EP1485695A1 - Dispositif de determination des parametres physiques et chimiques de formulations aerosol provenant d'aerosols de dosage - Google Patents

Dispositif de determination des parametres physiques et chimiques de formulations aerosol provenant d'aerosols de dosage

Info

Publication number
EP1485695A1
EP1485695A1 EP03704566A EP03704566A EP1485695A1 EP 1485695 A1 EP1485695 A1 EP 1485695A1 EP 03704566 A EP03704566 A EP 03704566A EP 03704566 A EP03704566 A EP 03704566A EP 1485695 A1 EP1485695 A1 EP 1485695A1
Authority
EP
European Patent Office
Prior art keywords
measuring
physical
determining
chemical parameters
aerosol
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.)
Withdrawn
Application number
EP03704566A
Other languages
German (de)
English (en)
Inventor
Thomas Schwarze
Heinz-Joachim Belt
Michael Pittroff
Uwe Becker
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.)
Solvay Fluor GmbH
Original Assignee
Solvay Fluor und Derivate 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 Solvay Fluor und Derivate GmbH filed Critical Solvay Fluor und Derivate GmbH
Publication of EP1485695A1 publication Critical patent/EP1485695A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00—Sampling; Preparing specimens for investigation
    • G01N1/02—Devices for withdrawing samples
    • G01N1/22—Devices for withdrawing samples in the gaseous state
    • G01N1/2202—Devices for withdrawing samples in the gaseous state involving separation of sample components during sampling
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00—Sampling; Preparing specimens for investigation
    • G01N1/02—Devices for withdrawing samples
    • G01N1/22—Devices for withdrawing samples in the gaseous state
    • G01N1/2202—Devices for withdrawing samples in the gaseous state involving separation of sample components during sampling
    • G01N2001/222—Other features
    • G01N2001/2223—Other features aerosol sampling devices

Definitions

  • the invention relates to a device for determining the physical and chemical parameters of aerosol formulations from metered dose aerosols (MDI).
  • MDI metered dose aerosols
  • Dosage aerosols have been shown to prolong the life of medication for patients suffering from asthma, chronic bronchitis or pulmonary emphysema.
  • the handy, easy-to-use MDIs are used to deliver a precisely measured dose of the ate pathogen-expanding medication directly to the lungs in acute situations.
  • the delivery of an active ingredient by means of metered dose aerosols is not limited to the indicated indications, but is continuously expanded, as is known from research reports.
  • These MDIs consist of a metal cartridge, usually an aluminum container, with a metering chamber and valve system and a holder with a mouthpiece.
  • blowing agents are required that release the active substances under constant pressure as a finely divided spray, the aerosol.
  • the complete formulations contain as Blowing agents fluorinated hydrocarbons, preferably HFKW227ea, HFKWl34a or mixtures thereof.
  • the object of the invention is to provide a device with which it is possible to fill the pressurized aerosol formulation without loss into a measuring container, where the physical and chemical parameters can be determined directly by means of inserted probes.
  • the device according to the invention comprises
  • stirrer at the bottom of the measuring chamber (e.g. magnetic stirrer)
  • the MDI opening mechanism includes
  • This sleeve is detachably or non-detachably connected to the housing, whereby a connection to the measuring chamber is guaranteed,
  • An actuator (6) preferably a screw head for pressing the cartridge onto the needle or the mandrel.
  • the cartridge (5) is pressed against the needle (7) by the screw head (6) and thus opened.
  • the complete formulation reaches the measuring chamber through an opening connected to the needle.
  • a further connection between the sleeve and the measuring chamber can be arranged.
  • a measuring electrode (2) e.g. B. to determine the pH.
  • the measuring electrode can e.g. B. can also be a conductivity measuring cell, a moisture measuring cell or an ion sensitive electrode.
  • the measuring chamber is made of chemical resistant material, e.g. B. stainless steel. It is also within the scope of the invention to provide the measuring chamber with a viewing window.
  • the device according to the invention makes it possible to transfer the contents of the cartridge into the measuring chamber without changing the composition of the metered dose aerosol formulation.
  • GC gas chromatographs
  • hygrometers X-ray spectrometers
  • mass spectrometers mass spectrometers
  • polarimeters crystal structure analyzers
  • calorimeters calorimeters
  • refractometers HPLC devices
  • NMR devices electrophoresis devices
  • devices for measuring the TIC and TOC content devices for recording adsorption in the area of infrared (IR), " ultraviolet (UV), Fourier transformed infrared (FTIR) or measuring arrangements for determining the solubility of the permeation behavior, the thermal conductivity, the contents of individual components (eg by means of AAS) and couplings thereof (e.g. GC-MS, GC-IR, GC-FTIR).
  • measuring a GMP-compliant statistical number of samples e.g. reactions which change the homogeneity or pH, as in the example of insulin, e.g. by destroying the insulin.
  • the measuring chamber can also be equipped with other sensors or complete measuring systems, the range of changes to be measured, physical and chemical, can be expanded to include these measuring systems.
  • a decrease in an aliquot of the total amount is easier to achieve by the apparatus according to the invention than by taking a larger sample through the metering valve.
  • the filled metal cartridge was inserted into the sleeve and pressed against the mandrel by means of the actuator, so that the contents of the cartridge thus opened were placed in the measuring chamber was transferred.
  • the pH was measured using a pressure-stable measuring electrode. To ensure a homogeneous distribution, the measuring apparatus was moved on a vibrating bench. The measurements were carried out when the apparatus was at a standstill.
  • Figure 1 shows a simplified embodiment of the device.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • Physics & Mathematics (AREA)
  • Chemical & Material Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Pathology (AREA)
  • Investigating Or Analyzing Materials By The Use Of Electric Means (AREA)
  • Sampling And Sample Adjustment (AREA)
  • Containers And Packaging Bodies Having A Special Means To Remove Contents (AREA)

