JP5752679B2 - 乾燥粉末吸入器のための回転カセットシステム - Google Patents
乾燥粉末吸入器のための回転カセットシステム Download PDFInfo
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- JP5752679B2 JP5752679B2 JP2012512067A JP2012512067A JP5752679B2 JP 5752679 B2 JP5752679 B2 JP 5752679B2 JP 2012512067 A JP2012512067 A JP 2012512067A JP 2012512067 A JP2012512067 A JP 2012512067A JP 5752679 B2 JP5752679 B2 JP 5752679B2
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- 239000000843 powder Substances 0.000 title claims description 21
- 239000003814 drug Substances 0.000 claims description 56
- 229940079593 drug Drugs 0.000 claims description 51
- 230000007246 mechanism Effects 0.000 claims description 6
- 239000007788 liquid Substances 0.000 claims description 2
- 230000029058 respiratory gaseous exchange Effects 0.000 claims description 2
- 239000002245 particle Substances 0.000 description 13
- 239000002775 capsule Substances 0.000 description 8
- 229940112141 dry powder inhaler Drugs 0.000 description 7
- 238000005553 drilling Methods 0.000 description 5
- 239000013543 active substance Substances 0.000 description 4
- 239000003795 chemical substances by application Substances 0.000 description 3
- 210000004072 lung Anatomy 0.000 description 3
- 239000003570 air Substances 0.000 description 2
- 230000008901 benefit Effects 0.000 description 2
- 230000008859 change Effects 0.000 description 2
- 238000010586 diagram Methods 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- 230000006872 improvement Effects 0.000 description 2
- 238000000034 method Methods 0.000 description 2
- 239000000546 pharmaceutical excipient Substances 0.000 description 2
- 210000002345 respiratory system Anatomy 0.000 description 2
- 208000023504 respiratory system disease Diseases 0.000 description 2
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 description 1
- 230000009471 action Effects 0.000 description 1
- 239000000654 additive Substances 0.000 description 1
- 230000000996 additive effect Effects 0.000 description 1
- 239000000853 adhesive Substances 0.000 description 1
- 230000001070 adhesive effect Effects 0.000 description 1
- 230000002411 adverse Effects 0.000 description 1
- NDAUXUAQIAJITI-UHFFFAOYSA-N albuterol Chemical compound CC(C)(C)NCC(O)C1=CC=C(O)C(CO)=C1 NDAUXUAQIAJITI-UHFFFAOYSA-N 0.000 description 1
- 239000012080 ambient air Substances 0.000 description 1
- 208000006673 asthma Diseases 0.000 description 1
- 239000004020 conductor Substances 0.000 description 1
- 238000010276 construction Methods 0.000 description 1
- 238000001816 cooling Methods 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
- 230000008021 deposition Effects 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 230000005611 electricity Effects 0.000 description 1
- 230000007613 environmental effect Effects 0.000 description 1
- 239000010419 fine particle Substances 0.000 description 1
- 238000010438 heat treatment Methods 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 230000003434 inspiratory effect Effects 0.000 description 1
- 239000008101 lactose Substances 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 239000012254 powdered material Substances 0.000 description 1
- 238000003825 pressing Methods 0.000 description 1
- 230000008569 process Effects 0.000 description 1
- 238000004080 punching Methods 0.000 description 1
- 229960002052 salbutamol Drugs 0.000 description 1
