JP2015516845A - テストステロン組成物の針支援式ジェット注入投与 - Google Patents
テストステロン組成物の針支援式ジェット注入投与 Download PDFInfo
- Publication number
- JP2015516845A JP2015516845A JP2015504755A JP2015504755A JP2015516845A JP 2015516845 A JP2015516845 A JP 2015516845A JP 2015504755 A JP2015504755 A JP 2015504755A JP 2015504755 A JP2015504755 A JP 2015504755A JP 2015516845 A JP2015516845 A JP 2015516845A
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- Prior art keywords
- testosterone
- needle
- drug
- administration
- plasma
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Abstract
Description
[0001]本出願は、2012年4月6日に出願された米国仮特許出願第61/621,298号、2013年3月14日に出願された米国仮特許出願第61/783,444号、2013年2月11日に出願された米国仮特許出願第61/763,395号、および、2013年3月11日に出願された米国仮特許出願第61/776,283号の優先権を主張し、それらのすべてが、参照により本明細書に組み込まれている。
[0037]「リークバック」は、その用語が本明細書で使用されているときには、薬剤の注入の間の、および/または、薬剤の注入の後の、注入部位からの薬剤のリーケージを参照している。
[0047]本開示は、注入器の実施形態、ならびに、単独で、または、注入器の実施形態と組み合わせて使用するのに適切な組成物および方法を包含する。
[0049]典型的な皮下注射シリンジは、ユーザーの指のうちの1つまたは複数の押し出す力を利用し、注入を送達する。いくつかの実施形態では、本開示の動力駆動式注入器は、被投与者が、そのような押し出し力を利用する必要なしに、それぞれの注入において、事前に設定された深さに、テストステロン製剤を繰り返して正確に迅速に投与することを助けるように構成されている。
[00111]1つまたは複数の代替的な実施形態では、本開示は、(例えば、防腐剤の入っていない)テストステロンを含む所定の投与量の薬剤を注出するための自動注入器に関し、自動注入器は、好ましくは、より人間工学的となるように、形状が長円形または楕円形であるハウジングを含む。これらの代替的な実施形態では、米国特許第7,449,012号および米国特許第7,794,432号は、その全体が参照により本明細書に組み込まれている。長円形形状は、取扱説明書を表示するためのより大きい表面積を提供しながら、自動注入器がテーブルまたは平坦な表面から転がり落ちることを防止する。カートリッジ容器は、ハウジングの中に配設されている。カートリッジは、カートリッジ容器の中に受け入れられている。カートリッジは、カートリッジの中に少なくとも1つの開口部を有し、薬剤を含有する。薬剤は、プランジャーによって、後方を閉じ込められている。カートリッジは、針アッセンブリを含み、針アッセンブリを通して薬剤を注出する。カートリッジは、カートリッジ容器の中を貯蔵位置から動作位置へ前進させられ、動作位置において、針はカートリッジ容器から延在し、薬剤の1回用量が投与され得るようになっている。アクチュエーションアッセンブリまたはパワーパックは、貯蔵エネルギー供給源を提供し、貯蔵エネルギー供給源は、解放することが可能であり、カートリッジの中のプランジャーを駆動し、薬剤を、針アッセンブリを通してユーザーの中へ注出し、駆動のときに針がアクセス可能となることを可能にする。
[00119]特定の実施形態では、本発明の薬剤は、テストステロンを含む任意の薬物とすることが可能であり、それは、単独で、または、本明細書に包含されている他の実施形態および/またはデバイスと組み合わせて、有用である可能性がある。一実施形態では、薬物は、テストステロンである。
[00128]本開示は、部分的に、性腺機能低下症、不妊症、性無欲症または***不全、骨粗しょう症、および貧血症を治療するための方法、デバイス、および組成物、陰茎肥大および身長成長を促進させるための方法、ならびに、骨髄および食欲を刺激する方法を提供する。
