ES2623936T3 - Soluciones pediátricas que contienen propranolol - Google Patents

Soluciones pediátricas que contienen propranolol Download PDF

Info

Publication number
ES2623936T3
ES2623936T3 ES10717263.7T ES10717263T ES2623936T3 ES 2623936 T3 ES2623936 T3 ES 2623936T3 ES 10717263 T ES10717263 T ES 10717263T ES 2623936 T3 ES2623936 T3 ES 2623936T3
Authority
ES
Spain
Prior art keywords
log
pediatric
propranolol
solutions containing
solution
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
ES10717263.7T
Other languages
English (en)
Other versions
ES2623936T5 (es
Inventor
Christine Chaumont
Jean-François CORDOLIANI
Elie Leverd
Valérie MUGUET
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.)
Pierre Fabre Dermo Cosmetique SA
Original Assignee
Pierre Fabre Dermo Cosmetique SA
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=40940328&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=ES2623936(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Pierre Fabre Dermo Cosmetique SA filed Critical Pierre Fabre Dermo Cosmetique SA
Publication of ES2623936T3 publication Critical patent/ES2623936T3/es
Application granted granted Critical
Publication of ES2623936T5 publication Critical patent/ES2623936T5/es
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/135Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/138Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38Cellulose; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic 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
    • A61P9/00Drugs for disorders of the cardiovascular system

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Inorganic Chemistry (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Seasonings (AREA)
  • Saccharide Compounds (AREA)
  • Polysaccharides And Polysaccharide Derivatives (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Abstract

Una solución pediátrica acuosa sin alcohol etílico que comprende propranolol o sales farmacéuticamente aceptables de los mismos, un edulcorante de tipo sin azúcar y menos de 0,01% p/v de cualquier agente conservante, distinto del propio propranolol, para uso como medicamento en el tratamiento de hemangiomas.

Description

imagen1
imagen2
imagen3
imagen4
imagen5
imagen6
imagen7
Clorhidrato de propranolol
0,50 g 0,50 g 0,50 g
Hidroxietilcelulosa, por ejemplo, Natrosol HHX250
0,35g 0,35g 0,35 g
Sacarina sódica
0,15g 0,15g 0,15 g
Saborizante hidrofílico
0,5 g (vainilla) 0,5 g (caramelo/vainilla) 0,50 g (fresa)
Ácido cítrico monohidratado
Hasta pH = 5,00 Hasta pH = 3,00 Hasta pH = 3,0
Conservante
No Metilparabeno 0,1 g No
Agua purificada
Hasta 100 ml Hasta 100 ml Hasta 100 ml