- 230000003068 static effect Effects 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 230000008961 swelling Effects 0.000 description 1
- 229940124597 therapeutic agent Drugs 0.000 description 1
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D83/00—Containers or packages with special means for dispensing contents
- B65D83/06—Containers or packages with special means for dispensing contents for dispensing powdered or granular material
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- A61M15/00—Inhalators
- A61M15/0028—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
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- A61M15/00—Inhalators
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- A61M15/00—Inhalators
- A61M15/0001—Details of inhalators; Constructional features thereof
- A61M15/0005—Details of inhalators; Constructional features thereof with means for agitating the medicament
- A61M15/001—Details of inhalators; Constructional features thereof with means for agitating the medicament using ultrasonic means
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- 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
- A61M15/0001—Details of inhalators; Constructional features thereof
- A61M15/0021—Mouthpieces therefor
- A61M15/0025—Mouthpieces therefor with caps
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- 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
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- A61M15/0033—Details of the piercing or cutting means
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- A61M15/00—Inhalators
- A61M15/0028—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
- A61M15/003—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using capsules, e.g. to be perforated or broken-up
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- A61M15/00—Inhalators
- A61M15/0028—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
- A61M15/0045—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using multiple prepacked dosages on a same carrier, e.g. blisters
- A61M15/0046—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using multiple prepacked dosages on a same carrier, e.g. blisters characterized by the type of carrier
- A61M15/005—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using multiple prepacked dosages on a same carrier, e.g. blisters characterized by the type of carrier the dosages being arranged on a cylindrical surface
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- A—HUMAN NECESSITIES
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- A61M15/00—Inhalators
- A61M15/0028—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
- A61M15/0063—Storages for pre-packed dosages
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- 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
- A61M15/0065—Inhalators with dosage or measuring devices
- A61M15/0068—Indicating or counting the number of dispensed doses or of remaining doses
- A61M15/007—Mechanical counters
- A61M15/0071—Mechanical counters having a display or indicator
- A61M15/0075—Mechanical counters having a display or indicator on a disc
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- A—HUMAN NECESSITIES
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- 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
- A61M15/0065—Inhalators with dosage or measuring devices
- A61M15/0068—Indicating or counting the number of dispensed doses or of remaining doses
- A61M15/0083—Timers
-