[00132]ある実施形態では、本明細書に包含されているように被投与者へ投与されるテストステロンを含む組成物(例えば、防腐剤の入っていないテストステロン組成物)は、薬物動態(全身バイオアベイラビリティーを含む)を提供し、それは、同じ用量のテストステロンが、針およびシリンジを使用して、筋肉内にまたは皮下に、前記被投与者へ投与されるときに、実質的に同じ(または、同様の)テストステロンの薬物動態(全身バイオアベイラビリティーを含む)を有する。別の実施形態では、本明細書に包含されているような性腺機能低下症を治療する方法は、針支援式のジェット注入デバイスから、被投与者の皮下組織、皮肉組織、または筋肉内組織の中へ、約5mg〜約400mgの範囲にある用量の(例えば、防腐剤の入っていない)テストステロンを含む組成物を導入するステップを含み、前記針支援式のジェット注入デバイスによって送達される前記テストステロンの薬物動態プロファイルは、針およびシリンジを介して、筋肉内に、または皮下に、前記被投与者へ投与されるときの、同じ用量の前記テストステロンの薬物動態プロファイルと実質的に同じである。
[00140]一実施形態では、テストステロンを投与する方法は、薬学的に許容可能なキャリアーの中に、単位用量の(例えば、防腐剤の入っていない)テストステロン、または、薬学的に許容可能なテストステロンエステルもしくはテストステロン塩を含む組成物を、哺乳類へ皮下に投与するステップを含み、投与後に、血漿中テストステロンレベルが、所定の期間にわたって、治療効果のあるレベルに維持される。一実施形態では、Z1期間は、血漿中テストステロンレベルが治療効果のあるレベルに維持される期間である。
[00148]別の実施形態では、それを必要としている哺乳類の中で、上昇した血漿中テストステロンレベルを維持するための方法が提供される。特定の実施形態では、これは、皮下投与からの血漿中レベルを、拡張された期間にわたって、治療域のレベル(例えば、約400ng/dl、約500ng/dl、約600ng/dl、約700ng/dl、約800ng/dl、約900ng/dl)以上に維持することを必要とする。いくつかの実施形態では、そのレベルは、同じ体積および濃度の筋肉内用量よりも長い期間にわたって維持される。ある実施形態では、方法は、薬学的に許容可能なキャリアーの中に、単位用量の(例えば、防腐剤の入っていない)テストステロン、または、薬学的に許容可能なテストステロンエステルもしくはテストステロン塩を含む組成物を、哺乳類へ皮下に投与するステップを含み、投与後、血漿中テストステロンレベルは、所定の期間にわたって、最大約1800ng/dlまでの上昇したレベルに維持される。ある実施形態では、血漿中テストステロンレベルが上昇したレベルに維持される期間は、「Z2期間」と称される。
[00153]別の実施形態では、それを必要としている哺乳類の中に、ピーク血漿中テストステロンレベルを得るための方法が、本明細書で提供されている。ある実施形態では、本明細書に包含されている組成物およびデバイスを使用して、テストステロンのピーク血漿中濃度を得る(その後に、テストステロンの血漿中濃度は、所定の期間にわたって、治療効果のあるレベルに減少する)方法が、本明細書で提供される。別の実施形態では、本明細書に包含されている組成物およびデバイスを使用して、テストステロンのピーク血漿中濃度を得る(その後に、テストステロンの血漿中濃度は、所定の期間にわたって、上昇したレベルに減少する)方法が、本明細書で提供される。
[00158]ある実施形態では、驚くことには、本明細書に包含されているようなテストステロン組成物の投与は、所定の血漿中テストステロンレベルを提供し、所定の血漿中テストステロンレベルは、経皮的クリーム、ジェル、もしくはパッチ、または、針およびシリンジのうちの1つを介して、筋肉内に、皮肉に、または皮下に、同じ被投与者へ投与されるときに、同等な用量のテストステロンよりも長い期間にわたって、治療効果のあるレベルに維持されるということが見出された。ある実施形態では、注入後に、本明細書に包含されているような(例えば、防腐剤の入っていない)テストステロン組成物は、経皮的クリーム、ジェル、もしくはパッチ、または、同じ期間にわたる針およびシリンジによる筋肉内注入のうちの1つを介して、同じ被投与者へ投与される同等のテストステロンよりも高いテストステロンの血漿中濃度を維持する。
