JP2018527044A - 医薬品の製造のための製造ライン及びそのような製造ラインを含む製造設備 - Google Patents
医薬品の製造のための製造ライン及びそのような製造ラインを含む製造設備 Download PDFInfo
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- A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
- A61J3/07—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
- B29C48/25—Component parts, details or accessories; Auxiliary operations
- B29C48/36—Means for plasticising or homogenising the moulding material or forcing it through the nozzle or die
- B29C48/395—Means for plasticising or homogenising the moulding material or forcing it through the nozzle or die using screws surrounded by a cooperating barrel, e.g. single screw extruders
- B29C48/40—Means for plasticising or homogenising the moulding material or forcing it through the nozzle or die using screws surrounded by a cooperating barrel, e.g. single screw extruders using two or more parallel screws or at least two parallel non-intermeshing screws, e.g. twin screw extruders
- B29C48/402—Means for plasticising or homogenising the moulding material or forcing it through the nozzle or die using screws surrounded by a cooperating barrel, e.g. single screw extruders using two or more parallel screws or at least two parallel non-intermeshing screws, e.g. twin screw extruders the screws having intermeshing parts
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
- A61J3/06—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of pills, lozenges or dragees
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
- A61J3/08—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of suppositories or sticks
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
- B29C48/022—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor characterised by the choice of material
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
- B29C48/14—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor characterised by the particular extruding conditions, e.g. in a modified atmosphere or by using vibration
- B29C48/141—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor characterised by the particular extruding conditions, e.g. in a modified atmosphere or by using vibration extruding in a clean room
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
- B29C48/25—Component parts, details or accessories; Auxiliary operations
- B29C48/36—Means for plasticising or homogenising the moulding material or forcing it through the nozzle or die
- B29C48/395—Means for plasticising or homogenising the moulding material or forcing it through the nozzle or die using screws surrounded by a cooperating barrel, e.g. single screw extruders
- B29C48/40—Means for plasticising or homogenising the moulding material or forcing it through the nozzle or die using screws surrounded by a cooperating barrel, e.g. single screw extruders using two or more parallel screws or at least two parallel non-intermeshing screws, e.g. twin screw extruders
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
- B29C48/25—Component parts, details or accessories; Auxiliary operations
- B29C48/88—Thermal treatment of the stream of extruded material, e.g. cooling
- B29C48/911—Cooling
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
- B29C48/25—Component parts, details or accessories; Auxiliary operations
- B29C48/92—Measuring, controlling or regulating
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J2200/00—General characteristics or adaptations
- A61J2200/20—Extrusion means, e.g. for producing pharmaceutical forms
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J2200/00—General characteristics or adaptations
- A61J2200/40—Heating or cooling means; Combinations thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J2200/00—General characteristics or adaptations
