JP2013508296A - 組成物 - Google Patents
組成物 Download PDFInfo
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- JP2013508296A JP2013508296A JP2012534391A JP2012534391A JP2013508296A JP 2013508296 A JP2013508296 A JP 2013508296A JP 2012534391 A JP2012534391 A JP 2012534391A JP 2012534391 A JP2012534391 A JP 2012534391A JP 2013508296 A JP2013508296 A JP 2013508296A
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- emulsion
- omega
- fatty acid
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Abstract
Description
ω−3脂肪酸油と比較して、ω−3脂肪酸油の1つ以上の成分のω−3脂肪酸の経口吸収(曝露)、経口生体利用率、および/または経口有効性を増加させること、
改善された治療方法、例えば上昇したトリグリセリド(例えば>500mg/dL、または≧200mg/dL、または≧150mg/dLのトリグルセリドレベル)の低下等の上昇したトリグリセリドの治療を供給すること、および/または
効果的療法を達成するのに必要とされるω−3脂肪酸油の投薬レベルおよび/または頻度の低下(例えば、カプセルの数および/またはサイズの低下)を可能にすること
ができる。
a)熱力学的に安定、すなわち常温(20〜30℃、特に25℃)で、例えば長期間にわたって、光学的に観察可能な分離、またはより大きな粒子サイズまたは沈殿の実質的な形成なしに、安定したままである。好ましいエマルションは、少なくとも3時間、より好ましくは少なくとも6時間、最も好ましくは少なくとも24時間の期間にわたって周囲温度で安定したままである。および/または
b)最小の撹拌および混合により容易にまたは自然に形成される。
本発明のエマルションおよびエマルション前濃縮物組成物は、1つまたは複数のω−3脂肪酸を含むω−3脂肪酸油を含む。
a)ω−3多価不飽和長鎖遊離脂肪酸(例えばエイコサペンタエン酸C20:5(「EPA」)、ドコサヘキサエン酸C22:6(「DHA」)、α−リノレン酸)を含む、ω−3多価不飽和遊離脂肪酸(例えば、12〜22炭素、特に18〜22炭素の脂肪族末端を有する)と、
b)モノグリセリド、ジグリセリドおよびトリグリセリド等の、ω−3脂肪酸(例えばω−3多価不飽和遊離脂肪酸、例えば長鎖)のグリセロールとのエステルと、
c)脂肪酸のメチルエステルおよびエチルエステル等の、ω−3脂肪酸(例えばω−3多価不飽和遊離脂肪酸、例えば長鎖)および第一級アルコール、第二級アルコールまたは第三級アルコールのエステルと
を含む。ω−3脂肪酸油は前述のもののいずれかの混合物を含むことができる。
本発明のエマルションおよびエマルション前濃縮物組成物は1つまたは複数の界面活性剤をさらに含んでなる。
a)ω−3脂肪酸油と混和性(すなわち単相を生成)または部分的に混和性である(任意の共溶媒と共にまたはなしに使用した場合)、
b)医薬製品、栄養製品または栄養補助製品における使用に安全である(例えば、かかる製品における使用に承認され、かかる製品において安全に使用され、および/またはGRAS(安全性認定)として分類される)、
c)<5の過酸化物価および<2.0の水分含量を有する、および/または
d)高HLB(「親水‐親油性バランス」)、例えば10〜18のHLB値を有する。
a)商標名「CREMOPHOR」(BASF社、Mount Olive、NJ)下で市販のものを含む、ポリオキシエチレンヒマシ油誘導体、特に、
