JP2016036737A - 水不溶性治療剤を組み込む組成物およびデバイスならびにその使用方法 - Google Patents
水不溶性治療剤を組み込む組成物およびデバイスならびにその使用方法 Download PDFInfo
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- JP2016036737A JP2016036737A JP2015155874A JP2015155874A JP2016036737A JP 2016036737 A JP2016036737 A JP 2016036737A JP 2015155874 A JP2015155874 A JP 2015155874A JP 2015155874 A JP2015155874 A JP 2015155874A JP 2016036737 A JP2016036737 A JP 2016036737A
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Abstract
Description
本明細書で使用する「治療効果」という用語は、ヒト患者もしくは動物患者の病理学的症状、疾患の進行、または、例えば、再狭窄などの障害に関連する生理学的状態、もしくはそれに対する抵抗性の改善をもたらす、向上させる、または他に引き起こす効果を意味する。治療剤に関して使用する「治療有効量」という用語は、ヒト患者または動物患者に治療効果を付与する治療剤の量を意味する。
本発明の一態様は、少なくとも1種の水不溶性治療剤と少なくとも1種のガレート含有化合物とを含む組成物に関する。特定の実施形態では、組成物は、水性溶媒、例えば、水または薬学的に許容される緩衝液を含む。これらの実施形態では、ガレート含有化合物が存在すると、ガレート含有化合物が存在しない場合に同じ条件下で可能となり得る濃度より高い濃度で、水不溶性治療剤が水性溶媒に溶解している水溶液が得られる。
本開示の他の態様は、少なくとも1種のガレート含有化合物のマトリックス内に可溶化された少なくとも1種の水不溶性治療剤を含む放出可能な成分を組み込む医療用デバイス、ならびにこのような医療用デバイスの製造方法および使用方法に関する。特定の実施形態では、医療用デバイスは、上記で開示した組成物でコーティングされているか、または他の方法でそれを含有する。
A.活性化緩衝液:水、pH6に調節
C.没食子酸440mg(Sigma chemicals)
D.スルホ−NHS(製品番号24510.Thermo fisher)
E.EDC(Sigma chemicals)
F.デンドリマー G0.(Dendritech)2g/16mlで1ml=125mg
EDC(約1.5M)573mgおよびスルホ−NHS(約2M)868mgを没食子酸(15%ETOH中1.3M、溶解)440mgと共にpH5〜6の水2mlに添加し、pH4〜7で、室温で30分間反応させた。これは、撹拌して没食子酸が溶液中に維持されるかどうかに依存した。試薬が溶解しなかった場合、さらに水を添加した。
EGCGまたはタンニン酸中の薬物の薄膜は、エタノール溶液から流涎した。EGCGまたはタンニン酸中の薬物をエタノールに最終総濃度が20%w/vになるように溶解し、ピペットを用いて繰り返し10μlの容量で点着し、点着間に乾燥させた。これにより薄膜が堆積し、乾燥した。幾つかの溶液は、EGCGまたはタンニン酸に対して10%または20%w/wのグリセリンまたはポリエチレングリコール300を含有した。薄膜を乾燥させて、光学顕微鏡で薬物の析出を調べた。薬物の結晶を同定するためにフィルムを示差走査熱量測定(DSC)で分析した。
乳酸グリコール酸共重合体をテトラヒドロフラン:ジメチルホルムアミド、75:25に20%w/vになるように溶解した。PLGA溶液に対して30%のEGCGまたはタンニン酸と、EGCGまたはタンニン酸に対して2%w/wのパクリタキセルまたはクルクミン。溶液をアルミニウム箔上に20000ボルトで電界紡糸した。3時間後、ナノ繊維の微細なマットが紡糸された。顕微鏡検査で、このメッシュは性質が均質に見えた。
フィナステリドに対するEGCGまたはタンニン酸の可溶化効果。
直径約200μmのPLGAマイクロスフェアへのパクリタキセルとタンニン酸またはEGCGの封入
方法:本方法は、ポリマーPLGA(通常、20%w/v)と薬物(通常、ポリマーに対して5%w/w)とEGCG(例えば、ポリマーに対して20%w/w/)とのジクロロメタン(DCM)(5ml)溶液をピペットで取り、2.5%PVA水溶液100mlに450rpmで撹拌しながら入れる工程を含んだ。懸濁液を2時間撹拌し、マイクロスフェアを蒸留水中で4回洗浄した。次いで、マイクロスフェアを2日間減圧乾燥した。薬物の封入は、既知の重量のマイクロスフェアをジクロロメタン1mlに溶解した後、アセトニトリル/水(60:40)10mlですぐに希釈することにより測定した。この溶液の上相および下相中の薬物またはEGCGの量は、HPLC法(移動相、アセトニトリル:水:メタノール、58:37:5。c18カラムで毎分1mlの流量、232nmで検出)を用いて測定した。
ガレート含有化合物および水不溶性治療剤を含む組成物と、
を含む医療用デバイスであって、ガレート含有化合物と水不溶性治療剤が1:40〜500:1の重量比で存在し、組成物が基部構造に少なくとも部分的に組み込まれている、医療用デバイス。
