ES2540057T3 - Composiciones líquidas que comprenden fenilefrina y acetaminofeno y su uso en el tratamiento de enfermedades respiratorias - Google Patents

Composiciones líquidas que comprenden fenilefrina y acetaminofeno y su uso en el tratamiento de enfermedades respiratorias Download PDF

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Publication number
ES2540057T3
ES2540057T3 ES07735699.6T ES07735699T ES2540057T3 ES 2540057 T3 ES2540057 T3 ES 2540057T3 ES 07735699 T ES07735699 T ES 07735699T ES 2540057 T3 ES2540057 T3 ES 2540057T3
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Prior art keywords
acetaminophen
phenylephrine
treatment
liquid compositions
respiratory diseases
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ES2540057T5 (es
Inventor
Kelly Lee Martin
Susan Elaine Criss
Douglas William Gledhill
Aloysius Ike Ononye
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Procter and Gamble Co
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Procter and Gamble Co
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0087Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • 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
    • A61K31/137Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/16Amides, e.g. hydroxamic acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/16Amides, e.g. hydroxamic acids
    • A61K31/165Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/192Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid 
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic 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
    • A61K31/47Quinolines; Isoquinolines
    • A61K31/485Morphinan derivatives, e.g. morphine, codeine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A61K31/52Purines, e.g. adenine
    • A61K31/522Purines, e.g. adenine having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/55Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/60Salicylic acid; Derivatives thereof
    • A61K31/612Salicylic acid; Derivatives thereof having the hydroxy group in position 2 esterified, e.g. salicylsulfuric acid
    • A61K31/616Salicylic acid; Derivatives thereof having the hydroxy group in position 2 esterified, e.g. salicylsulfuric acid by carboxylic acids, e.g. acetylsalicylic acid
    • 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
    • A61P11/02Nasal agents, e.g. decongestants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • A61P11/04Drugs for disorders of the respiratory system for throat disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • A61P11/10Expectorants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

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  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Pulmonology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Emergency Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pain & Pain Management (AREA)
  • Otolaryngology (AREA)
  • Rheumatology (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Una composición líquida que comprende una sustancia farmacéuticamente activa seleccionada de fenilefrina, sus formas libre y de sal de adición, y mezclas de las mismas; y acetaminofeno, estando caracterizada la composición por un pH de 6,75 a 7,5.

Description

imagen1
imagen2
imagen3
imagen4
imagen5
imagen6
E07735699
22-06-2015
Ejemplo 1
Se ilustran a continuación varios ejemplos de composiciones de la presente invención. Todos los ejemplos siguientes tendrán un pH de aproximadamente 7,1.
Descripción del material
% p/p % p/p % p/p % p/p % p/p
Premezcla de glicol
Propilenglicol USP
16 16 12 8 16
Polietilenglicol 400 NF
0 4 8 8 8
Sorbitol
8 4 4 8 0
Acetaminofeno USP
1,78 1,78 1,78 1,78 1,78
Dextrometorfano HBr USP
0,05 0,05 0,05 0,05 0,05
Sabor
0,30 0,30 0,30 0,30 0,31
Premezcla de agua
Agua purificada USP
6,6 4 8 8 6,6
Citrato sódico hidratado USP
1,6 1,6 1,6 1,6 1,6
Fenilefrina
0,033 0,033 0,033 0,033 0,033
Ácido cítrico anhidro USP
0,02 0,02 0,02 0,02 0,02
Sacarina sódica USP
0,08 0,08 0,08 0,08 0,08
Color
0,06 0,06 0,06 0,06 0,06
Glicerina USP
4 8 16 12 4,1
Azúcar líquido n.°1
53,8 49 40 45 53,8
Agua purificada USP
c.s. c.s. c.s. c.s. c.s.
Propilenglicol comercializado por Dow Chemical Corp. Plaqremine, LA, EE. UU. Dextrometorfano HBr comercializado por Hoffman-LaRoche, Branchburg, NJ, EE. UU. Acetaminofeno comercializado por Mallinckrodt, Raleigh, NC, EE. UU.
10 Glicerina comercializada por Procter & Gamble Company, Cincinnati, OH, EE. UU. Citrato sódico comercializado por Hoffman-LaRoche, Branchburg, NJ, EE. UU. Ácido cítrico comercializado por ADM, Cork, Ireland Fenilefrina HCL comercializada por Iwaki, Ku Tokyo, Japan Sacarina sódica comercializada por PMC Specialties grupo, Inc., Cincinnati, OH, EE. UU.
15 Azúcar líquido comercializado por Imperial Sugar, Port Wentworth, CA, EE. UU.
8