CREMOPHOR ELまたはELP(PEG 35ヒマシ油、ポリエトキシル化ヒマシ油、マクロゴグリセロリ・リシノレアス(macrogoglyceroli ricinoleas)、マクロゴグリセロリ・ヒドロキシステアラス(macrogoglyceroli hydroxystearas、POE−35ヒマシ油、PEGリシノレアートとも称される);CREMOPHOR ELP(水、Kおよび遊離脂肪酸が低含量であり、CREMOPHOR ELの精製グレードである、ポリオキシエチレングリコール化ヒマシ油)、およびCREMOPHOR RH 40(ポリオキシル40水素添加ヒマシ油、マクロゴールグリセロールヒドロキシステアリン酸、ポリオキシエチレン40水素添加ヒマシ油、PEG−40水素添加ヒマシ油とも称される)、ならびに
b)商標名「TWEEN」(ICI Americas社)下で市販のものを含む、ポリオキシエチレンソルビタン脂肪酸エステル、特に、
TWEEN 80(80[ポリオキシエチレン(20)モノオレイン酸ソルビタン]、ポリソルベート80としても公知);ポリオキシエチレン20モノオレイン酸ソルビタン(エチレンオキシドと重合させたソルビトールおよびその無水物の部分的な脂肪酸エステル)、より具体的にはポリオキシエチレン−ソルビタン−脂肪酸モノ−オレイルエステル、(ミリスチン酸、パルミチン酸、パルミトレイン酸、ステアリン酸、オレイン酸およびリノレン酸、主にオレイン酸を含む脂肪酸の混合物を含む)、
TWEEN 85(85[ポリオキシエチレン(20)トリオレイン酸ソルビタン]、ポリソルベート85としても公知);ポリオキシエチレン20トリオレイン酸ソルビタン(エチレンオキシドと重合させたソルビトールおよびその無水物の部分的な脂肪酸エステル)、具体的には、ポリオキシエチレン−ソルビタン−脂肪酸トリ−オレイルエステル(ミリスチン酸、パルミチン酸、パルミトレイン酸、ステアリン酸、オレイン酸およびリノレン酸、主にオレイン酸を含む脂肪酸の混合物を含む)、
TWEEN 20(ポリソルベート20、ポリ(オキシ−1,2−エタンジイル)誘導体としても公知);ポリオキシエチレン20ラウレート;ポリオキシエチレン20モノラウリン酸ソルビタン、ソルビタンモノドデカノアート;
TWEEN 60(ポリソルベート60、、ポリオキシエチレン20ステアレート(ソルビタンモノオクタデカノアートポリ(オキシ−1,2−エタンジイル)誘導体としても公知)、ならびに
TWEEN 40(ポリソルベート40、ポリオキシエチレン20ソルビタンモノパルミテート、ソルビタンモノヘキサデカノアートとしても公知)。
本発明のエマルションまたはエマルション前濃縮物組成物は1つまたは複数の共溶媒を任意で含むことができる。理論、機序または同種のものによって束縛されることは意図しないが、共溶媒を使用して、例えばω−3脂肪酸油および界面活性剤の混和性を改善することができる。いくつかの実施形態において、共溶媒は、1つまたは複数の界面活性剤と前混合される。
本発明の組成物中の成分の相対的比率は、例えば考慮される特定のタイプの組成物(例えばそれがエマルション前濃縮物、エマルション、エマルションから形成される経口製剤などであっても)および用いられた特定の成分に依存して変動するだろう。任意の特定の実例における実行可能な比率の決定は、概して本開示に照らして当業者の能力の範囲内であるだろう。本明細書において記載されたすべての示された比率および相対的重量範囲は、したがって、好ましいかまたはより特定の教示のみを表し、本発明をその最も広い意味で限定するものではないとして理解される。
いくつかの実施形態において、本発明のエマルション前濃縮物組成物は、
約60〜約85重量%(例えば約60〜約80重量%、例えば約70重量%)のω−3脂肪酸油と、約15〜約40重量%(例えば約20〜約40重量%(例えば約30の重量%)の界面活性剤とを含み、
エマルション前濃縮物組成物の全重量に基づいて、0〜約5重量%(例えば約0.1〜約5重量%、または約0.7〜約5重量%、または約0.7〜約1.2重量%)の共溶媒を任意でさらに含んでなることができる。
エマルション前濃縮物組成物中のω−3脂肪酸油および界面活性剤の重量に基づいて、
約60〜約80重量%のω−3脂肪酸油と、
約20〜約40重量%の界面活性剤と、任意で、
エマルション前濃縮物組成物の全重量に基づいて、約0.7〜約5重量%(例えば約0.7〜約1.2重量%)の共溶媒と
を含んでなることができ、
またはいくつかの実施形態において、