Abstract

L'invention concerne un dispositif de détermination de paramètres physiques et chimiques tels que pH, teneur en humidité ou conductivité électrique de formulations aérosol provenant d'aérosols de dosage. Ledit dispositif comporte essentiellement un boîtier contenant une chambre de mesure, une électrode de mesure et un système destiné à enserrer et à ouvrir une cartouche d'aérosol. Selon l'invention, l'aérosol à examiner est prélevé directement dans la cartouche telle qu'elle est employée dans des inhalateurs d'aérosol, et transféré dans une chambre de mesure dans laquelle la mesure adéquate est effectuée au moyen d'une électrode de mesure.
EP03704566A 2002-03-13 2003-02-07 Dispositif de determination des parametres physiques et chimiques de formulations aerosol provenant d'aerosols de dosage Withdrawn EP1485695A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE20203999U 2002-03-13
DE20203999U DE20203999U1 (de) 2002-03-13 2002-03-13 Vorrichtung zur Bestimmung der physikalischen und chemischen Parameter von Aerosol-Formulierungen aus Dosieraerosolen
PCT/EP2003/001205 WO2003076907A1 (fr) 2002-03-13 2003-02-07 Dispositif de determination des parametres physiques et chimiques de formulations aerosol provenant d'aerosols de dosage

Publications (1)

Publication Number Publication Date
EP1485695A1 true EP1485695A1 (fr) 2004-12-15

Family

ID=7968891

Family Applications (1)

Application Number Title Priority Date Filing Date
EP03704566A Withdrawn EP1485695A1 (fr) 2002-03-13 2003-02-07 Dispositif de determination des parametres physiques et chimiques de formulations aerosol provenant d'aerosols de dosage

Country Status (6)

Country Link
US (1) US20040031486A1 (fr)
EP (1) EP1485695A1 (fr)
AU (1) AU2003206858A1 (fr)
CA (1) CA2460767A1 (fr)
DE (1) DE20203999U1 (fr)
WO (1) WO2003076907A1 (fr)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB0320171D0 (en) * 2003-08-28 2003-10-01 Optinose As Delivery devices
SE0303030D0 (sv) * 2003-11-14 2003-11-14 Astrazeneca Ab Canister piercer
WO2008088270A1 (fr) * 2007-01-16 2008-07-24 Astrazeneca Ab Procédé et système permettant d'analyser une dose d'un dispositif doseur
EP2561333B1 (fr) * 2010-04-19 2015-11-25 Battelle Memorial Institute Pulvérisation électro-hydro-dynamique
EP2604995A1 (fr) 2011-12-16 2013-06-19 Deva Holding Anonim Sirketi Extracteur de contenu pour un inhalateur doseur
EA039832B1 (ru) * 2020-12-25 2022-03-17 Общество С Ограниченной Ответственностью "Научно-Производственный Инновационный Внедренческий Центр" Ооо "Нп Ивц" Модуль генерации аэрозоля ингаляционного устройства

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SU546812A1 (ru) * 1974-08-23 1977-02-15 Предприятие П/Я Р-6900 Аэрозольно-оптический газоанализатор
FR2298099A1 (fr) * 1975-01-15 1976-08-13 Aquitaine Petrole Dispositif pour la mesure de la masse des particules d'un aerosol par unite de volume
FR2773884B1 (fr) * 1998-01-22 2000-03-24 Proengin Appareil combinant la spectrophotometrie et la detection de l'ionisation d'une flamme, pour l'analyse d'une composition gazeuse
US6055052A (en) * 1998-01-26 2000-04-25 Mie Corporation System for, and method of, monitoring airborne particulate, including particulate of the PM2.5 class
DE19824744A1 (de) * 1998-06-03 1999-03-18 Schmidt Ott Andreas Prof Dr Vorrichtung zur Messung des Staubgehalts in Gasen
US6397838B1 (en) * 1998-12-23 2002-06-04 Battelle Pulmonary Therapeutics, Inc. Pulmonary aerosol delivery device and method

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO03076907A1 *

Also Published As

Publication number Publication date
WO2003076907A1 (fr) 2003-09-18
DE20203999U1 (de) 2002-08-22
AU2003206858A1 (en) 2003-09-22
US20040031486A1 (en) 2004-02-19
CA2460767A1 (fr) 2003-09-18

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