[00169]複数の治療は、本明細書に包含されている組成物、デバイス、および方法の組み合わせによる、2回以上の用量の(例えば、防腐剤の入っていない)テストステロンの投与を含むことが可能である。ある実施形態では、Z3期間の血漿中テストステロンレベルは、治療効果のあるレベル(例えば、300ng/dlもしくはそれ以上、約400ng/dlもしくはそれ以上、または、本明細書で上記に説明されているような他の可能値の定常状態)に維持される。ある実施形態では、第2の用量が投与されるが、Z3期間の血漿中テストステロンレベルは、治療効果のあるレベルまたはそれ以上に維持される。ある実施形態では、Z3期間の血漿中テストステロンレベルは、第2の用量が投与されるまで、治療効果のあるレベルの上方に維持される。ある実施形態では、Z3期間の血漿中テストステロンレベルは、上昇したレベルに維持される。ある実施形態では、Z3期間の血漿中テストステロンレベルは、第2の用量が投与されるまで、300ng/dlから700ng/dlの間、300ng/dlから1100ng/dlの間、300ng/dlから1800ng/dlの間、700ng/dlから1100ng/dlの間、700ng/dlから1800ng/dlの間、または、1100ng/dlから1800ng/dlの間、および/または、約300ng/dlの上方のレベルに維持され、その後、テストステロンの血中レベルは、良く理解されている薬物動態にしたがって再び増加することが起こり得ることとなる。
[00172]別の実施形態では、本明細書に包含されているようなテストステロン組成物の投与は、注入の直後に促進効果を提供し、血漿中テストステロンレベルが、所定の期間にわたって、血漿治療域のテストステロンレベルを上回るが、被投与者に有害となるほど高くはならないようになっている。血漿中テストステロンレベルが促進レベルから低下した後に、血漿中テストステロンレベルは、本明細書で議論されているように治療効果のあるレベル内にある。ある実施形態では、本明細書に包含されているテストステロン組成物の投与は、注入の直後に最小促進効果を提供し、血漿中テストステロンレベルが、所定の期間にわたって、血漿治療域のテストステロンレベルを上回るが、被投与者に有害となるほど高くはならないようになっており、その後に、血漿中テストステロンレベルは、本明細書で議論されているように治療効果のあるレベル内にある。ある実施形態では、本明細書に包含されているテストステロン組成物の投与は、注入の直後に促進効果を提供せず、血漿中テストステロンレベルは、本明細書で議論されているように治療効果のあるレベル維持される。
Claims (50)
- 遠位端部および近位端部を有するハウジング部材と、
前記ハウジング部材の中に配設されているチャンバーであって、前記チャンバーは、テストステロンを含む防腐剤の入っていない薬剤の量を保持するように構成されている、チャンバーと、
前記チャンバーと動作可能に関連付けされた針であって、前記針は、リークバックを最小化するのに十分な、患者の皮膚の下の深さにおいて、注入部位に前記薬剤を送達するのに十分な長さを有している、針と、
前記チャンバーの中で移動可能なプランジャーと、
前記薬剤の少なくとも一部分を前記チャンバーから前記針を通して約20秒未満で噴出させるのに十分な力を前記プランジャーに提供することができる力発生源と
を含む、注入デバイス。 - 請求項1に記載の注入デバイスであって、前記注入部位が皮下にある、注入デバイス。
- 請求項1に記載の注入デバイスであって、前記プランジャーにかかる前記力が、前記薬剤の少なくとも一部分を前記チャンバーから前記針を通して約15秒未満で噴出させるように構成されている、注入デバイス。
- 請求項1に記載の注入デバイスであって、前記プランジャーにかかる前記力が、前記薬剤のすべてを前記チャンバーから前記針を通して約15秒未満で噴出させるように構成されている、注入デバイス。
- 請求項1に記載の注入デバイスであって、前記プランジャーにかかる前記力が、前記薬剤のすべてを前記チャンバーから前記針を通して約10秒未満で噴出させるように構成されている、注入デバイス。
- 請求項1に記載の注入デバイスであって、前記針の長さが、約5mmを上回る、注入デバイス。
- 請求項1に記載の注入デバイスであって、前記針の長さが、約20mm未満である、注入デバイス。
- 請求項1に記載の注入デバイスであって、前記針の長さが、約5mmから12mmの間である、注入デバイス。
- 請求項1に記載の注入デバイスであって、前記針ゲージが、27ゲージである、注入デバイス。
- 請求項1に記載の注入デバイスであって、前記針ゲージが、25ゲージから30ゲージである、注入デバイス。
- 請求項1に記載の注入デバイスであって、前記針が、薄壁の針である、注入デバイス。
- 請求項1に記載の注入デバイスであって、使用されるときに、実質的にリークバックが存在しない、注入デバイス。
- 請求項1に記載の注入デバイスであって、使用されるときに、リークバックが存在しない、注入デバイス。
- 請求項1に記載の注入デバイスであって、使用されるときに、前記注入の約95%において、リークバックが存在しない、注入デバイス。
