JP2009528276A - 安定な製剤ならびにそれらを調製および使用する方法 - Google Patents
安定な製剤ならびにそれらを調製および使用する方法 Download PDFInfo
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- JP2009528276A JP2009528276A JP2008554395A JP2008554395A JP2009528276A JP 2009528276 A JP2009528276 A JP 2009528276A JP 2008554395 A JP2008554395 A JP 2008554395A JP 2008554395 A JP2008554395 A JP 2008554395A JP 2009528276 A JP2009528276 A JP 2009528276A
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- rapamycin
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Abstract
Description
治療剤を含む製剤ならびにそれらを調製および使用する方法が本明細書に記載される。ラパマイシン製剤ならびにそれらを調製および使用する方法が本明細書に記載される。
この出願は、2006年2月9日に出願された表題「Stable Formulations, And Methods Of Their Preparation And Use」の米国仮特許出願第60/772,018号(この内容は、全ての目的に関してその全体が参考として本明細書に援用される)に関し、かつそれからの優先権を主張する。
治療薬を含む多数の製剤は、ある期間後には、例えばある期間にわたって保管された場合は、それらを不安定にする1つ以上の要素もしくは状態に対して感受性である。1つのそのような要素もしくは状態は、例えば前記製剤を含有する容器の死腔もしくはヘッドスペースなどの前記製剤を取り囲む空間において、酸素を含むがそれには限定されない空気の1つ以上の要素に対して感受性である。また別のそのような要素もしくは状態は、前記製剤中の酸素を含むがそれには限定されない気体もしくは溶解ガスの存在、または前記製剤の1つ以上の要素の光線、汚染物質、もしくは細菌などの微生物への曝露である。また別のそのような状態もしくは要素は、ヘッドスペース対充填容積の比率である。また別のそのような状態もしくは要素は、前記製剤の活性物質を含むがそれには限定されない製剤中の1つ以上の成分の量に比較した特定分子の量である。
本明細書では、ラパマイシンを含む安定性製剤を含む治療薬を含む安定性製剤、医薬製剤、単位製剤、キット、安定性製剤を調製する方法、および安定性製剤を使用する方法について記載する。安定性製剤には、制限なく、液剤、懸濁剤、自己乳化製剤、およびインサイチューゲル化(in situ gelling)製剤が含まれる。
本明細書では、製剤、医薬製剤、単位製剤、キット、および本明細書に記載した安定性製剤を調製および使用する方法について記載する。これらの安定性製剤および医薬製剤は、本明細書に記載した1つ以上のプロセスによって調製できる。一部の変形形態では、安定性製剤は、空気の1つ以上の成分に対して感受性である1つ以上の成分を含んでいる。一部の変形形態では、治療薬は、酸素を含むがそれには限定されない空気の1つ以上の成分に対して感受性である。一部の変形形態では、治療薬は、ラパマイシンである。
状況が明確に他のことを指示しない限り、本明細書に記載した製剤もしくは医薬製剤のいずれも本明細書に記載した方法によって調製できる。状況が明確に他のことを指示しない限り、本明細書に記載したように調製される任意の製剤もしくは医薬製剤は、本明細書に記載したとおりに安定性である。本明細書に記載した前記安定性製剤および医薬製剤の非限定的な例は、安定性の液剤、エマルジョン、自己乳化製剤、ゲル化製剤、インサイチューゲル化製剤、懸濁剤、またはナノ懸濁剤である。安定性非液体製剤の非限定的な例には、ポリマーインプラントもしくは錠剤を含むがそれらに限定されない非液体もしくは固体製剤が含まれる。状況が明確に他のことを指示しない限り、任意の液体製剤は、溶解窒素もしくは酸素のレベルのいずれか1つまたは複数を本明細書に記載したレベルに修正する工程によって安定性にすることができる。