- A61J2200/40—Heating or cooling means; Combinations thereof
- A61J2200/42—Heating means
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J2200/00—General characteristics or adaptations
- A61J2200/40—Heating or cooling means; Combinations thereof
- A61J2200/44—Cooling means
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C2791/00—Shaping characteristics in general
- B29C2791/004—Shaping under special conditions
- B29C2791/005—Using a particular environment, e.g. sterile fluids other than air
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
- B29C48/14—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor characterised by the particular extruding conditions, e.g. in a modified atmosphere or by using vibration
- B29C48/142—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor characterised by the particular extruding conditions, e.g. in a modified atmosphere or by using vibration using force fields, e.g. gravity or electrical fields
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- Animal Behavior & Ethology (AREA)
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- Extrusion Moulding Of Plastics Or The Like (AREA)
- Medicines Containing Plant Substances (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Medicinal Preparation (AREA)
- Glanulating (AREA)
Abstract
Description
−製造ラインが、押出機を制御するための遠隔制御端末と、押出機と制御端末との間でデータを交換するための無線通信装置とを含む。
−冷却部材が、押出物のための経路を画定し、経路周りで冷却流体を案内するための少なくとも1つの案内流路を有するシースを含む。
−冷却部材がバレルの下に位置している。
−経路が実質的に鉛直に配向されている。
−製造ラインが、押出機を支持するフレームと、実質的に鉛直方向に沿ってバレルをフレームに対して移動させるための移動機構とを含む。
−スクリュー又は各スクリューが、特定の軸に沿って伸長されており、押出機が、その軸回りにスクリュー又は各スクリューを回転させるための駆動装置を含み、駆動装置及びスクリュー又は各スクリューが、駆動装置にスクリュー又は各スクリューを可逆的に固定するための相補的な協働部材を含み、スクリュー又は各スクリューが固定された場合に、前記協働部材が、その軸に沿って前記スクリューがバレルに対して並進移動することを防止するのに適している。
−製造設備が、活性成分又は各活性成分と、賦形剤又は各賦形剤とを含む粉末化混合物を押出機に供給するための供給装置を含み、前記供給装置が、クリーンルームの外側に設置された、粉末化混合物を収容するための開口を含む。
−製造設備が、製造ラインを制御するための制御システムを含み、前記制御システムが、クリーンルームの外側に設置されている。
Claims (13)
- 少なくとも1つの活性成分を含む医薬品を製造するための製造ライン(12)であり、前記製造ライン(12)が、前記活性成分と、前記活性成分の封入マトリックスを形成することが意図された少なくとも1つの賦形剤とから押出物を製造するための押出機(20)と、前記押出機(20)の出口で前記押出物を冷却するための冷却部材(24)とを含み、前記押出機(20)が、バレル(30)と、前記バレル(30)内に収容されており、かつ、前記活性成分又は各活性成分を前記賦形剤又は各賦形剤と混合するために相互に貫入している少なくとも2つの平行なスクリュー(32)とを含む製造ライン(12)であって、
前記バレル(30)が実質的に鉛直に配向されていることを特徴とする、製造ライン(12)。 - 前記製造ライン(12)により占有された設置面積が0.5m2未満である、請求項1に記載の製造ライン(12)。
- 前記押出機(20)を制御するための遠隔制御端末(92)と、前記押出機(20)と前記制御端子(92)との間でデータを交換するための無線通信装置(94)とを含む、請求項1又は2に記載の製造ライン(12)。
- 前記冷却部材(24)が、前記押出物のための経路(66)を画定し、かつ、前記経路(66)の周りで冷却流体を案内するための少なくとも1つの案内流路(68)を有するシース(64)を含む、請求項1〜3のいずれか1項に記載の製造ライン(12)。
- 前記冷却部材(24)が前記バレル(30)の下に位置している、請求項4に記載の製造ライン(12)。
- 前記経路(66)が実質的に鉛直に配向されている、請求項4又は5に記載の製造ライン(12)。
- 前記押出機(20)を支持するフレーム(28)と、実質的に鉛直方向に沿って前記バレル(30)を前記フレーム(28)に対して移動させるための移動機構(70)とを含む、請求項1〜6のいずれか1項に記載の製造ライン(12)。
- 各スクリュー(32)が特定の軸に沿って伸長されており、前記押出機(20)が、前記軸の周りに各スクリュー(32)を回転させるための駆動装置(33)を含み、前記駆動装置(33)及び各スクリュー(32)が、前記駆動装置(33)に各スクリュー(32)を可逆的に固定するための相補的な協働部材(49、54)を含み、各スクリュー(32)が固定された場合に、前記協働部材(49、54)が、前記軸に沿って前記スクリュー(32)が前記バレル(30)に対して並進運動することを防止するのに適している、請求項1〜7のいずれか1項に記載の製造ライン(12)。
- 少なくとも1つの活性成分を含む医薬品を製造するための製造設備(10)であり、前記医薬品が製造されるクリーンルーム(14)を含む製造設備(10)であって、前記医薬品を製造するための、請求項1〜8のいずれか1項に記載の製造ライン(12)を含み、前記押出機(20)が前記クリーンルーム(14)内に設置されていることを特徴とする、製造設備(10)。
- 前記活性成分又は各活性成分と、前記賦形剤又は各賦形剤とを含む粉末化混合物を前記押出機(20)に供給するための供給装置(16)を含み、前記供給装置(16)が、前記クリーンルーム(14)の外側に設置された、前記粉末化混合物を収容するための開口(86)を含む、請求項9に記載の製造設備(10)。
- 前記製造ライン(12)を制御するための制御システム(18)を含み、前記制御システム(18)が前記クリーンルーム(14)の外側に設置されている、請求項9又は10に記載の製造設備(10)。
- 少なくとも1つの活性成分を含む医薬品が、請求項1〜8のいずれか1項に記載の製造ラインを使用して製造される、医薬品を製造するための方法。
