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WO2007066113A1 - Verification de la delivrance de particules fines - Google Patents

Verification de la delivrance de particules fines Download PDF

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Publication number
WO2007066113A1
WO2007066113A1 PCT/GB2006/004572 GB2006004572W WO2007066113A1 WO 2007066113 A1 WO2007066113 A1 WO 2007066113A1 GB 2006004572 W GB2006004572 W GB 2006004572W WO 2007066113 A1 WO2007066113 A1 WO 2007066113A1
Authority
WO
WIPO (PCT)
Prior art keywords
cloud
wavelength
optical
optical response
particles
Prior art date
Application number
PCT/GB2006/004572
Other languages
English (en)
Inventor
Olga Kusmartseva
Peter Smith
Original Assignee
Loughborough University Enterprises Limited
Simpson, Terry, Anthony
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 Loughborough University Enterprises Limited, Simpson, Terry, Anthony filed Critical Loughborough University Enterprises Limited
Priority to EP06820446A priority Critical patent/EP1963826A1/fr
Publication of WO2007066113A1 publication Critical patent/WO2007066113A1/fr

Links

Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/47—Scattering, i.e. diffuse reflection
    • G01N21/49—Scattering, i.e. diffuse reflection within a body or fluid
    • G01N21/53—Scattering, i.e. diffuse reflection within a body or fluid within a flowing fluid, e.g. smoke
    • G01N21/534—Scattering, i.e. diffuse reflection within a body or fluid within a flowing fluid, e.g. smoke by measuring transmission alone, i.e. determining opacity
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01F—MEASURING VOLUME, VOLUME FLOW, MASS FLOW OR LIQUID LEVEL; METERING BY VOLUME
    • G01F1/00—Measuring the volume flow or mass flow of fluid or fluent solid material wherein the fluid passes through a meter in a continuous flow
    • G01F1/704—Measuring the volume flow or mass flow of fluid or fluent solid material wherein the fluid passes through a meter in a continuous flow using marked regions or existing inhomogeneities within the fluid stream, e.g. statistically occurring variations in a fluid parameter
    • G01F1/708—Measuring the time taken to traverse a fixed distance
    • G01F1/7086—Measuring the time taken to traverse a fixed distance using optical detecting arrangements
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01F—MEASURING VOLUME, VOLUME FLOW, MASS FLOW OR LIQUID LEVEL; METERING BY VOLUME
    • G01F1/00—Measuring the volume flow or mass flow of fluid or fluent solid material wherein the fluid passes through a meter in a continuous flow
    • G01F1/704—Measuring the volume flow or mass flow of fluid or fluent solid material wherein the fluid passes through a meter in a continuous flow using marked regions or existing inhomogeneities within the fluid stream, e.g. statistically occurring variations in a fluid parameter
    • G01F1/708—Measuring the time taken to traverse a fixed distance
    • G01F1/712—Measuring the time taken to traverse a fixed distance using auto-correlation or cross-correlation detection means