En los ensayos siguientes, cada uno de los productos prueba se inoculó con 200 µl de cada una de las cepas de ensayo diluidas en sal de triptona. Se realizaron recuentos microbiológicos al día 0, 14 y 28, 5 después de que se neutralizaron las muestras en 9 ml de una solución neutralizante (10 minutos) que comprendía Tween 80 (10%), lecitina (2%), tiosulfato de saponina (0,5%) y agua destilada estéril, y que 1 ml de esa mezcla neutralizada se transfiriera en placas de Petri y se cubriera con 15 ml de medio de agar (medio a base de agar de tripticasa de soja para bacterias aerobias y medio basado en agar saburaud con dextrosa para levaduras y mohos). Los recuentos se lograron después de 24-48 10 horas de incubación a 32,5°C ± 2,5°C para bacterias aeróbicas, y 48-72 horas a 22,5°C ± 2,5°C para levaduras y mohos. Para cada solución ensayada, los siguientes resultados indican el número de unidades formadoras de colonias por ml, es decir, CFU/ml del producto de ensayo y la relación de reducción (en log) en comparación con el número de microorganismos introducidos en el inóculo. Los resultados se expresan en la siguiente tabla en UFC/ml de producto de ensayo y en reducción
15 logarítmica.
Las muestras analizadas se probaron a los siguientes microorganismos: Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Candida albicans y Aspergillus niger.
20 Para cada solución ensayada, los resultados siguientes indican el número de microorganismos recuperados para las diferentes cepas, así como la relación de reducción (en log) en comparación con el número de microorganismos introducidos en el inóculo. Típicamente, una reducción de > 4,7 log o más indica la desaparición completa de los microorganismos, debido a la sensibilidad de las prendas.
25 Solución A.
Cepa
Inóculo D0 14 días 28 días De acuerdo con el criterio de la farmacopea europea
S. aureus
9,8x105 1,10 < 10 > 5 log <10 > 5 log +
P. aeruginosa
5x105 <10 < 10 > 4,7 log < 10 > 4,7 log +
E. coli
1,3x106 2,8x105 < 10 > 5 log < 10 > 5 log +
C. albicans
1,7x105 < 10 > 4 log < 10 > 4 log +
A. niger
1,3x105 2,9x105 6,8x103 1,3 log 5,3x103 1,4 log +
Solución B.
Cepa
Inóculo D0 14 días 28 días De acuerdo con el criterio de la farmacopea europea
S. aureus
9,8x105 8,6x106 < 10 > 5 log <10 > 5 log +
P. aeruginosa
5x105 <10 < 10 > 4,7 log < 10 > 4,7 log +
E. coli
1,3x106 8,5x105 < 10 > 5 log < 10 > 5 log +
C. albicans
0,9x105 1,3x105 < 10 > 4 log < 10 > 4 log +
A. niger
1,3x105 3,4x105 4,1x103 1,5 log 1,8x103 1,9 log +
Solución E.
Cepa
log R después de 14 días log R después de 28 días De acuerdo con el criterio de la farmacopea europea De acuerdo con el criterio de la farmacopea de los Estados Unidos
S. aureus
> 5 log > 5 log + +
P. aeruginosa
> 4,7 log > 4,7 log + +
9
imagen8
imagen9
imagen10
imagen11

