JPWO2009051147A1 - マイクロニードルデバイス - Google Patents
マイクロニードルデバイス Download PDFInfo
- Publication number
- JPWO2009051147A1 JPWO2009051147A1 JP2009538116A JP2009538116A JPWO2009051147A1 JP WO2009051147 A1 JPWO2009051147 A1 JP WO2009051147A1 JP 2009538116 A JP2009538116 A JP 2009538116A JP 2009538116 A JP2009538116 A JP 2009538116A JP WO2009051147 A1 JPWO2009051147 A1 JP WO2009051147A1
- Authority
- JP
- Japan
- Prior art keywords
- coating
- microneedle
- pullulan
- physiologically active
- active substance
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
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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
- A61K9/0012—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
-
- 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
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
- A61P37/04—Immunostimulants
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Abstract
Description
2 マイクロニードル基板
3、21 マイクロニードル
4、40 コーティング
23 テーブル
24 開口部
25 マスク版
27 コーティング液
28 ヘラ
他の既知の製剤補助物質は、それらがコーティングの必要な溶解性および粘度の特徴ならびに乾燥されたコーティングの性状および物性に有害な影響を及ぼさない限りは、コーティングに添加してもよい。
また、分子量が1000程度であれば、ワクチン、低分子ペプチド、糖、核酸等の生理活性物質でも構わない。
操作手法
各種ポリマーとBSA,OVAとを、下記の表1−1,1−2、表2−1,2−2の条件にしたがって、それぞれ混合水溶液を調製し、凝集物の発生の有無や遠心脱泡後(遠心条件は表に記載)の相分離発生の有無を確認することで、相溶性について評価した(均一な液性=○、不均一な液性=×)。表1−1,1−2、表2−1,2−2において、○印は相溶性を有するものであり、×印は相溶性を有しないものである。なお、以下の記載において%表記は重量%である。コーティング含量の測定は、上述の図2に示す方法でコーティングを行った後、1mL精製水で抽出し、BSAまたはOVA含量(付着量)を測定した。また、「不可」の記載は、ポリマーの針への付着性が認められなかったことを示す。
ライナー上に20%PVA220、20%PVA117、30%プルランの各コーティング液を厚み50μmで展膏し、面積(8cm2)に打ち抜いたものを作製し、電子天秤上に設置し、室温条件下で経時的な重量変化を測定した。図3は、上記各種ポリマー水溶液の展膏後の経時重量変化の一例を示す図である。図の横軸は放置時間(分)、縦軸は重量減少率(対初期重量)である。図3に示すように、2種のPVAは、計測時間内において、経時で重量が減少傾向を示したのに対して、プルランは初期に重量減少が見られたものの、ほぼ一定の重量値を示しており、湿潤性を保持したまま、安定した物性を示した。
設定条件
(a)コーティング液設定濃度
・プルラン濃度:5,10,20,24(%)
・BSA(モデルタンパク)濃度:20(%)固定
(b)マイクロニードル
・高さ250μm、900本/cm2、製剤面積1cm2
(c)メタルマスク版
・ピッチ:300μm,T(マスク厚):100μm,開口部:四角形状(一辺200μm)
(d)環境設定:室温,低温加湿法条件下
操作手法
上記の通り、BSA(ウシ血清アルブミン)濃度を20%に固定して、プルラン濃度を4濃度に設定したコーティング液を調製した。コーティングは上述の図2に示す方法で行った。加湿条件下、コーティング液をメタルマスク開口部にヘラにより充填した。充填した開口部にマイクロニードル(針)を進入させてコーティングされたマイクロニードルを1mL精製水で抽出し、BCA法(BSA標準)によりBSA含量(付着量)を測定した(n=10)。表3および図4にその結果を示す。図4において横軸はプルラン濃度(%)、縦軸はBSA含量(μg/patch)である。
設定条件
(a)プルラン水溶液設定濃度:5〜30(%)
(b)プルランベースコーティング液設定濃度
・プルラン:10〜28.5(%)
・BSA:5〜40(%)
操作手法
上記条件に調製した水溶液の粘度を、粘度計(リオン株式会社製ビスコテスターVF−04)を用いて測定した。その結果をプルラン濃度と粘度との相関関係として図5に示す。図5に示すように、プルラン単体の水溶液では、濃度の上昇にしたがって、2次曲線的な粘度上昇が確認された。プルランとBSAとの混合では、BSA濃度が低値設定の場合には、プルランの濃度依存の粘度特性が確認され、BSA濃度が支配的な溶液条件(40%BSA・10%プルラン)では、前記のプルラン濃度依存性から逸脱した粘度となった。図5の結果から、高分子生理活性物質の溶媒に対する溶解度が低い場合等で、処方設計上、高分子生理活性物質濃度を低値設定とする際には、コーティング担体(プルラン等)の濃度を適宜設定することにより、コーティング液の粘度の制御が可能となり所望量のコーティングが可能となる。
Claims (2)
- 基板上に皮膚を穿孔可能な複数のマイクロニードルを備えたマイクロニードルデバイスであって、前記マイクロニードルおよび/または前記基板の一部又は全面に、高分子生理活性物質および前記高分子生理活性物質と相溶性を有する多糖類を含むコーティング担体が固着化されたコーティングを有することを特徴とするマイクロニードルデバイス。
- 前記多糖類が、プルラン、ヒドロキシプロピルセルロースおよびヒアルロン酸からなる群から選ばれる1または2以上であることを特徴とする請求項1記載のマイクロニードルデバイス。
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CN109701152A (zh) * | 2019-01-14 | 2019-05-03 | 浙江工业大学 | 一种装载药物的可溶性微针贴片及其制备方法 |
CN111349551B (zh) * | 2020-03-06 | 2023-05-09 | 华中科技大学同济医学院附属协和医院 | 一种可提取皮肤组织液中微生物的微针贴片及其制备方法 |
KR102238031B1 (ko) | 2020-04-23 | 2021-04-08 | 주식회사 에스엔비아 | 이식형 마이크로니들 및 이의 제조 방법 |
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GB0017999D0 (en) * | 2000-07-21 | 2000-09-13 | Smithkline Beecham Biolog | Novel device |
MXPA06007832A (es) * | 2004-01-09 | 2007-01-26 | Johnson & Johnson | Metodo y sistema de suministro de agente transdermico asistido por frecuencia. |
KR20070100820A (ko) * | 2005-01-31 | 2007-10-11 | 가부시키가이샤 바이오세렌택 | 경피 흡수 제제, 경피 흡수 제제 유지 시트 및 경피 흡수제제 유지 용구 |
JP2006335754A (ja) * | 2005-06-01 | 2006-12-14 | Technofarm Axesz Kk | 経皮投与剤担持薄膜とその製造法 |
JP2007089792A (ja) * | 2005-09-28 | 2007-04-12 | Nano Device & System Research Inc | 経皮投与装置 |
ATE532553T1 (de) * | 2006-02-10 | 2011-11-15 | Hisamitsu Pharmaceutical Co | Transdermales arzneiverabreichungsgerät mit mikronadeln |
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2008
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US20100221314A1 (en) | 2010-09-02 |
WO2009051147A1 (ja) | 2009-04-23 |
US20120283642A1 (en) | 2012-11-08 |
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