JPWO2009066763A1 - 体表適用製剤、並びに、体表適用製剤保持シート - Google Patents
体表適用製剤、並びに、体表適用製剤保持シート Download PDFInfo
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- JPWO2009066763A1 JPWO2009066763A1 JP2009542602A JP2009542602A JPWO2009066763A1 JP WO2009066763 A1 JPWO2009066763 A1 JP WO2009066763A1 JP 2009542602 A JP2009542602 A JP 2009542602A JP 2009542602 A JP2009542602 A JP 2009542602A JP WO2009066763 A1 JPWO2009066763 A1 JP WO2009066763A1
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Abstract
Description
2 体表挿入端(先端)
3 押圧端(後端)
5 先端部(区分)
6,6a〜6i 後端部(区分)
7,7a〜7c 中間部(区分)
8 皮膚(体表)
21,22,23,25,26 体表適用製剤
50 体表適用製剤保持シート
58 支持体
インスリン;インターフェロン;エリスロポエチン(EPO);腫瘍壊死因子(TNF);顆粒球コロニー刺激因子(G−CSF);顆粒球単球コロニー刺激因子(GM−CSF);カルシトニン;絨毛性ゴナドトロピン;酢酸デモプレッシン;成長ホルモン;インフルエンザワクチン、肝炎ワクチン、小児マヒワクチンなどのワクチン;酢酸リュープロレリン;ボツリヌストキシン;グルコセレブロシダーゼ;第VII因子;卵巣刺激ホルモン;グレリン;血小板由来成長因子(PDGF)などの各種成長因子;DNA、RNA、オリゴヌクレオチド(例えば、アンチセンス用)などの核酸。
ジクロフェナックなど
〔角膜投与用の薬物の例〕
塩酸ピロカルピンなど
〔口腔内粘膜投与用の薬物の例〕
塩酸リドカインなど
〔栄養素の例〕
ビタミンC(アスコルビン酸)など
〔化粧品用成分の例〕
レチノールなど
実施例5,6で作製したパッチ剤各1枚から、100個のマイクロニードルを集め、1.5mL容の遠心分離用サンプルカップに入れた。1.0mLのリン酸緩衝液にて溶解し、その100μLをHPLCに供してインスリン含量を測定した。各実施例についてパッチ剤1枚あたりの含量(平均値)を算出した。その結果、実施例5のパッチ剤では0.70 IU、実施例6のパッチ剤では0.37 IUであった。
体重約350gのWistar系雄性ラットをペントバルビタール麻酔下で手術台に固定して腹部の除毛を施した。この時点でまず頸静脈より約0.2mL採血した。次に、実施例5又は6のパッチ剤1枚を、除毛したラットの腹部皮膚に押し当て、インスリンを皮膚から投与した。投与後5時間にわたり頸静脈より採血を行い、循環血液を採取した。得られた各血液から血清サンプルを調製し、各血清サンプル中のグルコース濃度(血糖値)を、グルコースアッセイキット(グルコースC−IIテストワコー;和光純薬社)を用いて測定した。各血糖値を、投与前における血糖値を100%としたときの相対値で表した。全てのデータは1群当たり3〜4匹のラットの平均値±SDとして算出した。結果を図11に示す。図11中の■印で示されるデータは実施例5の製剤、□印で示されるデータは実施例6の製剤の試験結果である。図11から明らかなように、いずれの製剤においても投与1時間後に血糖値が最低値を示しており、インスリンの効果が認められた。
実施例6と同様の手順で100個のマイクロニードルを集め、実施例7,8で作製したパッチ剤1枚あたりのEPO含量(平均値)を算出した。EPO濃度はEPO ELISAキット(ロシュ・ダイアグノスティクス社)を用いて測定した。その結果、実施例7のパッチ剤では12.5±1.5 IU、実施例8のパッチ剤では31.3±5.9 IUであった。
基本的に、実施例6と同様の手順で実験を行った。ラットは3〜4匹を一群として用いた。EPO投与後は24時間にわたり頸動脈より採血を行い、循環血液を採取した。EPO ELISAキットを用いて、各血清サンプル中のEPO濃度を測定した。図12に結果を示す。図12中の■印で示されるデータは実施例7の製剤(低投与群)、□印で示されるデータは実施例8の製剤(高投与群)の試験結果である。図12から明らかなように、いずれの製剤においても血清中EPO濃度はマイクロニードル中EPO含量に比例して上昇し、良好な投与量依存性が認められた。
Claims (25)
- 生体内溶解性の物質からなる基剤と当該基剤に保持された目的物質とを有し、体表に挿入して使用され、基剤が溶解することにより目的物質が体内に吸収される針状の体表適用製剤であって、
挿入方向に分けられた2以上の区分からなり、最後端の区分以外の少なくとも1つの区分に目的物質が保持されており、
目的物質が保持された区分は、目的物質を溶解させた基剤を固化して得られるものである体表適用製剤。 - 生体内溶解性の物質からなる基剤と当該基剤に保持された目的物質とを有し、体表に挿入して使用され、基剤が溶解することにより目的物質が体内に吸収される針状の体表適用製剤であって、
挿入方向に分けられた2以上の区分からなり、最後端の区分以外の少なくとも1つの区分に目的物質が保持されており、
目的物質が保持された区分は、
(a)細胞を分散させた基剤、
(b)目的物質を脂質分散体として分散させた基剤、又は、
(c)平均粒径10マイクロメートル以下の微粒子からなる目的物質を分散させた基剤、