を含む、医療用デバイスの製造方法。
Claims (20)
- 表面を有する基部構造と、
ガレート含有化合物のマトリックス内に可溶化された水不溶性治療剤を含む前記表面上のコーティングと、
を含む医療用デバイス。 - 前記ガレート含有化合物と前記水不溶性治療剤が、ガレート含有化合物対水不溶性治療剤の重量比1:40〜500:1で存在する、請求項1に記載の医療用デバイス。
- 前記コーティングが、前記治療剤の放出速度を変化させる追加のポリマー担体または非ポリマー担体を含まない、請求項1に記載の医療用デバイス。
- 前記ガレート含有化合物が、エピガロカテキンガレート、タンニン酸およびエピカテキンガレートからなる群から選択される、請求項1に記載の医療用デバイス。
- 前記ガレート含有化合物が、デンドリマー、ポリマー、高分子または低分子などのガレート置換分子を含む、請求項1に記載の医療用デバイス。
- 前記ガレート含有化合物がタンニン酸である、請求項4に記載の医療用デバイス。
- 前記ガレート含有化合物がエピガロカテキンガレートである、請求項4に記載の医療用デバイス。
- 前記ガレート含有化合物と前記水不溶性治療剤が、ガレート含有化合物対水不溶性治療剤の重量比30:1〜500:1で存在する、請求項1に記載の医療用デバイス。
- 前記水不溶性治療剤が前記ガレート含有化合物のマトリックス内に含有され、前記水不溶性治療剤がガレート含有化合物対水不溶性治療剤の重量比30:1〜100:1で存在する、請求項8に記載の医療用デバイス。
- 前記埋め込み型医療用デバイスが拡張型バルーンまたは拡張型ステントである、請求項1に記載の医療用デバイス。
- 前記医療用デバイスが、ステント、脈管用ステント、尿管用ステント、カテーテル、バルーン、バルーンカテーテル、ステントグラフト、ワイヤガイド、およびカニューレからなる群から選択される、請求項1に記載の医療用デバイス。
- 前記水不溶性治療剤が、免疫抑制剤、増殖抑制剤、微小管安定剤、再狭窄抑制剤、または哺乳類ラパマイシン標的阻害剤である、請求項1に記載の医療用デバイス。
- 前記水不溶性治療剤がタキサン化合物である、請求項12に記載の医療用デバイス。
- 前記タキサン化合物がパクリタキセルまたはドセタキセルである、請求項13に記載の医療用デバイス。
- 前記治療剤がマクロライド系免疫抑制剤である、請求項14に記載の医療用デバイス。
- 前記コーティング層が前記基部構造の表面に直接接着している、請求項1に記載の医療用デバイス。
- 前記ガレート含有化合物が、前記コーティングからの前記水不溶性治療剤の放出速度を増加させるのに有効な量で存在する、請求項1に記載の医療用デバイス。
- 前記コーティングが前記水不溶性治療剤と前記ガレート含有化合物とから本質的になる、請求項1に記載の医療用デバイス。
- バルーンまたはステントを含む基部構造と、
ガレート含有化合物およびタキサン剤を含む組成物であって、前記ガレート含有化合物と前記タキサン剤がガレート含有化合物対タキサン剤の重量比1:40〜500:1で存在する組成物と、
を含む医療用デバイス。 - タキサン剤がパクリタキセルまたはドセタキセルである、請求項19に記載の医療用デバイス。
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BIOCHEMICAL AND BIOPHYSICAL RESEARCH COMMUNICATION, vol. 391, JPN6016030955, 2010, pages 716 - 721, ISSN: 0003594418 * |
Cited By (2)
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JP2020002061A (ja) * | 2018-06-28 | 2020-01-09 | 株式会社ファンケル | 胃内浮遊錠剤 |
JP7044649B2 (ja) | 2018-06-28 | 2022-03-30 | 株式会社ファンケル | 胃内浮遊錠剤 |
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US10328183B2 (en) | 2019-06-25 |
US9180226B1 (en) | 2015-11-10 |
US11058805B2 (en) | 2021-07-13 |
US20170100524A1 (en) | 2017-04-13 |
EP2982388A1 (en) | 2016-02-10 |
US20190262511A1 (en) | 2019-08-29 |
US20210386918A1 (en) | 2021-12-16 |
US20180280590A1 (en) | 2018-10-04 |
US11896742B2 (en) | 2024-02-13 |
JP6270165B2 (ja) | 2018-01-31 |
US9572914B2 (en) | 2017-02-21 |
EP2982388B1 (en) | 2018-04-11 |
US20240245839A1 (en) | 2024-07-25 |
US20160129161A1 (en) | 2016-05-12 |
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