JP7171494B2 - 医薬品基材のコーティング方法 - Google Patents
医薬品基材のコーティング方法 Download PDFInfo
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- JP7171494B2 JP7171494B2 JP2019071781A JP2019071781A JP7171494B2 JP 7171494 B2 JP7171494 B2 JP 7171494B2 JP 2019071781 A JP2019071781 A JP 2019071781A JP 2019071781 A JP2019071781 A JP 2019071781A JP 7171494 B2 JP7171494 B2 JP 7171494B2
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- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
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- 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
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/501—Inorganic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
- A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
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- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2009—Inorganic compounds
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
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- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
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- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
- A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
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- 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
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5015—Organic compounds, e.g. fats, sugars
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
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- C—CHEMISTRY; METALLURGY
- C23—COATING METALLIC MATERIAL; COATING MATERIAL WITH METALLIC MATERIAL; CHEMICAL SURFACE TREATMENT; DIFFUSION TREATMENT OF METALLIC MATERIAL; COATING BY VACUUM EVAPORATION, BY SPUTTERING, BY ION IMPLANTATION OR BY CHEMICAL VAPOUR DEPOSITION, IN GENERAL; INHIBITING CORROSION OF METALLIC MATERIAL OR INCRUSTATION IN GENERAL
- C23C—COATING METALLIC MATERIAL; COATING MATERIAL WITH METALLIC MATERIAL; SURFACE TREATMENT OF METALLIC MATERIAL BY DIFFUSION INTO THE SURFACE, BY CHEMICAL CONVERSION OR SUBSTITUTION; COATING BY VACUUM EVAPORATION, BY SPUTTERING, BY ION IMPLANTATION OR BY CHEMICAL VAPOUR DEPOSITION, IN GENERAL
- C23C16/00—Chemical coating by decomposition of gaseous compounds, without leaving reaction products of surface material in the coating, i.e. chemical vapour deposition [CVD] processes
- C23C16/22—Chemical coating by decomposition of gaseous compounds, without leaving reaction products of surface material in the coating, i.e. chemical vapour deposition [CVD] processes characterised by the deposition of inorganic material, other than metallic material
- C23C16/30—Deposition of compounds, mixtures or solid solutions, e.g. borides, carbides, nitrides
- C23C16/40—Oxides
- C23C16/403—Oxides of aluminium, magnesium or beryllium
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- C—CHEMISTRY; METALLURGY
- C23—COATING METALLIC MATERIAL; COATING MATERIAL WITH METALLIC MATERIAL; CHEMICAL SURFACE TREATMENT; DIFFUSION TREATMENT OF METALLIC MATERIAL; COATING BY VACUUM EVAPORATION, BY SPUTTERING, BY ION IMPLANTATION OR BY CHEMICAL VAPOUR DEPOSITION, IN GENERAL; INHIBITING CORROSION OF METALLIC MATERIAL OR INCRUSTATION IN GENERAL
- C23C—COATING METALLIC MATERIAL; COATING MATERIAL WITH METALLIC MATERIAL; SURFACE TREATMENT OF METALLIC MATERIAL BY DIFFUSION INTO THE SURFACE, BY CHEMICAL CONVERSION OR SUBSTITUTION; COATING BY VACUUM EVAPORATION, BY SPUTTERING, BY ION IMPLANTATION OR BY CHEMICAL VAPOUR DEPOSITION, IN GENERAL
