JP5897077B2 - ポリウレタン系ポリマーを有する長期薬物送達装置の生産方法 - Google Patents
ポリウレタン系ポリマーを有する長期薬物送達装置の生産方法 Download PDFInfo
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- JP5897077B2 JP5897077B2 JP2014157923A JP2014157923A JP5897077B2 JP 5897077 B2 JP5897077 B2 JP 5897077B2 JP 2014157923 A JP2014157923 A JP 2014157923A JP 2014157923 A JP2014157923 A JP 2014157923A JP 5897077 B2 JP5897077 B2 JP 5897077B2
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Description
本出願は、2008年9月30日出願の米国特許出願第12/242,497号の優先権を主張するものであり、出願の全開示は、参照により本明細書に援用されている。
その優れた生体適合性、生体安定性および物理的特性のため、ポリウレタンまたはポリウレタン含有ポリマーは、ペースメーカーリード、人工心臓、心臓弁、ステントカバー、人工腱、動脈および静脈をはじめとする、多数の埋め込み可能型装置の作製に用いられてきた。しかし、ポリウレタン埋め込み可能型装置を用いる活性薬物の送達用の処方物は、ゼロ次速度での薬物の拡散のために液体媒体または担体を必要とする。
[O−(CH2−CH2−CH2−CH2)]x−O−
と表され、この式では、「x」の増加は、可撓性の増加(「曲げ係数」、「Flex Modulus、FM」、の減少)を表し、約1,000〜92,000psiにわたるFMを生じさせる。これらの材料からの薬物放出の観点からすると、相対的に疎水性のAPIの放出は、FMが増加するにつれて減少する。
−[O−(CH2)n]x−O−
と表され、この式では、「n」および「x」の増加が親水性の変動を表し、約5%〜43%にわたる平衡含水率(%EWC)を生じさせる。これらの材料からの薬物放出の観点からすると、相対的に親水性のAPIの放出は、%EWCが増加するにつれて増加する。
O−[(CH2)6−CO3]n−(CH2)−O−
と表され、この式では、「n」の増加が可撓性の増加(FM減少)を表し、約620〜92,000psiにわたるFMを生じさせる。これらの材料からの薬物放出の観点からすると、相対的に疎水性のAPIの放出は、FMが増加するにつれて減少する。
(式中、
dM/dt :薬物放出速度;
h :装置の充填された部分の長さ;
ΔC :リザーバ壁にわたる濃度勾配;
ro/ri :装置の外半径の内半径に対する比;および
p :使用されるポリマーの透過係数。)
Tecophilic(登録商標)ポリウレタンポリマーチューブは、Thermedics Polymer Productsにより供給されており、精密押出プロセスによって製造される。Tecophilic(登録商標)ポリウレタンは、乾燥樹脂重量の150%以下の異なる平衡含水率(EWC)に配合することができる脂肪族ポリエーテル系熱可塑性ポリウレタンの1ファミリーである。押出しグレードの処方物を、熱成形チューブ材料または他の構成要素の最大の物理的特性をもたらすように設計する。例示的チューブおよび先端キャップ構造を図1〜3に図示する。
HP−60D−35を0.30mmの厚みと1.75mmの内径を有するチューブに押出す。その後、そのチューブを長さ32mmに切断する。ヒートシーラーを使用してチューブの片側を封止する。封止時間は、1分未満である。ナルトレキソンのペレット6個をそのチューブに装入し、チューブの両方の開口側面を熱で封止する。それぞれのペレットは、おおよそ15.0mgの重量であり、合計で91mgである。第一の先端の場合と同じ方法で第二の先端開口部を熱で封止する。その後、その装入されたインプラントをコンディショニングし、プライミングする。コンディショニングは、0.9%食塩水中で1週間、室温で行う。コンディショニングが完了したら、そのインプラントをプライミングに付す。プライミングは、1.8%食塩水中で1週間、室温で行う。各インプラントは、人体において見出されるpHを模倣するように選択した媒体中でインビトロで試験する。選択した媒体の温度を、その試験の間おおよそ37℃に保つ。それらの放出速度を図5および表3に示す。
図6において、含水率の異なる2つのグレードのポリマーを使用してインビトロでのナルトレキソンの放出速度を比較する。インプラントのポリマーが24%の含水率を有する場合の試験を3回行い、分析し、およびインプラントのポリマーが30%の含水率を有する場合の試験を3回行った。放出速度を時間に対してプロットした。24%含水率での試験に使用したポリマーは、ThermedicsからのTecophilic(登録商標)HP−60−D35であった。30%含水率での試験に用いたポリマーは、ThermedicsからのTecophilic(登録商標)HP−60−D60であった。この実施例において得たデータは、本発明に従って作製した場合のインプラントの良好な再現性を示している。
図7は、時間に対するヒストレリン(LHRHアゴニスト)の放出速度のプロットである。この実施例におけるポリマーは、15%の含水率を有した。使用したポリマーは、ThermedicsからのTecophilic(登録商標)HP−60−D20であった。週1回、データ点を取った。
図8は、時間に対するクロニジンの放出速度のプロットである。この実施例におけるポリマーは、15%の含水率を有した。使用したポリマーは、ThermedicsからのTecophilic(登録商標)HP−60−D20であった。週1回、データ点を取った。
