# US 11,079,305 B2 · Sampling apparatus for determining the amount and uniformity of a delivered dose of drug and related methods > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,079,305 B2 - Document ID: US11079305B2 - Status: Granted - Kind: B2 - Application number: 16/591,159 - Filed: 2019-10-02 - Published: 2020-03-12 - Granted: 2021-08-03 - Earliest claimed: 2014-06-30 - Assignees: Proveris Scientific Corporation - Applicants: Proveris Scientific Corporation - Inventors: Dino J. Farina; Timothy R. L'Ecuyer; Spencer Pallas; Jason Graaf - Web page: https://patentgrep.com/patent/US11079305B2 ## CPC - G01N 1/2205: {with filters} - A61M 15/009: {using medicine packages with incorporated spraying means, e.g. aerosol cans (pocket atomiser of the injector type A61M11/08)} - A61M 15/00: Inhalators {(drug delivery in endotracheal tubes A61M16/04)} - A61M 2202/064: Powder - A61M 2206/14: Static flow deviators in tubes disturbing laminar flow in tubes, e.g. archimedes screws - A61M 2209/02: Equipment for testing the apparatus - G01N 1/2202: {involving separation of sample components during sampling} - G01N 2001/2223: {aerosol sampling devices} - G01N 2001/2285: {Details of probe structures} - G01N 2001/248: {Evacuated containers} - 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) - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} ## Abstract In an embodiment, the present invention is an apparatus, configured to collect emitted sample dose from a drug delivery device, wherein the sample dose is an aerosol, wherein the apparatus comprises a collection assembly and a removable plunger. ## Claims ### Claim 1 A collection assembly for collecting a sample dose from a drug delivery device, the collection assembly comprising: i) a collection container that comprises a hollow cylinder having an inner surface and an outer surface, and a first opening at a proximal end and a second opening at a distal end of the hollow cylinder, wherein the second opening is configured to allow the collection container to connect to a system configured to apply negative pressure through the second opening; ii) a closure assembly that comprises a resealable inlet baffle operatively connected to the proximal end of the collection container and comprises a central opening which receives a mouthpiece of the drug delivery device and forms a seal between the collection container and the mouthpiece, and wherein the central opening of the resealable inlet baffle is configured to receive a removable plunger such that the removable plunger passes through the resealable inlet baffle into the collection container and contacts the inner surface of the collection container; and iii) a resealable nozzle operatively connected to the second opening. ### Claim 2 (depends on 1) The collection assembly of claim 1, wherein the collection container is a syringe. ### Claim 3 (depends on 1) The collection assembly of claim 1, wherein the collection container is glass, plastic, polypropylene, or polyethylene. ### Claim 4 (depends on 1) The collection assembly of claim 1, wherein the closure assembly further comprises a removable inlet baffle cap which is configured to seal the resealable inlet baffle. ### Claim 5 (depends on 1) The collection assembly of claim 1, wherein the drug delivery device is a metered dose inhaler (MDI), a pressurized metered dose inhaler (pMDI), or a dry powder inhaler (DPI). ### Claim 6 (depends on 1) The collection assembly of claim 1, wherein the resealable inlet baffle is configured to accept the mouthpiece of variously sized and shaped metered dose inhalers (MDI), pressurized metered dose inhalers (pMDI), or dry powder inhalers (DPI). ### Claim 7 (depends on 1) The collection assembly of claim 1, wherein the sample dose is an aerosol sample dose. ### Claim 8 (depends on 1) The collection assembly of claim 1, further comprising a removable nozzle cap which is configured to seal the resealable nozzle. ### Claim 9 (depends on 8) The collection assembly of claim 8, wherein the distal end of the collection container has a threaded surrounding wall that mates with a threaded surrounding wall of the removable nozzle cap, or has a tapered surrounding wall that mates with a tapered surrounding wall of the removable nozzle cap. ### Claim 10 (depends on 1) The collection assembly of claim 1, further comprising a connection assembly for affixing the resealable inlet baffle to the collection container, wherein the connection assembly comprises an inlet ring and an inlet locking ring, wherein the inlet locking ring is lockingly engaged with the inlet ring and the proximal end of the collection container. ### Claim 11 (depends on 10) The collection assembly of claim 10, wherein the connection assembly further comprises a sensor, wherein the sensor is situated on the connection assembly or an outer wall of the resealable inlet baffle. ### Claim 12 (depends on 11) The collection assembly of claim 11, wherein the sensor stores or transmits data or both stores and transmits data that: (i) identifies a manufacturer of the collection assembly; (ii) identifies or limits a number of times the collection assembly may be used, or both; (iii) identifies a sample that is to be contained within the collection assembly; (iv) identifies patient data; (v) identifies a time or date of use of the collection assembly, or both; or (vi) any combination thereof. ### Claim 13 (depends on 1) The collection assembly of claim 1, wherein the drug delivery device is a metered dose inhaler (MDI), a pressurized metered dose inhaler (pMDI), or a dry powder inhaler (DPI); and wherein the collection container further comprises a removable nozzle cap which is configured to