- 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
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
- A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
- A61M2016/0015—Accessories therefor, e.g. sensors, vibrators, negative pressure inhalation detectors
- A61M2016/0018—Accessories therefor, e.g. sensors, vibrators, negative pressure inhalation detectors electrical
- A61M2016/0024—Accessories therefor, e.g. sensors, vibrators, negative pressure inhalation detectors electrical with an on-off output signal, e.g. from a switch
-
- 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
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- 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
- A61M2205/00—General characteristics of the apparatus
- A61M2205/02—General characteristics of the apparatus characterised by a particular materials
- A61M2205/0272—Electro-active or magneto-active materials
- A61M2205/0294—Piezoelectric materials
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- 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
- A61M2205/00—General characteristics of the apparatus
- A61M2205/50—General characteristics of the apparatus with microprocessors or computers
-
- 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
- A61M2205/00—General characteristics of the apparatus
- A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
- A61M2205/587—Lighting arrangements
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- 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
- A61M2205/00—General characteristics of the apparatus
- A61M2205/82—Internal energy supply devices
- A61M2205/8206—Internal energy supply devices battery-operated
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Hematology (AREA)
- Pulmonology (AREA)
- Animal Behavior & Ethology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Public Health (AREA)
- Anesthesiology (AREA)
- Biophysics (AREA)
- Mechanical Engineering (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Medicinal Preparation (AREA)
- Basic Packing Technique (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Peptides Or Proteins (AREA)
- Moulding By Coating Moulds (AREA)
- Materials For Medical Uses (AREA)
Description
(1)寸法が小さい粒子は、その製造及び保管中に粒子自体が静電帯電し得る。これが粒子を集塊又は凝集させて、有効寸法が5ミクロンより大きい粒子のクラスタを生じさせることがある。すると、これらの大きいクラスタが肺の深部に到達する可能性が低減する。そしてこれにより、包装された薬剤が患者に吸収されるように利用され得る確率が低下する。
(2)患者に投与されるべき活性薬剤の量は、約10マイクログラムであり得る。例えば、アルブテロール(喘息に使用する薬)の場合、通常、25マイクログラム〜50マイクログラムである。現在製造されている機器は、ミリグラム量範囲では一定分量の薬剤を許容精度で効率的に投与することができる。従って、活性薬剤を賦形剤又は膨張剤(例えばラクトース)と混合することが標準的に行われている。また、この添加剤は、薬剤を「流れ易く」(“easy to flow”)する。この賦形剤は担体とも称される。なぜなら、薬剤粒子がこれらの粒子に静電気又は化学接着剤により付着もするからである。これらの担体粒子の寸法は薬剤粒子の寸法よりも非常に大きい。乾燥粉末吸入器の、薬剤を担体から分離させる性能は、設計の有効性における重要な性能パラメータである。
(3)5ミクロンより大きい寸法を有する活性薬剤粒子は、口又は喉に堆積するであろう。これは、別のレベルの不確実性をもたらす。なぜなら、これらの位置における薬剤の生物学的利用能及び吸収性は、肺での堆積の場合と異なるからである。乾燥粉末吸入器は、これらの位置に堆積される薬剤を、薬剤の生物学的利用能に関する不確実性を低減するために最小限にする必要がある。
2 マウスピース
3 カバー
4 カバー
5 シャーシ
10 カムディスク
11 レバーアーム
11A ボタン領域
12 ラチェット歯
13 カートリッジインデックス連結部
14 バイブレータ連結部
15 穿孔連結部
18 ブリスタ輸送連結部
20 カートリッジ
21 ブリスタパック
22 ブリスタカルーセル
23 上部ハウジング
24 下部ハウジング
25 ドーズカウンタ
26 解除タブ
27 ブリスタキャリア
28 ブリスタ輸送スレッド
30 フローチャネル
32 穴
40 振動組立体
41 圧電トランスデューサ
42 ばね
43 スロット
50 穿孔組立体
51 ピアサ
61 フローセンサ
82 プリント回路基板組立体
Claims (12)
- 薬剤を収容しているブリスタパックを収容するためのハウジングと、
前記ハウジング内の振動要素と、
前記ブリスタパックと連通するフローチャネルを画成しているチャンバと、
前記振動要素を前記ブリスタパックに直接付勢し、前記ブリスタパックを適切な位置に保持するためのばねとを備え、
前記ブリスタパックが、前記振動要素に隣接した位置にて前記チャンバによりクランプされる薬剤吸入器。 - 前記ブリスタパックが第1の面及び第2の面を含み、前記第2の面が前記振動要素と直接接触して配置される請求項1に記載の吸入器。