Claims (1)

  1. imagen1
ES10717263T 2009-04-21 2010-04-12 Soluciones pediátricas que contienen propranolol Active ES2623936T5 (es)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP09290298 2009-04-21
EP09290298A EP2246044A1 (en) 2009-04-21 2009-04-21 Paediatric solutions comprising a beta-blocker
PCT/IB2010/051573 WO2010122442A1 (en) 2009-04-21 2010-04-12 Paediatric solutions comprising a beta-blocker

Publications (2)

Publication Number Publication Date
ES2623936T3 true ES2623936T3 (es) 2017-07-12
ES2623936T5 ES2623936T5 (es) 2022-11-28

Family

ID=40940328

Family Applications (2)

Application Number Title Priority Date Filing Date
ES12155472T Active ES2685178T5 (es) 2009-04-21 2010-04-12 Soluciones pediátricas que contienen un beta bloqueante
ES10717263T Active ES2623936T5 (es) 2009-04-21 2010-04-12 Soluciones pediátricas que contienen propranolol

Family Applications Before (1)

Application Number Title Priority Date Filing Date
ES12155472T Active ES2685178T5 (es) 2009-04-21 2010-04-12 Soluciones pediátricas que contienen un beta bloqueante

Country Status (32)

Country Link
US (2) US20120035270A1 (es)
EP (4) EP2246044A1 (es)
JP (1) JP5695029B2 (es)
KR (1) KR101713866B1 (es)
CN (1) CN102405041A (es)
AR (2) AR076338A1 (es)
AU (1) AU2010240551B2 (es)
BR (1) BRPI1015447B1 (es)
CA (1) CA2755175C (es)
CL (1) CL2011002634A1 (es)
CO (1) CO6410278A2 (es)
CY (2) CY1119390T1 (es)
DK (2) DK2497461T4 (es)
ES (2) ES2685178T5 (es)
GE (1) GEP20146087B (es)
HR (2) HRP20170610T4 (es)
HU (2) HUE039937T2 (es)
IL (1) IL214674A (es)
LT (2) LT2421504T (es)
MA (1) MA33003B1 (es)
MX (1) MX337463B (es)
NZ (1) NZ594592A (es)
PL (2) PL2497461T5 (es)
PT (2) PT2497461T (es)
RS (2) RS57668B2 (es)
RU (1) RU2011139233A (es)
SG (1) SG172960A1 (es)
SI (2) SI2497461T2 (es)
TN (1) TN2011000350A1 (es)
TW (1) TWI429459B (es)
UA (1) UA107570C2 (es)
WO (1) WO2010122442A1 (es)

Families Citing this family (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2246044A1 (en) 2009-04-21 2010-11-03 Pierre Fabre Dermo-Cosmétique Paediatric solutions comprising a beta-blocker
CN103501775A (zh) * 2011-03-04 2014-01-08 格吕伦塔尔有限公司 他喷他多的胃肠外给药
MX388963B (es) 2011-03-04 2025-03-20 Gruenenthal Gmbh Formulacion farmaceutica acuosa de tapentadol para administracion oral
JP2019142972A (ja) * 2011-03-04 2019-08-29 グリュネンタール・ゲゼルシャフト・ミト・ベシュレンクテル・ハフツング タペンタドールの非経口的投与
US9724297B2 (en) 2014-04-01 2017-08-08 Arbor Pharmaceuticals, Inc. Sotalol compositions and uses of the same
PE20171651A1 (es) 2015-03-27 2017-11-13 Gruenenthal Chemie Formulacion estable para administracion parenteral de tapentadol
EP3515412B1 (en) 2016-09-23 2025-04-23 Grünenthal GmbH Stable formulation for parenteral administration of tapentadol
CN108261411B (zh) * 2016-12-30 2021-04-30 武汉科福新药有限责任公司 用于婴幼儿血管瘤治疗的口腔膜剂及其制备方法
CN107320467A (zh) * 2017-07-21 2017-11-07 江苏云阳集团药业有限公司 一种盐酸普萘洛尔药用组合物及其制备方法
CN108299279B (zh) * 2018-02-09 2021-03-23 北京梅尔森医药技术开发有限公司 取代芳基胺醇化合物及其制备方法和用途
US11547123B2 (en) * 2019-08-16 2023-01-10 The Folger Coffee Company Methods for reducing negative flavor attributes in coffee and compositions therefrom
US10610502B1 (en) * 2019-08-30 2020-04-07 Metacel Pharmaceuticals, LLC Oral baclofen solutions
JPWO2022071481A1 (es) 2020-09-30 2022-04-07
CN116407495A (zh) * 2023-03-09 2023-07-11 北京梅尔森医药技术开发有限公司 一种阿替洛尔口服溶液及其制备方法和应用
GB2628566A (en) 2023-03-29 2024-10-02 Novumgen Ltd An orally rapidly disintegrating tablet of propranolol and its process of preparation
WO2025068937A1 (en) 2023-09-30 2025-04-03 Liqmeds Worldwide Limited An oral liquid formulation of metoprolol
CN118021718B (zh) * 2024-04-12 2024-07-02 成都瑞尔医药科技有限公司 一种盐酸普罗帕酮注射液及其制备方法