seal the resealable nozzle, and a removable inlet baffle cap which is configured to seal the resealable inlet baffle. ### Claim 14 An apparatus for collecting a sample dose from a drug delivery device, wherein the apparatus comprises a) a collection assembly that comprises i) a collection container that comprises a hollow cylinder having an inner surface and an outer surface, and a first opening at a proximal end and a second opening at a distal end of the hollow cylinder, wherein the second opening is configured to allow the collection container to connect to a system configured to apply negative pressure through the second opening; ii) a closure assembly that comprises a resealable inlet baffle operatively connected to the proximal end of the collection container and comprises a central opening which receives a mouthpiece of the drug delivery device and forms a seal between the collection container and the mouthpiece, and wherein the central opening of the resealable inlet baffle is configured to receive a removable plunger such that the removable plunger passes through the resealable inlet baffle into the collection container and contacts the inner surface of the collection container; and iii) a resealable nozzle operatively connected to the second opening; and b) a removable plunger configured to pass through the resealable inlet baffle into the collection container and contact the inner surface of the collection container. ### Claim 15 (depends on 14) The apparatus of claim 14, further comprising a negative pressure source operatively connected to the distal end of the collection container. ### Claim 16 (depends on 15) The apparatus of claim 15, wherein an air flow rate from the negative pressure source is fixed at a desirable rate for a user's test purposes. ### Claim 17 (depends on 14) The apparatus of claim 14, wherein the drug delivery device is a metered dose inhaler (MDI), a pressurized metered dose inhaler (pMDI), or a dry powder inhaler (DPI). ### Claim 18 (depends on 14) A method of using an apparatus of claim 14, to collect a sample dose from a drug delivery device, comprising: (a) connecting a negative pressure source to the distal end of the collection container; (b) inserting a mouthpiece of a drug delivery device into the resealable inlet baffle; (c) actuating the drug delivery device into the collection container and then removing the drug delivery device from the resealable inlet baffle; (d) removing the negative pressure source from the distal end of the collection container; (e) covering the distal end of the collection container; (f) adding a solvent to the collection container through the resealable inlet baffle; (g) agitating the collection assembly; and (h) pushing the removable plunger through the resealable inlet baffle and fully into the collection container to force the sample dose out of the distal end of the collection container. ### Claim 19 (depends on 18) The method of claim 18, wherein the removable plunger contacts the inner surface of the collection container. ### Claim 20 (depends on 18) The method of claim 18, further comprising analyzing the sample dose by High Pressure Liquid Chromatography (HPLC) or ultraviolet (UV) spectrophotometry. ### Claim 21 (depends on 18) The method of claim 18, wherein a single sample dose is obtained. ### Claim 22 (depends on 18) The method of claim 18, wherein at least two sample doses are obtained. ### Claim 23 (depends on 18) The method of claim 18, further comprising determining an amount and uniformity of the sample dose. ### Claim 24 (depends on 18) The method of claim 18, wherein the drug delivery device is a metered dose inhaler (MDI), a pressurized metered dose inhaler (pMDI), or a dry powder inhaler (DPI). ### Claim 25 (depends on 14) A method of using an apparatus of claim 14, to collect a sample dose, comprising: (a) connecting a negative pressure source to the distal end of the collection container; (b) inserting a mouthpiece of a drug delivery device into the resealable inlet baffle; (c) actuating the drug delivery device into the collection container and then removing the drug delivery device from the resealable inlet baffle; (d) removing the negative pressure source from the distal end of the collection container; (e) covering the distal end of the collection container with a nozzle cap; (f) adding a solvent to the collection container through the resealable inlet baffle; (g) sealing the resealable inlet baffle with an inlet baffle cap; (h) agitating the collection assembly; (i) removing the inlet baffle cap from the resealable inlet baffle; (j) removing the nozzle cap from the distal end of the collection container; and (k) pushing the removable plunger through the resealable inlet baffle and fully into the collection container to force the sample dose out of the distal end of the collection container. ### Claim 26 (depends on 25) The method of claim 25, wherein the removable plunger contacts the inner surface of the collection container. ### Claim 27 (depends on 25) The method of claim 25, further comprising analyzing the sample dose by High Pressure Liquid Chromatography (HPLC) or ultraviolet (UV) spectrophotometry. ### Claim 28 (depends on 25) The method of claim 25, wherein a single sample dose is obtained. ### Claim 29 (depends on 25) The method of claim 25, wherein at least two sample doses are obtained. ### Claim 30 (depends on 25) The method of claim 25, further comprising determining an amount and uniformity of the sample dose. ### Claim 31 (depends on 25) The method of claim 25, wherein the drug delivery device is a metered dose inhaler (MDI), a pressurized metered dose inhaler (pMDI), or a dry powder inhaler (DPI).