HRP20170445T1 - Poboljšani rekonstituirani pripravak surfaktanta koji sadrži analoge surfaktant-proteina b (sp-b) i surfaktant-proteina c (sp-c) - Google Patents

Poboljšani rekonstituirani pripravak surfaktanta koji sadrži analoge surfaktant-proteina b (sp-b) i surfaktant-proteina c (sp-c) Download PDF

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Publication number
HRP20170445T1
HRP20170445T1 HRP20170445TT HRP20170445T HRP20170445T1 HR P20170445 T1 HRP20170445 T1 HR P20170445T1 HR P20170445T T HRP20170445T T HR P20170445TT HR P20170445 T HRP20170445 T HR P20170445T HR P20170445 T1 HRP20170445 T1 HR P20170445T1
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Croatia
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surfactant
reconstituted surfactant
reconstituted
protein
seq
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HRP20170445TT
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English (en)
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Fausto Pivetti
Monica Bocchi
Annamaria Soliani Raschini
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Chiesi Farmaceutici S.P.A.
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Application filed by Chiesi Farmaceutici S.P.A. filed Critical Chiesi Farmaceutici S.P.A.
Publication of HRP20170445T1 publication Critical patent/HRP20170445T1/hr

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/395Alveolar surfactant peptides; Pulmonary surfactant peptides
    • 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
    • A61K9/007Pulmonary tract; Aromatherapy
    • A61K9/0082Lung surfactant, artificial mucus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • A61P11/16Central respiratory analeptics
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/46Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates
    • C07K14/47Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates from mammals
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/785Alveolar surfactant peptides; Pulmonary surfactant peptides

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pulmonology (AREA)
  • Organic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Zoology (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Immunology (AREA)
  • Toxicology (AREA)
  • Biochemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Emulsifying, Dispersing, Foam-Producing Or Wetting Agents (AREA)
  • Cosmetics (AREA)
  • General Preparation And Processing Of Foods (AREA)

Claims (15)