状況が明確に他のことを指示しない限り、任意の液体製剤は、ヘッドスペースガス中の窒素もしくは酸素のレベルのいずれか1つまたは複数を本明細書に記載したレベルに修正する工程によって安定性にすることができる。状況が明確に他のことを指示しない限り、任意の液体製剤は、ヘッドスペース対充填容積比を本明細書に記載したとおりに修正する工程によって安定性にすることができる。状況が明確に他のことを指示しない限り、任意の液体製剤は、本明細書に記載した液体製剤中において、ラパマイシンなどの活性物質のmgを含むがそれには限定されない製剤成分1mg当たりのヘッドスペース内の酸素ガスの量を含むがそれには限定されない1つの要素のμL数を修正する工程によって安定性にすることができる。状況が明確に他のことを指示しない限り、表2に示した任意の製剤は、本明細書に記載した方法の1つ以上の工程によって調製された場合は本明細書に記載した安定性製剤にすることができ、そして本明細書に記載した任意の安定性製剤は、本明細書に記載した方法において使用されることができる。表2に列挙した製剤は、液剤(「S」)、懸濁剤(「SP」)、インサイチューゲル化製剤(「ISG」)、または自己乳化製剤(SEF)のうちの1つまたは複数として表示される。これらの製剤についての詳細は、例えばLIQUID FORMULATIONS FOR TREATMENT OF DISEASES OR CONDITIONSと題する弁護士事件整理番号57796−20004.00が付された2006年2月9日に出願された同時係属出願の第11/351,761号、およびLIQUID FORMULATIONS FOR TREATMENT OF DISEASES OR CONDITIONSと題する弁護士事件整理番号57796−30004.00が付された2005年2月9日に出願された米国特許第60/664,040号の中に見いだすことができるが、それらの各々は全体として参照して組み込まれる。
最も一般的には、空気の1つ以上の成分、熱、もしくは光線に対して感受性である任意の化合物は、本明細書に記載した安定性製剤において使用できる。状況が他のことを指示しない限り、本明細書に記載した製剤、医薬製剤、単位製剤、キット、調製方法、および使用方法のいずれか1つまたは複数において任意の治療薬を使用できる。一部の変形形態では、治療薬は、酸素、熱、もしくは光線の1つまたは複数に対して感受性である。
トリアムシノロンベネトニド、およびトリアムシノロンヘキサセトニド、非ステロイド性抗炎症薬、アミノアリールカルボン酸誘導体系(例えば、エンフェナム酸、エトフェナメート、フルフェナム酸、イソニキシン、メクロフェナム酸、メフェナム酸、ニフルミン酸、タルニフルメート、テロフェナメート、トルフェナム酸)、アリール酢酸誘導体系(例えば、アセクロフェナク、アセメタシン、アルクロフェナク、アムフェナク、アムトルメチングアシル、ブロムフェナク、ブフェキサマク、シンメタシン、クロピラク、ジクロフェナクナトリウム、エトドラク、フェルビナク、フェンクロジン酸、フェンチアザク、グルカメタシン、イブフェナク、インドメタシン、イソフェゾラク、イソキセパック、ロナゾラク、メチアジン酸、モフェゾラク、オキサメタシン、ピラゾラク、プログルメタシン、スリンダク、チアラミド、トルメチン、トロペシン、ゾメピラク)、アリール酪酸誘導体系(例えば、ブマジゾン、ブチブフェン、フェンブフェン、キセンブシン)、アリールカルボン酸系(例えば、クリダナク、ケトロラク、チノリジン)、アリールプロピオン酸誘導体系(例えば、アルミノプロフェン、ベノキサプロフェン、ベルモプロフェン、ブクロクス酸、カルプロフェン、フェノプロフェン、フルノキサプロフェン、フルルビプロフェン、イブプロフェン、イブプロキサム、インドプロフェン、ケトプロフェン、ロキソプロフェン、ナプロキセン、オキサプロジン、ピケトプロレン、ピルプロフェン、プラノプロフェン、プロチジン酸、スプロフェン、チアプロフェン酸、キシモプロフェン、ザルトプロフェン)、ピラゾール系(例えば、ジフェナミゾール、エピリゾール)、ピラゾロン系(例えば、アパゾン、ベンズピペリロン、フェプラゾン、モフェブタゾン、モラゾン、オキシフェンブタゾン、フェニルブタゾン、ピペブゾン、プロピフェナゾン、ラミフェナゾン、スキシブゾン、チアゾリノブタゾン)、サリチル酸誘導体系(例えば、アセトアミノザロール、アスピリン、ベノリレート、ブロモサリゲニン(bromosaligenin)、アセチルサリチル酸カルシウム、ジフルニサル、エテルサレート、フェンドーサル、ゲンチジン酸、サリチル酸グリコール、サリチル酸イミダゾール、アセチルサリチル酸リシン、メサラミン、サリチル酸モルホリン、サリチル酸1−ナフチル、オルサラジン、パルサルミド、アセチルサリチル酸フェニル、サリチル酸フェニル、サラセタミド、サリチルアミドO−酢酸(salicylamide