エマルション前濃縮物組成物中のω−3脂肪酸油および界面活性剤の重量に基づいて、
約70重量%のω−3脂肪酸油と、
約30重量%の界面活性剤と、任意で
エマルション前濃縮物組成物の全重量に基づいて、
約0.7〜約5重量%(例えば約0.7〜約1.2重量%)の共溶媒と
を含んでなることができる。
いくつかの実施形態において、本発明のエマルション組成物は、
約15〜約30重量%のω−3脂肪酸油と、
約5〜約10重量%の界面活性剤と、
約65〜約80重量%の水を提供する水性液体と、
任意で約0〜約5重量%の共溶媒(水以外の)と
を含み、
重量パーセンテージはエマルション組成物の全重量に基づく。
ω−3脂肪酸油を使用することができる本発明の他の実施形態は、疾患、病態または同種のもののいずれかの治療に好適な医薬製品(または医薬品)栄養製品、栄養補助製品の製造のための本発明のエマルションまたはエマルションの前濃縮物の組成物の使用を提供する。
静的レーザー光散乱技法を使用して粒子サイズを測定するMalvern粒子サイズ分析装置(Mastersizer 2000バージョン5.40; Malvern Instruments社、Westborough、MA、アメリカ)または同等物を用いて、前濃縮物から形成されるエマルションを含むエマルションの粒子サイズを決定する。
摂食に続いて、ω−3脂肪酸エステルからのω−3脂肪酸の消化および吸収は、以下の異なる3工程を含む。ω−3脂肪酸が結合されたアルコールからの加水分解、腸の腸細胞の中への吸収/輸送、および続いて腸での使用または体への輸送のためのパッケージング(当業者によって理解されるように、対応する遊離脂肪酸の摂取に続く消化および吸収は、最後の2工程を含むだろう)。
Cmax−観察された最大濃度
AUC−濃度−時間曲線下面積
AUC(0−x)−ゼロ(用量前)時間からある固定した基準時間までのAUC
AUC(0−t)−すべての治療にわたる被験体内の定量化可能な濃度のゼロ(用量前)から最終時間までのAUC
AUC(0−∞)−ゼロ(用量前)時間から無限時間までの推定AUC
Tmax−Cmaxの出現した時間
t1/2−最終相半減期
CV−変動係数(CVb=被験体間;CVw=被験体内)
CI−信頼区間
LS−最小二乗
他の統計用語は、特別の指示の無い限り、一般に使用される意味に沿って明示的にまたは文脈によって使用される。
イヌにおける2つの個別の研究において、100%のK85EE油の相対的生体利用率を7つのK85EE油のエマルション処方物と比較した(5つの前濃縮物カプセルおよび2つの液体処方物)。各処方物は、26.8および20.5mg/kgのEPAおよびDHAのエチルエステル(EE)の標的用量で、単一経口投与として(液体処方物の場合は強制経口投与により)絶食させたオスのビーグル犬へそれぞれ与えた。
試験処方
F=AUC(0−t)試験処方物/AUC(0−t)参照処方物
結果を表1中に示す:
第2の研究において、K85EEの6つの処方物(5つの前濃縮物カプセルおよび1つの液体(強制投与による))をイヌ(n=4/群)へ投与した。研究は6つの別個の研究日に行った。
試験処方:
F=AUC(0−8)試験処方物/AUC(0−8)参照処方物。
市販K85EE(例えばLOVAZA(登録商標)カプセル)と比較して、K85EE液体エマルションおよび/またはエマルション前濃縮物のカプセルの経口投与後の血漿中のEPAおよびDHAの相対的生体利用率、およびエマルションによる反復投薬後のリン脂質の中へのEPAおよびDHAの取り込みにおける任意の用量相関性の増加を評価する研究を行った。
2リンゴジュース中の分散に際して、生じたエマルションの中央粒子サイズは150nmであった。
3最低10時間の断食。
以下の表3〜4は、パートA中のレジメンについて得られた全および遊離EPAおよびDHA(ベースラインに対して補正した)についてのいくつかの血漿AUCおよびCmaxデータを要約する(来院1日目)。
レジメンの手引きは以下の通り。
A−エマルションカプセル1.68g
B−液体エマルション1.68g
C−LOVAZA 4g
2.n=14。
3.n=13。
レジメンの手引きは以下の通り。
A−エマルションカプセル1.68g
B−液体エマルション1.68g
C−LOVAZA 4g