- 前記ブリスタパックが第1の面及び第2の面を含み、前記第1の面がクラウン状部を有し、且つ、前記第1の面が前記チャンバと少なくとも部分的に直接係合される請求項1に記載の吸入器。
- 前記チャンバが、さらに、前記ブリスタパックの前記クラウン状部を少なくとも部分的に取り囲む、前記ブリスタパックをクランプする面を含み、前記ブリスタパッククランプ面が、前記ブリスタパックの、前記クラウン状部の底部よりも前記クラウン状部の頂部に近い前記第1の面と直接係合する請求項3に記載の吸入器。
- 以下の特徴、すなわち、
(a)前記振動要素が圧電トランスデューサである、
(b)前記薬剤が乾燥粉末又は液体を含む、
(c)さらに、患者の呼吸を検知するためのフローセンサ、及び、前記振動要素を作動させるための電気回路を備える、
(d)さらに、バッテリ及びプリント回路基板を備える、
(e)さらに、前記ハウジングに取り付けられたマウスピースを備える、
(f)さらに、前記ハウジング内に収容された穿孔要素を備える、及び、
(g)さらに、バッテリ、及び、前記フローセンサから信号を受信して前記振動要素の作動を制御するマイクロプロセッサを備える、のうち一つ以上を特徴とする請求項1乃至4のいずれかに記載の吸入器。 - 前記ハウジング内に保持された、各々が特定量の薬剤を収容している個々に場所が特定可能な複数のブリスタパックと、
選択されたブリスタパックを、収容されている位置と分与位置との間で移動させる機構とをさらに含む請求項1乃至5のいずれかに記載の吸入器。 - 前記複数のブリスタパックがカセット上に保持され、且つ、前記カセットが、前記ハウジング内に回転可能に取り付けられている請求項6に記載の吸入器。
- 前記複数の個々のブリスタパックのうちの1つの、前記個々のブリスタパックが前記振動要素と前記穿孔要素との間でクランプされる前記分与位置への移動を調整する、回転可能に取り付けられたディスクをさらに含む請求項5に記載の吸入器。
- 前記ディスクが、さらに、前記穿孔要素が前記ブリスタパックを前記分与位置にて穿孔する前記穿孔要素の移動、及び/又は、前記振動要素が前記分与位置にて前記ブリスタパックと直接接触する前記振動要素の移動を調整する請求項8に記載の吸入器。
- 前記ディスクの回転が、前記ハウジングから突出しているレバーアームを患者が用いることにより制御される請求項8に記載の吸入器。
- 前記マウスピースを覆うための、前記ハウジングに枢動可能に連結されたカバーをさらに備え、且つ、前記カバーを前記回転ディスクに連結する連結部をさらに備え、前記ディスクの枢動運動が前記カバーを引き込むように機能する請求項5に記載の吸入器。
- 前記複数の個々のブリスタパックが円形面に配置され、前記ブリスタパックの面が前記カートリッジの面に対してほぼ垂直であり、且つ、前記ディスクが、さらに、前記回転可能に取り付けられたカセットの移動を調整する請求項6乃至11のいずれかに記載の吸入器。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US18039609P | 2009-05-21 | 2009-05-21 | |
US61/180,396 | 2009-05-21 | ||
PCT/US2010/035817 WO2010135672A1 (en) | 2009-05-21 | 2010-05-21 | Rotary cassette system for dry powder inhaler |
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JP2014114763A Division JP5804583B2 (ja) | 2009-05-21 | 2014-06-03 | 乾燥粉末吸入器 |
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JP2012527329A JP2012527329A (ja) | 2012-11-08 |
JP5752679B2 true JP5752679B2 (ja) | 2015-07-22 |
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JP2012512067A Expired - Fee Related JP5752679B2 (ja) | 2009-05-21 | 2010-05-21 | 乾燥粉末吸入器のための回転カセットシステム |
JP2014114763A Expired - Fee Related JP5804583B2 (ja) | 2009-05-21 | 2014-06-03 | 乾燥粉末吸入器 |
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EP (1) | EP2432536B1 (ja) |
JP (2) | JP5752679B2 (ja) |
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CN (1) | CN102438685B (ja) |
AU (1) | AU2010249402B2 (ja) |
BR (1) | BRPI1011194A2 (ja) |
CA (1) | CA2762819C (ja) |
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MY (1) | MY159925A (ja) |
NZ (1) | NZ596564A (ja) |
PE (1) | PE20121146A1 (ja) |
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EP2432536A4 (en) | 2015-12-23 |
AU2010249402A1 (en) | 2011-12-15 |
CN102438685B (zh) | 2014-07-02 |
CA2762819A1 (en) | 2010-11-25 |
EP2432536A1 (en) | 2012-03-28 |
JP2014193390A (ja) | 2014-10-09 |
JP2012527329A (ja) | 2012-11-08 |
PE20121146A1 (es) | 2012-08-27 |
ES2682996T3 (es) | 2018-09-24 |
CA2762819C (en) | 2016-12-20 |
AU2010249402B2 (en) | 2014-08-21 |
US8763606B2 (en) | 2014-07-01 |
KR20120036873A (ko) | 2012-04-18 |
EA026215B1 (ru) | 2017-03-31 |
KR101585707B1 (ko) | 2016-01-14 |
JP5804583B2 (ja) | 2015-11-04 |
WO2010135672A1 (en) | 2010-11-25 |
NZ596564A (en) | 2012-11-30 |
EA201171452A1 (ru) | 2012-05-30 |
CL2011002900A1 (es) | 2012-09-07 |
US20100294278A1 (en) | 2010-11-25 |
BRPI1011194A2 (pt) | 2016-12-27 |
MY159925A (en) | 2017-02-15 |
MX2011012265A (es) | 2012-04-11 |
EP2432536B1 (en) | 2018-07-04 |
CN102438685A (zh) | 2012-05-02 |
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