- 請求項1に記載の注入デバイスであって、使用されるときに、リークバックの量が、注入される前記薬剤の合計体積の約15%未満である、注入デバイス。
- 請求項1に記載の注入デバイスであって、使用されるときに、リークバックの量が、注入される前記薬剤の合計体積の約0.05%〜約15%、注入される前記薬剤の合計体積の約0.1%〜約12.5%、注入される前記薬剤の合計体積の約0.2%〜約10%、注入される前記薬剤の合計体積の約0.3%〜約7.5%、注入される前記薬剤の合計体積の約0.4%〜約5%、注入される前記薬剤の合計体積の約0.5%〜約3%、注入される前記薬剤の合計体積の約0.6%〜約2%、注入される前記薬剤の合計体積の約0.7%〜約1%からなる群から選択されるリークバックの量を超えない、注入デバイス。
- 請求項1に記載の注入デバイスであって、使用されるときに、リークバックの量が、注入される前記薬剤の合計重量の約15%未満である、注入デバイス。
- 請求項1に記載の注入デバイスであって、使用されるときに、リークバックの量が、注入される前記薬剤の合計重量の約0.1%〜約15%、注入される前記薬剤の合計重量の約0.5%〜約12.5%、注入される前記薬剤の合計重量の約1%〜約10%、注入される前記薬剤の合計重量の約2%〜約7.5%、および、注入される前記薬剤の合計重量の約3%〜約5%からなる群から選択されるリークバックの量を超えない、注入デバイス。
- 請求項1に記載の注入デバイスであって、前記注入デバイスが、カラーをさらに含み、前記カラーが、前記針を取り囲み、カラーキャビティーを画定しており、前記カラーが、周辺のおよび前方の皮膚に接触する表面を有しており、前記表面は、前記針および注入部位を取り囲み、不連続的であり、前記針および注入部位から所定の領域だけ半径方向に間隔を置いて配置されており、前記所定の領域は、患者の皮膚が前記カラーキャビティーの中に移動することを可能にするのに十分な大きさであり、前記針を適正に位置付けし、前記注入部位への前記物質の皮肉送達のために前記患者を突き通し、前記皮膚の中の押し戻し圧力が前記注入部位を通して前記物質を押し出すことを抑制または防止しながら、前記注入された物質が前記皮膚の下に広がることを可能にする、注入デバイス。
- ハウジングと、
前記ハウジングの中に配設されているカートリッジ容器と、
前記カートリッジ容器の中に受け入れられるカートリッジであって、前記カートリッジは、少なくとも1つの開口部をその中に有し、テストステロンを含む薬剤を含有しており、前記薬剤は、プランジャーによって後方を閉じ込められており、前記カートリッジは、それを通して前記薬剤を注出する針アッセンブリを含み、前記針アッセンブリは、針、および、取り外し不可能な保護用の針シースを含み、前記針は、リークバックを最小化するのに十分な、患者の皮膚の下の深さにおいて、注入部位に前記薬剤を送達するのに十分な長さを有している、カートリッジと、
貯蔵エネルギー供給源を提供するアクチュエーションアッセンブリであって、前記貯蔵エネルギー供給源は、前記保護用の針シースを通して前記針を送るように解放され、および、前記カートリッジの中に前記プランジャーを送り、前記針アッセンブリを通して前記薬剤を注出させるように解放されることが可能であり、前記貯蔵エネルギー供給源は、前記薬剤の少なくとも一部分を前記チャンバーから前記針を通して約20秒未満で噴出させるのに十分な力を提供する、アクチュエーションアッセンブリと、
前記ハウジングの中に受け入れられる針カバーであって、前記針カバーは、その中に形成された開口部を有し、薬剤を注出する動作の間に前記開口部を通して前記針アッセンブリを通過させることを許容し、前記針カバーは、第1のロック位置を有しており、それによって、前記針カバーは、前記自動注入器の駆動の前に、ロックされた後退位置にあり、前記針カバーは、第2のロック位置を有しており、それによって、前記針カバーは、前記自動注入器の動作の後に、ロックされた拡張位置にある、針カバーと、
前記針カバーを前記第1のロック位置に保持する第1のロッキングアッセンブリと、
前記針カバーを前記第2のロック位置に保持する第2のロッキングアッセンブリと
を含む、注入デバイス。 - 薬学的に許容可能なキャリアーの中に入っている、防腐剤の入っていない単位用量のテストステロン、または、薬学的に許容可能なテストステロンエステルまたはテストステロン塩。
- 請求項21に記載の防腐剤の入っていない単位用量であって、前記単位用量が、プレフィルドシリンジの中に含有されている、防腐剤の入っていない単位用量。
- 請求項21に記載の防腐剤の入っていない単位用量であって、前記単位用量が、皮下投与に適切である、防腐剤の入っていない単位用量。