表6および7は、パートB中のレジメンについて得られた、ベースラインについて補正した全および遊離EPA/DHAについてのいくつかの血漿AUCおよびCmaxのデータを要約する。
レジメンの手引きは以下の通り。
D=エマルションカプセル0.84g(N=11)。
E=エマルションカプセル1.68g(N=8)。
F=エマルションカプセル3.36g(N=10)。
G=LOVAZA 4g(N=9)。
P=プラセボ(プールした)(N=9)。
Claims (50)
- 水性液体を含んでなる水相と、
ω−3脂肪酸油を含んでなる油相と、
界面活性剤と
を含んでなる、エマルション組成物であって、
エマルションが、約100nm〜約3μmの中央粒子サイズを有する、エマルション組成物。 - 前記水相が、水である、請求項1に記載のエマルション組成物。
- 前記水相が、水を含んでなる飲用液体である、請求項1に記載のエマルション組成物。
- 組成物の全重量に基づいて、
約65〜約80重量%の水と、
約15〜約30重量%のω−3脂肪酸油と、
約5〜約10重量%の界面活性剤と
を含んでなる、請求項1〜3のいずれか一項に記載のエマルション組成物。 - 組成物の全重量に基づいて、
約65〜約80重量%の水と、
約15〜約30重量%のω−3脂肪酸油と、
約5〜約10重量%の界面活性剤と
を含んでなる、エマルション組成物。 - 前記ω−3脂肪酸油が、a)ω−3多価不飽和遊離脂肪酸(例えば長鎖)、b)多価不飽和遊離脂肪酸(例えば長鎖)のグリセロールとのエステル、c)多価不飽和遊離脂肪酸(例えば長鎖)および第一級アルコール、第二級アルコールまたは第三級アルコールのエステル、並びにd)それらの混合物から選択されるω−3脂肪酸を含んでなる、請求項1〜5のいずれか一項に記載のエマルション組成物。
- 前記ω−3脂肪酸油が、重量で少なくとも40%(例えば少なくとも80%)の1つまたは複数のω−3脂肪酸を含んでなる、請求項1〜6のいずれか一項に記載のエマルション組成物。
- 前記ω−3脂肪酸油が、重量で少なくとも50%(例えば少なくとも80%)のEPAおよびDHAを含んでなる、請求項1〜7のいずれか一項に記載のエマルション組成物。
- 前記ω−3脂肪酸油が、重量で約5〜約100%(例えば約40〜約55%)のEPAを含んでなる、請求項1〜8のいずれか一項に記載のエマルション組成物。
- 前記ω−3脂肪酸油が、重量で約5〜約100%(例えば約30〜約60%)のDHAを含んでなる、請求項1〜9のいずれか一項に記載のエマルション組成物。
- 前記ω−3脂肪酸油が、99:1〜1:99(例えば4:1〜1:4または2:1〜1:2)のEPA:DHAの重量比でEPAおよびDHAを含んでなる、請求項1〜10のいずれか一項に記載のエマルション組成物。
- 前記ω−3脂肪酸油が、組成物中の唯一の活性成分である、請求項1〜11のいずれか一項に記載のエマルション組成物。
- 前記界面活性剤が、ポリオキシエチレンヒマシ油誘導体(例えばPEG 35ヒマシ油)、ポリオキシエチレンソルビタン脂肪酸エステル(例えば80[ポリオキシエチレン(20)モノオレイン酸ソルビタン])、およびそれらの混合物から選択される、請求項1〜12のいずれか一項に記載のエマルション組成物。
- 共溶媒をさらに含んでなる、請求項1〜13のいずれか一項に記載のエマルション組成物。
- 前記共溶媒が、C1−4アルコール(例えばEtOH)、C12−22遊離脂肪酸(例えばオレイン酸)、およびそれらの混合物から選択される、請求項14に記載のエマルション組成物。
- 前記組成物が、組成物の重量に基づいて約0.1〜約5重量%の共溶媒を含んでなる、請求項14または15に記載のエマルション組成物。
- ω−3脂肪酸油と、界面活性剤とを含んでなる、エマルション前濃縮物組成物であって、前濃縮物が、水性液体と接触して、約100nm〜約3μmの中央粒子サイズを有するエマルションを形成することができる、エマルション前濃縮物組成物。
- 前記水性液体が、水である、請求項17に記載のエマルション前濃縮物組成物。
- 組成物中のω−3脂肪酸油および界面活性剤の全重量に基づいて、
約60〜約85重量%のω−3脂肪酸油と、
約15〜約40重量%の界面活性剤と