Claims (1)

  1. imagen1
ES07735699.6T 2006-04-28 2007-04-27 Composiciones líquidas que comprenden fenilefrina y acetaminofeno y su uso en el tratamiento de enfermedades respiratorias Active ES2540057T5 (es)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US413766 2003-04-15
US11/413,766 US20070254027A1 (en) 2006-04-28 2006-04-28 Compositions and methods useful for treatment of respiratory illness
PCT/IB2007/051583 WO2007125501A2 (en) 2006-04-28 2007-04-27 Liquid compositions comprising phenylephrine and acetaminophen and their use for the treatment of respiratory illness

Publications (2)

Publication Number Publication Date
ES2540057T3 true ES2540057T3 (es) 2015-07-08
ES2540057T5 ES2540057T5 (es) 2018-07-03

Family

ID=38480519

Family Applications (1)

Application Number Title Priority Date Filing Date
ES07735699.6T Active ES2540057T5 (es) 2006-04-28 2007-04-27 Composiciones líquidas que comprenden fenilefrina y acetaminofeno y su uso en el tratamiento de enfermedades respiratorias

Country Status (11)

Country Link
US (1) US20070254027A1 (es)
EP (1) EP2012765B2 (es)
JP (1) JP2009534372A (es)
CN (1) CN101431991B (es)
AU (1) AU2007245300B2 (es)
BR (1) BRPI0711065A2 (es)
CA (1) CA2649997C (es)
ES (1) ES2540057T5 (es)
MX (1) MX2008013664A (es)
PL (1) PL2012765T5 (es)
WO (1) WO2007125501A2 (es)

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US8940796B2 (en) 2006-02-21 2015-01-27 Wyeth Llc Phenylephrine liquid formulations
US10022339B2 (en) 2006-04-21 2018-07-17 The Procter & Gamble Company Compositions and methods useful for treatment of respiratory illness
US20070249727A1 (en) 2006-04-21 2007-10-25 The Proctor & Gamble Company Compositions and kits useful for treatment of respiratory illness
US20080014274A1 (en) * 2006-07-14 2008-01-17 Wyeth Enhanced stability phenylephrine liquid compositions
TR201107202T1 (tr) * 2008-11-11 2012-02-21 Berko İlaç Ve Ki̇mya Sanayi̇ A.Ş. İbuprofen, psödoefedrin ve klorfeniramin içeren bir farmasötik bileşim.
US8518439B2 (en) * 2008-12-03 2013-08-27 Novartis Ag Liquid therapeutic composition
US20130101578A1 (en) * 2010-04-12 2013-04-25 National University Of Singapore Biomarker for renal function in patients with type 2 diabetes
MX2015009681A (es) * 2013-02-04 2016-07-11 Aft Pharmaceuticals Ltd Un medicamento combinado que comprende finilefrina y paracetamol.
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Also Published As

Publication number Publication date
AU2007245300A1 (en) 2007-11-08
PL2012765T5 (pl) 2018-09-28
BRPI0711065A2 (pt) 2011-08-23
EP2012765B2 (en) 2018-04-11
ES2540057T5 (es) 2018-07-03
CN101431991A (zh) 2009-05-13
WO2007125501A2 (en) 2007-11-08
AU2007245300B2 (en) 2012-06-07
WO2007125501A3 (en) 2008-01-10
CN101431991B (zh) 2012-04-04
US20070254027A1 (en) 2007-11-01
CA2649997A1 (en) 2007-11-08
MX2008013664A (es) 2008-11-04
EP2012765A2 (en) 2009-01-14
JP2009534372A (ja) 2009-09-24
EP2012765B1 (en) 2015-03-25
CA2649997C (en) 2012-11-20
PL2012765T3 (pl) 2015-08-31

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