o−acetic acid)、サリチル硫酸、サルサレート、フルファサラジン)、チアジン力ルボキサミド系(例えば、アンピロキシカム、ドロキシカム、イソキシカム、ロモキシカム、ピロキシカム、テノキシカム)、ε−アセトアミドカプロン酸、S−アデノシルメチオニン、3−アミノ−4−ヒドロキシ酪酸、アミキセトリン、ベンダザック、ベンジダミン、a−ビサボロール、ブコローム、ジフェンピラミド、ジタゾール、エモルファゾン、フェプラジノール、グアイアズレン、ナブメトン、ニメスリド、オキサセプロール、パラニリン(paranyline)、ペリソキサール、プロカゾン、スーパーオキシドジスムターゼ、テニダプ、およびジロイトンが含まれる。
状況が明白に他のことを指示しない限り、本明細書に記載した任意の1つ以上の治療薬は、本明細書に記載した安定性製剤中に使用できることが意図されている。状況が明白に他のことを指示しない限り、本明細書に記載した任意の1つ以上の安定性製剤は、本明細書に記載した任意の1つ以上の疾患もしくは状態を治療する、予防する、阻害する、または発生を遅延させるために使用できることが意図されている。状況が明白に他のことを指示しない限り、前記安定性製剤は、必ずしも必要ではないが、本明細書に記載した任意の1つ以上の方法によって形成できることが意図されている。
本明細書に記載したように投与するための治療薬の、本明細書ではさらに「治療有効量」とも呼ぶ「有効量」は、被験体に投与された場合に求められる治療作用を提供する治療薬の量である。相違する治療作用を達成するには、治療薬の相違する有効量を必要とすることがある。例えば、疾患もしくは状態を予防するために使用する治療薬の治療有効量は、前記疾患もしくは状態を治療する、阻害する、発生を遅延させる、または退行を引き起こすために使用される治療有効量とは相違する可能性がある。さらに、治療有効量は、取り扱われる疾患もしくは状態に熟知した当業者にはよく知られているように、前記被験体の年齢、体重、およびその他の健康状態に依存することがある。そこで、治療有効量は、前記治療薬が投与される各被験体において同一ではない可能性がある。
使用できる1つの製剤もしくは液体製剤は、前記治療薬が溶媒成分中に溶解している製剤もしくは液体製剤である。一般に、その中に前記治療薬が溶解する所望の作用を有する任意の溶媒が使用されてよい。一部の変形形態では、溶媒は水性である。一部の変形形態では、溶媒は非水性である。「水性溶媒」は、少なくとも約50%の水を含有する溶媒である。
治療薬がラパマイシンである場合は、溶媒には、DMSO、グリセリン、エタノール、メタノール、イソプロピルアルコール;ヒマシ油、プロピレングリコール、トリエチレングリコール、トリアセチン、ジアセチン、コーン油、アセチルクエン酸トリエチル(ATC)、乳酸エチル、ポリビニルプロピレン、ポリソルベート80、ベンジルアルコール、ジメチルアセトアミド(DMA)、ジメチルホルムアミド(DMF)、グリセロールホルマール、エトキシジグリコール(Transcutol、Gattefosse)、トリエチレングリコールジメチルエーテル(Triglyme)、ジメチルイソソルビド(DMI)、γ−ブチロラクトン、N−メチル−2−ピロリジノン(NMP)、PEG 300およびPEG 400を含むがそれらに限定されない様々な分子量のポリエチレングリコール、ならびにポリグリコール酸カプリルグリセリド(Labrasol、Gattefosse)のうちのいずれか1つまたは複数が含まれるがそれらに限定されない上述の任意の溶媒が含まれるがそれらに限定されない。
一般に、本明細書に記載した液体製剤中には、任意の可溶化剤または可溶化剤の組み合わせを使用できる。
ラパマイシンのためには、本明細書に記載したものを含むがそれらに限定されない多数の可溶化剤を使用できる。
本明細書に記載した液体製剤は、粘度改変剤とともに投与することができる、または粘度改変剤をさらに含んでもよい。
状況が明確に他のことを指示しない限り、本明細書に記載した製剤のいずれも本明細書に記載した医薬製剤のいずれかに使用できる。
ラパマイシンを含む液体製剤を含むがそれには限定されない本明細書に記載した液体製剤を調製するために使用できる1つの非限定的な方法は、溶媒および治療薬を室温またはわずかに上昇させた温度で、任意で超音波処理装置を使用して溶液もしくは懸濁液が得られるまで一緒に混合し、その後に前記製剤を冷却させる工程による。上述したものを含むがそれらに限定されない他の成分は、次に前記製剤と混合されてよい。その他の調製方法を使用することができ、本明細書に記載した教示を前提にすると当業者であれば同定することができるであろう。