を含んでなる、請求項17または18に記載のエマルション前濃縮物組成物。 - 組成物中のω−3脂肪酸油および界面活性剤の全重量に基づいて、
約60〜約85重量%のω−3脂肪酸油と、
約15〜約40重量%の界面活性剤と
を含んでなる、エマルション前濃縮物組成物。 - 前記ω−3脂肪酸油が、a)ω−3多価不飽和遊離脂肪酸(例えば長鎖)、b)多価不飽和遊離脂肪酸(例えば長鎖)のグリセロールとのエステル、c)多価不飽和遊離脂肪酸(例えば長鎖)および第一級アルコール、第二級アルコールまたは第三級アルコールのエステル、並びにd)それらの混合物から選択されるω−3脂肪酸を含んでなる、請求項17〜20のいずれか一項に記載のエマルション前濃縮物組成物。
- 前記ω−3脂肪酸油が、重量で少なくとも40%(例えば少なくとも80%)の1つまたは複数のω−3脂肪酸を含んでなる、請求項17〜21のいずれか一項に記載のエマルション前濃縮物組成物。
- 前記ω−3脂肪酸油が、重量で少なくとも50%(例えば少なくとも80%)のEPAおよびDHAを含んでなる、請求項17〜22のいずれか一項に記載のエマルション前濃縮物組成物。
- 前記ω−3脂肪酸油が、重量で約5〜約100%(例えば約40〜約55%)のEPAを含んでなる、請求項17〜23のいずれか一項に記載のエマルション前濃縮物組成物。
- 前記ω−3脂肪酸油が、重量で約5〜約100%(例えば約30〜約60%)のDHAを含んでなる、請求項17〜24のいずれか一項に記載のエマルション前濃縮物組成物。
- 前記ω−3脂肪酸油が、99:1〜1:99(例えば、4:1〜1:4または2:1〜1:2)のEPA:DHAの重量比でEPAおよびDHAを含んでなる、請求項17〜25のいずれか一項に記載のエマルション前濃縮物組成物。
- 前記ω−3脂肪酸油が、組成物中の唯一の活性成分である、請求項17〜26のいずれか一項に記載のエマルション前濃縮物組成物。
- 前記界面活性剤が、ポリオキシエチレンヒマシ油誘導体(例えばPEG 35ヒマシ油)、ポリオキシエチレンソルビタン脂肪酸エステル(例えば80[ポリオキシエチレン(20)モノオレイン酸ソルビタン]、およびそれらの混合物から選択される、請求項17〜27のいずれか一項に記載のエマルション前濃縮物組成物。
- 組成物中のω−3脂肪酸油および界面活性剤の全重量に基づいて、
約60〜約80重量%のω−3脂肪酸油と、
約20〜約40重量%の界面活性剤と、
を含んでなる、請求項17〜28のいずれか一項に記載のエマルション前濃縮物組成物。 - 組成物中のω−3脂肪酸油および界面活性剤の全重量に基づいて、
約70重量%のω−3脂肪酸油と、
約30重量%の界面活性剤と
を含んでなる、請求項29に記載のエマルション前濃縮物組成物。 - 前記ω−3脂肪酸油対界面活性剤の重量比が、2:1を超える(例えば2:1を超える〜6:1の範囲)、請求項17〜30のいずれか一項に記載のエマルション前濃縮物組成物。
- 共溶媒をさらに含んでなる、請求項17〜31のいずれか一項に記載のエマルション前濃縮物組成物。
- 組成物の全重量に基づいて、約0.1〜約5重量%(例えば約0.7〜約5重量%または約0.7〜約1.2重量%)の共溶媒を含んでなる、請求項32に記載のエマルション前濃縮物組成物。
- 前記共溶媒が、水、C1−4アルコール(例えばEtOH)、C12−22遊離脂肪酸(例えばオレイン酸)、およびそれらの混合物から選択される、請求項32または33に記載のエマルション前濃縮物組成物。
- 前記共溶媒が、水である、請求項34に記載のエマルション前濃縮物組成物。
- 請求項17〜35のいずれか一項に記載のエマルション前濃縮物組成物を水性液体と接触させることによって形成される、エマルション。
- 前記エマルションが、約100nm〜約3μmの中央粒子サイズを有する、請求項36に記載のエマルション。
- 請求項1〜37のいずれか一項に記載のエマルション組成物またはエマルション前濃縮物組成物を含んでなる、医薬製品、栄養製品、または栄養補助製品である、経口製剤。
- 飲用液体組成物の形態である、請求項38に記載の経口製剤。
- 請求項17〜35のいずれか一項に記載のエマルション前濃縮物を含んでなる、ハードカプセルまたはソフトカプセル(例えばソフトゼラチンカプセル)の形態である、請求項38に記載の経口製剤。
