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RS50842B - Meke kapsule koje sadrže palonosetron hlorovodonik koji ima poboljšanu stabilnost i bioraspoloživost - Google Patents

Meke kapsule koje sadrže palonosetron hlorovodonik koji ima poboljšanu stabilnost i bioraspoloživost

Info

Publication number
RS50842B
RS50842B RSP-2009/0222A RSP20090222A RS50842B RS 50842 B RS50842 B RS 50842B RS P20090222 A RSP20090222 A RS P20090222A RS 50842 B RS50842 B RS 50842B
Authority
RS
Serbia
Prior art keywords
bioavailability
palonosetron
palonosetron hydrochloride
weight
improved stability
Prior art date
Application number
RSP-2009/0222A
Other languages
English (en)
Inventor
Daniele Bonadeo
Giorgio Calderari
Enrico Braglia
Riccardo Braglia
Original Assignee
Helsinn Healthcare S.A.
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=38921772&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=RS50842(B) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Helsinn Healthcare S.A. filed Critical Helsinn Healthcare S.A.
Publication of RS50842B publication Critical patent/RS50842B/sr

Links

Classifications

    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic 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
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/473—Quinolines; Isoquinolines ortho- or peri-condensed with carbocyclic ring systems, e.g. acridines, phenanthridines
    • 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
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4816—Wall or shell material
    • A61K9/4825—Proteins, e.g. gelatin
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5052—Proteins, e.g. albumin
    • A61K9/5057—Gelatin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/08—Drugs for disorders of the alimentary tract or the digestive system for nausea, cinetosis or vertigo; Antiemetics

Landscapes

  • Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Organic Chemistry (AREA)
  • Otolaryngology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Hospice & Palliative Care (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Meka želatinasta kapsula za oralnu primenu sadrži:a) meki želatinasti spoljašnji omotač koji ima propustljivost kiseonika manju od oko 1.0 x 10"3 mlcm/(cm2-24hr.atm); ib) lipofilnu tečnu unutrašnju kompoziciju za punjenje koja sadrži:i) više od oko 50 mas. % jedne ili više lipofolnih komponenti;ii) od oko 1 do 20 mas. % mešljive u vodi ili homogenizovane navedene jedne ili više lipofilnih komponenti;iii) od oko 0.05 do oko 2.0 mg palonosetrona kao palonosetron hlorovodonik rastvoren ili dispergovan u navedenoj vodi; iiv) površinski aktivne supstance,gde navedena kapsula pokazuje farmakokinetiku kada se proguta oralno u čvrstom stanju koja su bioekvivalentna za formulaciju koja ima više od 95 % apsolutne bioraspoloživosti, gde je bioekvivalencija utvrđena pomoću 90 % intervala pouzdanosti za AUC koja je između 80 % i 125 %.Prijava sadrži još 26 patentnih zahteva.
RSP-2009/0222A 2006-10-24 2007-10-19 Meke kapsule koje sadrže palonosetron hlorovodonik koji ima poboljšanu stabilnost i bioraspoloživost RS50842B (sr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US85434206P 2006-10-24 2006-10-24
PCT/EP2007/009098 WO2008049552A1 (en) 2006-10-24 2007-10-19 Soft capsules comprising palonosetron hydrochloride having improved stability and bioavailability

Publications (1)

Publication Number Publication Date
RS50842B true RS50842B (sr) 2010-08-31

Family

ID=38921772

Family Applications (1)

Application Number Title Priority Date Filing Date
RSP-2009/0222A RS50842B (sr) 2006-10-24 2007-10-19 Meke kapsule koje sadrže palonosetron hlorovodonik koji ima poboljšanu stabilnost i bioraspoloživost

Country Status (36)

Country Link
US (2) US20080152704A1 (sr)
EP (1) EP1940366B9 (sr)
JP (1) JP5144527B2 (sr)
KR (1) KR101441459B1 (sr)
CN (1) CN101573106B (sr)
AR (1) AR063362A1 (sr)
AT (1) ATE427742T1 (sr)
AU (1) AU2007308378B2 (sr)
BR (1) BRPI0718497B1 (sr)
CA (1) CA2666512C (sr)
CL (1) CL2007003055A1 (sr)
CO (1) CO6160289A2 (sr)
CR (1) CR10728A (sr)
CY (1) CY1109914T1 (sr)
DE (1) DE602007000856D1 (sr)
DK (1) DK1940366T3 (sr)
EA (1) EA016455B1 (sr)
ES (1) ES2325339T3 (sr)
GT (1) GT200900096A (sr)
HK (1) HK1117769A1 (sr)
HN (1) HN2009000785A (sr)
HR (1) HRP20090341T1 (sr)
IL (1) IL198225A (sr)
ME (1) ME01949B (sr)
MX (1) MX2009004461A (sr)
NO (1) NO342353B1 (sr)
NZ (1) NZ576237A (sr)
PL (1) PL1940366T3 (sr)
PT (1) PT1940366E (sr)
RS (1) RS50842B (sr)
SI (1) SI1940366T1 (sr)
SV (1) SV2009003238A (sr)
TW (1) TWI367212B (sr)
UA (1) UA97653C2 (sr)
WO (1) WO2008049552A1 (sr)
ZA (1) ZA200902773B (sr)