- 請求項21に記載の防腐剤の入っていない単位用量であって、前記単位用量が、エナント酸テストステロンおよびごま油を含む、防腐剤の入っていない単位用量。
- 請求項21に記載の防腐剤の入っていない単位用量であって、前記単位用量が、シピオン酸テストステロンおよびごま油を含む、防腐剤の入っていない単位用量。
- 請求項21に記載の防腐剤の入っていない単位用量であって、前記単位用量が、本質的に、エナント酸テストステロンおよびごま油からなる、防腐剤の入っていない単位用量。
- エナント酸テストステロンおよびごま油を含む組成物であって、前記エナント酸テストステロンは、約50mg/mlの濃度で存在している、組成物。
- エナント酸テストステロンおよびごま油を含む組成物であって、前記エナント酸テストステロンは、約5mg/mlから約400mg/mlの間の濃度で存在している、組成物。
- 請求項28に記載の組成物であって、前記エナント酸テストステロンが、約50mg/mlから約250mg/mlの間の濃度で存在している、組成物。
- エナント酸テストステロンおよびごま油を含む組成物であって、前記エナント酸テストステロンは、約50mg/ml、約75mg/ml、約100mg/ml、約125mg/ml、約150mg/ml、約175mg/ml、約200mg/ml、約225mg/ml、および約250mg/mlからなる群から選択される濃度で存在している、組成物。
- 請求項27から30までのいずれか一項に記載の組成物であって、前記組成物が、医薬品である、組成物。
- 請求項27から30までのいずれか一項に記載の組成物であって、前記組成物が、少なくとも1つの薬学的に許容可能なキャリアーをさらに含む、組成物。
- 請求項27から30までのいずれか一項に記載の組成物であって、前記組成物は、エナント酸テストステロン沈殿物が実質的に入っていない、組成物。
- 請求項27から30までのいずれか一項に記載の組成物であって、前記組成物の中のエナント酸テストステロン沈殿物の量が、27ゲージの針を有する注入器デバイスの針を詰まらせることとなる量未満である、組成物。
- テストステロンを投与する方法であって、前記方法は、薬学的に許容可能なキャリアーの中に入っている、単位用量のテストステロン、または、薬学的に許容可能なテストステロンエステルもしくはテストステロン塩を含む、防腐剤の入っていない組成物を、哺乳類へ皮下に投与するステップを含み、投与後に、血漿中テストステロンレベルが、Z1期間にわたって、約200ng/dlから約1800ng/dlの間に維持される、方法。
- 請求項35に記載の方法であって、前記血漿中テストステロンレベルが、約300ng/dlおよび約1100ng/dl、約350ng/dl〜約1050ng/dl、約400ng/dl〜約1000ng/dl、約450ng/dl〜約950ng/dl、約500ng/dl〜約900ng/dl、約550ng/dl〜約850ng/dl、約600ng/dl〜約800ng/dl、約650ng/dl〜約750ng/dl、ならびに、約675ng/dl〜約725ng/dlからなる群から選択される値に維持される、方法。
- 請求項36に記載の方法であって、前記血漿中テストステロンレベルが、約300ng/dl、約350ng/dl、約400ng/dl、約450ng/dl、約500ng/dl、約550ng/dl、約600ng/dl、約650ng/dl、約700ng/dl、約750ng/dl、約800ng/dl、約850ng/dl、約900ng/dl、約950ng/dl、約1000ng/dl、約1050ng/dl、および約1100ng/dlからなる群から選択される値に維持される、方法。
- 請求項36に記載の方法であって、前記血漿中テストステロンレベルが、少なくとも約300ng/dl、少なくとも約350ng/dl、少なくとも約400ng/dl、少なくとも約450ng/dl、少なくとも約500ng/dl、少なくとも約550ng/dl、少なくとも約600ng/dl、少なくとも約650ng/dl、少なくとも約700ng/dl、少なくとも約750ng/dl、少なくとも約800ng/dl、少なくとも約850ng/dl、少なくとも約900ng/dl、少なくとも約950ng/dl、少なくとも約1000ng/dl、少なくとも約1050ng/dl、および、少なくとも約1100ng/dlからなる群から選択される値に維持される、方法。
- 請求項35に記載の方法であって、Z1が、少なくとも6日である、方法。
- 請求項35に記載の方法であって、Z1が、少なくとも6.5日である、方法。
- 請求項35に記載の方法であって、Z1が、少なくとも7日である、方法。
