BR112016030972B1 - Aparelho de amostragem para a determinação da quantidade e da uniformidade de uma dose de medicamento fornecida e métodos correlatos - Google Patents
Aparelho de amostragem para a determinação da quantidade e da uniformidade de uma dose de medicamento fornecida e métodos correlatos Download PDFInfo
- Publication number
- BR112016030972B1 BR112016030972B1 BR112016030972-3A BR112016030972A BR112016030972B1 BR 112016030972 B1 BR112016030972 B1 BR 112016030972B1 BR 112016030972 A BR112016030972 A BR 112016030972A BR 112016030972 B1 BR112016030972 B1 BR 112016030972B1
- Authority
- BR
- Brazil
- Prior art keywords
- collection container
- inlet
- fact
- filter
- deflector
- Prior art date
Links
- 238000000034 method Methods 0.000 title claims abstract description 25
- 238000005070 sampling Methods 0.000 title abstract description 34
- 229940126601 medicinal product Drugs 0.000 title 1
- 239000003814 drug Substances 0.000 claims abstract description 42
- 239000000443 aerosol Substances 0.000 claims abstract description 22
- 229940079593 drug Drugs 0.000 claims description 35
- 229940112141 dry powder inhaler Drugs 0.000 claims description 27
- 239000002904 solvent Substances 0.000 claims description 23
- 230000014759 maintenance of location Effects 0.000 claims description 5
- 239000002245 particle Substances 0.000 claims description 4
- 239000003365 glass fiber Substances 0.000 claims description 3
- 229940071648 metered dose inhaler Drugs 0.000 claims 3
- 238000012377 drug delivery Methods 0.000 description 19
- 239000000463 material Substances 0.000 description 18
- 238000012360 testing method Methods 0.000 description 15
- 238000011049 filling Methods 0.000 description 7
- 239000004033 plastic Substances 0.000 description 4
- 229920003023 plastic Polymers 0.000 description 4
- 238000013019 agitation Methods 0.000 description 3
- 238000004458 analytical method Methods 0.000 description 3
- 238000003780 insertion Methods 0.000 description 3
- 230000037431 insertion Effects 0.000 description 3
- -1 polypropylene Polymers 0.000 description 3
- 239000000843 powder Substances 0.000 description 3
- 238000007789 sealing Methods 0.000 description 3
- 239000007921 spray Substances 0.000 description 3
- 239000004743 Polypropylene Substances 0.000 description 2
- 239000011152 fibreglass Substances 0.000 description 2
- 239000011521 glass Substances 0.000 description 2
- 238000004128 high performance liquid chromatography Methods 0.000 description 2
- 239000007788 liquid Substances 0.000 description 2
- 229920001155 polypropylene Polymers 0.000 description 2
- 238000002360 preparation method Methods 0.000 description 2
- 230000008569 process Effects 0.000 description 2
- 238000003756 stirring Methods 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- UPMLOUAZCHDJJD-UHFFFAOYSA-N 4,4'-Diphenylmethane Diisocyanate Chemical compound C1=CC(N=C=O)=CC=C1CC1=CC=C(N=C=O)C=C1 UPMLOUAZCHDJJD-UHFFFAOYSA-N 0.000 description 1
- 0 CC1*(C2CC3)[C@]2*=C3C(C)C1 Chemical compound CC1*(C2CC3)[C@]2*=C3C(C)C1 0.000 description 1
- 229920000538 Poly[(phenyl isocyanate)-co-formaldehyde] Polymers 0.000 description 1
- 239000004698 Polyethylene Substances 0.000 description 1
- 230000009471 action Effects 0.000 description 1
- 230000003213 activating effect Effects 0.000 description 1
- 230000004913 activation Effects 0.000 description 1
- 210000003323 beak Anatomy 0.000 description 1
- 230000000740 bleeding effect Effects 0.000 description 1
- 230000015556 catabolic process Effects 0.000 description 1
- 230000008878 coupling Effects 0.000 description 1
- 238000010168 coupling process Methods 0.000 description 1
- 238000005859 coupling reaction Methods 0.000 description 1
- 238000006731 degradation reaction Methods 0.000 description 1
- 238000004090 dissolution Methods 0.000 description 1
- 239000013583 drug formulation Substances 0.000 description 1
- 229940126534 drug product Drugs 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000001914 filtration Methods 0.000 description 1
- 238000010304 firing Methods 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 238000001746 injection moulding Methods 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 229920000573 polyethylene Polymers 0.000 description 1