1. Rekonstituirani pripravak surfaktanta koji sadrži sljedeće: a) od 1.2 do 1.8% po masi polipeptidnog analoga prirodnog surfaktant-proteina SP-C koji se sastoji od sekvencije prikazane formulom IPSSPVHLKRLKLLLLLLLLILLLILGALLLGL (SEQ. ID NO:1); b) od 0.1 do 0.5% po masi polipeptidnog analoga prirodnog surfaktant-proteina SP-B koji se sastoji od sekvencije prikazane formulom CWLCRALIKRIQALIPKGGRLLPQLVCRLVLRCS (SEQ. ID NO:2); c) mononezasićeni i zasićeni fosfolipid čiji je omjer mase u rasponu od 45: 55 do 55:45, gdje je rečeni mononezasićeni fosfolipid odabran iz skupine koja se sastoji od palmitoiloleoilfosfatidilkolina (POPC) i palmitoiloleoilfosfatidilglicerola (POPG) te gdje je rečeni zasićeni fosfolipid odabran iz skupine koja se sastoji od dipalmitoilfosfatidilkolina (DPPC) i dipalmitoilfosfatidilglicerola (DPPG); sve su količine izračunate relativno prema ukupnoj masi rekonstituiranog surfaktanta.
2. Rekonstituirani surfaktant prema patentnom zahtjevu 1, naznačeno time da sadrži sljedeće: a) oko 1.5% po masi polipeptidnog analoga prirodnog surfaktant-proteina SP-C koji se sastoji od sekvencije prikazane formulom IPSSPVHLKRLKLLLLLLLLILLLILGALLLGL (SEQ. ID NO:1); b) oko 0.2% po masi polipeptidnog analoga prirodnog surfaktant-proteina SP-B koji se sastoji od sekvencije prikazane formulom CWLCRALIKRIQALIPKGGRLLPQLVCRLVLRCS (SEQ. ID NO:2); c) 1,2-dipalmitoil-sn-glicero-3-fosfokolin (DPPC) i 1-palmitoil-2-oleil-sn-glicero-3-fosfoglicerol (POPG) u omjeru masa od oko 50:50; sve su količine izračunate relativno prema ukupnoj masi rekonstituiranog surfaktanta.
3. Rekonstituirani surfaktant prema patentnom zahtjevu 2, naznačeno time da sadrži sljedeće: a) oko 1.5% po masi polipeptidnog analoga prirodnog surfaktant-proteina SP-C koji se sastoji od sekvencije prikazane formulom IPSSPVHLKRLKLLLLLLLLILLLILGALLLGL (SEQ ID:NO.1); b) oko 0.2% po masi polipeptidnog analoga prirodnog surfaktant-proteina SP-B koji se sastoji od sekvencije prikazane formulom CWLCRALIKRIQALIPKGGRLLPQLVCRLVLRCS (SEQ ID:NO.2); c) oko 49.15% po masi 1,2-dipalmitoil-sn-glicero-3-fosfokolina (DPPC); te d) oko 49.15% po masi 1-palmitoil-2-oleil-sn-glicero-3-fosfoglicerola (POPG); sve su količine izračunate na ukupnoj masi rekonstituiranog surfaktanta.
4. Rekonstituirani surfaktant prema bilo kojem od patentnih zahtjeva 1 do 3, naznačeno time da je polipeptid SEQ ID:NO.2 u obliku disulfidom povezane molekule s intramolekulskom disulfidnom vezom između dvaju cisteinskih ostataka na položajima 1 i 33 i/ili između dvaju cisteinskih ostataka na položajima 4 i 27.
5. Rekonstituirani surfaktant prema bilo kojem od prethodnih patentnih zahtjeva, naznačeno time da je POPG u obliku farmaceutski prihvatljive soli.
6. Rekonstituirani surfaktant prema patentnom zahtjevu 5, naznačeno time da sol jest natrijeva sol.
7. Rekonstituirani surfaktant prema bilo kojem od prethodnih patentnih zahtjeva, naznačeno time da je svaki od rečenih polipeptida prisutan u obliku farmaceutski prihvatljive soli.
8. Rekonstituirani surfaktant prema patentnom zahtjevu 7, naznačeno time da sol jest acetatna sol.
9. Farmaceutska formulacija koja sadrži rekonstituirani surfaktant prema bilo kojem od patentnih zahtjeva 1 do 8, naznačeno time da je rečena formulacija u obliku otopine, disperzije, suspenzije ili suhog praška, a može biti u kombinaciji s jednim ili više farmaceutski prihvatljivih nosača.
10. Farmaceutska formulacija prema patentnom zahtjevu 9, naznačeno time da je rečena formulacija u obliku vodene suspenzije.
11. Farmaceutska formulacija prema patentnom zahtjevu 10, naznačeno time da je koncentracija rekonstituiranog surfaktanta između 0.1 i 160 mg/ml u vodenoj suspenziji.
12. Farmaceutski komplet koji sadrži sljedeće: a) rekonstituirani surfaktant prema bilo kojem od patentnih zahtjeva 1 do 8 u obliku praška u prvoj jedinici oblika doze; b) farmaceutski prihvatljiv nosač u drugoj jedinici oblika doze; te c) spremnik koji sadržava rečeni prvi i drugi oblik doze.
13. Rekonstituirani surfaktant prema bilo kojem od patentnih zahtjeva 1 do 8, naznačeno time da je za upotrebu kao lijek.
14. Rekonstituirani surfaktant prema bilo kojem od patentnih zahtjeva 1 do 8, naznačeno time da je za upotrebu za liječenje ili profilaksu respiratornog distres sindroma (RDS) kod prerano rođenih beba ili za liječenje ili profilaksu ostalih bolesti povezanih s nedostatkom ili disfunkcijom surfaktanta.
15. Rekonstituirani surfaktant za upotrebu prema patentnom zahtjevu 14, naznačeno time da bolest uključuje RDS kod odraslih (ARDS), sindrom aspiracije mekonija (MAS) i bronhopulmonarnu displaziju (BPD).
HRP20170445TT 2009-06-05 2017-03-21 Poboljšani rekonstituirani pripravak surfaktanta koji sadrži analoge surfaktant-proteina b (sp-b) i surfaktant-proteina c (sp-c) HRP20170445T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP09162052 2009-06-05
PCT/EP2010/003293 WO2010139442A1 (en) 2009-06-05 2010-05-31 Improved reconstituted surfactant composition containing analogs of surfactant protein b (sp-b) and surfactant protein c (sp-c)
EP10724708.2A EP2438086B1 (en) 2009-06-05 2010-05-31 Improved reconstituted surfactant composition containing analogs of surfactant protein b (sp-b) and surfactant protein c (sp-c)

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HRP20170445T1 true HRP20170445T1 (hr) 2017-05-19

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HRP20170445TT HRP20170445T1 (hr) 2009-06-05 2017-03-21 Poboljšani rekonstituirani pripravak surfaktanta koji sadrži analoge surfaktant-proteina b (sp-b) i surfaktant-proteina c (sp-c)

Country Status (36)

Country Link
US (1) US8399406B2 (hr)
EP (1) EP2438086B1 (hr)
JP (1) JP5666569B2 (hr)
KR (1) KR101668137B1 (hr)
CN (1) CN102459327B (hr)
AR (1) AR076973A1 (hr)
AU (1) AU2010256066B2 (hr)
BR (1) BRPI1010120B1 (hr)
CA (1) CA2764454C (hr)
CL (1) CL2011003003A1 (hr)
CO (1) CO6470858A2 (hr)
CY (1) CY1118676T1 (hr)
DK (1) DK2438086T3 (hr)
EA (1) EA021163B1 (hr)
ES (1) ES2621974T3 (hr)
GE (1) GEP20135967B (hr)
HK (1) HK1166332A1 (hr)
HR (1) HRP20170445T1 (hr)
HU (1) HUE034053T2 (hr)
IL (1) IL216718A (hr)
JO (1) JO3226B1 (hr)
LT (1) LT2438086T (hr)
MA (1) MA33374B1 (hr)
ME (1) ME01279B (hr)
MX (1) MX2011012951A (hr)
MY (1) MY159464A (hr)
NZ (1) NZ596848A (hr)
PE (1) PE20120541A1 (hr)
PL (1) PL2438086T3 (hr)
PT (1) PT2438086T (hr)
SG (1) SG176305A1 (hr)
SI (1) SI2438086T1 (hr)
TN (1) TN2011000558A1 (hr)
TW (1) TWI457132B (hr)
UA (1) UA103526C2 (hr)
WO (1) WO2010139442A1 (hr)