- テストステロンを投与する方法であって、前記方法は、薬学的に許容可能なキャリアーの中に入っている、単位用量のテストステロン、または、薬学的に許容可能なテストステロンエステルもしくはテストステロン塩を含む、防腐剤の入っていない組成物を、哺乳類へ皮下に投与するステップを含み、投与後に、前記血漿中テストステロンレベルが、Z2期間にわたって、治療効果のあるレベルに維持される、方法。
- テストステロンを必要としている哺乳類の中で、上昇した血漿中テストステロンレベルを維持する方法であって、前記方法は、薬学的に許容可能なキャリアーの中に入っている、単位用量のテストステロン、または、薬学的に許容可能なテストステロンエステルもしくはテストステロン塩を含む、防腐剤の入っていない組成物を、哺乳類へ皮下に投与するステップを含み、投与後に、前記血漿中テストステロンレベルが、Z2期間にわたって、最大約1800ng/dlの治療効果のあるレベルに維持される、方法。
- テストステロンを投与する方法であって、前記方法は、薬学的に許容可能なキャリアーの中に入っている、単位用量のテストステロン、または、薬学的に許容可能なテストステロンエステルもしくはテストステロン塩を含む、防腐剤の入っていない組成物を、哺乳類へ皮下に投与するステップを含み、投与後に、同等の筋肉内に投与された用量の血漿中レベルが、投与後の同じ時点において、皮下に投与された用量の血漿中レベルの下に降下した後に、前記血漿中テストステロンレベルが、Z2期間にわたって、約700ng/dlから約1800ng/dlの間に維持され、また、前記血漿中テストステロンレベルが、Z3期間にわたって、約300ng/dlから約1100ng/dlの間に維持される、方法。
- 請求項44に記載の方法であって、投与後に、前記血漿中テストステロンレベルが、Z2期間にわたって、約750ng/dlおよび約1750ng/dl、約800ng/dlおよび約1700ng/dl、約850ng/dlおよび約1650ng/dl、約900ng/dlおよび約1600ng/dl、約950ng/dlおよび約1550ng/dl、約1000ng/dlおよび約1500ng/dl、約1050ng/dlおよび約1450ng/dl、約1100ng/dlおよび約1400ng/dl、約1150ng/dlおよび約1350ng/dl、および約1200ng/dlおよび約1300ng/dlからなる群から選択されるレベルに維持される、方法。
- 請求項44に記載の方法であって、投与後に、前記血漿中テストステロンレベルが、Z2期間にわたって、約700ng/dl、約750ng/dl、約800ng/dl、約850ng/dl、約900ng/dl、約950ng/dl、約1000ng/dl、約1050ng/dl、約1100ng/dl、約1150ng/dl、約1200ng/dl、約1250ng/dl、約1300ng/dl、約1350ng/dl、約1400ng/dl、約1450ng/dl、約1500ng/dl、約1550ng/dl、約1600ng/dl、約1650ng/dl、約1700mg/ml、約1750mg/ml、および約1800ng/dlからなる群から選択されるレベルに維持される、方法。
- 請求項44に記載の方法であって、同等の筋肉内に投与された用量の前記血漿中レベルが、投与後の同じ時点において、皮下に投与された用量の前記血漿中レベルの下に降下した後に、前記血漿中テストステロンレベルが、Z3期間にわたって、約350ng/dl〜約1050ng/dl、約400ng/dl〜約1000ng/dl、約450ng/dl〜約950ng/dl、約500ng/dl〜約900ng/dl、約550ng/dl〜約850ng/dl、約600ng/dl〜約800ng/dl、約650ng/dl〜約750ng/dl、および、約675ng/dl〜約725ng/dlからなる群から選択される値に維持される、方法。
- 請求項44に記載の方法であって、同等の筋肉内に投与された用量の前記血漿中レベルが、投与後の同じ時点において、皮下に投与された用量の前記血漿中レベルの下に降下した後に、前記血漿中テストステロンレベルが、Z3期間にわたって、約300ng/dl、約350ng/dl、約400ng/dl、約450ng/dl、約500ng/dl、約550ng/dl、約600ng/dl、約650ng/dl、約700ng/dl、約750ng/dl、約800ng/dl、約850ng/dl、約900ng/dl、約950ng/dl、約1000ng/dl、約1050ng/dl、および約1100ng/dlからなる群から選択される値に維持される、方法。
- a)薬学的に許容可能なキャリアーの中にXmg/mlの濃度で入っている、単位用量のテストステロン、または、薬学的に許容可能なテストステロンエステルもしくはテストステロン塩の単位用量を含む、防腐剤の入っていない組成物であって、前記単位用量が被投与者に皮下注入によって投与されるときに、前記血漿中テストステロンレベルが、Z1期間にわたって、約300ng/dlから約1100ng/dlの間に維持されるようになっている、防腐剤の入っていない組成物と、
