JP6961859B1 - 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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- JP6961859B1 JP6961859B1 JP2021521438A JP2021521438A JP6961859B1 JP 6961859 B1 JP6961859 B1 JP 6961859B1 JP 2021521438 A JP2021521438 A JP 2021521438A JP 2021521438 A JP2021521438 A JP 2021521438A JP 6961859 B1 JP6961859 B1 JP 6961859B1
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- isoproterenol
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Abstract
Description
以下のとおり、異なる安定化剤を用いてマイクロニードルデバイスを製造し、1ヶ月後のイソプロテレノール塩酸塩の安定性を評価した。
HPLCの条件は次のとおりである:
カラム:ODS 80Ts QA5μm(4.6mmI.D.×150mm)
流速:0.5mL/min
測定波長:280nm
(式1):
コーティング中のイソプロテレノール塩酸塩の量(%)=1ヶ月保管後のコーティング中のイソプロテレノール塩酸塩の量/1ヶ月保管前のコーティング中のイソプロテレノール塩酸塩の量×100
(式2):
イソプロテレノール類縁物の生成率(%)=イソプロテレノール類縁物のピーク面積/イソプロテレノール塩酸塩のピーク面積×100
以下のとおり、異なる安定化剤を用いてマイクロニードルデバイスを製造し、製造過程(1〜約24時間)におけるイソプロテレノール塩酸塩の安定性を評価した。本試験は、温度19〜23℃及び湿度79〜83%RHの条件で行った。また、本試験で用いたマイクロニードルアレイは、試験例1−1で用いたマイクロニードルアレイと同様である。
(式3):
イソプロテレノール類縁物の生成率(%)=イソプロテレノール類縁物のピーク面積/イソプロテレノール塩酸塩のピーク面積×100
以下のとおり、異なる濃度のエチレンジアミン四酢酸二ナトリウム及びイソプロテレノール塩酸塩を用いてマイクロニードルデバイスを製造し、1〜2ヶ月後のイソプロテレノール塩酸塩の安定性を評価した。
試験例1−1〜1−3の結果から、エチレンジアミン四酢酸二ナトリウムを含むコーティング液を用いてマイクロニードルデバイスを製造すると、製造過程及び製造後におけるイソプロテレノール塩酸塩の安定性が高くなることが示された。一方、EDTA以外の安定化剤を含むコーティング液を用いてマイクロニードルデバイスを製造すると、製造過程又は製造後におけるイソプロテレノール塩酸塩の安定性が十分でないことも示された。また、試験例1−3の結果から、イソプロテレノール塩酸塩に対するエチレンジアミン四酢酸二ナトリウムの比が一定以上であると、製造後におけるイソプロテレノール塩酸塩の安定性がより高くなることが示された。
表5に示す組成のコーティング液を調製し、コーティング液をリザーバーに充填して、60分間スキージで混合した。試験例1で用いたマイクロニードルアレイと同様のマイクロニードルアレイを用意し、マイクロニードルの先端をリザーバー中のコーティング液に約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を乾燥させた。
Claims (6)
- 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塗布して、マイクロニードル上にコーティングを形成する工程を備え、
コーティング液は、
デクスメデトミジン又はその薬学的に許容可能な塩と、
イソプロテレノール又はその薬学的に許容可能な塩と、
エチレンジアミン四酢酸又はその薬学的に許容可能な塩と、
コンドロイチン硫酸又はその薬学的に許容可能な塩と、を含む、方法。 - コーティング液における、イソプロテレノール又はその薬学的に許容可能な塩に対するエチレンジアミン四酢酸又はその薬学的に許容可能な塩の質量比が、0.013以上である、請求項1に記載の方法。
- コーティング液におけるコンドロイチン硫酸又はその薬学的に許容可能な塩の濃度が、0.5質量%以上である、請求項1又は2に記載の方法。
- 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又はその薬学的に許容可能な塩と、
イソプロテレノール又はその薬学的に許容可能な塩と、
エチレンジアミン四酢酸又はその薬学的に許容可能な塩と、
コンドロイチン硫酸又はその薬学的に許容可能な塩と、を含む、マイクロニードルデバイス。 - イソプロテレノール又はその薬学的に許容可能な塩に対するエチレンジアミン四酢酸又はその薬学的に許容可能な塩の質量比が、0.013以上である、請求項4に記載のマイクロニードルデバイス。
- コーティング100質量部に対するコンドロイチン硫酸又はその薬学的に許容可能な塩の量が、0.5質量部以上である、請求項4又は5に記載のマイクロニードルデバイス。
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JPS6379820A (ja) * | 1986-09-22 | 1988-04-09 | Nitto Electric Ind Co Ltd | 経皮投与用医薬製剤 |
WO2012115207A1 (ja) * | 2011-02-24 | 2012-08-30 | 久光製薬株式会社 | マイクロニードルデバイス用生理活性非水組成物及びマイクロニードル上に付着している生理活性非水組成物 |
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JPS6379820A (ja) * | 1986-09-22 | 1988-04-09 | Nitto Electric Ind Co Ltd | 経皮投与用医薬製剤 |
WO2012115207A1 (ja) * | 2011-02-24 | 2012-08-30 | 久光製薬株式会社 | マイクロニードルデバイス用生理活性非水組成物及びマイクロニードル上に付着している生理活性非水組成物 |
WO2018123982A1 (ja) * | 2016-12-26 | 2018-07-05 | 久光製薬株式会社 | マイクロニードルデバイス |
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