Definitions

  • Embodiments of the present invention relate to the assessment of fine particle delivery, in particular, pulmonary drug delivery.
  • the drug particles that are greater in size than fine particles tend to be absorbed into a user's digestion system, which may cause side effects.
  • the ratio of the fine particle mass to the total dose mass it is referred to as the fine particle fraction and this indicates the efficiency of the delivery to the lung.
  • a method of assessing particle delivery comprising: measuring an optical response of a cloud of particles, which is moving in a first direction, to light of a first wavelength directed along a first axis that is substantially perpendicular to the first direction; determining, using the measured optical response to light of a first wavelength, a measure of the optical density, at the first wavelength, of a first portion of the cloud; measuring an optical response of the cloud of particles, which is moving in the first direction, to light of a second wavelength directed along a second axis that is substantially aligned with the first axis and perpendicular to the first direction; determining, using the measured optical response to light of a second wavelength, a measure of the optical density, at the second wavelength, of the first portion of the cloud ; and using the measures of the optical densities of the first portion of the cloud at the first wavelength and at the second wavelength, to assess the particles in the first portion of the cloud.
  • the method assesses the presence and compositions of particles.
  • a method of assessing the development of a cloud of particles as it moves along a first axis of a conduit comprising: i) for a first location along the conduit,
  • measurement apparatus for assessing particle delivery, comprising:
  • a conduit through which fluid carrying a cloud of particles moves in a first direction during delivery; a first sensor for directing light of a first wavelength along a first axis that is substantially perpendicular to the first direction into the cloud and for measuring a first optical response of the cloud; a second sensor for directing light of a second wavelength along a second axis that is substantially aligned with the first axis and perpendicular to the first direction, into the cloud and for measuring a second optical response of the cloud; a processor for determining, using the first and second optical responses, a measure of the optical density, at the first wavelength, of a first portion of the cloud and a measure of the optical density, at the second wavelength, of the first portion of the cloud and for processing the measures of the optical densities of the first portion of the cloud at the first wavelength and at the second wavelength, to assess the composition of the cloud.
  • a measurement apparatus for assessing particle delivery comprising:
  • a conduit through which fluid carrying a cloud of particles moves during delivery; a plurality of sensors arranged along the conduit each of which is operable to measure an optical response of a cloud of particles as it moves along the conduit; and a processor for identifying at which one of the plurality of sensors, a parameter of the optical responses has a turning point.
  • a method of assessing particle delivery comprising the steps of: measuring an optical response of a cloud of particles, which is moving in a first direction, to light of a first wavelength directed along a first axis that is substantially perpendicular to the first direction; determining, using the measured optical response to light of a first wavelength, a measure of optical density, at the first wavelength, of the cloud; measuring an optical response of the cloud of particles, which is moving in the first direction, to light of a second wavelength directed along a second axis that is substantially aligned with the first axis and perpendicular to the first direction; determining, using the measured optical response to light of a second wavelength, a measure of optical density, at the second wavelength, of the cloud ; and comparing the measures of the optical densities of the cloud at the first wavelength and at the second wavelength.
  • Fig. 1 illustrates an assessment system 10 for the rapid assessment of aerolised particle delivery
  • Fig 2A illustrates a cross-section through the measurement device illustrated in Fig 1 and XA ;
  • Fig 2B illustrates a cross-section through the measurement device illustrated in Fig 1 and XB ; and Fig 3 illustrates optical response for particles of different sizes at different wavelengths.
  • Fig. 1 illustrates an assessment system 10 for the rapid assessment of aerolised particle delivery, for example, in vivo pulmonary drug delivery.
  • the system 10 comprises in axial flow series a delivery device 12 including particles 14 for delivery, a measurement device 20 and a physiological actuator 16.