本明細書では、本明細書に記載した治療薬および製剤、液体製剤、ならびに方法を使用して、治療する、予防する、阻害する、発生を遅延させる、または退行を引き起こすことのできる疾患および状態の非限定的な例について記載する。一部の実施形態では、疾患もしくは状態は、本明細書に記載した治療薬および液体製剤、ならびに方法を用いて治療される。状況が他のことを指示しない限り、治療の方法の全部が実施される被験体にはヒト被験体が含まれることは想定されている。
本明細書に記載した製剤、方法、および液体製剤は、ヒト被験体を含むがそれには限定されない被験体に1つ以上の治療薬を送達する。
本明細書に記載した一部の変形形態では、ラパマイシンを含む安定性製剤は、ヒト被験体を含むがそれには限定されない被験体の眼の結膜下もしくは硝子体へ、例えばAMDにおいて観察されるようなCNVを治療する工程を含むがそれには限定されない眼における血管形成を予防する、治療する、阻害する、発生を遅延させる、または退行を引き起こすために送達される。一部の変形形態では、安定性製剤は、例えばAMDにおいて観察されるようなCNVを治療するためを含むがそれには限定されない眼における血管形成を治療するために使用される。ラパマイシンは、参照して全体として本明細書に組み込まれる米国特許出願第10/665,203号に記載されたラットおよびマウスモデルにおけるCNVを阻害することが証明されている。ラパマイシンは、全身性および網膜下に投与された場合にMatrigel(商標)およびレーザー誘導性CNVを阻害することが観察されている。
超音波処理によるラパマイシン含有溶液の調製
ラパマイシンを100%エタノール中に超音波処理によって溶解させた。過剰なエタノールは強制蒸発によって除去した。PEG 400を超音波処理した。ラパマイシン−エタノール溶液をPEG 400に加え、この混合液を溶液が形成されるまで超音波処理した。超音波処理は、長期間にわたって混合液の温度が40℃を超えないように実施した。最終製剤重量%としての最終濃度はおよそ、ラパマイシンは2%(w/w)、エタノールは4%(w/w)、およびPEG 400は94%(w/w)であった。この溶液を0.2ミクロンフィルターに通す濾過によって殺菌した。
回転蒸発によるラパマイシン含有溶液の調製
一部のサンプルでは、BHT(ブチル化ヒドロキシトルエン)は、シロリムス(ラパマイシン)のストック液を調製する前にエタノールに加えた。ラパマイシンは100%エタノールに加えたが、そのエタノールはBHTを有していた、または有していなかった。この混合液は、溶解酸素を減少させるために十分な期間にわたって、そして全ラパマイシンが溶液中に入ってラパマイシンストック液を形成するまで、超音波処理した。希釈溶媒は、溶解酸素を減少させるために十分な期間にわたってPEG 400を調製することによって調製した。
超音波処理、回転蒸発、および窒素スパージによるラパマイシン含有溶液の調製
液体製剤の調製および包装の1つの実施例では、約320gの100%エタノールを約10分間にわたって医療グレードの圧縮窒素を用いてスパージした。一部のサンプルでは、BHT(ブチル化ヒドロキシトルエン)は、ラパマイシンのストック液を調製する前にエタノールに加えた。40gのラパマイシンをエタノールに加えたが、そのエタノールはBHTを有していた、または有していなかった。混合液は、約20分間にわたって超音波処理したが、その終了時に全ラパマイシンは溶液中に入ってシロリムスストック液を形成していた。希釈溶媒は、約60分間にわたって約1,880gのPEG 400を超音波処理し、そして次に約10分間にわたって窒素を用いて溶媒をスパージした。
超音波処理、回転蒸発、窒素スパージ、および窒素被覆によるラパマイシン含有溶液の調製
(a)エタノールを排出するための回転蒸発工程、(b)溶液を濾過する工程、および(c)バイアルに充填する工程の各々の約5分後に医療グレードの圧縮窒素を用いてラパマイシン溶液を被覆する追加の工程を用いて実施例3に記載した方法を実施した。これらの実験では、サンプルにBHTを追加しなかった。全バイアルは2mLの透明ガラス製であり、0.5mLもしくは2.0mLいずれかの製剤を充填した。