- C23C16/00—Chemical coating by decomposition of gaseous compounds, without leaving reaction products of surface material in the coating, i.e. chemical vapour deposition [CVD] processes
- C23C16/22—Chemical coating by decomposition of gaseous compounds, without leaving reaction products of surface material in the coating, i.e. chemical vapour deposition [CVD] processes characterised by the deposition of inorganic material, other than metallic material
- C23C16/30—Deposition of compounds, mixtures or solid solutions, e.g. borides, carbides, nitrides
- C23C16/40—Oxides
- C23C16/405—Oxides of refractory metals or yttrium
-
- C—CHEMISTRY; METALLURGY
- C23—COATING METALLIC MATERIAL; COATING MATERIAL WITH METALLIC MATERIAL; CHEMICAL SURFACE TREATMENT; DIFFUSION TREATMENT OF METALLIC MATERIAL; COATING BY VACUUM EVAPORATION, BY SPUTTERING, BY ION IMPLANTATION OR BY CHEMICAL VAPOUR DEPOSITION, IN GENERAL; INHIBITING CORROSION OF METALLIC MATERIAL OR INCRUSTATION IN GENERAL
- C23C—COATING METALLIC MATERIAL; COATING MATERIAL WITH METALLIC MATERIAL; SURFACE TREATMENT OF METALLIC MATERIAL BY DIFFUSION INTO THE SURFACE, BY CHEMICAL CONVERSION OR SUBSTITUTION; COATING BY VACUUM EVAPORATION, BY SPUTTERING, BY ION IMPLANTATION OR BY CHEMICAL VAPOUR DEPOSITION, IN GENERAL
- C23C16/00—Chemical coating by decomposition of gaseous compounds, without leaving reaction products of surface material in the coating, i.e. chemical vapour deposition [CVD] processes
- C23C16/44—Chemical coating by decomposition of gaseous compounds, without leaving reaction products of surface material in the coating, i.e. chemical vapour deposition [CVD] processes characterised by the method of coating
- C23C16/455—Chemical coating by decomposition of gaseous compounds, without leaving reaction products of surface material in the coating, i.e. chemical vapour deposition [CVD] processes characterised by the method of coating characterised by the method used for introducing gases into reaction chamber or for modifying gas flows in reaction chamber
- C23C16/45523—Pulsed gas flow or change of composition over time
- C23C16/45525—Atomic layer deposition [ALD]
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- C—CHEMISTRY; METALLURGY
- C23—COATING METALLIC MATERIAL; COATING MATERIAL WITH METALLIC MATERIAL; CHEMICAL SURFACE TREATMENT; DIFFUSION TREATMENT OF METALLIC MATERIAL; COATING BY VACUUM EVAPORATION, BY SPUTTERING, BY ION IMPLANTATION OR BY CHEMICAL VAPOUR DEPOSITION, IN GENERAL; INHIBITING CORROSION OF METALLIC MATERIAL OR INCRUSTATION IN GENERAL
- C23C—COATING METALLIC MATERIAL; COATING MATERIAL WITH METALLIC MATERIAL; SURFACE TREATMENT OF METALLIC MATERIAL BY DIFFUSION INTO THE SURFACE, BY CHEMICAL CONVERSION OR SUBSTITUTION; COATING BY VACUUM EVAPORATION, BY SPUTTERING, BY ION IMPLANTATION OR BY CHEMICAL VAPOUR DEPOSITION, IN GENERAL
- C23C16/00—Chemical coating by decomposition of gaseous compounds, without leaving reaction products of surface material in the coating, i.e. chemical vapour deposition [CVD] processes
- C23C16/44—Chemical coating by decomposition of gaseous compounds, without leaving reaction products of surface material in the coating, i.e. chemical vapour deposition [CVD] processes characterised by the method of coating
- C23C16/455—Chemical coating by decomposition of gaseous compounds, without leaving reaction products of surface material in the coating, i.e. chemical vapour deposition [CVD] processes characterised by the method of coating characterised by the method used for introducing gases into reaction chamber or for modifying gas flows in reaction chamber