  • a flow of air F is drawn by the physiological actuator 16 from the delivery device 12, through the measurement device 20.
  • a seal may be required at the interface between the delivery device 12 and the measurement device 20 and a seal may be required between the physiological actuator 16 and the measurement device 20.
  • the air flow F created by the physiological actuator 16 may aerosolises agglomerates in the air flow F and create a cloud 11 of particles or the air flow F may draw an already existing aerosol cloud 11 into the measurement device 20.
  • the size of the particles and the distribution of particles within the cloud change as the cloud moves in the air flow F.
  • Aerosolised particle clouds scatter and absorb radiation according to the cloud composition, particularly the particle concentration and particle size distribution within the cloud.
  • the system 10 is arranged to quantitatively assess the effectiveness of pulmonary drug delivery from measurement profiles that indicate how detected radiation varies as the drug cloud passes between a radiation source and a radiation detector.
  • the drug for pulmonary delivery may be in any formulation including dry or liquid form or formulated as a solution/suspension with a solvent.
  • the delivery device 12 may be a real pulmonary drug delivery device. It could be a currently marketed device or a new design of device intended for the market. Examples of the possible types of suitable pulmonary drug delivery devices include: metered dose inhalers, dry powder inhalers, nebulizers, single breath liquid systems, and metered solution inhalers.
  • the physiological actuator may be provided by a breath in-take of a person or by the operation of a breathing simulator.
  • the measuring device 20 includes a straight optically translucent tube 22 connected between the output of a drug delivery device 12 and a physiological actuator 16.
  • the tube 22 in this example, has a 21 mm internal diameter and a fixed length of 60 mm. In other embodiments the tube 22 may have an internal diameter up to 30mm and a fixed length of between 5 and 200mm.
  • the measuring device also comprises sensors 24 that are exterior to the tube 22, memory buffers 23 connected to the sensors 24, a processor 30 connected to the memory buffers 23, a memory 32 and an output 34.
  • Each sensor 24 includes a radiation source 25 and a radiation detector 26 lying in a plane perpendicular to the longitudinal axis of the tube 22 and the flow direction F as illustrated in Figs 2A and 2B.
  • the sensors 24 operate by obscuration of light and the light source 25 and light detector 26 are positioned diametrically opposite each other.
  • the sensors 24 operates by light scattering and the source and detector are positioned in the same plane but the detector is not positioned in the 'line-of- sight' of the light source so that it detects light at a predetermined scattering angle.
  • a first sensor 24 A i includes a first radiation source 25AI and a first radiation detector 26 A i lying in a first plane P A perpendicular to the longitudinal axis 13 of the tube 22 and the flow direction F.
  • the first plane P A is located at position XA along the longitudinal axis 13 of the tube 22.
  • the first radiation source 25 A1 emits light 27 A i with a wavelength of ⁇ 2 and is positioned at azimuthal angle
  • a second sensor 24 A2 includes a second radiation source 25 A2 and a second radiation detector 26 A2 lying in the first plane P A .
  • the second radiation source 25 A2 emits light 27 A2 with a wavelength of ⁇ 2 and is positioned at azimuthal angle ⁇ 2 .
  • a third sensor 24 A3 includes a third radiation source 25 A3 and a third radiation detector 26 A3 lying in the first plane P A .
  • the third radiation source 25 A3 emits light 27 A3 with a wavelength of K 2 and is positioned at azimuthal angle ⁇ 3 .
  • the first plane P A of sensors is illustrated in plan view in Fig 2A.
  • a fourth sensor 24 B i includes a fourth radiation source 25 B i and a fourth radiation detector 26 B i lying in a second plane PB perpendicular to the longitudinal axis of the tube 22 and the flow direction F.
  • the second plane P B is located at position X B along the longitudinal axis of the tube 22.
  • the fourth radiation source 25 BI emits light 27BI with a wavelength of ⁇ i and is positioned at azimuthal angle ⁇ i so that it is aligned in the flow direction (i.e. paired) with the first radiation source 25 A i ⁇
  • a fifth sensor 24B 2 includes a fifth radiation source 25B2 and a fifth radiation detector 26 B2 lying in the second plane P 6 .
  • the fifth radiation source 25 B2 emits light 27 B2 with a wavelength of K 2 and is positioned at azimuthal angle ⁇ 2 so that it is aligned in the flow direction (i.e. paired) with the second radiation source 25 A2 .