表2に列挙した液体製剤のいずれか1つまたは複数は、超音波処理によって調製できる。一般に、酸素を含むがそれには限定されない空気の1つ以上の成分に対して感受性である治療薬を含む安定性製剤を調製するために、前記製剤の1つ以上の成分は、酸素含量を減少させるために処理される。液体製剤の1つ以上の成分は、前記1つ以上の成分を脱気するために十分な期間にわたって超音波処理される。前記1つ以上の成分は、前記液体製剤の他の成分との結合の前または後のいずれかに超音波処理される。超音波処理は、超音波処理前の治療薬に比較して治療薬の安定性を保持する条件下で実施される。液体製剤の1つ以上の成分が温度に感受性である場合は、超音波処理は、1つ以上の温度感受性成分の安定性が保持されるような条件下で実施される。治療薬がラパマイシンである場合は、その温度は、好ましくは長期間にわたって40℃を超えない。液体製剤の1つ以上の成分が光線に感受性である場合は、超音波処理は、1つ以上の温度感受性成分の安定性が保持されるような条件下で実施される。
表2に列挙した液体製剤のいずれか1つまたは複数は、本明細書に記載したプロセスによって調製される。一般に、酸素を含むがそれには限定されない空気の1つ以上の成分に対して感受性である治療薬を含む安定性製剤を調製するために、前記製剤の1つ以上の成分は、酸素含量を減少させるために処理される。前記製剤の1つ以上の成分は、窒素、アルゴン、もしくはヘリウムを含むがそれらに限定されない希ガスなどの不活性ガスでスパージされる。
表2に列挙した液体製剤のいずれか1つまたは複数は、本明細書に記載したプロセスによって調製される。一般に、酸素を含むがそれには限定されない空気の1つ以上の成分に対して感受性である治療薬を含む安定性製剤を調製するために、前記製剤の1つ以上の成分は、酸素含量を減少させるために処理される。前記製剤の1つ以上の成分は、窒素、アルゴン、もしくはヘリウムを含むがそれらに限定されない希ガスなどの不活性ガスで被覆される。
安定性懸濁液は、実施例5〜7に記載した安定性製剤を製造する方法のいずれか1つまたは複数によって調製される。一般に、酸素を含むがそれには限定されない空気の1つ以上の成分に対して感受性である治療薬を含む安定性懸濁液を調製するために、前記製剤の1つ以上の成分は、酸素含量を減少させるために処理される。前記液体製剤の1つ以上の成分は、超音波処理、不活性ガスを用いたスパージ、または不活性ガスを用いた被覆のうちの1つまたは複数によって処理されるが、このとき前記不活性ガスは、窒素、アルゴン、またはヘリウムである希ガスである。
溶解ガス中の酸素の測定
要約すると、光ファイバー酸素センサーは、ガスおよび液体中の酸素部分圧を監視するための位相蛍光光度計結合センサーであった。蛍光法を使用して、溶解もしくは気体酸素の部分圧を測定した。光ファイバーは、青色LEDによって生成された励起光をプローブチップの薄膜コーティングへ運んだ。プローブは、チップで発生した蛍光を収集し、光ファイバーを通してそれを高感受性分光計へ運んだ。蛍光消光度は、衝突回数に、このために酸素含有媒質の濃度、圧力および温度に関連している。
酸素レベルおよび製剤の安定性
2%(w/w)のラパマイシン、4%(w/w)のエタノール、94%(w/w)のPEG400製剤は、実施例3の方法によって調製され、表3に示した空気もしくは気体を用いて被覆された。窒素被覆は、ヘッドスペース内で0.8%酸素ガスを生じさせた。空気被覆は、ヘッドスペース内で20.4%酸素ガスを生じさせた。酸素被覆は、ヘッドスペース内で84.7%酸素ガスを生じさせた。
2%ラパマイシン製剤における製剤濃度とラパマイシン1mg当たりのヘッドスペース内の酸素(μL)との相関
2%ラパマイシン製剤におけるラパマイシン1mg当たりのヘッドスペース内の酸素の量(μL)は、多数のサンプルについて計算し、ある期間にわたる製剤濃度にラパマイシン1mg当たりの酸素の量(μL)が及ぼす作用は、図6A、6C、7A、および8Aに示されている。
ヘッドスペース対充填容積比と製剤濃度との相関関係
ヘッドスペース対充填容積の比率は、図6B、7Bおよび8Bに示した。ヘッドスペース対充填容積比は、ヘッドスペース容積を充填容積で割ることによって計算した。充填容積当たりのヘッドスペース比は表4に示した。バイアルは全部が2mLバイアルであったが、これらのバイアル中にはヘッドスペース対充填容積比を計算する際に考慮に入れた追加のヘッドスペース容積が存在することに留意されたい。
Claims (54)
- イムノフィリン結合化合物、それらの医薬上許容されるプロドラッグ、それらの医薬上許容されるアナログ、それらの医薬上許容される塩、それらの医薬上許容される誘導体、およびそれらの医薬上許容されるエステルからなる群より選択される、活性物質を含む液体製剤であって、溶解ガス中に20%以下の酸素%を有する、液体製剤。