Family Cites Families (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4600708A (en) 1985-07-19 1986-07-15 American Home Products Corporation Propranolol hydrochloride liquid formulations
HU209251B (en) 1992-03-13 1994-04-28 Synepos Ag Process for producing stable, peroral solution drug forms with controlled release of active ingredient and comprising beta-blocking pharmacons
EP0732064B1 (en) 1995-03-15 2001-06-06 Kao Corporation Use of a bitterness relieving agent
JPH1025253A (ja) * 1996-07-12 1998-01-27 Kao Corp 苦味低減化剤及び苦味低減化法
JPH11349492A (ja) * 1998-06-03 1999-12-21 Yamanouchi Pharmaceut Co Ltd 苦味を低減した経口用医薬組成物および苦味低減化方法
JP2001342151A (ja) * 2000-03-31 2001-12-11 Eisai Co Ltd 甘味を有する薬剤組成物
DE60213592T2 (de) * 2001-05-25 2007-08-09 Warner-Lambert Co. Llc Flüssige pharmazeutische zusammensetzung
EP1543831A1 (en) * 2003-12-18 2005-06-22 Pfizer GmbH Arzneimittelwerk Gödecke Pregabalin composition
WO2006093493A1 (en) * 2005-02-25 2006-09-08 Biomarin Pharmaceutical Inc. Room temperature stable aqueous liquid pharmaceutical composition
EP1888030A1 (en) * 2005-05-25 2008-02-20 Janssen Pharmaceutica N.V. Pediatric formulation of topiramate
DE102006020604A1 (de) * 2006-05-02 2007-11-08 Bayer Healthcare Ag Flüssige Arzneimittelformulierung
EP2050441A1 (en) 2007-10-19 2009-04-22 Université Victor Segalen Bordeaux 2 Use of beta blocker for the manufacture of a medicament for the treatment of hemangiomas
EP2268282B1 (en) * 2008-04-25 2014-10-29 Apotex Technologies Inc. Liquid formulation for deferiprone with palatable taste
EP2246044A1 (en) 2009-04-21 2010-11-03 Pierre Fabre Dermo-Cosmétique Paediatric solutions comprising a beta-blocker

Also Published As

Publication number Publication date
EP3384899A1 (en) 2018-10-10
WO2010122442A1 (en) 2010-10-28
PT2421504T (pt) 2017-06-16
DK2497461T3 (en) 2018-09-03
IL214674A (en) 2017-01-31
TN2011000350A1 (en) 2013-03-27
CY1120667T1 (el) 2019-12-11
MX337463B (es) 2016-03-07
HRP20181408T1 (hr) 2018-11-02
RU2011139233A (ru) 2013-05-27
PL2497461T5 (pl) 2022-06-27
EP2497461B2 (en) 2021-12-15
IL214674A0 (en) 2011-09-27
RS57668B1 (sr) 2018-11-30
CA2755175C (en) 2018-01-02
AR117621A2 (es) 2021-08-18
BRPI1015447A8 (pt) 2017-10-03
UA107570C2 (xx) 2015-01-26
MX2011010766A (es) 2011-10-21
NZ594592A (en) 2013-11-29
LT2421504T (lt) 2017-06-12
AR076338A1 (es) 2011-06-01
SI2497461T2 (sl) 2022-04-29
EP2421504A1 (en) 2012-02-29
AU2010240551B2 (en) 2015-07-16
DK2421504T3 (en) 2017-05-01
JP5695029B2 (ja) 2015-04-01
US20150087719A1 (en) 2015-03-26
BRPI1015447A2 (pt) 2016-04-19
CY1119390T1 (el) 2018-02-14
HRP20170610T1 (hr) 2017-07-28
EP2246044A1 (en) 2010-11-03
TWI429459B (zh) 2014-03-11
PT2497461T (pt) 2018-10-23
CN102405041A (zh) 2012-04-04
EP2421504B1 (en) 2017-03-08
ES2685178T5 (es) 2022-04-13
RS55862B2 (sr) 2022-12-30
SG172960A1 (en) 2011-08-29
CO6410278A2 (es) 2012-03-30
ES2685178T3 (es) 2018-10-05
EP2421504B2 (en) 2022-08-10
LT2497461T (lt) 2018-10-10
HUE039937T2 (hu) 2019-02-28
BRPI1015447B1 (pt) 2020-01-28
TW201039862A (en) 2010-11-16
SI2421504T1 (sl) 2017-06-30
CA2755175A1 (en) 2010-10-28
HRP20181408T4 (hr) 2022-03-04
DK2421504T4 (da) 2022-11-14
DK2497461T4 (da) 2022-02-14
RS55862B1 (sr) 2017-08-31
SI2497461T1 (sl) 2018-10-30
PL2421504T3 (pl) 2017-08-31
RS57668B2 (sr) 2022-03-31
US20120035270A1 (en) 2012-02-09
HRP20170610T4 (hr) 2022-12-09
AU2010240551A1 (en) 2011-08-04
GEP20146087B (en) 2014-05-13
EP2497461A3 (en) 2014-01-01
EP2497461B1 (en) 2018-06-20
ES2623936T5 (es) 2022-11-28
KR20120015305A (ko) 2012-02-21
JP2012524773A (ja) 2012-10-18
PL2497461T3 (pl) 2018-12-31
KR101713866B1 (ko) 2017-03-09
EP2497461A2 (en) 2012-09-12
CL2011002634A1 (es) 2012-06-08
PL2421504T5 (pl) 2023-01-02
MA33003B1 (fr) 2012-01-02
HUE034581T2 (en) 2018-02-28

