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WO2010066437A2 - Composition aqueuse contenant du dexpanthénol et du chlorure de sodium - Google Patents

Composition aqueuse contenant du dexpanthénol et du chlorure de sodium Download PDF

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Publication number
WO2010066437A2
WO2010066437A2 PCT/EP2009/008855 EP2009008855W WO2010066437A2 WO 2010066437 A2 WO2010066437 A2 WO 2010066437A2 EP 2009008855 W EP2009008855 W EP 2009008855W WO 2010066437 A2 WO2010066437 A2 WO 2010066437A2
Authority
WO
WIPO (PCT)
Prior art keywords
composition
composition according
sodium chloride
dexpanthenol
container
Prior art date
Application number
PCT/EP2009/008855
Other languages
German (de)
English (en)
Other versions
WO2010066437A3 (fr
Inventor
Max Werner Scheiwe
Henrik Von Wenckstern
Maria Genth
Original Assignee
Ratiopharm Gmbh
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 Ratiopharm Gmbh filed Critical Ratiopharm Gmbh
Publication of WO2010066437A2 publication Critical patent/WO2010066437A2/fr
Publication of WO2010066437A3 publication Critical patent/WO2010066437A3/fr

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
    • A61K9/08—Solutions
    • 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
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/164—Amides, e.g. hydroxamic acids of a carboxylic acid with an aminoalcohol, e.g. ceramides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0043—Nose
    • 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
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F03—MACHINES OR ENGINES FOR LIQUIDS; WIND, SPRING, OR WEIGHT MOTORS; PRODUCING MECHANICAL POWER OR A REACTIVE PROPULSIVE THRUST, NOT OTHERWISE PROVIDED FOR
    • F03D—WIND MOTORS
    • F03D9/00—Adaptations of wind motors for special use; Combinations of wind motors with apparatus driven thereby; Wind motors specially adapted for installation in particular locations
    • F03D9/20—Wind motors characterised by the driven apparatus
    • F03D9/22—Wind motors characterised by the driven apparatus the apparatus producing heat
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02E—REDUCTION OF GREENHOUSE GAS [GHG] EMISSIONS, RELATED TO ENERGY GENERATION, TRANSMISSION OR DISTRIBUTION
    • Y02E10/00—Energy generation through renewable energy sources
    • Y02E10/70—Wind energy
    • Y02E10/72—Wind turbines with rotation axis in wind direction