- 溶解ガス中に17.5%以下の酸素%を有する、請求項1に記載の液体製剤。
- 溶解ガス中に16.5%以下の酸素%を有する、請求項2に記載の液体製剤。
- イムノフィリン結合化合物、それらの医薬上許容されるプロドラッグ、それらの医薬上許容されるアナログ、それらの医薬上許容される塩、それらの医薬上許容される誘導体、およびそれらの医薬上許容されるエステルからなる群より選択される、活性物質を含む液体製剤を含む密封容器であって、該液体製剤は20%以下の酸素を有するヘッドスペースガスと接触している、密封容器。
- 前記活性物質は、ラパマイシン、SDZ−RAD、タクロリムス、エベロリムス、ピメクロリムス、CCI−779、AP23841、ABT−578、TAFA−93、RAD−001、テムシロリムス、AP23573、7−エピ−ラパマイシン、7−チオメチル−ラパマイシン、7−エピ−トリメトキシフェニル−ラパマイシン、7−エピ−チオメチル−ラパマイシン、7−デメトキシ−ラパマイシン、32−デメトキシ−ラパマイシン、2−デスメチル−ラパマイシン、ラパマイシンのモノエステル誘導体、ラパマイシンのジエステル誘導体、ラパマイシンの27−オキシム;ラパマイシンの42−オキソアナログ;二環式ラパマイシン;ラパマイシン二量体;ラパマイシンのシリルエーテル;ラパマイシンアリールスルホン酸塩、ラパマイシンスルファミン酸塩、31位および42位でのモノエステル、31位および42位でのジエステル、30−デメトキシラパマイシン、ならびにそれらの医薬上許容されるプロドラッグ、アナログ、塩およびエステルからなる群より選択される、請求項4に記載の密封容器。
- 前記活性物質は、ラパマイシン、SDZ−RAD、タクロリムス、エベロリムス、ピメクロリムス、CCI−779、AP23841、ABT−578、ならびにそれらの医薬上許容される塩およびエステルからなる群より選択される、請求項4に記載の密封容器。
- 前記活性物質は、ラパマイシンである、請求項6に記載の密封容器。
- 前記液体製剤は、10%以下の酸素ガスを有するヘッドスペースガスと接触している、請求項4に記載の密封容器。
- 前記液体製剤は、5%以下の酸素ガスを有するヘッドスペースガスと接触している、請求項4に記載の密封容器。
- 空気の1つ以上の成分に対して感受性である治療薬を含む眼に使用するための液体製剤であって、該治療薬の製剤濃度は、25℃および相対湿度60%で少なくとも2週間にわたって少なくとも80%であり、該製剤は眼の1つ以上の組織に対して毒性である保存料を含有していない液体製剤。
- 前記治療薬の製剤濃度は、25℃および相対湿度60%で少なくとも2週間にわたって少なくとも90%である、請求項10に記載の液体製剤。
- 前記治療薬の製剤濃度は、25℃および相対湿度60%で少なくとも1カ月間にわたって少なくとも90%である、請求項11に記載の液体製剤。
- 前記治療薬の製剤濃度は、25℃および相対湿度60%で少なくとも2カ月間にわたって少なくとも90%である、請求項11に記載の液体製剤。
- 前記治療薬の製剤濃度は、25℃および相対湿度60%で少なくとも3カ月間にわたって少なくとも90%である、請求項11に記載の液体製剤。
- 前記治療薬の製剤濃度は、5℃で少なくとも3カ月間にわたって少なくとも90%である、請求項10に記載の液体製剤。
- 前記治療薬の製剤濃度は、5℃で少なくとも約1年間にわたって少なくとも90%である、請求項15に記載の液体製剤。
- 前記治療薬の製剤濃度は、5℃で少なくとも2年間にわたって少なくとも90%である、請求項15に記載の液体製剤。
- 前記製剤は、保存料を含有していない、請求項10に記載の液体製剤。
- 前記製剤は、酸化防止剤を含有していない、請求項15に記載の液体製剤。
- 前記活性物質は、イムノフィリン結合化合物、それらの医薬上許容されるプロドラッグ、それらの医薬上許容されるアナログ、それらの医薬上許容される塩、それらの医薬上許容される誘導体、およびそれらの医薬上許容されるエステルからなる群より選択される、請求項15または17のいずれかに記載の液体製剤。
