EP1485695A1 - Device for determining the physical and chemical parameters of aerosol formulations discharged from metered dosed inhalers - Google Patents

Device for determining the physical and chemical parameters of aerosol formulations discharged from metered dosed inhalers

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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Withdrawn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)
French (fr)
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/en
Withdrawn legal-status Critical Current

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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.

Abstract

The invention relates to a device for determining physical and chemical parameters such as pH value, moisture content or electrical conductivity of aerosol formulations discharged from metered dosed inhalers. The device is essentially comprised of a housing with a measuring chamber, of a measuring electrode and of a device for fixing and opening an aerosol cartridge. In order to carry out a determination, the aerosol to be analyzed is directly transferred out of the cartridge, such as one used in aerosol inhalers, and into a measuring chamber inside of which the measuring electrode carries out the desired measurement.

Description

Vorrichtung zur Bestimmung der physikalischen und chemischen Parameter von Aerosol-Formulierungen aus Dosieraerosolen Device for determining the physical and chemical parameters of aerosol formulations from metered dose aerosols
Beschreibungdescription
Die Erfindung betrifft eine Vorrichtung zur Bestimmung der physikalischen und chemischen Parameter von Aerosolformulierungen aus Dosieraerosolen (MDI) .The invention relates to a device for determining the physical and chemical parameters of aerosol formulations from metered dose aerosols (MDI).
Zur Medikamentenversorgung von Patienten, die an Asthma, chronischer Bronchitis oder Lungenemphysem leiden, haben sich Dosieraerosole (metered dosed inhaler) als lebensverlängernd erwiesen. Die handlichen, einfach anzuwendenden Dosieraerosole dienen dazu, in Akutsituationen eine präzise bemessene Dosis der ate wegserweiternden Arzneimittel direkt in die Lunge zu befördern. Dabei ist die Abgabe eines Wirkstoffes mittels Dosieraerosols jedoch nicht auf die genannten Indikationen beschränkt, sondern wird wie aus Forschungsberichten bekannt, laufend erweitert. Diese Dosieraerosole bestehen aus einer Metallkartusche, meist einem Aluminiumbehälter, mit Dosierkammer und Ventilsystem und einer Halterung mit Mundstück.Dosage aerosols (metered dosed inhaler) 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. However, 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.
Damit vom ersten bis zum letzten Sprühstoß eine gleich bleibende und genau definierte Freisetzung der Wirkstoffe garantiert werden kann, sind Treibmittel erforderlich, die die Wirksubstanzen unter konstantem Druck als fein verteiltes Spray, dem Aerosol, freisetzen.So that a constant and precisely defined release of the active ingredients can be guaranteed from the first to the last spray, blowing agents are required that release the active substances under constant pressure as a finely divided spray, the aerosol.
Die kompletten Formulierungen enthalten neben dem pharmazeutischen Wirkstoff, Lösungsvermittler und Tenside, als Treibmittel fluorierte Kohlenwasserstoffe, vorzugsweise HFKW227ea, HFKWl34a oder Gemische daraus.In addition to the active pharmaceutical ingredient, solubilizers and surfactants, the complete formulations contain as Blowing agents fluorinated hydrocarbons, preferably HFKW227ea, HFKWl34a or mixtures thereof.
