JP6910309B2 - コエンザイムq10の固体分散体 - Google Patents
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- A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
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Description
a)コエンザイムQ10と、
b)リン脂質と、
c)カルボキシメチルセルロース、メチルセルロース、エチルセルロース、ヒドロキシプロピルセルロース、ヒドロキシエチルセルロース、ヒドロキシプロピルメチルセルロース、微晶質セルロース、酢酸フタル酸セルロース、ヒドロキシプロピルメチルフタル酸セルロースからなる群から選択される1種又は2種以上のセルロース誘導体、及び/又は、
d)ポリビニルピロリドン、ポリ酢酸ビニル、ポリ(メタクリル酸、メタクリル酸メチル)、ポロクサマー、キトサン、アルギン酸塩、ヒアルロン酸、ペクチン、プルラン、シクロデキストリン、スターチ重合体、D−αトコフェリルポリエチレングリコール1000コハク酸エステルからなる群から選択される重合体材料、を含む。
工程i)1又は2以上のセルロース誘導体、リン脂質、及び/又は重合体材料を有機溶媒に懸濁させた懸濁液を用意する工程、
工程ii)コエンザイムQ10を有機溶媒に溶解した溶液を用意する工程、
工程iii)工程ii)で得られた溶液と工程i)で得られた懸濁液を混合する工程、
工程iv)工程iii)で得られた懸濁液を40℃から70℃で撹拌する工程、
工程v)工程iv)で得られた懸濁液から、好ましくは減圧下で溶媒を除去する工程。
微晶質セルロース1.5kg、ひまわりレシチン2.0kg、セルロースエーテル(メチルセルロースとヒドロキシプロピルメチルセルロース)0.5kgを酢酸エチル50リットルに懸濁させ、1時間還流した。得られた懸濁液を40℃まで冷却した。
コエンザイムQ10とリン脂質の固体分散体を、示差走査熱量分析(DSC)により結晶コエンザイムQ10と比較分析した。
コエンザイムQ10の結晶粉末とリン脂質との固体分散体とをそれぞれ1回経口投与したときのラットの薬物動態学的パラメータ(Tmax、Cmax、絶対的生体利用効率)を測定した。
コエンザイムQ10固体分散体 400.0mg
微晶質セルロース 200.0mg
第二リン酸カルシウム(無水) 146.0mg
クロスカルメロースナトリウム 30.0mg
二酸化シリコン 8.0mg
タルク 8.0mg
ステアリン酸マグネシウム 8.0mg
フィルムコーティング 20.0mg
コエンザイムQ10固体分散体 250.0mg
アマニ油 384.0mg
モノステアリン酸グリセリル 10.0mg
レシチン 6.0mg
Claims (11)
- a)コエンザイムQ10と、
b)リン脂質と、
c)カルボキシメチルセルロース、メチルセルロース、エチルセルロース、ヒドロキシプロピルセルロース、ヒドロキシエチルセルロース、ヒドロキシプロピルメチルセルロース、微晶質セルロース、酢酸フタル酸セルロース、ヒドロキシプロピルメチルフタル酸セルロースからなる群から選択される1種又は2種以上のセルロース誘導体、を含み、前記コエンザイムQ10のリン脂質に対する比率が0.2から1である、固体分散体。 - 前記リン脂質は、大豆、ひまわり又は卵由来のレシチン、ホスファチジルコリン、ホスファチジルセリン、ホスファチジルエタノールアミンからなる群から選択される、請求項1に記載の固体分散体。
- 前記コエンザイムQ10のリン脂質に対する比率が0.5から1である、請求項1又は2に記載の固体分散体。
- 前記コエンザイムQ10のセルロース誘導体に対する比率が0.2から2である、請求項1から3のいずれか一項に記載の固体分散体。
- 前記コエンザイムQ10のセルロース誘導体に対する比率が0.5から1である、請求項4に記載の固体分散体。
- コエンザイムQ10と、リン脂質と、微晶質セルロース、ヒドロキシプロピルメチルセルロース、メチルセルロースからなる群から選択される1種又は2種以上のセルロース誘導体と、を含む、請求項1から5のいずれか一項に記載の固体分散体。
- 前記リン脂質は、大豆、ひまわり又は卵由来のレシチンである、請求項6に記載の固体分散体。
- 請求項1から7のいずれか一項に記載の固体分散体と、医薬的又は食物的に許容可能な賦形剤とを含む、経口投与のための医薬又は栄養補助製剤。
- i)1又は2以上のセルロース誘導体、及びリン脂質を有機溶媒に懸濁させた懸濁液を用意する工程、
ii)コエンザイムQ10を有機溶媒に溶解した溶液を用意する工程、
iii)工程ii)で得られた前記溶液と工程i)で得られた前記懸濁液を混合する工程、
iv)工程iii)で得られた懸濁液を40℃から70℃で撹拌する工程、
v)工程iv)で得られた懸濁液から溶媒を除去する工程、
を含む、請求項1に記載の固体分散体を製造する方法。 - 前記有機溶媒は、エタノール、アセトン、酢酸エチルからなる群から選択される、請求項9に記載の方法。
- 前記有機溶媒は酢酸エチルである、請求項9に記載の方法。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP15171943.2 | 2015-06-12 | ||
EP15171943.2A EP3103440A1 (en) | 2015-06-12 | 2015-06-12 | Solid dispersions of coenzyme q10 |
PCT/EP2016/063262 WO2016198576A1 (en) | 2015-06-12 | 2016-06-10 | Solid dispersions of coenzyme q10 |
Publications (2)
Publication Number | Publication Date |
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JP2018516945A JP2018516945A (ja) | 2018-06-28 |
JP6910309B2 true JP6910309B2 (ja) | 2021-07-28 |
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Application Number | Title | Priority Date | Filing Date |