- 前記活性物質は、ラパマイシン、SDZ−RAD、タクロリムス、エベロリムス、ピメクロリムス、CCI−779、AP23841、ABT−578、シクロフィリン、FK506結合タンパク質(FKBP)、TAFA−93、RAD−001、テムシロリムス、AP23573、7−エピ−ラパマイシン、7−チオメチル−ラパマイシン、7−エピ−トリメトキシフェニル−ラパマイシン、7−エピ−チオメチル−ラパマイシン、7−デメトキシ−ラパマイシン、32−デメトキシ−ラパマイシン、2−デスメチル−ラパマイシン、ラパマイシンのモノエステル誘導体、ラパマイシンのジエステル誘導体、ラパマイシンの27−オキシム;ラパマイシンの42−オキソアナログ;二環式ラパマイシン;ラパマイシン二量体;ラパマイシンのシリルエーテル;ラパマイシンアリールスルホン酸塩、ラパマイシンスルファミン酸塩、31位および42位でのモノエステル、31位および42位でのジエステル、30−デメトキシラパマイシン、ならびにそれらの医薬上許容されるプロドラッグ、アナログ、塩およびエステルからなる群より選択される、請求項15または17のいずれかに記載の液体製剤。
- 前記活性物質は、ラパマイシン、SDZ−RAD、タクロリムス、エベロリムス、ピメクロリムス、CCI−779、AP23841、ABT−578、ならびにそれらの医薬上許容される塩およびエステルからなる群より選択される、請求項2に記載の液体製剤。
- 前記活性物質は、ラパマイシンである、請求項15に記載の液体製剤。
- 前記ヘッドスペース容積対液体製剤容積の比は、1.5以下である、請求項11、17、または23のいずれかに記載の液体製剤。
- 前記ヘッドスペース容積対液体製剤容積の比は、1.5以下である、請求項21に記載の液体製剤。
- 前記ヘッドスペース容積対液体製剤容積の比は、0.5以下である、請求項25に記載の液体製剤。
- 前記ヘッドスペース内に前記液体製剤中の活性物質1mg当たり1μL以下の酸素を有している、請求項11、17、または23に記載の液体製剤。
- 前記ヘッドスペース内に前記液体製剤中の活性物質1mg当たり1μL以下の酸素を有している、請求項21に記載の液体製剤。
- 前記ヘッドスペース内に前記液体製剤中の活性物質1mg当たり0.5μL以下の酸素を有している、請求項27に記載の液体製剤。
- 前記液体製剤は、該液体製剤が曝露される光線の量を減少させるための二次包装によって取り囲まれている容器内にある、請求項5、11または15のいずれか一項に記載の液体製剤。
- 液体ポリエチレングリコールをさらに含む、請求項23に記載の液体製剤。
- 前記ラパマイシンは2%(w/w)で存在し、前記液体ポリエチレングリコールはPEG 400であり、該PEG 400は94%(w/w)で存在しており、そして前記液体製剤は4%(w/w)のエタノールをさらに含む、請求項31に記載の液体製剤。
- 1つ以上の空気の成分に対して感受性である1つ以上の成分を含む安定性製剤を調製する方法であって、該1つ以上の安定性製剤の成分の該1つ以上の空気の成分への曝露を減少させる工程を含み、眼の1つ以上の組織に対して毒性である保存料の添加を包含しない、方法。
- 不活性ガスを用いて前記液体製剤の1つ以上の成分をスパージする工程と、不活性ガスを用いて該液体製剤の1つ以上の成分を被覆する工程と、前記ヘッドスペース容積対液体製剤容積比を1.5以下にさせる工程と、および該ヘッドスペース内に該液体製剤中の前記活性物質1mg当たり1μL以下の酸素にさせる工程とのうちのいずれか1つまたは複数を含む、請求項33に記載の方法。
- 前記安定性製剤の1つ以上の成分が感受性である前記空気の1つ以上の成分が酸素である、請求項33に記載の方法。
- 前記不活性ガスは、希ガスである、請求項34に記載の方法。
- 前記希ガスは、窒素である、請求項36に記載の方法。
- 前記不活性ガスを用いて前記液体製剤の1つ以上の成分を被覆する工程と、前記ヘッドスペース容積対液体製剤容積比を1.5以下にさせる工程と、を含む請求項36または37のいずれかに記載の方法。
- 前記活性物質は、ラパマイシン、SDZ−RAD、タクロリムス、エベロリムス、ピメクロリムス、CCI−779、AP23841、ABT−578、シクロフィリン、FK506結合タンパク質(FKBP)、TAFA−93、RAD−001、テムシロリムス、AP23573、7−エピ−ラパマイシン、7−チオメチル−ラパマイシン、7−エピ−トリメトキシフェニル−ラパマイシン、7−エピ−チオメチル−ラパマイシン、7−デメトキシ−ラパマイシン、32−デメトキシ−ラパマイシン、2−デスメチル−ラパマイシン、ラパマイシンのモノエステル誘導体、ラパマイシンのジエステル誘導体、ラパマイシンの27−オキシム;ラパマイシンの42−オキソアナログ;二環式ラパマイシン;ラパマイシン二量体;ラパマイシンのシリルエーテル;ラパマイシンアリールスルホン酸塩、ラパマイシンスルファミン酸塩、31位および42位でのモノエステル、31位および42位でのジエステル、30−デメトキシラパマイシン、ならびにそれらの医薬上許容されるプロドラッグ、アナログ、塩およびエステルからなる群より選択される、請求項36または37のいずれかに記載の方法。
