JP6499598B2 - 経皮吸収シートの製造方法 - Google Patents
経皮吸収シートの製造方法 Download PDFInfo
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- JP6499598B2 JP6499598B2 JP2016022835A JP2016022835A JP6499598B2 JP 6499598 B2 JP6499598 B2 JP 6499598B2 JP 2016022835 A JP2016022835 A JP 2016022835A JP 2016022835 A JP2016022835 A JP 2016022835A JP 6499598 B2 JP6499598 B2 JP 6499598B2
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- mold
- electroforming
- pretreatment liquid
- pattern
- concave pattern
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Classifications
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- C25D—PROCESSES FOR THE ELECTROLYTIC OR ELECTROPHORETIC PRODUCTION OF COATINGS; ELECTROFORMING; APPARATUS THEREFOR
- C25D1/00—Electroforming
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- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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- B29C33/00—Moulds or cores; Details thereof or accessories therefor
- B29C33/38—Moulds or cores; Details thereof or accessories therefor characterised by the material or the manufacturing process
- B29C33/3842—Manufacturing moulds, e.g. shaping the mould surface by machining
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
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- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
- A61K9/0021—Intradermal administration, e.g. through microneedle arrays, needleless injectors
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- B29C39/00—Shaping by casting, i.e. introducing the moulding material into a mould or between confining surfaces without significant moulding pressure; Apparatus therefor
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- B29C41/00—Shaping by coating a mould, core or other substrate, i.e. by depositing material and stripping-off the shaped article; Apparatus therefor
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- B29C41/36—Feeding the material on to the mould, core or other substrate
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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
- B29C41/00—Shaping by coating a mould, core or other substrate, i.e. by depositing material and stripping-off the shaped article; Apparatus therefor
- B29C41/34—Component parts, details or accessories; Auxiliary operations
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- C—CHEMISTRY; METALLURGY
- C25—ELECTROLYTIC OR ELECTROPHORETIC PROCESSES; APPARATUS THEREFOR
- C25D—PROCESSES FOR THE ELECTROLYTIC OR ELECTROPHORETIC PRODUCTION OF COATINGS; ELECTROFORMING; APPARATUS THEREFOR
- C25D1/00—Electroforming
- C25D1/10—Moulds; Masks; Masterforms
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- C—CHEMISTRY; METALLURGY
- C25—ELECTROLYTIC OR ELECTROPHORETIC PROCESSES; APPARATUS THEREFOR
- C25D—PROCESSES FOR THE ELECTROLYTIC OR ELECTROPHORETIC PRODUCTION OF COATINGS; ELECTROFORMING; APPARATUS THEREFOR
- C25D17/00—Constructional parts, or assemblies thereof, of cells for electrolytic coating
- C25D17/10—Electrodes, e.g. composition, counter electrode
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- C—CHEMISTRY; METALLURGY
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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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- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
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- B—PERFORMING OPERATIONS; TRANSPORTING
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- B29K2105/00—Condition, form or state of moulded material or of the material to be shaped
- B29K2105/0058—Liquid or visquous
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- C25D17/02—Tanks; Installations therefor