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CA2829629A1 (en) * 2011-03-10 2012-09-13 Board Of Regents, The University Of Texas System Protein nanoparticle dispersions
EP2812018B1 (en) * 2012-02-09 2018-12-05 University Of Rochester Novel sp-b&sp-c peptides, synthetic lung surfactants, and use thereof
ES2644317T3 (es) 2012-11-21 2017-11-28 Chiesi Farmaceutici S.P.A. Tensioactivos pulmonares reconstituidos
CN104382942A (zh) * 2014-11-05 2015-03-04 烟台东诚药业集团股份有限公司 一种猪肺表面活性物质混悬液制备新工艺
EP3106090A1 (en) 2015-06-15 2016-12-21 CHIESI FARMACEUTICI S.p.A. System for effective breath-synchronized delivery of medicament to the lungs
CN107666933A (zh) 2015-04-22 2018-02-06 奇斯药制品公司 用于药物有效地呼吸同步递送到肺部的方法和系统
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CA3028551A1 (en) 2016-07-28 2018-02-01 Chiesi Farmaceutici S.P.A. Method and system for delivery of an aerosolized medicament
KR102395835B1 (ko) 2016-08-24 2022-05-10 키에시 파르마슈티시 엣스. 피. 에이. 재구성된 폐 계면활성제 조성물을 포함하는 안정한 약제학적 제제
BR112019008169A2 (pt) 2016-10-26 2019-07-09 Chiesi Farm Spa dispositivo para facilitar o posicionamento de um cateter, sistema para entrega de um medicamento em aerossol por meio de um cateter, método para utilização de um dispositivo e kit
EP3558376B1 (en) 2016-12-22 2021-10-20 Chiesi Farmaceutici S.p.A. A therapeutic combination comprising a pulmonary surfactant and a steroid for the treatment of evolving bpd
TW201927286A (zh) 2017-12-15 2019-07-16 義大利商凱西製藥公司 用於噴霧投藥之包含肺表面張力素的藥學調配物
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AU2019260526A1 (en) 2018-04-23 2020-11-19 Chiesi Farmaceutici S.P.A. A therapeutic combination comprising a pulmonary surfactant and a steroid for the prophylaxis of BPD
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US20230257446A1 (en) 2020-01-28 2023-08-17 Chiesi Farmaceutici S.P.A. Polypeptides having improved properties
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AU2010256066B2 (en) 2015-11-26
CA2764454A1 (en) 2010-12-09
CY1118676T1 (el) 2017-07-12
PT2438086T (pt) 2017-04-18
GEP20135967B (en) 2013-11-11
TWI457132B (zh) 2014-10-21
SG176305A1 (en) 2012-01-30
WO2010139442A1 (en) 2010-12-09
BRPI1010120B1 (pt) 2022-12-06
US8399406B2 (en) 2013-03-19
SI2438086T1 (sl) 2017-05-31
CL2011003003A1 (es) 2012-05-18
JP2012528810A (ja) 2012-11-15
JP5666569B2 (ja) 2015-02-12
TW201102083A (en) 2011-01-16
AR076973A1 (es) 2011-07-20
NZ596848A (en) 2013-06-28
EA201190292A1 (ru) 2012-06-29
UA103526C2 (ru) 2013-10-25
IL216718A0 (en) 2012-02-29
PE20120541A1 (es) 2012-05-12
ME01279B (me) 2013-06-20
AU2010256066A1 (en) 2012-01-12
MX2011012951A (es) 2011-12-16
KR101668137B1 (ko) 2016-10-20
EP2438086A1 (en) 2012-04-11
US20110003733A1 (en) 2011-01-06
CN102459327A (zh) 2012-05-16
EA021163B1 (ru) 2015-04-30
IL216718A (en) 2016-08-31
CA2764454C (en) 2018-06-12
CN102459327B (zh) 2015-06-03
ES2621974T3 (es) 2017-07-05
CO6470858A2 (es) 2012-06-29
MY159464A (en) 2017-01-13
TN2011000558A1 (en) 2013-05-24
JO3226B1 (ar) 2018-03-08
KR20120028892A (ko) 2012-03-23
HUE034053T2 (en) 2018-01-29
DK2438086T3 (en) 2017-04-10
BRPI1010120A2 (pt) 2019-03-26
LT2438086T (lt) 2017-04-10
PL2438086T3 (pl) 2017-07-31
EP2438086B1 (en) 2017-01-11
HK1166332A1 (en) 2012-10-26
MA33374B1 (fr) 2012-06-01

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