WO2010056216A1 - Composition pharmaceutique comprenant de l'ibuprofène, de la pseudoéphédrine et de la chlorophéniramine - Google Patents

Composition pharmaceutique comprenant de l'ibuprofène, de la pseudoéphédrine et de la chlorophéniramine Download PDF

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Publication number
WO2010056216A1
WO2010056216A1 PCT/TR2009/000046 TR2009000046W WO2010056216A1 WO 2010056216 A1 WO2010056216 A1 WO 2010056216A1 TR 2009000046 W TR2009000046 W TR 2009000046W WO 2010056216 A1 WO2010056216 A1 WO 2010056216A1
Authority
WO
WIPO (PCT)
Prior art keywords
amount
composition according
ibuprofen
sodium bicarbonate
pseudoephedrine
Prior art date
Application number
PCT/TR2009/000046
Other languages
English (en)
Inventor
M. Berat Beran
Original Assignee
Berko Ilac Ve Kimya San.A.S.
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 Berko Ilac Ve Kimya San.A.S. filed Critical Berko Ilac Ve Kimya San.A.S.
Priority to RU2011123762/15A priority Critical patent/RU2011123762A/ru
Priority to CN2009801449091A priority patent/CN102264358A/zh
Publication of WO2010056216A1 publication Critical patent/WO2010056216A1/fr

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Classifications

    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid 
    • 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
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • 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
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4402—Non condensed pyridines; Hydrogenated derivatives thereof only substituted in position 2, e.g. pheniramine, bisacodyl
    • 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
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/02—Nasal agents, e.g. decongestants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/14—Antivirals for RNA viruses
    • A61P31/16—Antivirals for RNA viruses for influenza or rhinoviruses

Definitions

  • the present invention relates to a pharmaceutical composition
  • a pharmaceutical composition comprising ibuprofen as an active agent, preferably chloropheniramine maleate as an antihistaminic agent, preferably pseudoephedrine HCI as a sympathomimetic amine, and an alkaline salt, such as sodium bicarbonate, in an amount adequate to maintain the final solution's pH level between 7 and 9.
  • Ibuprofen as a medicament, is known to have analgesic, antiphlogistic, and antipyretic affects. It is particularly disclosed, e.g. in US 5,100,675, as a pharmaceutical composition, containing inter alia, pseudoephedrine, for alleviating the symptoms of influenza, as well as of common cold, fever, sinusitis, or nasal congestion, headache, and general malaise.
  • US 5,071 ,643 and US 5,360,615 disclose a solvent system for preparing high- concentration pharmaceutical agents, including high-concentration solutions of acidic pharmaceutical agents, containing inter alia ibuprofen, in the form of tablets or softgels, or two-piece capsules.
  • the acidic character of the ibuprofen composition described in US 5,071 ,643 and US 5,360,615 may lead to adverse effects on a subject's stomach wall sensitive to acidic content of the medicinal product. Additionally, ibuprofen with acidic character has a low bioavailability due to the relatively-slow plasma-absorption and dissolution thereof.
  • the object of the present invention is to provide an efficient pharmaceutical composition for alleviating the symptoms particularly of influenza, as well as of common cold, fever, sinusitis, or nasal congestion, headache, and general malaise.
  • composition with high bioavailability comprising ibuprofen, pseudoephedrine HCI, chloropheniramine maleate, and an alkaline salt or a group of alkaline salts, thereby providing an ibuprofen sodium salt content, which is closer to the neutral level, and absorbed faster into the plasma.
  • Chloropheniramine maleate a histamin H1 -receptor antagonist
  • pseudoephedrine HCI a sympathomimetic amine
  • a pharmaceutical composition according to the present invention contains 4 to 200 mg/ml ibuprofen, 0.6 to 30 mg/ml pseudoephedrine HCI, 0.04 to 2 mg/ml chloropheniramine maleate, and 1.5 to 300 mg/ml sodium bicarbonate.
  • a preferred pharmaceutical composition according to the present invention contains 10 to 100 mg/ml ibuprofen, 1 to 6 mg/ml pseudoephedrine HCI, 0.1 to 1 mg/ml chloropheniramine maleate, and 6 to 200 mg/ml sodium bicarbonate.
  • the most preferred pharmaceutical composition according to the present invention contains 15 to 25 mg/ml ibuprofen, 2 to 4 mg/ml pseudoephedrine HCI, 0.15 to 0.25 mg/ml chloropheniramine maleate, and 15 to 20 mg/ml sodium bicarbonate.
  • composition according to the present invention further contains excipients, such as glycerin, nipagin M sodium, sugar, banana essence, Sunset Yellow, and deionized water.
  • excipients such as glycerin, nipagin M sodium, sugar, banana essence, Sunset Yellow, and deionized water.
  • the composition according to the present invention may contain an alkaline salt, such as sodium hydroxide, potassium hydroxide, calcium carbonate, magnesium hydroxide, or a mixture thereof.
  • composition according to the present invention is preferably in the form of a syrup, but it can also be prepared in any oral liquid form, including the aqueous suspension form.
  • oral administration thereof may be facilitated as compared to the tablet form, especially for children.
  • the aforesaid "liquid form” also comprises effervescent tablets which result in oral compositions following their dissolution in water, as well as the sachet forms containing single-use dosages.
  • 300 L of Deionized water is taken into and heated in a production vessel. 200 kg sugar are added therein and the mixer is activated, the sugar is entirely dissolved and transferred into the auxiliary vessel.
  • Nipagin M sodium 500 g is dissolved in 20 L of deionized water and taken into the vessel.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Virology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Pulmonology (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Emergency Medicine (AREA)
  • Molecular Biology (AREA)
  • Otolaryngology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