Zur Sicherung der Qualität und Entwicklung von Dosieraerosolen ist die Bestimmung physikalischer chemischer Parameter aus der kompletten Formulierung erforderlich.To ensure the quality and development of MDIs, the determination of physical chemical parameters from the complete formulation is necessary.
Die Aufgabe der Erfindung besteht darin, eine Vorrichtung bereitzustellen, mit der es möglich ist, die unter Druck stehende Aerosolformulierung verlustlos in einen Messbehälter zu füllen, wo mittels eingebrachter Sonden direkt die Bestimmung der physikalischen und chemischen Parameter erfolgen kann.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.
Die Entnahme einer Teilmenge zur weiteren Untersuchung soll ebenfalls möglich sein, genauso wie eine Online- Auswertung der Messergebnisse.It should also be possible to withdraw a subset for further investigation, as well as online evaluation of the measurement results.
Die erfindungsgemäße Vorrichtung umfasstThe device according to the invention comprises
- einen multiplen Probennahmekopf (3), gegebenenfalls mit Ventil und/oder interner Druckausgleichvorrichtung- A multiple sampling head (3), optionally with valve and / or internal pressure compensation device
- ein Gehäuse (1)- a housing (1)
- eine Messelektrode (2)- a measuring electrode (2)
- eine Messkammer (8)- a measuring chamber (8)
- einen Dosieraerosol-Öffnungsmechanismus- A MDI opening mechanism
- einen Rührer, am Boden der Messkammer (z. B. Magnetrührer)- a stirrer, at the bottom of the measuring chamber (e.g. magnetic stirrer)
- gegebenenfalls einen Evakuierungsanschluss- if necessary, an evacuation connection
- gegebenenfalls einen Thermostat- if necessary, a thermostat
Der Dosieraerosol-Öffnungsmechanismus umfasstThe MDI opening mechanism includes
- eine Hülse (4) zur Aufnahme der Metallkartusche (5) . Diese Hülle ist lösbar oder unlösbar mit dem Gehäuse verbunden, wobei eine Verbindung zur Messkammer gewährleistet ist,- A sleeve (4) for receiving the metal cartridge (5). This sleeve is detachably or non-detachably connected to the housing, whereby a connection to the measuring chamber is guaranteed,
- einen Dorn (7) oder eine Nadel (7) zum Öffnen der Kartusche, - ein Stellglied (6), vorzugsweise ein Schraubkopf zum Anpressen der Kartusche an die Nadel oder den Dorn.- a mandrel (7) or a needle (7) for opening the cartridge, - An actuator (6), preferably a screw head for pressing the cartridge onto the needle or the mandrel.
Die Kartusche (5) wird durch den Schraubkopf (6) an die Nadel (7) gepresst und somit geöffnet. Die komplette Formulierung gelangt über eine mit der Nadel verbundene Öffnung in die Messkammer.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.
Zur Gewährleistung, dass das Aerosol verlustlos in die Messkammer gelangt, kann eine weitere Verbindung zwischen Hülse und Messkammer angeordnet sein.To ensure that the aerosol gets into the measuring chamber without loss, a further connection between the sleeve and the measuring chamber can be arranged.
Entsprechende Dichtungen zur Vermeidung eines ungewollten Druckausgleiches sind ebenfalls vorgesehen.Appropriate seals to avoid unwanted pressure equalization are also provided.
In die Messkammer ragt eine Messelektrode (2), z. B. zur Bestimmung des pH-Wertes. Die Messelektrode kann z. B. auch eine Leitfähigkeitsmesszelle, eine Feuchtigkeitsmesszelle o- der eine Ionensensitivelektrode sein.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.
Die Messkammer wird aus chemikalienresistentem Material, z. B. Edelstahl, gefertigt. Es ist ebenfalls im Sinne der Erfindung, die Messkammer mit einem Sichtfenster zu versehen.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.
Die erfindungsgemäße Vorrichtung ermöglicht es, den Inhalt der Kartusche in die Messkammer zu überführen, ohne dass die Zusammensetzung der Dosieraerosol-Formulierung verändert wird.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.
