JP7477558B2 - マイクロニードルデバイス及びそれを製造する方法 - Google Patents
マイクロニードルデバイス及びそれを製造する方法 Download PDFInfo
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- JP7477558B2 JP7477558B2 JP2022072350A JP2022072350A JP7477558B2 JP 7477558 B2 JP7477558 B2 JP 7477558B2 JP 2022072350 A JP2022072350 A JP 2022072350A JP 2022072350 A JP2022072350 A JP 2022072350A JP 7477558 B2 JP7477558 B2 JP 7477558B2
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- microneedle
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- chondroitin sulfate
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Description
表1及び表2に示す成分を混和して、コーティング液1~4を調製した。表中、γ-PGAはγ-ポリグルタミン酸である。コンドロイチン硫酸ナトリウム(以下、CSNaということがある。)としては、マルハニチロ株式会社の医薬品グレードの製品を使用した。プルランとしては、株式会社林原の医薬品用の製品を使用した。γ-PGAとしては、日本ポリグル株式会社の製品を使用した。ポリビニルアルコールとしては、株式会社クラレの「クラレポバールPVA-205」(けん化度:約87.0mol%~89.0mol%、重合度:約500)を使用した。
デクスメデトミジン塩酸塩、コンドロイチン硫酸ナトリウム、L-システイン(安定化剤)及び注射用水を混和し、表5に示すコーティング液5~13(実施例)を調製した。使用したコンドロイチン硫酸ナトリウムの詳細は試験例1と同様である。1cm2の領域に密度156本/cm2でマイクロニードルを備え、各マイクロニードルの形状は高さ500μmの四角錐である、ポリ乳酸のマイクロニードルアレイを用意し、マイクロニードルをコーティング液5~13中に約140μmの深さまで浸漬した。コーティング液からマイクロニードルを引き上げた後、マイクロニードル上のコーティング液5~13の溶媒を乾燥させて、マイクロニードルデバイス5~13(実施例)を得た。
DEX量の理論値(ng/ニードル)=562(ng/ニードル)×コーティング液中のデクスメデトミジン塩酸塩の固形分換算の濃度(質量%)/100
図5に示されるように、CSNa/DEX比が0.044~0.222の場合は、多少のばらつきはあるものの、実測値と理論値が実質的に一致していた。一方、CSNa/DEX比が0.222を上回った場合は実測値が理論値を下回り、値の差はCSNa/DEX比の増加とともに大きくなった。このことから、0.222超のCSNa/DEX比ではコーティング液の物性に何らかの変化が起こり、この変化はマイクロニードルに担持されるDEX量の増加を阻害する方向に作用するものと推定される。
デクスメデトミジン塩酸塩(生理活性物質)、コンドロイチン硫酸ナトリウム(担持体)、及び注射用水を混和し、表7に示すコーティング液14~23(実施例)を調製した。使用したコンドロイチン硫酸ナトリウムの詳細は試験例1と同様である。1cm2の領域に密度156本/cm2でマイクロニードルを備え、各マイクロニードルの形状は高さ500μmの四角錐である、ポリ乳酸のマイクロニードルアレイを用意し、マイクロニードルをコーティング液14~23中に約140μmの深さまで浸漬した。コーティング液からマイクロニードルを引き上げた後、マイクロニードル上のコーティング液14~23の溶媒を乾燥させて、マイクロニードルデバイス14~23を得た。
DEX量の理論値(ng/ニードル)=822(ng/ニードル)×コーティング液中のデクスメデトミジン塩酸塩の固形分換算の濃度(質量%)/100
図8に示されるように、CSNa/DEX比が0.089~0.222の場合は、実測値と理論値が実質的に一致していた。一方、CSNa/DEX比が0.222を上回った場合は実測値が理論値を下回り、値の差はCSNa/DEX比の増加とともに大きくなった。このことから、0.222超のCSNa/DEX比ではコーティング液の物性に何らかの変化が起こり、この変化はマイクロニードルに担持されるDEX量の増加を阻害する方向に作用するものと推定される。
Claims (10)
- 基板と、
基板上に配置されたマイクロニードルと、
マイクロニードル上に形成されたコーティングと、を備え、
コーティングは、デクスメデトミジン塩酸塩と、コンドロイチン硫酸ナトリウムと、を含み、
デクスメデトミジン塩酸塩に対するコンドロイチン硫酸ナトリウムの質量比は0.01~0.36であり、
コーティング100質量部に対するコンドロイチン硫酸ナトリウムの量は、1質量部以上、27質量部以下である、マイクロニードルデバイス。 - デクスメデトミジン塩酸塩に対するコンドロイチン硫酸ナトリウムの質量比が、0.011~0.222である、請求項1に記載のマイクロニードルデバイス。
- デクスメデトミジン塩酸塩に対するコンドロイチン硫酸ナトリウムの質量比が、0.089~0.222である、請求項2に記載のマイクロニードルデバイス。
- マイクロニードルが、10本/cm2以上かつ850本/cm2以下の針密度で基板上に配置された、請求項1~3のいずれか一項に記載のマイクロニードルデバイス。
- マイクロニードル1本あたりのデクスメデトミジン塩酸塩の担持量が、390ng以上である、請求項1~4のいずれか一項に記載のマイクロニードルデバイス。
- マイクロニードルの材質が、シリコン、二酸化ケイ素、セラミック、金属、多糖類、又は樹脂である、請求項1~5のいずれか一項に記載のマイクロニードルデバイス。
- 基板と、基板上に配置されたマイクロニードルと、マイクロニードル上に形成されたコーティングと、を備えるマイクロニードルデバイスを製造する方法であって、
マイクロニードルに、コーティング液を浸漬コーティングにより塗布する工程を備え、
コーティング液は、デクスメデトミジン塩酸塩と、コンドロイチン硫酸ナトリウムと、を含み、
コーティング液における、デクスメデトミジン塩酸塩に対するコンドロイチン硫酸ナトリウムの質量比は0.01~0.36であり、
コーティング液におけるコンドロイチン硫酸ナトリウムの濃度は、0.5質量%以上、16質量%以下である、方法。 - コーティング液における、デクスメデトミジン塩酸塩に対するコンドロイチン硫酸ナトリウムの質量比が、0.011~0.222である、請求項7に記載の方法。
- コーティング液における、デクスメデトミジン塩酸塩に対するコンドロイチン硫酸ナトリウムの質量比が、0.089~0.222である、請求項8に記載の方法。
- マイクロニードルの材質が、シリコン、二酸化ケイ素、セラミック、金属、多糖類、又は樹脂である、請求項7~9のいずれか一項に記載の方法。
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