  • a sixth sensor 24 B3 includes a sixth radiation source 25 B3 and a sixth radiation detector 26B 3 lying in the second plane P B .
  • the sixth radiation source 25 B3 emits light 27 B3 with a wavelength of ⁇ 3 and is positioned at azimuthal angle ⁇ 3 so that it is aligned in the flow direction (i.e. paired) with the third radiation source 25 A3 .
  • the second plane P B of sensors is illustrated in plan view in Fig 2B.
  • Each memory buffer 23 records, during a delivery, real-time data from one of the six radiation detectors 26 and the processor 30 transfers the buffered data to memory 32.
  • the real-time data T( ⁇ , x, t) recorded in each buffer are measurement profiles of how the detected radiation varies with time.
  • the processor 30 may start transferring and processing data in response to user input. For example, a button of a user interface of the measurement device 20 could be depressed to start recording. Alternatively, the processor 30 could start automatically in response to a detection of the start of the in- take procedure. For example, a flow detector could be positioned upstream of the sensor 24 A , and the processor 30 could detect when the detected flow rate exceeds a predetermined threshold.
  • the measurement device 20 has been described as a separate add- on component to the drug delivery device 12, in other embodiments the functionality of the measurement device 20 may be integrated into the drug delivery device 12.
  • Figure 3 shows a plot of the light transmittance against the particle diameter at three light wavelengths 450nm, 650nm and 800nm. This Figure illustrates that for each wavelength the optical attenuation is very low for particles less than 0.1 ⁇ m in diameter and also for particles greater than 10 ⁇ m in diameter.
  • a non-variable particle cloud with a large proportion of particles of a diameter less than ⁇ 1 ⁇ m will have a significantly lower transmittance for 450nm than for 650nm and a higher Transmittance for 800nm than for 650nm.
  • the Transmittance for 450nm increases significantly more than that for 650nm and the Transmittance for 650nm increases more than that for 800nm. Consequently the Transmittance for 450nm will no longer be significantly less than for 650nm and the Transmittance for 800nm will not necessarily be higher than for 650nm.
  • Light is obscured according to a standard model of optical density (Beer-Lambert) and the recorded data are a set of six light intensity measurement profiles.
  • /,,(/I 2 ) is the light intensity of each of the radiation sources 25AJ
  • d Al are optical paths of each light-beam produced by the respective radiation sources 25AJ
  • ⁇ are extinction coefficients.
  • Variable p Al represents the particle population on the optical paths d Al .
  • the transmittance for each sensor channel associated with the first plane PA is:
  • I B ( ⁇ ,) is the light intensity of each of the radiation sources 25 B ⁇ .
  • d Bl are optical paths of each light-beam produced by the respective radiation sources 25 B i, and ⁇ are extinction coefficients.
  • Variable p Bl represents the particle population on the optical paths d Bl .
  • t A is the time of measurement at the sensor positioned at x A and t n is the time of measurement, of the same portion of the cloud, at the sensor positioned at ⁇ B i.e.
  • Z 1 (AOOnTnJ) > a would indicate the presence of the fine particles in the cloud at the azimuthal position ⁇ i at time.
  • the parameter a may be set to 1 or to some larger experimentally determined value.
  • the parameter b may be set to 1 or to some smaller experimentally determined value.
  • Fig 1 illustrates the sensors in the first and second planes as being operational at the same but being separated by a distance
  • an alternative embodiment may locate the first and second planes together but interleave the operation of the sensors of the first plane and the sensors of the second plane.
  • Fig.1 illustrates the use of three sensors, however it should be understood that two or more paired sensors may be used.
  • Fig.1 illustrates the use of two planes of paired sensors.
  • three planes of sensors may be used, for example, a third plane P c may be positioned before the first plane PA at a position x c along the longitudinal axis of the tube 22.
  • the third plane Pc is perpendicular to the longitudinal axis of the tube 22 and the flow direction F. It may have three sensors including a seventh sensor 24ci that uses light with a wavelength of ⁇ 3 and is positioned at azimuthal angle ⁇ i so that it is aligned in the flow direction (i.e.
  • an eighth sensor 24c 2 that emits light with a wavelength of ⁇ 2 and is positioned at azimuthal angle Q 2 so that it is aligned in the flow direction (i.e. paired) with the second radiation source 25 A2