b)請求項1に記載の前記注入デバイスと
を含む、治療域のパッケージであって、
項目b)の前記注入デバイスは、前記単位用量のすべてまたは一部の投与の前に、項目a)の前記単位用量を含有する、治療域のパッケージ。 - a)薬学的に許容可能なキャリアーの中に約50mg/mlの濃度で入っている、テストステロン、または、薬学的に許容可能なテストステロンエステルもしくはテストステロン塩を含む、防腐剤の入っていない医薬組成物であって、単位用量の前記医薬組成物が被投与者に皮下注入によって投与されるときに、前記血漿中テストステロンレベルが、Z1期間にわたって、約300ng/dlから約1100ng/dlの間に維持される、防腐剤の入っていない医薬組成物と、
b)請求項1に記載の前記注入デバイスと
を含む、治療域のパッケージであって、
項目b)の前記注入デバイスは、単位用量の前記医薬組成物のすべてまたは一部の投与の前に、項目a)の前記医薬組成物を含有する、治療域のパッケージ。
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- 2013-04-05 CN CN201380028911.9A patent/CN104487114A/zh active Pending
- 2013-04-05 WO PCT/US2013/035509 patent/WO2013152323A1/en active Application Filing
- 2013-04-05 KR KR1020147030766A patent/KR20150011346A/ko not_active Application Discontinuation
- 2013-04-05 EP EP13772839.0A patent/EP2833944A4/en not_active Ceased
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JP7464535B2 (ja) | 2018-05-24 | 2024-04-09 | ノバルティス アーゲー | 自動薬物送達装置 |
KR20210131406A (ko) | 2019-02-26 | 2021-11-02 | 벡톤 디킨슨 프랑스 | 자동 주사 장치를 위한 낙하 테스트 특징부를 구비한 강성 바늘 쉴드 분리기 |
JP2022521634A (ja) * | 2019-02-26 | 2022-04-11 | ベクトン ディキンソン フランス | 自動注射器用のドロップテスト機能付き硬質針シールド除去器 |
JP7385670B2 (ja) | 2019-02-26 | 2023-11-22 | ベクトン ディキンソン フランス | 自動注射器用のドロップテスト機能付き硬質針シールド除去器 |
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US10821072B2 (en) | 2020-11-03 |
US20210015741A1 (en) | 2021-01-21 |
JP2019058744A (ja) | 2019-04-18 |
US9950125B2 (en) | 2018-04-24 |
KR20150011346A (ko) | 2015-01-30 |
AU2013203784A1 (en) | 2013-10-24 |
US20230390187A1 (en) | 2023-12-07 |
US20130303985A1 (en) | 2013-11-14 |
US11771646B2 (en) | 2023-10-03 |
CA2868500C (en) | 2020-04-21 |
EP4186545A1 (en) | 2023-05-31 |
US20190030260A1 (en) | 2019-01-31 |
CN104487114A (zh) | 2015-04-01 |
CA2868500A1 (en) | 2013-10-10 |
EP2833944A4 (en) | 2016-05-25 |
US20170043103A1 (en) | 2017-02-16 |
WO2013152323A1 (en) | 2013-10-10 |
JP6457383B2 (ja) | 2019-01-23 |
EP2833944A1 (en) | 2015-02-11 |
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