Similar Documents

Publication Publication Date Title
ES2623936T3 (es) Soluciones pediátricas que contienen propranolol
ES2655876T3 (es) Extracto de Trigonella foenum-graecum
JP6159084B2 (ja) 酒さまたは赤面に関連する皮膚疾患を治療するための、ベルベリンまたはその類似体を含有する組成物
Kajaria et al. Evaluation of antimicrobial activity and bronchodialator effect of a polyherbal drug–Shrishadi
CN105078934A (zh) 白皮杉醇的新用途
US20130280355A1 (en) Formulations for the treatment of disorders of the upper respiratory tract
CN106466482A (zh) 一种预防、治疗或抑制粘膜疾病的组合物及其制备方法
Olmedo-Juárez et al. Acacia farnesiana pods (plant: Fabaceae) possesses anti-parasitic compounds against Haemonchus contortus in female lambs
ES2979393T3 (es) Composición antimicrobiana
WO2019207174A1 (es) Composición para su uso en la higiene, prevención y/o tratamiento de infecciones frecuentes en acuicultura
CN105232526A (zh) 含儿茶素的药物在制备抑菌药物中的用途
Tijjani et al. Synergistic activity of methanolic extract of Adenium obesum (Apocynaceae) stem-bark and oxytetracycline against some clinical bacterial isolates
CN104069124B (zh) 用于妇科感染的组合物及制剂
KR100813298B1 (ko) 강활 추출물을 포함하는 젖소 유방염의 예방 및 치료를위한 약학조성물
ES2732858T3 (es) Composición antimicrobiana de clorhexidina teñida de azul para la desinfección de la piel
CN101129379A (zh) 抗球虫药物组合物及其制备方法
AR046665A1 (es) Formulaciones orales de desoxipeganina y sus usos
Hassan et al. Prevalence of yeast infections in small in ruminants with particular references to their treatment by some natural herbal extracts
ES2245611B1 (es) Composicion farmaceutica para uso ototopico.
Kumar et al. Synergism between methanolic extract of Sesbania grandiflora (Fabaceae) flowers and oxytetracycline
Ananda et al. The Minimum Inhibitory Concentration (MIC) And Minimum Bactericidal Concentration (MBC) Of Sambiloto Leaf Extract Against Enterococcus Faecalis
CN115581718B (zh) 余甘子、千里光组合物及其抗真菌用途
Shivakumar Singh et al. Antimycotic activity of low polar petroleum ether and interpolar methanolic young leaf extracts of Solanum nigrum L.
Kumar et al. Overview on anti-acne activity of methanol extract of dried fruits of Embelia ribes
CN109700858A (zh) 红三七在制备抗真菌药物及其增效剂中的应用