Es ist ebenfalls Gegenstand der erfindungsgemäßen Vorrichtung, dass in der Messkammer Entnahmeöffnungen, z. B. Ventile, Kapillaren usw. angeordnet sind, damit Teilmengen aus der Gas- oder Flüssigphase der in der Messkammer befindlichen Formulierung entnommen werden können, die in externen Messgeräten, untersucht werden. Als externe Messgeräte können z. B. Gaschromatographen (GC) , Hygrometer, Röntgenspektrometer, Massenspektrometer, Polarimeter, Kristallstrukturanalysatoren, Kalorimeter, Refraktometer, HPLC-Geräte, NMR-Geräte, Elektrophorese-Geräte, Geräte zur Messung des TIC und TOC-Gehaltes, Apparaturen zur Aufnahme der Adsorption im Bereich von Infrarot (IR)," Ultraviolett (UV) , Fourier transformiertem Infrarot (FTIR) oder Messanordnungen zur Bestimmung der Löslichkeit des Permea- tionsverhaltens, der Wärmeleitfähigkeit, der Gehalte von Einzelkomponenten (z. B. mittels AAS) eingesetzt werden sowie Kopplungen daraus (z. B. GC-MS, GC-IR, GC-FTIR) .It is also the subject of the device according to the invention that in the measuring chamber removal openings, for. B. valves, capillaries, etc. are arranged so that portions can be removed from the gas or liquid phase of the formulation in the measuring chamber, which are examined in external measuring devices. As external measuring devices such. B. gas chromatographs (GC), hygrometers, X-ray spectrometers, mass spectrometers, polarimeters, crystal structure analyzers, 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).
Es ist ebenfalls möglich, Einrichtungen zur Online- Messdatenerfassung mit der erfindungsgemäßen Vorrichtung zu verbinden. Dies ist besonders in der Produktionskontrolle von Interesse .It is also possible to connect devices for online measurement data acquisition to the device according to the invention. This is of particular interest in production control.
Im Rahmen der Qualitätskontrolle können durch Vermessung einer GMP konformen statistischen Anzahl von Proben z.B. die Homogenität oder pH-Wert ändernde Reaktionen wie am Beispiel des Insulins, z.B. durch Zerstörung des Insulins, festgestellt werden.Within the scope of quality control, 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.
Da die Messkammer auch mit anderen Sensoren oder kompletten Messsystemen ausgestattet werden kann ist die Bandbreite der zu messenden Änderungen, physikalischer sowie chemischer Art, auf diese Messsysteme erweiterbar.Since 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.
Eine Abnahme eines aliquoten Teils der Gesamtmenge ist durch die erfindungsgemäße Apparatur leichter zu bewerkstelligen als durch Abnahme einer größeren Probe durch das Dosierventil .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.
Beispielexample
Die gefüllte Metallkartusche wurde in die Hülse eingesetzt und mittels des Stellgliedes an den Dorn gepresst, so dass der Inhalt der so geöffneten Kartusche in die Messkammer transferiert wurde. Mittels einer druckstabilen Messelektrode wurde der pH-Wert gemessen. Zur Gewährleistung einer homogenen Verteilung wurde die Messapparatur auf einer Rüttelbank bewegt. Die Messungen erfolgten bei Stillstand der Apparatur.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.
Die Figur 1 zeigt eine vereinfachte Ausführungsform der Vorrichtung.Figure 1 shows a simplified embodiment of the device.
B e z u α s z e i c h e nB e z u α s z e i c h e n
(1) Gehäuse(1) housing
(2) Messelektrode(2) measuring electrode
(3) multipler Probenahmekopf(3) multiple sampling head
(4) Hülse(4) sleeve
(5) Metallkartusche(5) metal cartridge
(6) Stellglied(6) actuator
(7) Dorn oder Nadel(7) thorn or needle
(8) Messkammer (8) measuring chamber