- ω−3脂肪酸油を用いることができる疾患、病態などのいずれかの治療に好適な、医薬製品、栄養製品、または栄養補助製品の製造のための、請求項1〜37のいずれか一項に記載のエマルション組成物またはエマルション前濃縮物組成物の使用。
- ω−3脂肪酸油を用いることができる疾患、病態などのいずれかの治療に好適な、薬剤の製造のための、請求項1〜37のいずれか一項に記載のエマルション組成物またはエマルション前濃縮物組成物の使用。
- ω−3脂肪酸油を用いることができる疾患、病態などのいずれかの治療のために、請求項1〜37のいずれか一項に記載のエマルション組成物またはエマルション前濃縮物組成物をそれを必要とする被験体(例えばヒトを含んでなる哺乳類)へ投与することを含んでなる、治療方法。
- 前記疾患または病態が、高トリグリセリド血症、高コレステロール血症、混合型脂質異常症、心血管性疾患、冠性心疾患(CHD)、血管性疾患、アテローム性動脈硬化性疾患および関連する病態、心血管イベントおよび/または血管イベント(MACE、MCEを含む)からなる群から独立して選択される、請求項41〜43のいずれか一項に記載の使用または方法。
- ω−3脂肪酸による治療を必要とする被験体において、ω−3脂肪酸の経口吸収および/または経口生体利用率を増加させる方法であって、請求項1〜37のいずれか一項に記載のエマルション組成物またはエマルション前濃縮物組成物を前記被験体へ経口投与することを含んでなり、経口吸収および/または経口生体利用率が、前記組成物中で使用されるω−3脂肪酸油の投与後の経口吸収および/または経口生体利用率と比較して増加する、方法。
- 前記ω−3脂肪酸が、EPAおよび/またはDHAである、請求項45に記載の方法。
- 全EPAおよび/またはDHAの血清レベルが増加する、請求項46に記載の方法。
- 全EPAおよび/またはDHAの血清レベルが、前記組成物中で使用されるω−3脂肪酸油の投与後の全EPAおよび/またはDHAの血清レベルと比較して、少なくとも約2、3または4倍(例えば約2倍〜約5倍)まで増加する、請求項47に記載の方法。
- 前記エマルション組成物またはエマルション前濃縮物組成物が、1日あたり約0.1g〜約10g(例えば1日あたり約0.75〜約4g、または約0.1g〜約2g)の1日量のω−3脂肪酸油を提供するように投与される、請求項45〜48のいずれか一項に記載の方法。
- 前記ω−3脂肪酸油の1日の用量が、1日あたり1〜10の用量(例えば1日あたり1〜4または1〜2の用量)で投与される、請求項49に記載の方法。
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US20200246299A1 (en) | 2020-08-06 |
JP6430608B2 (ja) | 2018-11-28 |
EP2488022A1 (en) | 2012-08-22 |
US20120207800A1 (en) | 2012-08-16 |
JP2019031555A (ja) | 2019-02-28 |
JP2022095815A (ja) | 2022-06-28 |
JP5951489B2 (ja) | 2016-07-13 |
JP2016222672A (ja) | 2016-12-28 |
ES2661812T3 (es) | 2018-04-04 |
EP2488022B1 (en) | 2018-01-10 |
EP2488022A4 (en) | 2014-02-19 |
JP7055840B2 (ja) | 2022-04-18 |
US10668038B2 (en) | 2020-06-02 |
WO2011047259A1 (en) | 2011-04-21 |
US20170304249A1 (en) | 2017-10-26 |
JP6728303B2 (ja) | 2020-07-22 |
JP2018048163A (ja) | 2018-03-29 |
US9717703B2 (en) | 2017-08-01 |
JP2020180132A (ja) | 2020-11-05 |
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