La présente invention concerne une composition pharmaceutique comportant de l'ibuprofène au titre de principe actif, préférentiellement du maléate de chlorophéniramine au titre d'agent antihistaminique, préférentiellement pseudoéphédrine HCl au titre d'amine sympathomimétique, ainsi qu'un sel alcalin comme le bicarbonate de sodium à une teneur suffisante pour maintenir le pH de la solution finale entre 7 et 9.
PCT/TR2009/000046 2008-11-11 2009-03-30 Composition pharmaceutique comprenant de l'ibuprofène, de la pseudoéphédrine et de la chlorophéniramine WO2010056216A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
RU2011123762/15A RU2011123762A (ru) 2008-11-11 2009-03-30 Фармацевтическая композиция, содержащая ибупрофен, псевдоэфедрин и хлорфенирамин
CN2009801449091A CN102264358A (zh) 2008-11-11 2009-03-30 包含布洛芬、伪麻黄碱和扑尔敏的药物组合物

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
TR200808511 2008-11-11
TR2008/08511 2008-11-11

Publications (1)

Publication Number Publication Date
WO2010056216A1 true WO2010056216A1 (fr) 2010-05-20

Family

ID=41055188

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/TR2009/000046 WO2010056216A1 (fr) 2008-11-11 2009-03-30 Composition pharmaceutique comprenant de l'ibuprofène, de la pseudoéphédrine et de la chlorophéniramine

Country Status (4)

Country Link
CN (1) CN102264358A (fr)
RU (1) RU2011123762A (fr)
TR (1) TR201107202T1 (fr)
WO (1) WO2010056216A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2965746A1 (fr) 2014-07-10 2016-01-13 Santa Farma Ilaç Sanayi A.S. Composition pharmaceutique orale comprenant de l'ibuprofène, du dihydrate de sodium d'ibuprofène, de l'hydrochlorure de pseudoéphédrine et du maléate de chlorophéniramine

Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5071643A (en) * 1986-10-17 1991-12-10 R. P. Scherer Corporation Solvent system enhancing the solubility of pharmaceuticals for encapsulation
CA2084028A1 (fr) * 1991-11-27 1993-05-28 Harish B. Pandya Composition pour le traitement de la grippe
WO2000059475A1 (fr) * 1999-04-06 2000-10-12 Lipocine, Inc. Compositions et procedes d'administration amelioree d'agents therapeutiques hydrophobes ionisables
WO2001089476A1 (fr) * 2000-05-19 2001-11-29 Npd Llc Gommes a macher, pastilles, bonbons, tablettes, liquides et sprays destines a une administration efficace de medicaments et de supplements dietetiques
WO2004041249A1 (fr) * 2002-11-08 2004-05-21 Hanmi Pharm. Co., Ltd. Concentre a administration orale de microemulsion de medicament anti-rhume hydrosoluble
WO2004056320A2 (fr) * 2002-12-18 2004-07-08 Wyeth Compositions de medicaments anti-inflammatoires non-steroidaux, decongestionnants et antihistaminiques
WO2005063199A1 (fr) * 2003-12-19 2005-07-14 Bayer Healthcare Ag Preparation effervescente d'une substance basique a action pharmaceutique
WO2005063219A2 (fr) * 2003-12-23 2005-07-14 Ranbaxy Laboratories Limited Capsules en gelatine molle contenant de l'ibuprofene
WO2007035336A2 (fr) * 2005-09-15 2007-03-29 Phyzz, Inc. Comprimes/granules pour boisson effervescente rehydratante
WO2007057858A2 (fr) * 2005-11-17 2007-05-24 The Procter & Gamble Company Compositions utiles dans la prevention et le traitement du rhume et des symptomes grippaux
WO2007125501A2 (fr) * 2006-04-28 2007-11-08 The Procter & Gamble Company Compositions et procédés utiles pour le traitement d'une maladie respiratoire

Patent Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5071643A (en) * 1986-10-17 1991-12-10 R. P. Scherer Corporation Solvent system enhancing the solubility of pharmaceuticals for encapsulation
CA2084028A1 (fr) * 1991-11-27 1993-05-28 Harish B. Pandya Composition pour le traitement de la grippe
WO2000059475A1 (fr) * 1999-04-06 2000-10-12 Lipocine, Inc. Compositions et procedes d'administration amelioree d'agents therapeutiques hydrophobes ionisables
WO2001089476A1 (fr) * 2000-05-19 2001-11-29 Npd Llc Gommes a macher, pastilles, bonbons, tablettes, liquides et sprays destines a une administration efficace de medicaments et de supplements dietetiques
WO2004041249A1 (fr) * 2002-11-08 2004-05-21 Hanmi Pharm. Co., Ltd. Concentre a administration orale de microemulsion de medicament anti-rhume hydrosoluble
WO2004056320A2 (fr) * 2002-12-18 2004-07-08 Wyeth Compositions de medicaments anti-inflammatoires non-steroidaux, decongestionnants et antihistaminiques
WO2005063199A1 (fr) * 2003-12-19 2005-07-14 Bayer Healthcare Ag Preparation effervescente d'une substance basique a action pharmaceutique
WO2005063219A2 (fr) * 2003-12-23 2005-07-14 Ranbaxy Laboratories Limited Capsules en gelatine molle contenant de l'ibuprofene
WO2007035336A2 (fr) * 2005-09-15 2007-03-29 Phyzz, Inc. Comprimes/granules pour boisson effervescente rehydratante
WO2007057858A2 (fr) * 2005-11-17 2007-05-24 The Procter & Gamble Company Compositions utiles dans la prevention et le traitement du rhume et des symptomes grippaux
WO2007125501A2 (fr) * 2006-04-28 2007-11-08 The Procter & Gamble Company Compositions et procédés utiles pour le traitement d'une maladie respiratoire

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2965746A1 (fr) 2014-07-10 2016-01-13 Santa Farma Ilaç Sanayi A.S. Composition pharmaceutique orale comprenant de l'ibuprofène, du dihydrate de sodium d'ibuprofène, de l'hydrochlorure de pseudoéphédrine et du maléate de chlorophéniramine
WO2016007105A1 (fr) 2014-07-10 2016-01-14 Santa Farma Ilaç Sanayi A. Ş. Composition pharmaceutique orale comprenant de l'ibuprofène, de l'ibuprofène sodique dihydraté, du chlorhydrate de pseudoéphédrine et du maléate de chlorphéniramine

Also Published As

Publication number Publication date
TR201107202T1 (tr) 2012-02-21
RU2011123762A (ru) 2012-12-20
CN102264358A (zh) 2011-11-30

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