JP2020500643A - カプセルシェル応力を軽減してひび割れや損傷の可能性を減少させる方法 - Google Patents
カプセルシェル応力を軽減してひび割れや損傷の可能性を減少させる方法 Download PDFInfo
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- JP2020500643A JP2020500643A JP2019531045A JP2019531045A JP2020500643A JP 2020500643 A JP2020500643 A JP 2020500643A JP 2019531045 A JP2019531045 A JP 2019531045A JP 2019531045 A JP2019531045 A JP 2019531045A JP 2020500643 A JP2020500643 A JP 2020500643A
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- 238000005336 cracking Methods 0.000 title abstract description 17
- 238000000034 method Methods 0.000 claims abstract description 76
- 238000010438 heat treatment Methods 0.000 claims abstract description 46
- 238000002844 melting Methods 0.000 claims abstract description 30
- 230000008018 melting Effects 0.000 claims abstract description 30
- 239000007902 hard capsule Substances 0.000 claims abstract description 22
- 230000009477 glass transition Effects 0.000 claims abstract description 17
- 239000007901 soft capsule Substances 0.000 claims abstract description 17
- 238000001035 drying Methods 0.000 claims description 28
- 238000004519 manufacturing process Methods 0.000 abstract description 22
- 238000010586 diagram Methods 0.000 abstract description 2
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- 239000004014 plasticizer Substances 0.000 description 20
- 108010010803 Gelatin Proteins 0.000 description 13
- 229920000159 gelatin Polymers 0.000 description 13
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- 235000019322 gelatine Nutrition 0.000 description 13
- 235000011852 gelatine desserts Nutrition 0.000 description 13
- 229920000642 polymer Polymers 0.000 description 12
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 10
- 239000007887 hard shell capsule Substances 0.000 description 10
- 150000001875 compounds Chemical class 0.000 description 8
- 230000015572 biosynthetic process Effects 0.000 description 7
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- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 6
- 230000002411 adverse Effects 0.000 description 5
- 230000008901 benefit Effects 0.000 description 5
- 235000011187 glycerol Nutrition 0.000 description 5
- 230000008569 process Effects 0.000 description 5
- 238000007789 sealing Methods 0.000 description 5
- 238000007796 conventional method Methods 0.000 description 4
- 238000007598 dipping method Methods 0.000 description 4
- 230000000694 effects Effects 0.000 description 4
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- 238000012360 testing method Methods 0.000 description 4
- 230000013011 mating Effects 0.000 description 3
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 2
- 238000001816 cooling Methods 0.000 description 2
- 238000002474 experimental method Methods 0.000 description 2
- 238000009863 impact test Methods 0.000 description 2
- 238000003860 storage Methods 0.000 description 2
- 230000001154 acute effect Effects 0.000 description 1
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- 238000004873 anchoring Methods 0.000 description 1
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- 230000009286 beneficial effect Effects 0.000 description 1
- 239000007963 capsule composition Substances 0.000 description 1
- 238000005266 casting Methods 0.000 description 1
- 239000002131 composite material Substances 0.000 description 1
- 238000013461 design Methods 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 239000008393 encapsulating agent Substances 0.000 description 1
- 239000003623 enhancer Substances 0.000 description 1
- 238000011156 evaluation Methods 0.000 description 1
- 238000005429 filling process Methods 0.000 description 1
- 229920005570 flexible polymer Polymers 0.000 description 1
- 239000006260 foam Substances 0.000 description 1
- 230000004927 fusion Effects 0.000 description 1
- 239000000499 gel Substances 0.000 description 1
- 239000003349 gelling agent Substances 0.000 description 1
- 238000009413 insulation Methods 0.000 description 1
- 238000005304 joining Methods 0.000 description 1
- 230000009191 jumping Effects 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 239000008177 pharmaceutical agent Substances 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 230000002028 premature Effects 0.000 description 1
- 230000009467 reduction Effects 0.000 description 1
- 230000004044 response Effects 0.000 description 1
- 230000000717 retained effect Effects 0.000 description 1
