JP2021501746A - 筋タンパク質合成を改善するためのアミノ酸補給の使用 - Google Patents
筋タンパク質合成を改善するためのアミノ酸補給の使用 Download PDFInfo
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Abstract
Description
本出願は、2017年11月2日出願の米国仮出願第62/580861号の利益を主張するものであり、その開示全体が参照により本明細書に組み込まれる。
本発明は、米国国立衛生研究所が授与するAR052293に基づく政府支援を受けて実施された。政府は本発明において、ある一定の権利を有する。
本明細書では、筋タンパク質合成の刺激に有用な組成の同化アミノ酸組成物を提供する。いくつかの実施形態では、組成物は、必須アミノ酸である、ヒスチジン、イソロイシン、ロイシン、リジン、メチオニン、フェニルアラニン、スレオニン、バリン、及びトリプトファンを含み得る。好ましい実施形態では、組成物は、必須アミノ酸である、ヒスチジン、イソロイシン、ロイシン、リジン、メチオニン、フェニルアラニン、スレオニン、バリン、及びトリプトファンに加えて、アミノ酸アルギニンを含み得る。
上記の各実施形態では、アミノ酸及び栄養素(存在する場合)を動物またはヒト用途に製剤化することができる。いくつかの実施形態では、各アミノ酸及び栄養素(存在する場合)は、別々に製剤化される。他の実施形態では、2つ以上のアミノ酸及び栄養素(存在する場合)が共に製剤化される。なおも他の実施形態では、本発明の組み合わせを構成するアミノ酸及び栄養素はすべて共に製剤化される。1つ以上の製剤をさらに1つ以上の剤形に加工して、同時に、逐次的に、またはある期間にわたって(例えば、1分、10分、30分、1時間、3時間、6時間、9時間、12時間、18時間、24時間、またはそれ以上にわたって)投与することができる。経口、非経口(例えば、静脈内、腹腔内、皮下、筋肉内)、頬側、舌下、または坐剤投与を含む効果的な標準技術を用いて投与を実施することができる。本明細書で使用される経口という用語は、動物飼料または他の食品への組成物の添加を含む、あらゆる形態の経口投与を指す。医薬組成物の製剤化については、例えば、Hoover,John E.,Remington’s Pharmaceutical Sciences,Mack Publishing Co.,Easton,Pa.(1975)、及びLiberman,H.A.and Lachman,L.,Eds.,Pharmaceutical Dosage Forms,Marcel Decker,New York,N.Y.(1980)で考察されている。
当業者は理解されるであろうが、本発明のアミノ酸組成物の用量は、対象の体重、性別、年齢、及び/または医学的病態、対象による身体運動の強度、投与方法に応じて変更でき、異なることになる。種の非限定的な例として、ヒト、コンパニオンアニマル、実験動物、動物園の動物、または農業用動物を含み得る。通常の実験により、必要な投与量を容易に確定することができる。経口投与のための典型的なアミノ酸用量は、用量あたり約7gであり得る。いくつかの実施形態では、約3、4、5、10、または12gのアミノ酸用量のアミノ酸組成物を投与することができる。他の実施形態では、約3、4、5、6、7、8、9、10、11、または12gのアミノ酸用量のアミノ酸組成物を投与することができる。例示的な実施形態では、アミノ酸用量は、用量あたり約7gであり得る。
本発明の組成物を静脈内注射、筋肉内注射、皮下注射として、または非経口経路で投与することができる。いくつかの実施形態では、組成物は、注射(例えば、腹腔内、静脈内、皮下、筋肉内など)による投与用に製剤化することができる。したがって、これらの組成物は、好ましくは、生理食塩水、リンゲル液、デキストロース溶液などの薬学的に許容されるビヒクルと組み合わされる。
本発明はまた、筋タンパク質合成を増加させる方法、筋肉量、筋力、筋機能、及び身体機能のいずれか1つの低下を予防及び/または治療する方法、またはそれらの任意の組み合わせを提供する。方法は、複数の必須アミノ酸と、場合により非必須アミノ酸及び/または栄養素を含む組成物を対象に投与することを含む。投与に適した組み合わせ及び製剤は、I項及びII項にそれぞれ上述されている。
本発明の方法は、アミノ酸組成物を与えられている対象の筋タンパク質合成を、上記アミノ酸組成物を与えられなかった対象と比較して向上させる。
またキットも提供する。そのようなキットは、本明細書に記載の組成物を含み得、特定の実施形態では、投与のための説明書を含み得る。そのようなキットは、本明細書に記載の方法の実施を容易にすることができる。キットとして供給する場合、組成物の種々の成分を別々の容器に包装し、使用直前に混合することができる。本明細書に記載されるように、成分はアミノ酸組成物を含むが、これに限定されない。そのような成分の個別包装は、必要に応じて、組成物を含有する1種以上の単位剤形を収容できるパックまたはディスペンサー装置の形態で提供することができる。パックは、例えばブリスターパックなどの金属箔またはプラスチック箔を含み得る。そのような成分の個別包装はまた、特定の場合には、成分の活性を損なうことなく長期保存を可能にすることができる。
