2014143247A (ru) 2016-05-20
IL234688B (en) 2020-01-30
BR112014024057A2 (OSRAM) 2017-06-20
CN104271118A (zh) 2015-01-07
PE20142302A1 (es) 2015-01-21
HK1206979A1 (en) 2016-01-22
RU2671500C2 (ru) 2018-11-01
AU2013237985A1 (en) 2014-10-02
JP2015514714A (ja) 2015-05-21
WO2013149013A1 (en) 2013-10-03
DK2723323T3 (en) 2016-01-11
PT2723323E (pt) 2016-01-27
US20140088025A1 (en) 2014-03-27
US8748397B2 (en) 2014-06-10
US20140088026A1 (en) 2014-03-27
US20150297524A1 (en) 2015-10-22
CA2867649C (en) 2021-02-16
MX2014011483A (es) 2014-12-08
AU2017239624B2 (en) 2017-11-23

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