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EP2364138A2 (en) * 2008-12-08 2011-09-14 Teva Pharmaceutical Industries Ltd. Palonosetron formulation
US20110003005A1 (en) * 2009-07-06 2011-01-06 Gopi Venkatesh Methods of Treating PDNV and PONV with Extended Release Ondansetron Compositions
CN102048705B (zh) * 2009-11-10 2012-07-18 齐鲁制药有限公司 盐酸帕洛诺司琼口腔崩解片制剂及其制备方法
CN102781939A (zh) * 2009-11-13 2012-11-14 赫尔辛医疗股份公司 帕洛诺司琼代谢物
LT2722045T (lt) * 2009-11-18 2016-09-26 Helsinn Healthcare Sa Kompozicija skirta gydyti centralizuotai kontroliuojamą pykinimą ir vėmimą
EP2722045B1 (en) 2009-11-18 2016-07-06 Helsinn Healthcare SA Compositions for treating centrally mediated nausea and vomiting
EP2759298B1 (en) 2011-10-18 2018-01-17 Helsinn Healthcare SA Therapeutic combinations of netupitant and palonosetron
CN103446072A (zh) * 2012-06-02 2013-12-18 正大天晴药业集团股份有限公司 帕洛诺司琼的固体药物组合物
BR112015021769A2 (pt) * 2013-03-19 2017-07-18 Galenicum Health Sl composições farmacêuticas compreendendo um agente ativo
AU2014306759B2 (en) 2013-08-12 2018-04-26 Pharmaceutical Manufacturing Research Services, Inc. Extruded immediate release abuse deterrent pill
US9492444B2 (en) 2013-12-17 2016-11-15 Pharmaceutical Manufacturing Research Services, Inc. Extruded extended release abuse deterrent pill
WO2015095391A1 (en) 2013-12-17 2015-06-25 Pharmaceutical Manufacturing Research Services, Inc. Extruded extended release abuse deterrent pill
BR112016014880A2 (pt) * 2013-12-23 2017-08-08 Samyang Biopharmaceuticals Composição farmacêutica incluindo palonosetron
WO2016010771A1 (en) 2014-07-17 2016-01-21 Pharmaceutical Manufacturing Research Services, Inc. Immediate release abuse deterrent liquid fill dosage form
EP3209282A4 (en) * 2014-10-20 2018-05-23 Pharmaceutical Manufacturing Research Services, Inc. Extended release abuse deterrent liquid fill dosage form
KR20160128573A (ko) * 2015-04-29 2016-11-08 주식회사 삼양바이오팜 약제학적 패키지
JP2019019067A (ja) * 2017-07-13 2019-02-07 ニプロ株式会社 液体製剤
CN111205283A (zh) * 2020-01-20 2020-05-29 广州九植医药科技有限公司 一种盐酸帕洛诺司琼有关物质b的合成方法
EP4385500A1 (en) 2022-12-12 2024-06-19 Alfred E. Tiefenbacher (GmbH & Co. KG) Fixed dose combination comprising netupitant and palonosetron
WO2024126398A1 (en) 2022-12-12 2024-06-20 Alfred E. Tiefenbacher (Gmbh & Co. Kg) Fixed dose combination comprising netupitant and palonosetron
WO2024126408A1 (en) 2022-12-12 2024-06-20 Alfred E. Tiefenbacher (Gmbh & Co. Kg) Antioxidant-free fixed dose combination of netupitant and palonosetron
EP4385497A1 (en) 2022-12-12 2024-06-19 Alfred E. Tiefenbacher (GmbH & Co. KG) Antioxidant-free fixed dose combination of netupitant and palonosetron

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Also Published As

Publication number Publication date
IL198225A (en) 2013-03-24
EP1940366B9 (en) 2009-12-02
NO342353B1 (no) 2018-05-07
ES2325339T3 (es) 2009-09-01
EA200970396A1 (ru) 2009-10-30
TWI367212B (en) 2012-07-01
AR063362A1 (es) 2009-01-21
CN101573106B (zh) 2013-07-24
BRPI0718497B1 (pt) 2024-02-06
CY1109914T1 (el) 2014-09-10
ME01949B (me) 2010-08-31
CA2666512C (en) 2014-05-27
EP1940366B1 (en) 2009-04-08
SI1940366T1 (sl) 2009-08-31
MX2009004461A (es) 2009-09-16
CA2666512A1 (en) 2008-05-02
GT200900096A (es) 2011-08-29
PL1940366T3 (pl) 2009-09-30
ATE427742T1 (de) 2009-04-15
IL198225A0 (en) 2009-12-24
EA016455B1 (ru) 2012-05-30
EP1940366A1 (en) 2008-07-09
CO6160289A2 (es) 2010-05-20
JP5144527B2 (ja) 2013-02-13
BRPI0718497A2 (pt) 2014-07-08
US20170035748A1 (en) 2017-02-09
UA97653C2 (ru) 2012-03-12
DE602007000856D1 (de) 2009-05-20
ZA200902773B (en) 2010-03-31
CL2007003055A1 (es) 2008-03-24
PT1940366E (pt) 2009-06-17
HRP20090341T1 (en) 2009-07-31
AU2007308378B2 (en) 2013-02-21
US20080152704A1 (en) 2008-06-26
NO20091945L (no) 2009-05-25
HN2009000785A (es) 2011-10-14
NZ576237A (en) 2011-12-22
DK1940366T3 (da) 2009-06-29
JP2009507933A (ja) 2009-02-26
CR10728A (es) 2009-07-23
CN101573106A (zh) 2009-11-04
SV2009003238A (es) 2009-11-09
HK1117769A1 (en) 2009-01-23
AU2007308378A1 (en) 2008-05-02
KR101441459B1 (ko) 2014-09-18
WO2008049552A1 (en) 2008-05-02
KR20090073234A (ko) 2009-07-02
TW200827355A (en) 2008-07-01

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