Definitions

  • the invention relates to an aqueous pharmaceutical composition containing dexpanthenol and sodium chloride, characterized in that the osmolality of the composition is 200 to 400 mosmol / kg, and their use for a medical device for the treatment and / or care of the nasal mucosa.
  • the invention also relates to a container containing the aqueous composition according to the invention.
  • Nasal sprays consisting of dexpanthenol and NaCl and their synergistic effect on the wound healing process of the nasal mucosa are known from EP 0 366 888.
  • the compositions described in the examples can be counterproductive in dry and inflamed mucous membranes, as they usually promote dehydration of the nasal mucosa. This is based on EP 0366888 market product Nasicur ® may therefore no longer than 4 weeks are applied.
  • the compositions shown as preferred in the examples also include benzalkonium chloride as a preservative. Preservatives have per se an allergic potential and an irritant effect.
  • the object of the present invention was therefore to provide a pharmaceutical composition, in particular in the form of a nasal spray, wherein the composition has a beneficial effect on the treatment and / or care of the nasal mucosa and exhibits good tolerability in the patient.
  • a composition is to be provided, which leads to a moistening of the nasal mucous membranes and prevents them from drying out.
  • a composition is to be provided which can also be used as a long-term use (i.e., over a period of more than 4 weeks).
  • the invention therefore relates to an aqueous pharmaceutical composition containing dexpanthenol and sodium chloride, characterized in that the osmolality of the composition is 200 to 400 mosmol / kg.
  • the invention further provides a container containing the aqueous pharmaceutical composition according to the invention.
  • the invention relates to the use of the aqueous composition according to the invention for a medical device for the treatment and / or care of the nasal mucosa.
  • composition of the invention contains water, dexpanthenol and sodium chloride (NaCl, also known in the art as “saline”). All components preferably satisfy the requirements of the European Pharmacopoeia. In particular, the water used meets the requirements of the European Pharmacopoeia for "water for injection”.
  • dexpanthenol (+) - (R) -2,4-dihydroxy-N- (3-hydroxypropyl) -3,3-dimethylbutyramide.
  • Dexpanthenol has the following structure:
  • Dexpanthenol is also referred to in the art as pantothenol or panthenol.
  • the osmolality of the composition is from 200 to 400 mosmol / kg, preferably from 250 to 350 mosmol / kg.
  • the osmolality indicates the number of osmotically active particles per kg of solution and is thus a measure of the osmotic pressure.
  • the osmolality is determined by measuring the freezing point depression. Between osmolality and freezing point depression ⁇ T, the relationship is as follows:
  • the device (osmometer) consists of a cooling device for the Meß duenis; - A temperature measuring device consisting of a temperature-dependent
  • a resistor having a device capable of measuring a current or a potential difference and having a display on which the freezing point depression or osmolality is to be read; and a mixing device.
  • aqueous composition of the invention is preferably in the form of a
  • aqueous composition according to the invention may also be present in the form of a dispersion.
  • the determination of the osmolality is carried out using the reference solutions and instructions for execution shown in the pharmacopoeia.
  • the composition according to the invention contains from 0.5 to 2.5% by weight, more preferably from 0.7 to 1.5% by weight of dexpanthenol, based on the total weight of the composition.
  • the composition according to the invention contains from 0.2 to 0.6% by weight, more preferably from 0.3 to 0.55% by weight, of sodium chloride, based on the total weight of the composition.
  • composition of the invention may consist of water, dexpanthenol and sodium chloride.
  • inventive aqueous composition contains (in addition to water, dexpanthenol and sodium chloride) a buffer substance.
  • Buffer substances are substance mixtures whose pH in aqueous solutions are essentially insensitive to small amounts of acid or base additive. For this purpose, preferably equimolecular mixtures of weak acids and their alkali metal salts are suitable. The same applies to the bases.
  • Suitable buffer substances are, for example, an acetate buffer, citrate buffer or phosphate buffer.
  • the acetate buffer is preferably a mixture of CH 3 COOH and CH 3 COOM.
  • the phosphate buffer is preferably a mixture of H 2 PO 4 M and HPO 4 M 2 .
  • M is an alkali metal, preferably potassium.
  • the phosphate buffer is particularly preferred. In particular, a potassium phosphate buffer is used as the buffer substance.
  • the buffer substance is preferably used in an amount of from 0.2 to 0.8% by weight, based on the total weight of the aqueous composition.
  • the aqueous composition of the invention is substantially free of preservatives.
  • the aqueous composition according to the invention consists of dexpanthenol, sodium chloride, buffer substance and water, in particular water for injection purposes.
  • the pH of the aqueous composition according to the invention is 6.0 to 7.0.
  • the aqueous composition according to the invention is preferably designed such that it is suitable for nasal application.
  • it is a sterile, aqueous composition.
  • a sterile composition is preferably achieved by sterile filtration.
  • filters of the type "Ultipor N66” or “N66 Posidyne” are suitable for sterile filtration.
  • composition of the invention is usually used as a medical device, preferably for the treatment and / or care of the nasal mucosa.
  • this is a dry and / or inflamed nasal mucosa.
  • the application is preferably carried out in the form of a nasal spray.
  • the aqueous composition according to the invention is filled into a container. It is preferably a multi-dose container system. In the multi-dose container system, after dispensing a dose, the remaining aqueous composition does not come into contact with air. Furthermore, the multi-dose container system, after dispensing a dose, the remaining aqueous composition does not come into contact with air. Furthermore, the multi-dose container system, after dispensing a dose, the remaining aqueous composition does not come into contact with air. Furthermore, the
  • Container in particular the product-contacting part of the spray head, preferably designed such that it can release silver ions.
  • composition according to the invention comprised the following steps:

Landscapes

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

Abstract

L'invention porte sur une composition pharmaceutique aqueuse contenant du dexpanthénol et du chlorure de sodium, caractérisée en ce que l'osmolalité de la composition est de 200 à 400 mosmol/kg, ainsi que sur son utilisation pour un produit médical destiné au traitement et/ou au soin de la muqueuse nasale. L'invention porte aussi sur un récipient contenant la composition aqueuse selon l'invention.
PCT/EP2009/008855 2008-12-12 2009-12-10 Composition aqueuse contenant du dexpanthénol et du chlorure de sodium WO2010066437A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE202008016517U DE202008016517U1 (de) 2008-12-12 2008-12-12 Wässrige Zusammensetzung enthaltend Dexpanthenol und Natriumchlorid
DE202008016517.2 2008-12-12

Publications (2)

Publication Number Publication Date
WO2010066437A2 true WO2010066437A2 (fr) 2010-06-17
WO2010066437A3 WO2010066437A3 (fr) 2011-02-24

Family

ID=40418672

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2009/008855 WO2010066437A2 (fr) 2008-12-12 2009-12-10 Composition aqueuse contenant du dexpanthénol et du chlorure de sodium

Country Status (2)

Country Link
DE (1) DE202008016517U1 (fr)
WO (1) WO2010066437A2 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2822537B1 (fr) 2012-05-14 2015-12-09 Maria Clementine Martin Klosterfrau Vertriebsgesellschaft mbH Agent de polytherapie pour le traitement de rhinites
WO2017005398A1 (fr) * 2015-07-06 2017-01-12 Maria Clementine Martin Klosterfrau Vertriebsgesellschaft Mbh Composition pour le traitement de la rhinite

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102011114094A1 (de) * 2011-09-21 2013-03-21 F. Holzer Gmbh Stimulierendes und belebendes Nasenspray und Nasentropfen
DE202021103126U1 (de) 2021-06-09 2021-06-23 Alexander Leiser Wässrige Zusammensetzung für präventive medizinische Anwendungen

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0366888A1 (fr) 1988-09-23 1990-05-09 CASSELLA Aktiengesellschaft Préparation pharmaceutique pour le traitement des inflammations des membranes muqueuses nasales

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE29807223U1 (de) * 1998-04-21 1998-09-17 STADA Arzneimittel AG, 61118 Bad Vilbel Pharmazeutische Zubereitung, umfassend Meerwasser und Pantothenol
DE10161110A1 (de) * 2001-12-12 2003-06-26 Ursapharm Arzneimittel Gmbh Pharmazeutische Zusammensetzung zur ophthalmologischen und rhinologischen Anwendung
DE102008036725B4 (de) * 2008-08-07 2021-01-28 Maria Clementine Martin Klosterfrau Vertriebsgesellschaft Mbh Pharmazeutische Zusammensetzung für die nasale Applikation

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0366888A1 (fr) 1988-09-23 1990-05-09 CASSELLA Aktiengesellschaft Préparation pharmaceutique pour le traitement des inflammations des membranes muqueuses nasales

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2822537B1 (fr) 2012-05-14 2015-12-09 Maria Clementine Martin Klosterfrau Vertriebsgesellschaft mbH Agent de polytherapie pour le traitement de rhinites
WO2017005398A1 (fr) * 2015-07-06 2017-01-12 Maria Clementine Martin Klosterfrau Vertriebsgesellschaft Mbh Composition pour le traitement de la rhinite

Also Published As

Publication number Publication date
DE202008016517U1 (de) 2009-03-05
WO2010066437A3 (fr) 2011-02-24

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