ES2528283T3 - Formulaciones tópicas con un óxido de amina terciaria - Google Patents

Formulaciones tópicas con un óxido de amina terciaria Download PDF

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Publication number
ES2528283T3
ES2528283T3 ES13154087.4T ES13154087T ES2528283T3 ES 2528283 T3 ES2528283 T3 ES 2528283T3 ES 13154087 T ES13154087 T ES 13154087T ES 2528283 T3 ES2528283 T3 ES 2528283T3
Authority
ES
Spain
Prior art keywords
tertiary amine
amine oxide
ppm
topical formulations
formulation
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
ES13154087.4T
Other languages
English (en)
Inventor
Zora Teresa Marlowe
Paramita Bandyopadhyay
Hongna Wang
Eric Phillips
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.)
Bausch and Lomb Inc
Original Assignee
Bausch and Lomb 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 Bausch and Lomb Inc filed Critical Bausch and Lomb Inc
Application granted granted Critical
Publication of ES2528283T3 publication Critical patent/ES2528283T3/es
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • 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
    • A61K9/0048Eye, e.g. artificial tears
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00Drugs for disorders of the senses
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • 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
    • 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

Landscapes

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

Abstract

El uso de un óxido de amina terciaria para mejorar la conservación de una formulación oftálmica que comprende un compuesto de amonio cuaternario como un compuesto conservante adicional, en donde el óxido de amina terciaria tiene la fórmula general I**Fórmula** en donde R1 es un alquilo C8-C18, y R2 y R3 se seleccionan independientemente entre un alquilo C1-C4 o hidroxialquilo C1-C4, y el óxido de amina terciaria está presente de 10 ppm a 1000 ppm, y el compuesto de amonio cuaternario es α-[4-tris (2-hidroxietil)-cloruro de amonio-2-butenil]poli[1-cloruro de dimetilamonio-2-butenil]-ω-tris(2-hidroxietil)cloruro de amonio (policuaternio-1), que está presente en la formulación de 0,5 ppm a 5 ppm.

Description

imagen1
imagen2
imagen3
imagen4
imagen5
imagen6
imagen7
imagen8
imagen9
E13154087
19-01-2015
Ejemplo
imagen10 C5 10 11 C6
propilenglicol
imagen11 0,6 0,6 0,6 0,6
Dequest®2016
imagen12 0,05 0,05 0,05 0,05
Prueba USP PE (días)
C5 10A 10B 11A 11B C6
S. aureus (14)
3,7 > 4,7 > 4,8 > 4,7 > 4,8 > 4,7
(28)
> 4,7 > 4,7 > 4,8 > 4,7 > 4,8 > 4,7
P. aeruginosa (14)
1,6 4,7 4,5 > 4,7 > 4,8 1,6
(28)
0,7 > 4,7 > 4,8 > 4,7 > 4,8 0,8
E. coli (14)
1,6 3,3 2,2 > 4,7 > 4,8 2,4
(28)
0,8 > 4,7 > 4,8 > 4,7 > 4,8 3,6
C. albicans (14)
0,7 > 48 > 5,0 > 4,8 > 5,0 0,8
(28)
2,5 > 4,8 > 5,0 > 4,8 > 5,0 3,0
A. niger (14)
1,2 > 4,7 4,7 4,1 > 4,7 1,2
(28)
1,2 > 4,7 > 4,7 > 4,7 > 4,7 1,1
a Protanal LF200M
Ejemplo de referencia 12,
5 Se prepara una formulación reconfortante oftálmica (ojo seco) de acuerdo con los componentes enumerados en la Tabla 11. Los datos de eficacia conservante a los 14 y 28 días también se presentan en la Tabla 11 para la formulación. La 12A son los datos iniciales de PE, y los datos 12B son los datos de PE después del almacenamiento en frascos de poli(tereftalato de etileno) (PET) durante cuatro meses a 40°C. Como se ha indicado, la eficacia conservante de la formulación se mantiene durante el almacenamiento bajo condiciones de temperatura
10 relativamente alta.
Tabla 11. Ejemplo de Referencia 12
ácido bórico
imagen13 0,5
hialuronato de Na
imagen14 0,15
polivinilpirrolidona
imagen15 0,1
PHMB (ppm)
imagen16 1,3
óxido de lauramina (ppm)
imagen17 100
glicerina
imagen18 0,6
propilenglicol
imagen19 0,6
Dequest®2016
imagen20 0,10
Prueba USP PE (días)
12A 12B
S. aureus (14)
> 4,8 > 4,8
(28)
> 4,8 > 4,8
P. aeruginosa (14)
> 4,8 > 4,8
(28)
> 4,8 > 4,8
E. coli (14)
> 4,7 > 4,8
(28)
> 4,7 > 4,8
C. albicans (14)
> 4,9 > 5,0
(28)
> 4,9 > 5,0
A. niger (14)
4,1 > 4,7
11
imagen21
imagen22
imagen23

Claims (1)

  1. imagen1
ES13154087.4T 2008-10-06 2009-10-06 Formulaciones tópicas con un óxido de amina terciaria Active ES2528283T3 (es)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US10297508P 2008-10-06 2008-10-06
US102975P 2008-10-06
US542739 2009-08-18
US12/542,739 US20100087550A1 (en) 2008-10-06 2009-08-18 Formulations with a Tertiary Amine Oxide

Publications (1)

