# US 8,783,089 B2 · Device and method for determining the properties of aerosol formulations

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- Number: US 8,783,089 B2
- Document ID: US8783089B2
- Status: Granted
- Kind: B2
- Application number: 12/996,709
- Filed: 2009-06-08
- Published: 2012-07-05
- Granted: 2014-07-22
- Earliest claimed: 2008-06-09
- Assignees: Boehringer Ingelheim International GmbH
- Applicants: Regis Cartier; Marc Egen; Cordula Krueger
- Inventors: Regis Cartier; Marc Egen; Michael Krueger
- Web page: https://patentgrep.com/patent/US8783089B2

## CPC

- G01N 1/2208: {with impactors}
- G01N 2001/2223: {aerosol sampling devices}
- G01N 2001/2244: {Exhaled gas, e.g. alcohol detecting}
- G01N 2013/006: {Dissolution of tablets or the like}
- G01N 2015/0261: {using impactors}
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## Abstract

A device (100) for determining the solution rate and release kinetics of aerosol formulations comprises an inhaler (2) connected to a cascade impactor (3), wherein a membrane (6) is disposed on a filter plate of the cascade impactor (2), and an air-liquid model system with a device for collecting measured data.

## Claims

### Claim 1

A test system for determining the solution rate and release kinetics of aerosol formulations, comprising:
an inhaler (1), which is connected to a cascade impactor (3), while a hydrophilic membrane (6) is disposed on a filter plate of the cascade impactor (3) and is charged with particles,
a Franz diffusion cell (13) into which the hydrophilic membrane (6) is disposed after being charged in the cascade impactor (3), wherein a first compartment (11) for receiving a liquid release medium is disposed underneath the hydrophilic membrane (6) and an air chamber is formed as a second compartment 12 above the hydrophilic membrane (6) within the Franz diffusion cell (13), and wherein the hydrophilic membrane (6) is in contact with a release medium, and
a device for measurement data acquisition wherein medium from the first compartment is carried,
wherein the hydrophilic membrane (6) comprises a material selected from among acrylic copolymer, polyethylene sulphone, polysulphone, cellulose, cellulose derivatives, cellulose esters and regenerated cellulose, and the hydrophilic membrane (6) has a maximum thickness of 100 μm.

### Claim 2 (depends on 1)

The test system according to claim 1, wherein the membrane (6) is made of cellulose.

### Claim 3 (depends on 1)

The test system according to claim 1, wherein the cascade impactor (3) is operated to correspond to human breathing.

### Claim 4 (depends on 1)

The test system according to claim 1, wherein the membrane (6) has a permeability of one of: (i) at least 20 liters per minute, and (ii) 39 liters per minute, and has a pore size of 0.45 μm.

### Claim 5 (depends on 1)

The test system according to claim 1, wherein the device for measurement data acquisition is one of: (i) a UV detector, and (ii) a fluorescence detector.

### Claim 6 (depends on 1)

The test system according to claim 1, wherein the Franz diffusion cell (13) is temperature controlled.

### Claim 7 (depends on 1)

The test system according to claim 1, wherein a magnetic stirrer (14) is associated with the Franz diffusion cell (13).

### Claim 8

A process for determining the solution rate and release kinetics of aerosol formulations, comprising the steps of:
releasing an aerosol that is to be measured from an inhaler (2) by means of a cascade impactor (3), wherein a membrane (6) is disposed on a filter plate in the cascade impactor (3), and
measuring the particles immobilised on the membrane (6) by means of a Franz diffusion cell (13), wherein in the Franz diffusion cell (13) a first compartment 11 for receiving a liquid release medium is disposed underneath the membrane (6) and an air chamber is formed as a second compartment 12 above the membrane (6), and a device for measurement data acquisition,
wherein the membrane (6) is made of a material selected from along acrylic copolymer, polyethylene sulphone, polysulphone, cellulose, cellulose derivatives, cellulose esters and regenerated cellulose, and the membrane having a maximum thickness of 100 μm.

### Claim 9 (depends on 8)

The process according to claim 8, wherein a membrane (6) made of cellulose is used.

### Claim 10 (depends on 8)

The process according to claim 8, wherein the cascade impactor (3) is operated to correspond to human breathing with an airflow of 39 liters per minute over a period of 6.15 seconds.

### Claim 11 (depends on 8)

The process according to one of claim 8, wherein the membrane (6) is used with a minimum permeability of one of: (i) 20 liters per minute, and (ii) 30 liters per minute and with a pore size of 0.45 μm.

### Claim 12 (depends on 8)

The process according to claim 8, wherein one of: (i) a UV detector and (ii) a fluorescence detector, is used as the device for measurement data acquisition.

### Claim 13 (depends on 8)

The process according claim 8, wherein the Franz diffusion cell (13) is temperature controlled.

### Claim 14 (depends on 8)

The process according to claim 8, wherein a magnetic stirrer (14), is used to mix the liquid release medium.

### Claim 15 (depends on 8)

The process according to claim 8 wherein a pump is used to carry the medium from the lower compartment by tubes to the device for measurement data acquisition.

### Claim 16 (depends on 1)

The test system according to claim 1 wherein the lower compartment is connected to a pump by tubes that carry the medium to the device for measurement data acquisition.