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- C25D3/00—Electroplating: Baths therefor
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Description
φ8インチの大きさで、1.5mmの厚さのLLDPE(直鎖状低密度ポリエチレン:Linear Low Density Polyethylene)材料の表面に、0.9mmの深さで略円錐形の凹部を1mmのピッチで形成することにより、針状の凹状パターンを有するLDPE製の母型を準備した。母型に対する前処理として、凹状パターンを有する母型に、スパッター処理により、0.2μmの厚みNi膜を形成した。前処理された母型を、電鋳槽に保持され45℃に温度管理された電鋳液に浸漬し、母型を浸漬した後、0.15mmの厚みの電鋳金型が得られるように電鋳処理を行った。電鋳液として、スルファミン酸ニッケル電鋳液(昭和化学株式会社製、NS160)を用いた。
電鋳液に浸漬する前に、以下の条件で脱泡処理を行った。前処理された母型を前処理液槽に保持される25℃に温度管理された前処理液に浸漬した。前処理液として純水を用いた。真空脱気装置(チヨダエレクトリック社製、水系真空脱気装置TKH−11)により、5L/分の処理水量で純水に対し脱気処理を行いながら、600Wの出力で、35kHzの基本周波数の超音波を、母型の凹状パターンに3分間印加した。純水の溶存酸素濃度は1.0mg/L以下であった。
電鋳液に浸漬する前に、以下の条件で脱泡処理を行った。前処理された母型を前処理液槽に保持される25℃に温度管理された純水に浸漬した。600Wの出力で、35kHzの基本周波数の超音波を、母型の凹状パターンに3分間印加した。実施例1とは異なり、真空脱気装置による脱気処理を行わなかった。
脱泡処理を行わずに、基本条件にしたがい電鋳処理を行った。
図11は、実施例1に係る電鋳金型の突起状パターンの外観写真であり、図12は比較例1に係る電鋳金型の外観写真であり、図13は、比較例2に係る電鋳金型の外観写真である。
実施例1により得られた電鋳金型の上に、0.6mmの厚みのシリコーンゴム(ダウコーニング社製SILASTIC−MDX4−4210)の膜を形成した。電鋳金型の先端部を膜表面から50μm突出させた状態で、シリコーンゴムの膜を熱硬化させた。次いで、電鋳金型から硬化されたシリコーンゴムの膜を剥離した。約30μmの直径の貫通孔を有するシリコーンゴムの反転品のモールドを作製した。モールドの中央部に10列×10行の2次元配列された凹状パターンを形成した。凹状パターンの開口部が広い方をモールドの表面とし、30μmの直径の貫通孔(空気抜き孔)を有する面をモールドの裏面とした。
ヒドロキシエチルスターチ(Fresenius Kabi社製)を水で溶解し、8%の水溶液に調液した。次に、薬剤として2質量%のヒト血清アルブミン(和光純薬社製)を水溶液に添加した。この水溶液を、薬剤を含むポリマー溶解液とした。調液後、3kPaの減圧環境下で4分間晒し、薬剤を含むポリマー溶解液(薬液)に対して脱気を行った。
ヒドロキシプロピルセルロース(日本曹達社製)を水で溶解し、30%の水溶液に調液したものを、薬剤を含まないポリマー溶解液とした。調液後、3kPaの減圧環境下で4分間晒し、薬剤を含まないポリマー溶解液(基材液)に対して脱気を行った。
薬液充填装置を用いてモールドの凹状パターンに薬液を充填した。薬液充填装置は、モールドとノズルの相対位置座標を制御するX軸駆動部、及びZ軸駆動部を有する駆動部と、ノズルを取り付け可能な液供給装置(武蔵エンジニアリング社製超微量定量ディスペンサーSMP−III)と、モールドを固定する吸引台と、モールド表面形状を測定するレーザー変位計(パナソニック社製HL−C201A)と、ノズル押し込み圧力を測定するロードセル(共和電業製LCX−A−500N)と、表面形状、押し付け圧力の測定値のデータを基にZ軸を制御する制御システムと、液供給装置に取り付けられたステンレスのノズルと、を備える。
開口部を有するステンレス製の薄板を型として準備した。薬液を充填したモールドを吸引装置に吸引固定した。モールドの凹状パターンが、ステンレス製薄板の開口部の中に入るように位置合わせした。モールドの表面にステンレス製薄板を重ね合せた。ステンレス製薄板の開口部に基材液を流し込み、過剰な基材液をスキージまたは丸棒で掻きとった。基材液を凹状パターンに充填した。
エアーで吸引しながらポリマーシートを引き上げる方法により、ポリマーシートをモールドから剥離した。先端に薬剤を含む層と薬剤を含まない層とにより構成される三次元配列構造の突起状パターンを有する経皮吸収シートを製造した。
経皮吸収シートの突起状パターンに欠陥は見られなかった。実施例1で作製された電鋳金型に空洞、及び/又は欠けが発生していない。この電鋳金型を利用して反転型のモールドを作製し、このモールドから経皮吸収シートを製造しているので、突起状パターンに欠陥が見られなかった。また、電鋳金型を利用しているので、反転型のモールドを効率的に作製でき、結果として経皮吸収シートを効率的に製造することができる。
10A 凹状パターン
10B 表面
12 凹部
14 熱可塑性樹脂
20 陰極
22 シャフト
24 陰極板
26 固定部材
30 前処理液槽
32 前処理液
34 循環流路
36 真空脱気装置
38 超音波振動子
40 溶存酸素計
50 モールド
50A 凹状パターン
50B 表面
60 電鋳装置
62、62A 電鋳液
64 電鋳槽
66 ドレーン槽
68 ペレット
70 チタンケース
72 排水配管
74 供給配管
80 金属体
82 電鋳金型
82A 突起状パターン
100 原版
100A 突起状パターン
100B 平面
200 ポリマー溶解液
210 ポリマーシート
220 経皮吸収シート
220A 突起状パターン
300 基材
Claims (10)
- 針状の凹状パターンを有する母型を準備する準備工程と、
前処理液槽に保持される脱気された前処理液に前記母型を浸漬し、前記母型の凹状パターンに超音波振動子から発生される超音波を印加し、前記凹状パターンを構成する凹部に前記前処理液を充填する充填工程と、
前記前処理液槽から前記母型を取り出す取出し工程と、
前記母型を、電鋳槽に保持される電鋳液に浸漬し、電鋳処理することにより前記母型の凹状パターンの面に金属体を形成する形成工程と、
前記金属体を前記母型から剥離して、前記凹状パターンの反転形状の突起状パターンを有する電鋳金型を得る剥離工程と、
前記電鋳金型を用いて凹状パターンを有するモールドを作製する工程と、
前記モールドの凹状パターンへ薬剤を含むポリマー溶解液を充填し、次いで前記ポリマー溶解液を乾燥させることによりポリマーシートを形成する工程と、
を含む経皮吸収シートの製造方法。 - 前記前処理液が水である請求項1に記載の経皮吸収シートの製造方法。
- 前記超音波振動子と前記母型の前記凹状パターンの形成される表面とを対向配置させる、請求項1又は2に記載の経皮吸収シートの製造方法。
- 前記母型が樹脂材料で構成される、請求項1から3の何れか一項に記載の経皮吸収シートの製造方法。
- 前記樹脂材料が、熱可塑性樹脂、又は紫外線硬化樹脂である、請求項4に記載の経皮吸収シートの製造方法。
- 前記脱気された前処理液の溶存酸素濃度が0.5mg/L以下である請求項1から5の何れか一項に記載の経皮吸収シートの製造方法。
- 前記前処理液槽に循環流路を介して接続される真空脱気装置を備え、前記脱気された前処理液は、前処理液を前記前処理液槽と前記真空脱気装置との間を循環させることにより準備される請求項1から6の何れか一項に記載の経皮吸収シートの製造方法。
- 前記モールドを作製する工程は、前記電鋳金型の突起状パターンの反転形状である凹状パターンを有する樹脂製のモールドを作製することを含む請求項1から7の何れか一項に記載の経皮吸収シートの製造方法。
- 前記ポリマーシートを前記モールドから剥離する剥離工程を含む請求項1から8の何れか一項に記載の経皮吸収シートの製造方法。
- 前記ポリマー溶解液が水溶性材料を含む請求項1から9の何れか一項に記載の経皮吸収シートの製造方法。
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