- 238000003825 pressing Methods 0.000 description 1
- 238000010926 purge Methods 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 238000000527 sonication Methods 0.000 description 1
- 238000005507 spraying Methods 0.000 description 1
- 229910001220 stainless steel Inorganic materials 0.000 description 1
- 239000010935 stainless steel Substances 0.000 description 1
Images
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
- G01N1/2205—Devices for withdrawing samples in the gaseous state involving separation of sample components during sampling with filters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M15/00—Inhalators
- A61M15/009—Inhalators using medicine packages with incorporated spraying means, e.g. aerosol cans
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M15/00—Inhalators
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2202/00—Special media to be introduced, removed or treated
- A61M2202/06—Solids
- A61M2202/064—Powder
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2206/00—Characteristics of a physical parameter; associated device therefor
- A61M2206/10—Flow characteristics
- A61M2206/14—Static flow deviators in tubes disturbing laminar flow in tubes, e.g. archimedes screws
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2209/00—Ancillary equipment
- A61M2209/02—Equipment for testing the apparatus
-
- 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
-
- 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
- G01N2001/2285—Details of probe structures
-
- 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
- G01N1/24—Suction devices
- G01N2001/248—Evacuated containers
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- General Health & Medical Sciences (AREA)
- Biomedical Technology (AREA)
- General Physics & Mathematics (AREA)
- Pulmonology (AREA)
- Analytical Chemistry (AREA)
- Biochemistry (AREA)
- Physics & Mathematics (AREA)
- Molecular Biology (AREA)
- Immunology (AREA)
- Pathology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical & Material Sciences (AREA)
- Anesthesiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Hematology (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Sampling And Sample Adjustment (AREA)
- Investigating Or Analysing Biological Materials (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201462019228P | 2014-06-30 | 2014-06-30 | |
| US62/019,228 | 2014-06-30 | ||
| PCT/US2015/038658 WO2016004103A1 (en) | 2014-06-30 | 2015-06-30 | Sampling apparatus for determining the amount and uniformity of a delivered dose of drug related methods |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| BR112016030972A2 BR112016030972A2 (pt) | 2018-07-17 |
| BR112016030972B1 true BR112016030972B1 (pt) | 2020-12-15 |
Family
ID=54930177
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| BR112016030972-3A BR112016030972B1 (pt) | 2014-06-30 | 2015-06-30 | Aparelho de amostragem para a determinação da quantidade e da uniformidade de uma dose de medicamento fornecida e métodos correlatos |
Country Status (11)
| Country | Link |
|---|---|
| US (3) | US9360400B2 (https=) |
| EP (2) | EP3160521B1 (https=) |
| JP (2) | JP6564407B2 (https=) |
| CN (1) | CN106573082B (https=) |
| AU (1) | AU2015284195B2 (https=) |
| BR (1) | BR112016030972B1 (https=) |
| CA (1) | CA2953830C (https=) |
| DK (1) | DK3160521T3 (https=) |
| ES (1) | ES2952510T3 (https=) |
| IL (2) | IL249753B (https=) |
| WO (1) | WO2016004103A1 (https=) |
Families Citing this family (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106573082B (zh) * | 2014-06-30 | 2020-01-17 | 普罗沃锐斯科学有限公司 | 用于确定药物的递送剂量的量和均匀性的采样装置及相关方法 |
| CA3016890A1 (en) | 2016-03-09 | 2017-09-14 | Proveris Scientific Corporation | Methods for measuring dose content uniformity performance of inhaler and nasal devices |
| JP6268342B2 (ja) * | 2016-04-27 | 2018-01-31 | 株式会社ジェイテックコーポレーション | 大量細胞培養システム及びそれに用いる回転細胞培養装置 |
| ES2929335T3 (es) | 2016-05-27 | 2022-11-28 | Proveris Scient Corporation | Dispositivos para el uso de dispositivos de medicamento |