Claims

Schutzansprüche protection claims
1. Vorrichtung zur Bestimmung der physikalischen und chemischen Parameter von Aerosol-Formulierungen aus Dosieraerosolen, umfassend ein Gehäuse mit eingelassener Messkammer, einem multiplen Probenahmekopf mit mindestens einem Ventil, einer Öffnung zur Aufnahme der Messelektrode und einem Dosieraerosol-Öffnungsmechanismus .1. Device for determining the physical and chemical parameters of aerosol formulations from metered aerosols, comprising a housing with an embedded measuring chamber, a multiple sampling head with at least one valve, an opening for receiving the measuring electrode and a metering aerosol opening mechanism.
2. Vorrichtung zur Bestimmung der physikalischen und chemischen Parameter nach Anspruch 1, dadurch gekennzeichnet, dass die Messkammer mindestens ein Ventil zur Druckentlastung aufweist .2. Device for determining the physical and chemical parameters according to claim 1, characterized in that the measuring chamber has at least one valve for pressure relief.
3. Vorrichtung zur Bestimmung der physikalischen und chemischen Parameter nach Anspruch 1, dadurch gekennzeichnet, dass die Messelektrode eine PH-Wert-Messelektrode, eine Leitfähigkeitsmesszelle, eine Feuchtigkeitsmesszelle oder eine Ionensensitivelektrode ist.3. Device for determining the physical and chemical parameters according to claim 1, characterized in that the measuring electrode is a pH value measuring electrode, a conductivity measuring cell, a moisture measuring cell or an ion sensitive electrode.
4. Vorrichtung zur Bestimmung der physikalischen und chemischen Parameter nach Anspruch 1, dadurch gekennzeichnet, dass der Dosieraerosol-Öffnungsmechanismus eine mit dem Gehäuse lösbar oder unlösbar verbundene Hülse zur Aufnahme einer Kartusche des Dosieraerosols, an deren der Messkammer zugewandten Fläche ein in die Hülse ragender Dorn oder eine Nadel zum Öffnen der Kartusche angebracht ist, ein Stellglied zum Anpressen der Kartusche an den Dorn oder die Nadel, Dichtungen, um einen ungewollten Druckausgleich zu vermeiden, und mindestens eine Verbindungsöffnung zur Messkammer, durch die die komplette Aerosolformulierung in die Messkammer gelangt, aufweist.4. The device for determining the physical and chemical parameters according to claim 1, characterized in that the metering aerosol opening mechanism has a sleeve which is detachably or non-detachably connected to the housing for receiving a cartridge of the metering aerosol, on the surface of which faces the measuring chamber, a mandrel projecting into the sleeve or a needle for opening the cartridge is attached, an actuator for pressing the cartridge onto the mandrel or the needle, seals to avoid unwanted pressure equalization, and at least one connection opening to the measuring chamber through which the complete aerosol formulation reaches the measuring chamber ,
5. Vorrichtung zur Bestimmung der physikalischen und chemischen Parameter nach Anspruch 1, dadurch gekennzeichnet, dass die Messkammer mit weiteren Messgeräten verbunden ist. 5. Device for determining the physical and chemical parameters according to claim 1, characterized in that the measuring chamber is connected to further measuring devices.
EP03704566A 2002-03-13 2003-02-07 Device for determining the physical and chemical parameters of aerosol formulations discharged from metered dosed inhalers Withdrawn EP1485695A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE20203999U 2002-03-13
DE20203999U DE20203999U1 (en) 2002-03-13 2002-03-13 Device for determining the physical and chemical parameters of aerosol formulations from metered dose aerosols
PCT/EP2003/001205 WO2003076907A1 (en) 2002-03-13 2003-02-07 Device for determining the physical and chemical parameters of aerosol formulations discharged from metered dosed inhalers

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EP1485695A1 true EP1485695A1 (en) 2004-12-15

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EP03704566A Withdrawn EP1485695A1 (en) 2002-03-13 2003-02-07 Device for determining the physical and chemical parameters of aerosol formulations discharged from metered dosed inhalers

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US (1) US20040031486A1 (en)
EP (1) EP1485695A1 (en)
AU (1) AU2003206858A1 (en)
CA (1) CA2460767A1 (en)
DE (1) DE20203999U1 (en)
WO (1) WO2003076907A1 (en)

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EP2104852A4 (en) * 2007-01-16 2012-09-26 Astrazeneca Ab Method and system for analysing a dose formulation of a metered dose device
US9200987B2 (en) 2010-04-19 2015-12-01 Battelle Memorial Institute Electrohydrodynamic spraying
EP2604995A1 (en) 2011-12-16 2013-06-19 Deva Holding Anonim Sirketi Content extractor for metered dose inhalers
EA039832B1 (en) * 2020-12-25 2022-03-17 Общество С Ограниченной Ответственностью "Научно-Производственный Инновационный Внедренческий Центр" Ооо "Нп Ивц" Module of aerosol generation for inhalation device

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CA2460767A1 (en) 2003-09-18
AU2003206858A1 (en) 2003-09-22
US20040031486A1 (en) 2004-02-19
WO2003076907A1 (en) 2003-09-18
DE20203999U1 (en) 2002-08-22

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