Publication Number Publication Date
ES2528283T3 true ES2528283T3 (es) 2015-02-06

Family

ID=42076272

Family Applications (2)

Application Number Title Priority Date Filing Date
ES13154095.7T Active ES2496919T3 (es) 2008-10-06 2009-10-06 Formulaciones tópicas con un óxido de amina terciaria
ES13154087.4T Active ES2528283T3 (es) 2008-10-06 2009-10-06 Formulaciones tópicas con un óxido de amina terciaria

Family Applications Before (1)

Application Number Title Priority Date Filing Date
ES13154095.7T Active ES2496919T3 (es) 2008-10-06 2009-10-06 Formulaciones tópicas con un óxido de amina terciaria

Country Status (5)

Country Link
US (1) US20100087550A1 (es)
EP (3) EP2591780B1 (es)
ES (2) ES2496919T3 (es)
PL (2) PL2591780T3 (es)
WO (1) WO2010042459A1 (es)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9125405B2 (en) 2008-10-28 2015-09-08 Bausch & Lomb Incorporated Contact lens solution with a tertiary amine oxide
US9161923B2 (en) 2010-07-02 2015-10-20 Brien Holden Vision Institute Composition for prevention and treatment of contact lens papillary conjunctivitis and allergic eye disease
GB201111490D0 (en) * 2011-07-05 2011-08-17 Bio Technics Ltd Biocidal composition
UA113434C2 (uk) * 2012-05-04 2017-01-25 Алкон Рісерч, Лтд. Офтальмологічна композиція з поліпшеним захистом від зневоднювання й утриманням
KR102096204B1 (ko) * 2019-05-31 2020-04-02 최명석 국소지방 파괴 방법 및 국소지방 파괴용 저장성 용액

Family Cites Families (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
NZ227813A (en) * 1988-02-10 1990-03-27 Richardson Vicks Inc Oil in water emulsion having 3-40% oil and an amphipathic emulsifying agent in the range 0.02-2% and method of forming such emulsions
US5300296A (en) 1989-11-06 1994-04-05 Frank J. Holly Antimicrobial agent for opthalmic formulations
NZ235991A (en) 1989-11-09 1993-05-26 Sandoz Ltd Macrolide compounds and pharmaceutical compositions thereof
JP2811036B2 (ja) * 1992-05-26 1998-10-15 参天製薬株式会社 ビタミンe点眼剤
IL114193A (en) 1994-06-20 2000-02-29 Teva Pharma Ophthalmic pharmaceutical compositions based on sodium alginate
JP3420647B2 (ja) * 1994-12-15 2003-06-30 株式会社トーメー コンタクトレンズ用洗浄剤
US6274626B1 (en) 1998-12-22 2001-08-14 Bausch & Lomb Incorporated Pheniramine-containing compositions and method for treating allergic responses
IT1306123B1 (it) 1999-04-02 2001-05-30 Technopharma Sa Soluzione oftalmica viscosizzata con azione detergente sulle lenti acontatto.
US6479454B1 (en) * 2000-10-05 2002-11-12 Ecolab Inc. Antimicrobial compositions and methods containing hydrogen peroxide and octyl amine oxide
CA2443472A1 (en) * 2002-02-07 2003-08-14 Ophtecs Corporation Liquid formulation for contact lenses
AU2003213210A1 (en) 2002-02-22 2003-09-09 Pharmacia Corporation Ophthalmic formulation with gum system
US20040034042A1 (en) * 2002-08-14 2004-02-19 Masao Tsuji Preservative composition
PT1551417E (pt) * 2002-10-18 2008-10-31 Aqueous Pharma Ltd Formulação de lágrimas com três camadas
TWI335819B (en) * 2002-12-24 2011-01-11 Alcon Inc Use of oculosurface selective glucocorticoid in the treatment of dry eye
JP4980226B2 (ja) 2004-10-25 2012-07-18 ボーシュ アンド ローム インコーポレイティド 眼科用組成物及びその使用方法
US7417056B2 (en) 2004-11-12 2008-08-26 Schering Ag 5-substituted quinoline and isoquinoline derivatives, a process for their production and their use as anti-inflammatory agents
US7276476B2 (en) * 2005-07-13 2007-10-02 Allergan, Inc. Cyclosporin compositions
JP2007106727A (ja) * 2005-10-17 2007-04-26 Lion Corp 化粧料原料組成物及び化粧料原料組成物の防腐方法
US20080194518A1 (en) * 2005-12-23 2008-08-14 MOOKERJEE Pradip Antimicrobial Compositions
US20080057022A1 (en) * 2006-08-30 2008-03-06 Erning Xia Ophthalmic Pharmaceutical Compositions and Uses Thereof
US8138156B2 (en) * 2006-10-18 2012-03-20 Bausch & Lomb Incorporated Ophthalmic compositions containing diglycine

Also Published As

Publication number Publication date
EP2591780B1 (en) 2014-08-13
EP2349251B1 (en) 2013-03-06
EP2591779B1 (en) 2014-11-19
EP2591779A1 (en) 2013-05-15
ES2496919T3 (es) 2014-09-22
US20100087550A1 (en) 2010-04-08
PL2591780T3 (pl) 2015-01-30
WO2010042459A1 (en) 2010-04-15
PL2591779T3 (pl) 2015-04-30
EP2591780A1 (en) 2013-05-15
EP2349251A1 (en) 2011-08-03

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