- 前記活性成分又は各活性成分を含む粉末化混合物を前記製造ライン(12)に供給する工程と、前記押出機(20)中で前記粉末化混合物の成分を溶かす工程と、前記スクリュー(32)の作用の下でこれらの成分を混合する工程と、前記スクリュー(32)を使用して、これらの混合成分を前記押出機(20)の出口に向けて駆動させる工程であって、前記混合成分が押出物の形態で前記押出機(20)を出る工程と、前記冷却部材(24)を使用して前記押出物を冷却する工程とを含む、請求項12に記載の医薬品を製造するための方法。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
FR1555783A FR3037789A1 (fr) | 2015-06-23 | 2015-06-23 | Ligne de production pour la production de medicaments, et installation de production comprenant une telle ligne de production |
FR1555783 | 2015-06-23 | ||
PCT/EP2016/064539 WO2016207279A1 (fr) | 2015-06-23 | 2016-06-23 | Ligne de production pour la production de médicaments, et installation de production comprenant une telle ligne de production |
Publications (1)
Publication Number | Publication Date |
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JP2018527044A true JP2018527044A (ja) | 2018-09-20 |
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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JP2017567233A Pending JP2018527044A (ja) | 2015-06-23 | 2016-06-23 | 医薬品の製造のための製造ライン及びそのような製造ラインを含む製造設備 |
Country Status (17)
Country | Link |
---|---|
US (1) | US10945923B2 (ja) |
EP (1) | EP3313353B1 (ja) |
JP (1) | JP2018527044A (ja) |
KR (1) | KR20180055760A (ja) |
CN (1) | CN108200765A (ja) |
CA (1) | CA2987913C (ja) |
CR (1) | CR20170585A (ja) |
DK (1) | DK3313353T3 (ja) |
ES (1) | ES2740198T3 (ja) |
FR (1) | FR3037789A1 (ja) |
HR (1) | HRP20191394T1 (ja) |
HU (1) | HUE045470T2 (ja) |
IL (1) | IL256429B (ja) |
MX (1) | MX2017016698A (ja) |
PL (1) | PL3313353T3 (ja) |
PT (1) | PT3313353T (ja) |
WO (1) | WO2016207279A1 (ja) |
Families Citing this family (1)
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CA3100548A1 (en) * | 2018-06-11 | 2019-12-19 | Continuus Pharmaceuticals, Inc. | System for molding and coating of pharmaceutical tablets |
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-
2015
- 2015-06-23 FR FR1555783A patent/FR3037789A1/fr not_active Withdrawn
-
2016
- 2016-06-23 WO PCT/EP2016/064539 patent/WO2016207279A1/fr active Application Filing
- 2016-06-23 EP EP16733396.2A patent/EP3313353B1/fr active Active
- 2016-06-23 MX MX2017016698A patent/MX2017016698A/es active IP Right Grant
- 2016-06-23 PT PT16733396T patent/PT3313353T/pt unknown
- 2016-06-23 PL PL16733396T patent/PL3313353T3/pl unknown
- 2016-06-23 DK DK16733396.2T patent/DK3313353T3/da active
- 2016-06-23 CA CA2987913A patent/CA2987913C/fr active Active
- 2016-06-23 HU HUE16733396A patent/HUE045470T2/hu unknown
- 2016-06-23 KR KR1020177037103A patent/KR20180055760A/ko not_active Application Discontinuation
- 2016-06-23 JP JP2017567233A patent/JP2018527044A/ja active Pending
- 2016-06-23 ES ES16733396T patent/ES2740198T3/es active Active
- 2016-06-23 CN CN201680036251.2A patent/CN108200765A/zh active Pending
- 2016-06-23 CR CR20170585A patent/CR20170585A/es unknown
- 2016-06-23 US US15/738,401 patent/US10945923B2/en active Active
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2017
- 2017-12-19 IL IL256429A patent/IL256429B/en active IP Right Grant
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Publication number | Publication date |
---|---|
IL256429A (en) | 2018-02-28 |
US20180185244A1 (en) | 2018-07-05 |
WO2016207279A1 (fr) | 2016-12-29 |
HRP20191394T1 (hr) | 2019-11-01 |
FR3037789A1 (fr) | 2016-12-30 |
EP3313353A1 (fr) | 2018-05-02 |
KR20180055760A (ko) | 2018-05-25 |
ES2740198T3 (es) | 2020-02-05 |
IL256429B (en) | 2021-01-31 |
HUE045470T2 (hu) | 2019-12-30 |
DK3313353T3 (da) | 2019-08-12 |
MX2017016698A (es) | 2018-11-09 |
PT3313353T (pt) | 2019-08-19 |
US10945923B2 (en) | 2021-03-16 |
CA2987913C (fr) | 2023-10-17 |
PL3313353T3 (pl) | 2019-11-29 |
CR20170585A (es) | 2018-08-06 |
CN108200765A (zh) | 2018-06-22 |
CA2987913A1 (fr) | 2016-12-29 |
EP3313353B1 (fr) | 2019-05-01 |
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