  • a ninth sensor 24 C2 that emits light with a wavelength of ⁇ i and is positioned at azimuthal angle ⁇ 3 so that it is aligned in the flow direction (i.e. paired) with the third radiation source 25A 3 .
  • Fig 1 illustrates a single grouping of planes of sensors, it should be understood that two or more groups of planes of sensors may be used. The separation along the longitudinal axis between groups of planes of sensors is much greater than the separation of the planes of sensors within a group.
  • ? 1(/)) is the time of measurement at the sensor of plane P A at positionx-i and t ] ⁇ B) is the time of measurement, of the same portion of the cloud, at the sensor of plane P B at position x-
  • the difference between t-i(B) and t-i(A) is calculated by cross-correlating T A2 ( ⁇ 2 ,x KA) ,t ) and T 112 (A 2 , x KB) ,t ) .
  • T A2 ⁇ 2 ,x KA) ,t
  • T 112 A 2 , x KB
  • t 2 ⁇ A) is the time of measurement at the sensor of plane PA at position X 2
  • t 2 ⁇ B) is the time of measurement, of the same portion of the cloud, at the sensor of plane P B at position X 2 .
  • ⁇ 2 the difference between t 2 (B) and t2(A) is calculated by cross-correlating T 42 (Z 2 , x 2( ⁇ A) , t ) and T B2 (X 2 ,x 2(B) j ) .
  • T 42 (Z 2 , x 2( ⁇ A) , t ) is calculated and constant , it can be used to calculate the cloud flow velocity at X 2 , V 2 .
  • v may be the average of vi and V 2 .
  • the measurements at multiple locations and at multiple colours may facilitate the indicators for the cloud development, e.g. the cloud volume and r- distribution of the particle population in the cloud.
  • ⁇ u (400nmj) > ⁇ would indicate the presence of the fine particles in the cloud at the azimuthal position ⁇ 1 at time.
  • the parameter a may be set to 1 or to some larger experimentally determined value.
  • ⁇ t may also indicate the presence of the fine particles in the cloud at the azimuthal position ⁇ 3 .
  • the parameter b may be set to 1 or to some smaller experimentally determined value.
  • each sensor may calculate the intensity of light sensed at each sensor according to a colorimetric scale at each location.
  • a colorimetric scale At a first location, one may calculate for each sensor, the intensity at that sensor divided by the sum of the intensities at the other sensors at that location.
  • one has three sensors at a location one has three normalised values for the intensities recorded at each sensor. By tracking how these values evolve as one moves from location to location, one can determine important information about the development of the cloud.
  • Sensors can be arranged along the conduit. Each sensor measures the intensity of the light as the cloud passes through.
  • the measurement profile created represents the optical response, at the location of that sensor, of the cloud of particles as it moves along the conduit.
  • Each measurement profile may have a number of associated parameters such as its asymmetry, its height, the area under a fitted curve, etc.
  • the processor can process the plurality of measurement profiles received from the plurality of sensors to extract a parameter for each sensor location and then determine where the turning point of that parameter is located. For example, the amplitude of the measurement profile may increase and then decrease as one moves along the conduit. However, the location where the amplitude is maximum may be where the fine particle dose is maximum. In a further example, the integral under a curve fitted to the measurement profile may increase and then decrease as one moves along the conduit. The location where the integral is maximum may be where the fine particle dose is maximum.
  • the sensors used may be colored or monochrome.
  • Signal processing techniques can be used to generate parametric (e.g. autoregressive moving average) or non-parametric models (e.g. Welch power spectrum estimation) of the evolution of the measurement profiles recorded at different positions along the conduit.
  • a linear model can be created which represents the dispersion of a given profile with respect to another (e.g. a digital filter).
  • the measurement profile can be considered as a superposition of many individual profiles travelling at different speeds.
  • these composite profiles will be displaced with respect to one another and hence the overall profile will be altered.
  • a sufficiently accurate physical model of the evolution process e.g. evaporation of the aerosol propellant in MDIs
  • it will be possible to invert the measurement profile data sets into physical properties of the particle clouds e.g. particle size distribution
  • Optical labels may be used for further discrimination of the cloud characteristics.
  • drug particles might be labelled differently from carrier particles or in the case of multiple drugs delivery each species could be labelled separately.

