JP2018171519A - 持続型薬物送達インプラント - Google Patents
持続型薬物送達インプラント Download PDFInfo
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
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- A61K9/0051—Ocular inserts, ocular implants
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- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
- A61F9/0008—Introducing ophthalmic products into the ocular cavity or retaining products therein
- A61F9/0017—Introducing ophthalmic products into the ocular cavity or retaining products therein implantable in, or in contact with, the eye, e.g. ocular inserts
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- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
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Abstract
Description
本出願は、2013年2月15日に出願の米国特許仮出願第61/765,554号の優先権を主張する。この仮出願の全内容は、参照により本明細書に組み込まれる。
いくつかの実施形態では、眼内インプラントは、適切なポリマー処理方法により形成できる。一実施形態では、治療薬(ブリモニジン遊離塩基など)の混合物を、タービュラ(Turbula)ミキサーなどのミキサーを使ってPLA及び/またはPLGAポリマーと混合できる。一実施形態では、眼内インプラントは押出成形により形成できる。押出成形は、Haake押出機などの適切な押出機により行うことができる。治療薬とポリマーマトリックスを一緒に混合した後、それらを押出機中に圧送供給して、フィラメントに成形できる。次に、押し出したフィラメントを目標重量のインプラントに切断できる。いくつかの実施形態では、800μgのインプラントを切断して、ブリモニジン遊離塩基送達期間の間、約300μg、400μg、500μgの薬剤を送達する。その後、インプラントは、25G塗布器などの注入装置に充填し、滅菌できる。一部の実施形態では、押し出されたフィラメントは、1000μg未満、800μg未満、または600μg未満の重量に切断される。いくつかの実施形態では、インプラントは、ガンマ線滅菌してもよい。インプラントは、例えば、20kGy〜60kGy、25kGy〜50kGy、25kGy〜40kGy、等の線量でガンマ線滅菌できる。
一実施形態では、後眼部疾患を治療する方法は、ヒトまたは動物患者の、好ましくは生きている人または動物の眼の眼球後区に、本明細書で開示のインプラントなどのインプラントを投与する工程を含む。いくつかの実施形態では、患者を治療する方法は、インプラントを眼の後眼房に直接配置する工程を含むことができる。いくつかの実施形態では、患者を治療する方法は、硝子体内注射、結膜下注射、テノン嚢下注射、眼球後注射、及び上脈絡膜注射の内の少なくとも1種により、患者にインプラントを投与する工程を含むことができる。
酒石酸ブリモニジンまたはブリモニジン遊離塩基及び生分解性ポリマーマトリックスを含む眼内インプラント実施例を作製し、それらの放出及び分解特性を試験した。酒石酸ブリモニジンまたはブリモニジン遊離塩基を、最初に秤量し、タービュラミキサーでPLA及び/またはPLGAポリマーと30分間混合した。次に、得られた粉末混合物を圧送機によりHaake押出機に供給した。押し出したフィラメントを、インプラント当たり300μgの酒石酸ブリモニジンまたは400μgのブリモニジン遊離塩基を送達するために、例えば、857μgまたは800μgの目標重量のインプラントに切り出した。インプラントを25G塗布器に充填し、25〜40kGy線量でガンマ線滅菌した。インプラント当たりの効力をHPLCアッセイにより確認した。
重量減少調査
インプラント重量減少調査では、各インプラントを最初に秤量し、プラスチックマイクロメッシュカセット中に移し、ガラスジャーの中でPBS(pH7.4、0.01M)を満たしその後37℃、50rpmに設定した振盪ウオーターバス中に置いてインキュベートした。指定の時点にインプラントを採取し、真空下で乾燥した。乾燥したインプラントの重量を記録し、インプラントの重量減少を計算した。結果を表Eにまとめている。この結果は、酒石酸ブリモニジンのインプラントより早くブリモニジン遊離塩基インプラントの重量が減少し、マトリックスの分解速度が異なることを意味し、実証していることを示す。
インプラント膨潤を調査するために、各インプラントを、20mLのPBS(pH7.4、0.01M)中でガラスシンチレーションバイアルに入れ、37℃、50rpmに設定した振盪ウオーターバス中に置いてインキュベートした。インプラント画像を記録し、表Fにまとめた。結果は、ブリモニジン遊離塩基インプラントが膨潤し、酒石酸ブリモニジンのインプラントよりもかなり高速で分解したことを示している。
ウサギとサルの眼における酒石酸ブリモニジン製剤の薬物放出を図3と4にそれぞれ示す。ウサギとサルの眼におけるブリモニジン遊離塩基製剤の薬物放出を図5と6に示す。
Claims (7)
- ヒト患者における後眼部疾患の治療用の眼内インプラントであって、
少なくとも1種の生分解性ポリマーを含む生分解性ポリマーマトリックスと、
ブリモニジン遊離塩基剤と
を含み、
前記インプラントが6ヶ月までのブリモニジン遊離塩基剤送達期間の間、後眼部疾患を罹患している患者の眼の硝子体に前記ブリモニジン遊離塩基剤を送達するように構成され、かつ前記生分解性ポリマーマトリックスが、前記眼の硝子体中に配置されると、前記ブリモニジン遊離塩基剤送達期間の約2倍の期間またはそれに満たない期間以内に、完全にまたはほぼ完全に分解するように構成される、
インプラント。 - 前記ブリモニジン遊離塩基剤が、前記インプラントの総重量を基準として、前記インプラントの約50重量%の量で前記インプラント中に存在する、請求項1に記載のインプラント。
- 前記インプラントがロッド形状をさらに含み、前記ロッド形状が約356μmのロッド径と約6mmのロッド長さを有する、請求項1に記載のインプラント。
- 前記ブリモニジン遊離塩基剤が前記生分解性ポリマーマトリックス内に均一に分散される、請求項1に記載のインプラント。
- 前記少なくとも1種の生分解性ポリマーがポリ(D,L−ラクチド−co−グリコリド)及びポリ(D,L−ラクチド)を含む、請求項1に記載のインプラント。
- 前記生分解性ポリマーマトリックスが酸エンドキャップポリ(D,L−ラクチド−co−グリコリド)及び酸エンドキャップポリ(D,L−ラクチド)からなる群から選択される少なくとも1種のポリマーを含む、請求項1に記載のインプラント。
- 前記ブリモニジン遊離塩基剤送達期間が約1ヶ月〜約6ヶ月の範囲である、請求項1に記載のインプラント。
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CA2901280A1 (en) | 2014-08-21 |
US20140234389A1 (en) | 2014-08-21 |
RU2015134774A (ru) | 2017-03-21 |
AU2019203546A1 (en) | 2019-06-13 |
JP6511401B2 (ja) | 2019-05-15 |
JP2016513109A (ja) | 2016-05-12 |
BR112015019546A2 (pt) | 2017-07-18 |
US20190209467A1 (en) | 2019-07-11 |
CN104994815A (zh) | 2015-10-21 |
US20210113458A1 (en) | 2021-04-22 |
RU2641021C2 (ru) | 2018-01-17 |
CN104994815B (zh) | 2018-07-31 |
CN109602691A (zh) | 2019-04-12 |
US20230172842A1 (en) | 2023-06-08 |
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