- 前記液体製剤は、ラパマイシンを含む、請求項39に記載の方法。
- 被験体における眼の疾患もしくは状態を治療する、予防する、または発生を遅延させるための方法であって、該被験体の眼に請求項10、21、または32のいずれかに記載の液体製剤を投与する工程を含む方法。
- 前記眼の疾患もしくは状態は、脈絡膜血管新生、加齢性黄斑変性、ブドウ膜炎、アレルギー性結膜炎、ドライアイ、緑内障、色素性網膜炎、中心網膜静脈閉塞疾患、網膜血管疾患、黄斑浮腫、虹彩血管新生、糖尿病性網膜症、角膜血管新生、もしくは角膜移植拒絶反応である、請求項41に記載の方法。
- 前記眼の疾患もしくは状態は、ヒト被験体における加齢性黄斑変性であり、前記治療薬はラパマイシンを含んでおり、このとき前記液体製剤は、該被験体の眼の中もしくは近傍の位置に投与される、請求項42に記載の方法。
- 前記液体製剤は、投与後に少なくとも30日間にわたって前記ヒト被験体に治療有効量のラパマイシンを送達する、請求項43に記載の方法。
- 前記液体製剤は安定性医薬製剤であり、硝子体、結膜、強膜と結膜との間、強膜内もしくは近傍、テノン下、眼球後、および後近強膜からなる群からの一員に投与される、請求項43に記載の方法。
- 前記液体製剤は安定性医薬製剤であり、眼に局所的に投与される、請求項43に記載の方法。
- 前記液体製剤は、前記ヒト被験体の眼の硝子体に投与される、請求項45に記載の方法。
- 前記液体製剤は、前記ヒト被験体の強膜と結膜の間に投与される、請求項45に記載の方法。
- 前記液体製剤は、少なくとも約20/40の視力を有する眼に投与される、請求項48に記載の方法。
- 前記加齢性黄斑変性は、湿性加齢性黄斑変性である、請求項47に記載の方法。
- 前記加齢性黄斑変性は、湿性加齢性黄斑変性である、請求項48に記載の方法。
- 前記加齢性黄斑変性は、乾性加齢性黄斑変性である、請求項47に記載の方法。
- 前記加齢性黄斑変性は、乾性加齢性黄斑変性である、請求項48に記載の方法。
- 前記密封容器は、予め充填されたシリンジである、請求項5〜8のいずれか一項に記載の密封容器。
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JP2016166242A (ja) * | 2010-04-16 | 2016-09-15 | アラーガン、インコーポレイテッドAllergan,Incorporated | 眼房内ビマトプロスト注入物による眼圧低下 |
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JP5528708B2 (ja) | 2014-06-25 |
EP2001438A2 (en) | 2008-12-17 |
CA2635797C (en) | 2015-03-31 |
WO2007092620A3 (en) | 2009-03-26 |
CN101605529B (zh) | 2013-03-13 |
KR101478164B1 (ko) | 2014-12-31 |
KR20140093764A (ko) | 2014-07-28 |
CA2635797A1 (en) | 2007-08-16 |
WO2007092620A2 (en) | 2007-08-16 |
US20140011834A1 (en) | 2014-01-09 |
CN101605529A (zh) | 2009-12-16 |
KR20080094814A (ko) | 2008-10-24 |
BRPI0707612B8 (pt) | 2021-05-25 |
US8492400B2 (en) | 2013-07-23 |
BRPI0707612B1 (pt) | 2020-09-24 |
US8658667B2 (en) | 2014-02-25 |
AU2007212271A1 (en) | 2007-08-16 |
US20070203173A1 (en) | 2007-08-30 |
AU2007212271B2 (en) | 2012-11-01 |
BRPI0707612A2 (pt) | 2011-05-10 |
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