を固化して得られるものである体表適用製剤。 - 最先端の区分に目的物質が保持されている請求項1又は2に記載の体表適用製剤。
- 挿入方向における全長が200〜600マイクロメートルの範囲である請求項1〜3のいずれかに記載の体表適用製剤。
- 挿入方向における全長が400〜600マイクロメートルの範囲である請求項4に記載の体表適用製剤。
- 最後端の区分を除いた区分の挿入方向における合計長さが350マイクロメートル以下である請求項5に記載の体表適用製剤。
- 生体内溶解性の物質からなる基剤と当該基剤に保持された目的物質とを有し、体表に挿入して使用され、基剤が溶解することにより目的物質が体内に吸収される針状の体表適用製剤であって、
基剤中において目的物質は挿入方向に沿って偏在していると共に後端側よりも先端側に目的物質が多く存在しており、
目的物質が存在している部分は、目的物質を溶解させた基剤を固化して得られるものである体表適用製剤。 - 生体内溶解性の物質からなる基剤と当該基剤に保持された目的物質とを有し、体表に挿入して使用され、基剤が溶解することにより目的物質が体内に吸収される針状の体表適用製剤であって、
基剤中において目的物質は挿入方向に沿って偏在していると共に後端側よりも先端側に目的物質が多く存在しており、
目的物質が存在している部分は、
(a)細胞を分散させた基剤、
(b)目的物質を脂質分散体として分散させた基剤、又は、
(c)平均粒径10マイクロメートル以下の微粒子からなる目的物質を分散させた基剤、
を固化して得られるものである体表適用製剤。 - 挿入方向における全長が200〜600マイクロメートルの範囲である請求項7又は8に記載の体表適用製剤。
- 挿入方向における全長が400〜600マイクロメートルの範囲である請求項9に記載の体表適用製剤。
- 先端から後端に向かって350マイクロメートル以内の部分に目的物質が保持されている請求項10に記載の体表適用製剤。
- 生体内溶解性の物質からなる基剤と当該基剤に保持された目的物質とを有し、体表に挿入して使用され、基剤が溶解することにより目的物質が体内に吸収される針状の体表適用製剤であって、
挿入方向に分けられた3以上の区分からなり、最先端の区分と最後端の区分のいずれにも属さない少なくとも1つの区分に目的物質が保持されており、
目的物質が保持された区分は、目的物質を分散させた基剤を固化して得られるものである
体表適用製剤。 - 最先端の区分に隣接する区分に目的物質が保持されている請求項12に記載の体表適用製剤。
- 挿入方向における全長が200〜600マイクロメートルの範囲である請求項12又は13に記載の体表適用製剤。
- 挿入方向における全長が400〜600マイクロメートルの範囲である請求項14に記載の体表適用製剤。
- 最後端の区分を除いた区分の挿入方向における合計長さが350マイクロメートル以下である請求項15に記載の体表適用製剤。
- 目的物質が、
(i)マイクロカプセルに包含されたもの、又は、
(ii)平均粒径が10マイクロメートル以下の微粒子、
である請求項12〜16のいずれかに記載の体表適用製剤。 - 体表が皮膚、角膜、口腔軟組織、歯茎、又は鼻腔粘膜である請求項1〜17のいずれかに記載の体表適用製剤。
- 基剤が高分子物質からなる請求項1〜18のいずれかに記載の体表適用製剤。
- 高分子物質が、多糖類、タンパク質、ポリビニルアルコール、カルボキシビニルポリマー、及びこれらの共重合体、並びにこれらの塩からなる群より選ばれた少なくとも1種である請求項19に記載の体表適用製剤。
- 目的物質が、ペプチド、タンパク質、核酸、又は多糖類である請求項1〜20のいずれかに記載の体表適用製剤。
- 目的物質が、薬物、ワクチン、栄養素、又は化粧品用成分である請求項1〜21のいずれかに記載の体表適用製剤。
- 基剤が多孔性物質を含有しており、目的物質が当該多孔性物質に保持され、当該目的物質が徐放される請求項1〜22のいずれかに記載の体表適用製剤。
- シート状の支持体の少なくとも一方の面に請求項1〜23のいずれかに記載の体表適用製剤が1又は2個以上保持され、体表に押し当てることにより前記体表適用製剤を体表に挿入可能である体表適用製剤保持シート。
- 体表適用製剤が最後端の区分に粘着性物質を含むものである請求項24に記載の体表適用製剤保持シート。
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JP2015136422A (ja) * | 2014-01-21 | 2015-07-30 | 凸版印刷株式会社 | マイクロニードル、および、マイクロニードルの製造方法 |
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CA2706404A1 (en) | 2009-05-28 |
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EP2213284B1 (en) | 2017-11-15 |
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JP5538897B2 (ja) | 2014-07-02 |
CA2706404C (en) | 2017-04-11 |
US8491534B2 (en) | 2013-07-23 |
AU2008327083B2 (en) | 2014-01-16 |
CN101868229A (zh) | 2010-10-20 |
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EP2213284A1 (en) | 2010-08-04 |
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