- 230000002269 spontaneous effect Effects 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 238000012546 transfer Methods 0.000 description 1
- 230000007704 transition Effects 0.000 description 1
- 238000005303 weighing Methods 0.000 description 1
Images
Classifications
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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
- A61J3/07—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
- A61J3/071—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 into the form of telescopically engaged two-piece capsules
- A61J3/077—Manufacturing capsule shells
-
- 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
- A61J3/07—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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F26—DRYING
- F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
- F26B11/00—Machines or apparatus for drying solid materials or objects with movement which is non-progressive
- F26B11/02—Machines or apparatus for drying solid materials or objects with movement which is non-progressive in moving drums or other mainly-closed receptacles
- F26B11/04—Machines or apparatus for drying solid materials or objects with movement which is non-progressive in moving drums or other mainly-closed receptacles rotating about a horizontal or slightly-inclined axis
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F26—DRYING
- F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
- F26B21/00—Arrangements or duct systems, e.g. in combination with pallet boxes, for supplying and controlling air or gases for drying solid materials or objects
- F26B21/004—Nozzle assemblies; Air knives; Air distributors; Blow boxes
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F26—DRYING
- F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
- F26B21/00—Arrangements or duct systems, e.g. in combination with pallet boxes, for supplying and controlling air or gases for drying solid materials or objects
- F26B21/02—Circulating air or gases in closed cycles, e.g. wholly within the drying enclosure
- F26B21/04—Circulating air or gases in closed cycles, e.g. wholly within the drying enclosure partly outside the drying enclosure
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F26—DRYING
- F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
- F26B21/00—Arrangements or duct systems, e.g. in combination with pallet boxes, for supplying and controlling air or gases for drying solid materials or objects
- F26B21/06—Controlling, e.g. regulating, parameters of gas supply
- F26B21/08—Humidity
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F26—DRYING
- F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
- F26B21/00—Arrangements or duct systems, e.g. in combination with pallet boxes, for supplying and controlling air or gases for drying solid materials or objects
- F26B21/06—Controlling, e.g. regulating, parameters of gas supply
- F26B21/10—Temperature; Pressure
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F26—DRYING
- F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
- F26B21/00—Arrangements or duct systems, e.g. in combination with pallet boxes, for supplying and controlling air or gases for drying solid materials or objects
- F26B21/06—Controlling, e.g. regulating, parameters of gas supply
- F26B21/12—Velocity of flow; Quantity of flow, e.g. by varying fan speed, by modifying cross flow area
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F26—DRYING
- F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
- F26B3/00—Drying solid materials or objects by processes involving the application of heat
- F26B3/02—Drying solid materials or objects by processes involving the application of heat by convection, i.e. heat being conveyed from a heat source to the materials or objects to be dried by a gas or vapour, e.g. air
- F26B3/06—Drying solid materials or objects by processes involving the application of heat by convection, i.e. heat being conveyed from a heat source to the materials or objects to be dried by a gas or vapour, e.g. air the gas or vapour flowing through the materials or objects to be dried
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4816—Wall or shell material
- A61K9/4825—Proteins, e.g. gelatin
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F26—DRYING
- F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
- F26B3/00—Drying solid materials or objects by processes involving the application of heat