| EP3752019B1 (en) * | 2018-02-16 | 2024-06-12 | Zefon International, Inc. | Improved device for collecting particulate matter |
| TWI667463B (zh) * | 2018-03-21 | 2019-08-01 | 巨研科技股份有限公司 | 快篩管柱 |
| WO2020215028A1 (en) * | 2019-04-18 | 2020-10-22 | Jon Greenfield | Positive pressure inhaler for delivery of inhalable medication and methods for use |
| US12194229B2 (en) | 2019-07-24 | 2025-01-14 | Trudell Medical International Inc. | Portable holding chamber |
| USD1010101S1 (en) | 2020-09-18 | 2024-01-02 | Trudell Medical International | Holding chamber |
| CN116583316A (zh) | 2020-10-15 | 2023-08-11 | 普罗沃锐斯科学有限公司 | 用于吸入器测试的系统和方法 |
| US12227730B2 (en) * | 2020-11-18 | 2025-02-18 | Global Life Sciences Solutions Usa Llc | System and method for aseptic sampling and fluid addition |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| US3275744A (en) | 1962-10-01 | 1966-09-27 | Spraying Systems Co | Apparatus for spray analysis |
| US4004550A (en) | 1973-11-29 | 1977-01-25 | White Ronald D | Apparatus for preparing microscope slides |
| US4357670A (en) | 1979-03-02 | 1982-11-02 | E. Allman & Company Limited | Devices for testing spraying nozzles |
| US4415265A (en) | 1981-06-25 | 1983-11-15 | The United States Of America As Represented By The United States Department Of Energy | Method and apparatus for aerosol particle absorption spectroscopy |
| US4614300A (en) | 1982-04-19 | 1986-09-30 | E. I. Du Pont De Nemours And Company | Computerized spray machine |
| JPS60104205A (ja) | 1983-11-10 | 1985-06-08 | Nippon Denso Co Ltd | 噴射体の形状測定方法及びその装置 |
| JPS60112324U (ja) * | 1984-01-05 | 1985-07-30 | 三菱重工業株式会社 | 抽出装置 |
| JP2569303B2 (ja) | 1985-07-05 | 1997-01-08 | 日本電装株式会社 | 画像デ−タの累積加算を行う画像処理装置 |
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| CN106573082B (zh) | 2014-06-30 | 2020-01-17 | 普罗沃锐斯科学有限公司 | 用于确定药物的递送剂量的量和均匀性的采样装置及相关方法 |
| CA3016890A1 (en) | 2016-03-09 | 2017-09-14 | Proveris Scientific Corporation | Methods for measuring dose content uniformity performance of inhaler and nasal devices |
-
2015
- 2015-06-30 CN CN201580044394.3A patent/CN106573082B/zh active Active
- 2015-06-30 ES ES15814981T patent/ES2952510T3/es active Active
- 2015-06-30 BR BR112016030972-3A patent/BR112016030972B1/pt active IP Right Grant
- 2015-06-30 DK DK15814981.5T patent/DK3160521T3/da active
- 2015-06-30 WO PCT/US2015/038658 patent/WO2016004103A1/en not_active Ceased
- 2015-06-30 US US14/788,324 patent/US9360400B2/en active Active
- 2015-06-30 CA CA2953830A patent/CA2953830C/en active Active
- 2015-06-30 EP EP15814981.5A patent/EP3160521B1/en active Active
- 2015-06-30 JP JP2016576046A patent/JP6564407B2/ja active Active
- 2015-06-30 EP EP23177771.5A patent/EP4235142A3/en active Pending
- 2015-06-30 AU AU2015284195A patent/AU2015284195B2/en active Active
-
2016
- 2016-12-22 US US15/388,797 patent/US10473564B2/en active Active
- 2016-12-25 IL IL249753A patent/IL249753B/en active IP Right Grant
-
2019
- 2019-07-25 JP JP2019136543A patent/JP6858811B2/ja active Active
- 2019-10-02 US US16/591,159 patent/US11079305B2/en active Active
-
2020
- 2020-11-11 IL IL278640A patent/IL278640B/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| EP3160521B1 (en) | 2023-06-07 |
| AU2015284195A1 (en) | 2017-02-02 |
| US20150377749A1 (en) | 2015-12-31 |
| ES2952510T3 (es) | 2023-10-31 |
| US9360400B2 (en) | 2016-06-07 |
| WO2016004103A1 (en) | 2016-01-07 |
| EP3160521A4 (en) | 2018-05-16 |
| IL249753A0 (en) | 2017-02-28 |
| IL278640B (en) | 2022-03-01 |
| BR112016030972A2 (pt) | 2018-07-17 |
| AU2015284195B2 (en) | 2019-01-24 |
| JP6564407B2 (ja) | 2019-08-21 |
| JP2017523405A (ja) | 2017-08-17 |
| CN106573082A (zh) | 2017-04-19 |
| US10473564B2 (en) | 2019-11-12 |
| IL249753B (en) | 2020-11-30 |
| CA2953830C (en) | 2023-01-03 |
| DK3160521T3 (da) | 2023-08-28 |
| CN106573082B (zh) | 2020-01-17 |
| JP2020008585A (ja) | 2020-01-16 |
| EP4235142A3 (en) | 2023-11-22 |
| CA2953830A1 (en) | 2016-01-07 |
| US20170307483A1 (en) | 2017-10-26 |
| EP3160521A1 (en) | 2017-05-03 |
| JP6858811B2 (ja) | 2021-04-14 |
| EP4235142A2 (en) | 2023-08-30 |
| US11079305B2 (en) | 2021-08-03 |
| US20200080917A1 (en) | 2020-03-12 |
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