表4A〜Cは、3つの異なるクラスのポリウレタン化合物(Tecophilic(登録商標)、Tecoflex(登録商標)およびCarbothane(登録商標))からの活性薬物の放出速度を示すものである。これらの放出速度をインプラントの表面積で正規化し、それによって、それらの様々な埋め込み可能型装置のサイズのわずかな差を調整した。ある範囲の可溶性(例えば、様々なLogP値によって示され、示したデータの意味については、約2.0より大きいLogP値では水溶液に容易に溶解しないと考える)および分子量にわたる活性薬物を選択した。水溶性活性薬物に対する様々な親和性および(曲げ係数の変動によって示されるような)様々な可撓性を有するポリウレタンを選択した。
ポリウレタン埋め込み可能型装置からのリスペリドンの溶出
図9〜14は、様々な期間にわたっての様々な埋め込み可能型装置からのリスペリドンの溶出プロフィールを示すグラフである。
リスペリドンを含むポリウレタン皮下インプラント装置のビーグル犬における評価
この研究の目的は、1つまたは2つのインプラントからのリスペリドンの血液レベルおよびそれらのインプラントが薬物を放出する継続期間を測定することである。リスペリドンを含むペレットを含むポリウレタン系埋め込み可能型装置をビーグルに埋め込んで、インビボでのリスペリドンの放出速度を測定した。サンプル分析結果を表5および図14にまとめる。リスペリドンは、第3月の終わりに依然として高レベルでイヌの血漿に存在する。この研究は、WCFPの標準操作手順書(standard operating procesures:SOPs)、そのプロトコル、および任意のプロトコルの改定に従って行った。すべての手順は、実験動物の管理と使用に関する指針(the Guide for the Care and Use of Laboratory Animals)(National Research Center,National Academy Press,Washington,DC.1996)に従って行い、WCFPにおける研究機関内動物管理使用委員会(the Institutional Animal Care and Use Committee)によって承認されたものであった。
種:イヌ科の動物
系統:ビーグル犬
供給業者:Guangzhou Pharm.Industril Reserch Institute,Certification No:SCXK(YUE)2003−0007
処置開始時の歳:6〜9ヶ月
体重:8〜10kg
数および性別:オス6匹
本開示は、本出願に記載する特定の実施形態によって限定されず、これらの実施形態は、様々な態様の例示を意図するものである。当業者には明らかであるように、本開示の精神および範囲を逸脱することなく、多くの変更および変形を加えることができる。本明細書において列挙するものに加えて、本開示の範囲内の機能的に等価の方法、系および装置が、上記の説明から当業者には明らかであろう。そのような変更および変形は、添付のクレームの範囲内に入ると解釈される。本開示は、添付のクレームと、当該クレームの均等物の全範囲によってのみ限定されるものである。本開示が、特定の方法、試薬、化合物、組成物または生体系に限定されない(これらは勿論様々であり得る)ことは、理解されよう。本明細書において用いる用語が、単に特定の実施形態を説明するためのものであり、限定を意図したものでないことも理解されよう。当業者には理解されるように、任意のまたはすべての意味で、例えば、記載する説明の提供に関して、本明細書に開示するすべての範囲は、任意のおよびすべての可能な下位範囲およびそれらの下位範囲の組み合わせも包含する。
Claims (17)
- 少なくとも1つの活性薬物を長期間にわたって制御放出して局所性または全身性薬理効果を生じさせる薬物送達装置の生産方法であって、
前記薬物送達装置は、
a)ポリオールセグメントの一般構造が、[O−(CH2−CH2−CH2−CH2)]x−O−と表され、前記xが増加すると曲げ係数が減少する、ポリウレタン系ポリマーと、
b)少なくとも1つの活性薬物と医薬的に許容される担体としてのステアリン酸とを含む固形医薬処方物と、
を含み、
前記固形医薬処方物が、円筒形リザーバの前記中空空間内にあり、
前記生産方法は、
ポリウレタン系ポリマーを通しての拡散による、前記活性薬物の放出が、ポリウレタン系ポリマーの曲げ係数の低下により一般的に増加する関係を利用して、該ポリウレタン系ポリマーを選択することを特徴とする、薬物送達装置の生産方法。 - 少なくとも1つの活性薬物を長期間にわたって制御放出して局所性または全身性薬理効果を生じさせる薬物送達装置の生産方法であって、
前記薬物送達装置は、
a)ポリオールセグメントの一般構造が、O−[(CH2)6−CO3]n−(CH2)−O−と表され、前記nが増加すると曲げ係数が減少するポリウレタン系ポリマーと、
b)少なくとも1つの活性薬物を含む固形医薬処方物と、
を含み、
前記固形医薬処方物が、円筒形リザーバの前記中空空間内にあり、
前記生産方法は、
ポリウレタン系ポリマーを通しての拡散による、前記活性薬物の放出が、ポリウレタン系ポリマーの曲げ係数の低下により一般的に増加する関係を利用して、該ポリウレタン系ポリマーを選択することを特徴とする、薬物送達装置の生産方法。 - 前記薬物送達装置が、前記少なくとも1つの活性薬物の前記水溶性特性に合わせて選択された条件下で、該活性薬物の前記ポリウレタン系ポリマー中への装填を促進するように所定の媒体中に放置するコンディショニング、および該活性薬物の前記ポリウレタン系ポリマー中への装填を抑制するように所定の媒体中に放置するプライミングに付される、請求項1又は2に記載の薬物送達装置の生産方法。