- F26B3/02—Drying solid materials or objects by processes involving the application of heat by convection, i.e. heat being conveyed from a heat source to the materials or objects to be dried by a gas or vapour, e.g. air
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S53/00—Package making
- Y10S53/90—Capsules
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- Engineering & Computer Science (AREA)
- Health & Medical Sciences (AREA)
- Mechanical Engineering (AREA)
- General Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Chemical & Material Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Manufacturing & Machinery (AREA)
- Microbiology (AREA)
- Epidemiology (AREA)
- Drying Of Solid Materials (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Manufacturing Of Micro-Capsules (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Disintegrating Or Milling (AREA)
Abstract
Description
ソフトカプセルの硬度と衝撃反応に及ぼす熱処理の影響を調べた。対照実験のために、親油性充填材料を含有するカプセルを、周囲条件でナプキンを上に置いた計量ボートに置いて、乾燥させた。親水性材料を使用しても同様の結果が得られると予想される。
Claims (20)
- 軟または硬カプセルシェルを処理する方法であって、
前記軟または硬カプセルシェルの少なくも1部分を加熱する工程であって、前記カプセルシェル内の内部応力を減少させるのに十分な時間の間、前記カプセルシェルのガラス転移温度より高い温度であるが前記カプセルシェルの溶融温度より低い温度に加熱する、加熱工程を有する方法。 - 請求項1記載の方法において、前記カプセルシェルの前記部分は前記カプセルシェルの溶融温度より2〜10℃低い温度に加熱されるものである。
- 請求項1記載の方法において、前記カプセルシェルの前記部分は前記カプセルシェルの溶融温度よりも2〜7℃低い温度に加熱されるものである。
- 請求項1記載の方法において、前記カプセルシェルの前記部分は、前記カプセルシェルの溶融温度よりも2〜3℃低い温度に加熱されるものである。
- 請求項1記載の方法において、前記カプセルシェルは、硬カプセルシェルである、方法。
- 請求項5記載の方法において、前記カプセルシェルの前記部分は、キャップ部分である、方法。
- 請求項5記載の方法において、
前記硬カプセルシェルの前記部分は、前記キャップ部分が前記カプセルシェルの本体部分と重なる部分である、方法。 - 請求項5記載の方法において、
前記硬カプセルシェルの前記部分はカプセルシェル全体である、方法。 - 請求項5記載の方法において、
前記加熱工程は、前記キャップ部分と前記本体部分とを互いに嵌合することによって前記硬カプセルシェルを閉じる直前に行われるものである。 - 請求項5記載の方法において、
前記加熱工程は、前記硬カプセルシェルが前記キャップ部分と前記本体部分とを互いに嵌合することによって閉じられた後に行われるものである。 - 請求項1記載の方法において、
前記カプセルシェルは、軟質弾性カプセルシェルである、方法。 - 請求項11記載の方法において、
前記加熱工程は、前記軟質弾性カプセルシェルの乾燥工程と同時に行われるものである。 - 請求項11記載の方法において、
前記加熱工程は、前記軟質弾性カプセルシェルの乾燥工程の完了時に行われるものである、方法。 - 請求項11記載の方法において、
前記軟質弾性カプセルシェルの前記部分は、カプセルシェル全体である、方法。 - 請求項1記載の方法において、
前記時間は、2秒から24時間である、方法。 - 請求項1記載の方法において、
前記時間は、12時間から24時間である、方法。 - 請求項1記載の方法において、
前記時間は、2秒から1時間である、方法。 - 請求項1記載の方法において、
前記時間は、1時間から12時間である、方法。 - 請求項1記載の方法において、
前記カプセルは軟カプセルであり、前記熱処理工程は、前記カプセルシェルがガラス転移温度を超える温度で終了しない乾燥工程の後に行われるものである。 - 請求項19記載の方法において、
前記乾燥工程は、前記カプセルシェルを前記ガラス転移温度より高い温度にまで加熱しないものである。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201662431569P | 2016-12-08 | 2016-12-08 | |
US62/431,569 | 2016-12-08 | ||
PCT/US2017/065398 WO2018107080A1 (en) | 2016-12-08 | 2017-12-08 | A method to relieve stress in capsule shells to reduce propensity to break |
Publications (4)
Publication Number | Publication Date |
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JP2020500643A true JP2020500643A (ja) | 2020-01-16 |
JP2020500643A5 JP2020500643A5 (ja) | 2020-12-24 |
JPWO2018107080A5 JPWO2018107080A5 (ja) | 2022-07-15 |
JP7129977B2 JP7129977B2 (ja) | 2022-09-02 |
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Application Number | Title | Priority Date | Filing Date |
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JP2019531045A Active JP7129977B2 (ja) | 2016-12-08 | 2017-12-08 | カプセルシェル応力を軽減してひび割れや損傷の可能性を減少させる方法 |
JP2019530494A Active JP7013465B2 (ja) | 2016-12-08 | 2017-12-08 | 制御された環境におけるソフトカプセルの加速乾燥 |
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JP2019530494A Active JP7013465B2 (ja) | 2016-12-08 | 2017-12-08 | 制御された環境におけるソフトカプセルの加速乾燥 |
Country Status (14)
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US (2) | US20200069524A1 (ja) |
EP (2) | EP3551158A4 (ja) |
JP (2) | JP7129977B2 (ja) |
KR (2) | KR102475555B1 (ja) |
CN (2) | CN110167510B (ja) |
AU (2) | AU2017371180B2 (ja) |
BR (2) | BR112019010644A2 (ja) |
CA (2) | CA3041560A1 (ja) |
CO (2) | CO2019005095A2 (ja) |
ES (1) | ES2927068T3 (ja) |
IL (2) | IL266694B2 (ja) |
MX (2) | MX2019005930A (ja) |
RU (2) | RU2745334C9 (ja) |
WO (2) | WO2018107019A1 (ja) |
Cited By (1)
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JP2020501101A (ja) * | 2016-12-08 | 2020-01-16 | アール.ピー.シェーラー テクノロジーズ、エルエルシー | 制御された環境におけるソフトカプセルの加速乾燥 |
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US20210154099A1 (en) * | 2019-11-22 | 2021-05-27 | Karl Wei Cao | Top liquid fill method and apparatus for hard capsules |
JP7314416B2 (ja) * | 2019-12-11 | 2023-07-25 | ダブリュ.エル.ゴア アンド アソシエイツ,インコーポレイティド | 蒸気ポンプの性能を評価するための方法 |
CN115792141B (zh) * | 2023-01-06 | 2023-05-02 | 广州兰泰仪器有限公司 | 一种提高水活度仪平衡检测效率的方法及系统 |
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