- C23C16/45523—Pulsed gas flow or change of composition over time
- C23C16/45525—Atomic layer deposition [ALD]
- C23C16/45555—Atomic layer deposition [ALD] applied in non-semiconductor technology
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- Epidemiology (AREA)
- Inorganic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
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- Bioinformatics & Cheminformatics (AREA)
- Pain & Pain Management (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
- Rheumatology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Description
医薬品粒子(表1に示す)を、静的粒子床反応器を備えたBeneq社のTFS 500 ALD装置でコーティングした。このタイプの粒子反応器は、少量の粒子に適している。反応器は、互いに重なり合う5つのセルから構築される。各セルは、直径が200mmで、高さが20mmである。パラセタモール粉末を、前処理なしで反応器セルの底部にロードし、次に反応器セルを、反応器に装着し、約2ミリバールの操作圧力まで減圧した。Al2O3及びTiO2を、100~140℃の温度で、平均粒子サイズ約50μmでパラセタモール粒子上に堆積させた。Al2O3膜を、トリメチルアルミニウム(TMA)と温度20℃で供給源から気化させた水から成長させた。TiO2膜を、温度41℃で供給源から気化させたテトラキス(ジメチルアミド)チタン(TDMAT)と温度20℃で供給源から気化させた水から成長させた。Al2O3の一回の堆積サイクルは、2秒の金属前駆体(TMA)パルス、2.5秒のN2パージ、0.5秒の水パルス、及び1秒のN2パージから成った。同様にTiO2堆積のために用いられた時間設定の順序は、1-5-1.5-2であった。両酸化物の堆積されたALDサイクルの数は、500であった。
実施例2:錠剤化の検討
Claims (11)
- 医薬製剤の製造方法であって、原子層堆積又は分子層堆積によって活性医薬品基材のナノ粒子又はマイクロ粒子をコーティングして活性医薬品基材のナノ粒子又はマイクロ粒子にコンフォーマルでピンホールがないコーティングを提供すること、及び前記コーティングされた医薬品基材のナノ粒子又はマイクロ粒子を剤形に加工することを含む方法。
- 原子層堆積又は分子層堆積によって添加剤を活性医薬品基材のナノ粒子又はマイクロ粒子と共にコーティングすること、及び前記コーティングされた添加剤と前記コーティングされた医薬品基材のナノ粒子又はマイクロ粒子との混合物を剤形に加工することを含む、請求項1の方法。
- 原子層堆積又は分子層堆積によって添加剤をコーティングすること、及び前記コーティングされた添加剤と前記コーティングされた医薬品基材のナノ粒子又はマイクロ粒子との混合物を剤形に加工することを含む、請求項1の方法。
- コーティング層が、一つ以上の異なる無機物質若しくは有機物質、又はそれらの組み合わせを含むことを特徴とする請求項1の方法。
- 無機物質が、金属酸化物を含むことを特徴とする請求項4の方法。
- 金属酸化物が、酸化アルミニウムAl2O3又は酸化チタンTiO2であることを特徴とする請求項5の方法。
- 有機物質が、味マスキング剤より構成されることを特徴とする請求項4の方法。
- 味マスキング剤が、甘味料であることを特徴とする請求項7の方法。
- 味マスキング剤が、糖アルコールであることを特徴とする請求項7の方法。
- 医薬品基材のナノ粒子又はマイクロ粒子の加工が、圧縮することによって行われる、請求項1の方法。
- 医薬品基材のナノ粒子又はマイクロ粒子が、錠剤に圧縮される、請求項10の方法。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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FI20125962 | 2012-09-18 | ||
FI20125962A FI126168B (en) | 2012-09-18 | 2012-09-18 | A method for coating pharmaceutical substrates |
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JP2015531616A Division JP2015528487A (ja) | 2012-09-18 | 2013-09-17 | 医薬品基材のコーティング方法 |
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JP2019104763A JP2019104763A (ja) | 2019-06-27 |
JP7171494B2 true JP7171494B2 (ja) | 2022-11-15 |
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JP2015531616A Pending JP2015528487A (ja) | 2012-09-18 | 2013-09-17 | 医薬品基材のコーティング方法 |
JP2019071781A Active JP7171494B2 (ja) | 2012-09-18 | 2019-04-04 | 医薬品基材のコーティング方法 |
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JP2015531616A Pending JP2015528487A (ja) | 2012-09-18 | 2013-09-17 | 医薬品基材のコーティング方法 |
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US (4) | US20150250731A1 (ja) |
EP (1) | EP2897596A4 (ja) |
JP (2) | JP2015528487A (ja) |
CN (1) | CN104837484A (ja) |
FI (1) | FI126168B (ja) |
WO (1) | WO2014044907A1 (ja) |
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US11672764B2 (en) | 2023-06-13 |
CN104837484A (zh) | 2015-08-12 |
EP2897596A1 (en) | 2015-07-29 |
EP2897596A4 (en) | 2016-06-29 |
US20200197313A1 (en) | 2020-06-25 |
FI126168B (en) | 2016-07-29 |
JP2019104763A (ja) | 2019-06-27 |
US20230059964A1 (en) | 2023-02-23 |
US11986559B2 (en) | 2024-05-21 |
FI20125962A (fi) | 2014-03-19 |
US10603284B2 (en) | 2020-03-31 |
WO2014044907A1 (en) | 2014-03-27 |
US20150250731A1 (en) | 2015-09-10 |
JP2015528487A (ja) | 2015-09-28 |
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