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  • Physics & Mathematics (AREA)
  • General Physics & Mathematics (AREA)
  • Fluid Mechanics (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Pathology (AREA)
  • Investigating Or Analysing Materials By Optical Means (AREA)

Abstract

L'invention porte sur un procédé de vérification de la délivrance de particules consistant: (i) à mesurer les réponses optiques d'un nuage de particules se déplaçant dans une première direction sous de la lumière d'une première et d'une deuxième longueur d'onde dirigées selon un premier axe sensiblement perpendiculaire à la première direction; (ii) à déterminer à l'aide desdites réponses optiques une mesure pour la première et la deuxième longueur d'onde de la densité optique d'une première partie du nuage; et (iii) et utilisation des mesures des densités optiques de la première partie du nuage avec la première longueur d'onde et la deuxième longueur d'onde pour vérifier la présence des particules dans la première partie du nuage. L'invention porte également sur une méthode de vérification de la délivrance des particules en plusieurs points situés le long du conduit de la réponse à un nuage de particules se déplaçant dans une première direction le long du conduit et identification du point un point de la réponse optique présente un point de rebroussement.
PCT/GB2006/004572 2005-12-07 2006-12-07 Verification de la delivrance de particules fines WO2007066113A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP06820446A EP1963826A1 (fr) 2005-12-07 2006-12-07 Verification de la delivrance de particules fines

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GBGB0524911.5A GB0524911D0 (en) 2005-12-07 2005-12-07 Assessment of fine particle delivery
GB0524911.5 2005-12-07

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WO2007066113A1 true WO2007066113A1 (fr) 2007-06-14

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GB (1) GB0524911D0 (fr)
WO (1) WO2007066113A1 (fr)

Cited By (3)

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Publication number Priority date Publication date Assignee Title
WO2009095679A3 (fr) * 2008-02-01 2009-12-10 Cambridge Consultants Limited Dispositif photométrique
CN102798730A (zh) * 2011-05-26 2012-11-28 基德科技公司 使用粉化器和药剂流速指示器的速度测量
EP3283855A4 (fr) * 2015-04-17 2018-10-03 Protecsom Amerique du Nord Inc. Appareil de mesure optique du débit et appareil d'inhalation le comprenant

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WO2001063255A2 (fr) * 2000-02-22 2001-08-30 Shofner Engineering Associates, Inc. Mesure de la concentration de la masse d'un aerosol et du taux de distribution de la masse
WO2002037083A1 (fr) * 2000-10-30 2002-05-10 Haw-Ingenieure Gbr Procede pour mesurer la taille des particules, la concentration en particules et la distribution granulometrique des particules de systemes disperses
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DE2218522A1 (de) * 1972-04-17 1973-10-25 Siemens Ag Einrichtung zur kontinuierlichen truebungsmessung
DE4025789A1 (de) * 1990-08-10 1992-02-13 Appsys Gmbh Mess Versorgungs U Optisches verfahren zur bestimmung des partikelgehaltes in gasen und fluessigkeiten
US5363198A (en) * 1992-11-09 1994-11-08 Fournier Thomas J Apparatus and method for measuring smoke opacity of a plume of smoke using an array of light beams
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Publication number Priority date Publication date Assignee Title
WO2009095679A3 (fr) * 2008-02-01 2009-12-10 Cambridge Consultants Limited Dispositif photométrique
US8742368B2 (en) 2008-02-01 2014-06-03 Cambridge Consultants Limited Device and method for measuring scattering of radiation
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EP2527818A3 (fr) * 2011-05-26 2012-12-19 Kidde Technologies, Inc. Étude de vitesse avec poudre et indicateur d'écoulement d'agent
AU2012202978B2 (en) * 2011-05-26 2013-11-21 Kidde Technologies, Inc Velocity survey with powderizer and agent flow indicator
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AU2012202978B8 (en) * 2011-05-26 2014-04-03 Kidde Technologies, Inc Velocity survey with powderizer and agent flow indicator
US9207172B2 (en) 2011-05-26 2015-12-08 Kidde Technologies, Inc. Velocity survey with powderizer and agent flow indicator
EP3283855A4 (fr) * 2015-04-17 2018-10-03 Protecsom Amerique du Nord Inc. Appareil de mesure optique du débit et appareil d'inhalation le comprenant

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Publication number Publication date
GB0524911D0 (en) 2006-01-11
EP1963826A1 (fr) 2008-09-03

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