本明細書で使用される用語はすべて、特定の実施形態の記載のみを目的としており、いかなる方法または範囲での限定を意図しないものと理解されるべきである。例えば、本明細書及び添付の特許請求の範囲で使用される場合、単数形「a」、「an」、及び「the」は、文脈によって特に明示されない限り、複数の指示対象物を包含し得る。用語「含む(comprising)」、「含む(including)」、及び「有する(having)」は包括的であることを意図し、列挙した要素以外の追加要素が存在し得ることを意味する。さらに、すべての単位、接頭辞、及び記号は、SI公認形式で表され得る。
以下の試験は、以下のアミノ酸製剤の2回用量に対する応答を定量するために実施した:
・1〜2%のヒスチジン
・9〜11%のイソロイシン
・35〜38%のロイシン
・14〜17%のリジン
・2〜4%のメチオニン
・5〜7%のフェニルアラニン
・8〜9%のスレオニン
・9〜11%のバリン
・0.002〜0.8%のトリプトファン
・8〜11%のアルギニン
表1.対象の特性
表2 アミノ酸濃度(mol/L/3時間)*
**BCAAは分枝鎖アミノ酸、ロイシン、バリン、及びイソロイシンである
Claims (17)
- 筋タンパク質合成を刺激するための方法であって、前記方法は、w/w%に換算して、以下の濃度のアミノ酸:約1〜2%のヒスチジン、約9〜11%のイソロイシン、約35〜38%のロイシン、約14〜17%のリジン、約2〜4%のメチオニン、約5〜7%のフェニルアラニン、約8〜9%のスレオニン、約9〜11%のバリン、約0.005〜0.8%のトリプトファン、及び約8〜11%のアルギニンを含む組成物を対象に投与することを含み、前記アミノ酸組成物を投与しない対象と比較して筋タンパク質合成の刺激を増加させる、前記方法。
- 身体運動を伴わずに筋タンパク質合成を改善する、請求項1に記載の方法。
- 前記対象が哺乳動物である、請求項1に記載の方法。
- 前記対象がヒトである、請求項1に記載の方法。
- 前記対象が40歳以上のヒトである、請求項1に記載の方法。
- 3.6グラムの最小用量で筋タンパク質合成が約50%改善する、請求項1に記載の方法。
- 前記組成物が、w/w%に換算して、以下の濃度のアミノ酸:1.5%のヒスチジン、9.7%のイソロイシン、36.4%のロイシン、15.2%のリジン、3%のメチオニン、6.1%のフェニルアラニン、8.5%のスレオニン、10%のバリン、0.6%のトリプトファン、及び9%のアルギニンを含む、請求項1に記載の方法。
- 12g用量の前記組成物を1日1回ヒト対象に投与する、請求項6に記載の方法。
- 3.6g用量の前記組成物を1日3回ヒト対象に与える、請求項6に記載の方法。
- 3.6g用量の前記組成物を1日1回ヒト対象に与える、請求項6に記載の方法。
- 3.6g用量の前記組成物を1日2回ヒト対象に与える、請求項6に記載の方法。
- 6.7g用量の前記組成物を1日1回ヒト対象に与える、請求項6に記載の方法。
- 6.7g用量の前記組成物を1日2回ヒト対象に与える、請求項6に記載の方法。
- 6.7g用量の前記組成物を1日3回ヒト対象に与える、請求項6に記載の方法。
- 運動の有無を問わず、12グラム未満の投与量で、50%超、筋タンパク質合成を刺激する、ヒスチジン、イソロイシン、ロイシン、リジン、メチオニン、フェニルアラニン、スレオニン、バリン、トリプトファン、及びアルギニンのアミノ酸を含む組成物。
- 12グラム未満の投与量を用いて筋タンパク質合成を刺激するための方法であって、前記方法は、w/w%に換算して、以下の濃度のアミノ酸:約1〜2%のヒスチジン、約9〜11%のイソロイシン、約35〜38%のロイシン、約14〜17%のリジン、約2〜4%のメチオニン、約5〜7%のフェニルアラニン、約8〜9%のスレオニン、約9〜11%のバリン、約0.005〜0.8%のトリプトファン、及び約8〜11%のアルギニンを含む組成物を対象に投与することを含み、前記アミノ酸組成物を投与しない対象と比較して筋タンパク質合成を刺激する、前記方法。
- 12グラム未満の投与量を用いて筋タンパク質合成を刺激するための方法であって、前記方法は、w/w%に換算して、以下の濃度のアミノ酸:約1〜2%のヒスチジン、約9〜11%のイソロイシン、約35〜38%のロイシン、約14〜17%のリジン、約2〜4%のメチオニン、約5〜7%のフェニルアラニン、約8〜9%のスレオニン、約9〜11%のバリン、約0.005〜0.8%のトリプトファン、及び約8〜11%のアルギニンを含む組成物を対象に投与することを含み、運動をしていない、前記アミノ酸組成物を投与しない対象と比較して筋タンパク質合成を刺激する、前記方法。
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