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JP2017563338A Active JP6910309B2 (ja) | 2015-06-12 | 2016-06-10 | コエンザイムq10の固体分散体 |
Country Status (17)
Country | Link |
---|---|
US (1) | US10905657B2 (ja) |
EP (2) | EP3103440A1 (ja) |
JP (1) | JP6910309B2 (ja) |
KR (1) | KR20180017016A (ja) |
CN (1) | CN107750158B (ja) |
AU (1) | AU2016274662B2 (ja) |
CA (1) | CA2988478C (ja) |
DK (1) | DK3307244T3 (ja) |
ES (1) | ES2768950T3 (ja) |
HK (1) | HK1250652A1 (ja) |
HU (1) | HUE047668T2 (ja) |
IL (1) | IL256159B (ja) |
PL (1) | PL3307244T3 (ja) |
PT (1) | PT3307244T (ja) |
RU (1) | RU2742579C2 (ja) |
SI (1) | SI3307244T1 (ja) |
WO (1) | WO2016198576A1 (ja) |
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CA3094591C (en) | 2018-04-06 | 2024-03-26 | Capsugel Belgium Nv | Spray drying process for low aspect ratio particles comprising poly[(methyl methacrylate)-co-(methacrylic acid)] |
CN111374965B (zh) * | 2018-12-28 | 2024-01-16 | 上海融澈水性材料有限公司 | 一种稳定性高的水溶性辅酶q10包合物及其制备方法 |
IT201900003907A1 (it) | 2019-03-18 | 2020-09-18 | Indena Spa | Composizioni comprendenti curcumina e coenzima q10 |
WO2021040027A1 (ja) * | 2019-08-30 | 2021-03-04 | 三栄源エフ・エフ・アイ株式会社 | 非晶質の難水溶性素材を含有する固体組成物、及びその製造方法 |
EP4023246A4 (en) * | 2019-08-30 | 2023-10-04 | San-Ei Gen F.F.I., INC. | SOLID COMPOSITION CONTAINING AN AMORPHOUS MATERIAL, POORLY SOLUBLE IN WATER, AND METHOD FOR PRODUCING SAME |
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JPS61172832A (ja) * | 1985-01-28 | 1986-08-04 | Nikko Kemikaruzu Kk | 難溶性薬剤含有製剤組成物 |
DE4327063A1 (de) * | 1993-08-12 | 1995-02-16 | Kirsten Dr Westesen | Ubidecarenon-Partikel mit modifizierten physikochemischen Eigenschaften |
IL117773A (en) | 1996-04-02 | 2000-10-31 | Pharmos Ltd | Solid lipid compositions of coenzyme Q10 for enhanced oral bioavailability |
CN101277682B (zh) * | 2005-07-28 | 2015-07-29 | Isp投资有限公司 | 无定形依发韦仑及其生产 |
JP5426165B2 (ja) * | 2005-07-28 | 2014-02-26 | アイエスピー インヴェストメンツ インコーポレイテッド | 優れた生物学的利用能のベンゾキノン類 |
JP2007153866A (ja) * | 2005-11-09 | 2007-06-21 | Yoshida Kikai Co Ltd | 乳化型化粧料 |
KR100956583B1 (ko) | 2006-01-26 | 2010-05-11 | 주식회사 대웅제약 | 유비데카레논의 고체분산체와 그 제조방법 및 이를포함하는 약제학적 조성물 |
WO2007125915A1 (ja) * | 2006-04-24 | 2007-11-08 | Kaneka Corporation | 補酵素q含有固形物 |
US20080145411A1 (en) | 2006-10-06 | 2008-06-19 | Kaneka Corporation | Composition of high absorbability for oral administration comprising oxidized coenzyme q10 |
EP2227085A4 (en) * | 2007-12-06 | 2013-10-09 | Berg Pharma Llc | INGREDIBLE COMPOSITIONS WITH INCREASED BIOLOGICAL AVAILABILITY |
US9655849B2 (en) * | 2011-03-18 | 2017-05-23 | Particle Dynamics International, Llc | Solid particulate compositions comprising coenzyme Q10 |
CN103536574A (zh) | 2013-09-29 | 2014-01-29 | 邵爱霞 | 一种辅酶q10软胶囊及其制备方法 |
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BR112017026291A2 (pt) | 2018-09-11 |
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