- 前記少なくとも1つの薬物が、中枢神経系に作用する薬物、精神賦活薬、精神安定薬、抗痙攣薬、筋弛緩薬、抗パーキンソン薬、鎮痛薬、抗炎症薬、麻酔薬、鎮痙薬、筋収縮薬、抗菌薬、抗マラリア薬、ホルモン薬、交感神経興奮薬、心血管薬、利尿薬および抗寄生虫薬からなる群より選択される、請求項1又は2に記載の薬物送達装置の生産方法。
- 前記固形医薬処方物が、医薬的に許容される担体をさらに含む、請求項2に記載の薬物送達装置の生産方法。
- 前記医薬的に許容される担体が、ステアリン酸である、請求項5に記載の薬物送達装置の生産方法。
- 適切なコンディショニングおよびプライミングパラメータを、前記少なくとも1つの活性薬物の前記所望の送達速度を確立するように選択することができ、前記プライミングパラメータが、時間、温度、コンディショニング媒体およびプライミング媒体である、請求項3に記載の薬物送達装置の生産方法。
- 前記活性薬物がリスペリドンである、請求項1又は2に記載の薬物送達装置の生産方法。
- 前記活性薬物がデキサメタゾンである、請求項1又は2に記載の薬物送達装置の生産方法。
- 前記活性薬物がナルトレキソンである、請求項1又は2に記載の薬物送達装置の生産方法。
- 前記活性薬物がメトラゾンである、請求項1又は2に記載の薬物送達装置の生産方法。
- 前記活性薬物がクロニジンである、請求項1又は2に記載の薬物送達装置の生産方法。
- 前記活性薬物がセレギリンである、請求項1又は2に記載の薬物送達装置の生産方法。
- 前記ポリウレタン系ポリマーの曲げ係数が、1,000〜92,000psiである、請求項1に記載の薬物送達装置の生産方法。
- 前記ポリウレタン系ポリマーの曲げ係数が、620〜92,000psiである、請求項2に記載の薬物送達装置の生産方法。
- 前記固形医薬処方物は2%のステアリン酸を含むことを特徴とする、請求項1又は6に記載の薬物送達装置の生産方法。
- 前記リザーバの壁の厚さが0.2mmである、請求項1又は2に記載の薬物送達装置の生産方法。
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JP (2) | JP5677962B2 (ja) |
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- 2009-09-28 CN CN200980142350.9A patent/CN102202647B/zh not_active Expired - Fee Related
- 2009-09-28 UA UAA201105432A patent/UA106593C2/uk unknown
- 2009-09-28 KR KR1020117008350A patent/KR20110063536A/ko not_active Application Discontinuation
- 2009-09-28 WO PCT/US2009/058571 patent/WO2010039641A2/en active Application Filing
- 2009-09-28 BR BRPI0920824A patent/BRPI0920824A2/pt not_active Application Discontinuation
- 2009-09-28 CA CA2739178A patent/CA2739178C/en not_active Expired - Fee Related
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HK1157646A1 (zh) | 2012-07-06 |
UA106593C2 (uk) | 2014-09-25 |
US8460274B2 (en) | 2013-06-11 |
JP5677962B2 (ja) | 2015-02-25 |
AU2009298720B2 (en) | 2015-07-16 |
US20090098182A1 (en) | 2009-04-16 |
KR20110063536A (ko) | 2011-06-10 |
EP2344123A2 (en) | 2011-07-20 |
US8303977B2 (en) | 2012-11-06 |
US20140012222A1 (en) | 2014-01-09 |
AU2009298720C1 (en) | 2015-12-17 |
CA2739178A1 (en) | 2010-04-08 |
US20120231061A1 (en) | 2012-09-13 |
JP2012504138A (ja) | 2012-02-16 |
CN102202647A (zh) | 2011-09-28 |
RU2508089C2 (ru) | 2014-02-27 |
US20150105746A1 (en) | 2015-04-16 |
US8784865B2 (en) | 2014-07-22 |
JP2014224137A (ja) | 2014-12-04 |
US7858110B2 (en) | 2010-12-28 |
IL211954A0 (en) | 2011-06-30 |
MX2011003299A (es) | 2011-06-09 |
AU2009298720A1 (en) | 2010-04-08 |
CN102202647B (zh) | 2015-11-25 |
RU2011117328A (ru) | 2012-11-10 |
US20110184376A1 (en) | 2011-07-28 |
CA2739178C (en) | 2016-09-06 |
WO2010039641A3 (en) | 2010-07-29 |
WO2010039641A2 (en) | 2010-04-08 |
BRPI0920824A2 (pt) | 2018-05-29 |
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