JP2015522366A - ピルビン酸塩を含有するヒアルロン酸製剤 - Google Patents
ピルビン酸塩を含有するヒアルロン酸製剤 Download PDFInfo
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Abstract
Description
ΔTanδ1Hz=(添加物有のTanδ1Hzゲル)−(Tanδ1Hz NaHA対照)
リドカインを含むマトリックスNaHAゲル(リドカインが0.3%w/w)にピルビン酸ナトリウムを0.01%w/w〜1%w/wの含量で導入した。ゲルは加圧加熱された。27G針を用いて13mm/分の速度で押出力(F)を計測した。
ゲルは、−2N≦ΔF≦2Nで、
ΔF=(添加物を含むFゲル)−(F NaHA対照)である場合、および
ΔTanδ1Hz≦0.1で、
ΔTanδ1Hz=(添加物を含むTanδ1Hzゲル)−(Tanδ1Hz NaHA対照)である場合、
加圧加熱中に安定していると考えられる。
実施例1で調製された製剤およびリドカインを有するNaHAマトリックスの、45℃での60日間の貯蔵寿命を試験した。ゲルのpHは経時的に安定していた。続いてレオロジー特性を60日間、45℃で試験した。図1は対照(0%ピルビン酸塩)および0.01%ピルビン酸塩および1%ピルビン酸塩を含むHA組成物の45℃で60日間保管されている間の押出力のプロットであり、図2はそれらの弾性係数のプロットであり、図3はそれらの粘性係数のプロットである。表2は、これらの組成物について、ゲルにピルビン酸塩を添加することでゲルを安定化させる助けとなることが示している。45℃での保管中におけるtanδ増加への影響はピルビン酸塩含量と相関しており、安定改善平坦域に約0.25%で到達した。
60日間でのΔTanδ1Hz<0である場合にピルビン酸塩によってゲル安定性が向上している
リドカインを有するNaHAゲル(リドカインが0.3%w/w)と0.6%w/wの含量のVitagenとのマトリックスにピルビン酸ナトリウムを導入した。ゲルは120℃〜130℃の間で5〜15分間加圧加熱された。表3に示すように、ピルビン酸塩を含む組成物では加圧加熱後の安定性(pH、押出力、tanδ)の向上が観察されたが、Vitagenを含むがピルビン酸塩を含まない組成物は加圧加熱中に安定していない。
ΔTanδ1Hz=(添加物を有するTanδ1 Hzゲル)−(Tanδ1Hz NaHA対照)
−2N≦ΔF≦2NおよびΔTanδ1Hz≦0.1である場合にゲルが安定していると考えられる
実施例1で調製された製剤およびリドカインを有するNaHAマトリックスの45℃で60日間における貯蔵寿命を試験した。pHおよびレオロジー特性がその後に続いた。ピルビン酸塩を製剤に添加することは、添加物を有さないゲルおよびVitagenしか含まないゲルの安定性に著しい影響を与えた。
実施例3の加圧加熱された試料上に残るVitagenの量をHPLCで計測した。表4は、Vitagenを含む製剤にピルビン酸塩を添加することが熱安定性中の添加物を安定させることに貢献することを示す。
Claims (14)
- ヒアルロン酸とピルビン酸塩とを含む組成物であって、前記ヒアルロン酸は架橋されており、前記組成物は真皮充填剤としての使用に適しており、前記組成物は加熱滅菌に安定性を示すゲルである、前記組成物。
- 前記ゲルが、ピルビン酸塩を含まない実質的に同一のゲルと比べて向上した熱安定性を有する、請求項1に記載の組成物。
- 前記ゲルが加熱滅菌後に約0.004未満のΔTanδ1Hzを有する、請求項1または2に記載の組成物。
- 前記ゲルが45℃で60日間保管した後に約−0.03未満のΔTanδ1Hzを有する、請求項1〜3のいずれか一項に記載の組成物。
- 架橋ヒアルロン酸とピルビン酸塩とを含むゲルを加熱処理することを含むプロセスによって調製される、前記組成物。
- リドカインをさらに含む、請求項1〜5のいずれか一項に記載の組成物。
- リドカインが約0.05%w/w〜約1%w/wの濃度で存在する、請求項6に記載の組成物。
- ヒアルロン酸が約0.1%w/vの濃度で存在する、請求項1〜7のいずれか一項に記載の組成物。
- ピルビン酸塩が約0.01%w/w〜約2%w/wの濃度で存在する、請求項1〜8のいずれか一項に記載の組成物。
- 前記ピルビン酸塩が約0.05%w/w〜約1%w/wの濃度で存在する、請求項9に記載の組成物。
- 3−アミノプロピル−L−アスコルビルホスフェートをさらに含む、請求項1〜10のいずれか一項に記載の組成物。
- 請求項1〜11のいずれか一項に記載の組成物を含む、真皮充填剤製品。
- 真皮充填剤製品の熱安定性を改善する方法であって、
ピルビン酸塩と架橋ヒアルロン酸との組み合わせを含むゲルを形成することを含み、
ピルビン酸塩が前記ゲルの熱安定性を改善するのに有効である、前記方法。 - 前記ゲル中で、ピルビン酸塩が約0.1%w/w〜約1%w/wの濃度を有する、請求項17に記載の方法。
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PCT/IB2012/001525 WO2014013286A1 (en) | 2012-07-18 | 2012-07-18 | Hyaluronic acid formulation containing pyruvate |
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ES2725430T3 (es) * | 2014-07-11 | 2019-09-24 | Allergan Ind Sas | Geles de ácido hialurónico reticulados por trimetafosfato de sodio |
CN111265505A (zh) * | 2020-03-09 | 2020-06-12 | 上海中医药大学附属岳阳中西医结合医院 | 丙酮酸的新用途 |
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FR2861734B1 (fr) | 2003-04-10 | 2006-04-14 | Corneal Ind | Reticulation de polysaccharides de faible et forte masse moleculaire; preparation d'hydrogels monophasiques injectables; polysaccharides et hydrogels obtenus |
FR2878444B1 (fr) | 2004-11-30 | 2008-04-25 | Corneal Ind Soc Par Actions Si | Solutions viscoelastiques renfermant du hyaluronate de sodiu et de l'hydroxypropylmethylcellulose, preparation et utilisations |
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CN101423559A (zh) * | 2008-11-12 | 2009-05-06 | 山东阜丰生物科技开发有限公司 | 一种制备在淡水中粘度高的黄原胶的方法 |
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AU2019283808A1 (en) | 2020-01-16 |
KR102062420B1 (ko) | 2020-01-03 |
KR20200036064A (ko) | 2020-04-06 |
RU2015105317A (ru) | 2016-09-10 |
TR201802330T4 (tr) | 2018-03-21 |
AU2018203692A1 (en) | 2018-06-14 |
US10507172B2 (en) | 2019-12-17 |
KR102097933B1 (ko) | 2020-04-06 |
CA2879011C (en) | 2021-05-04 |
KR102239020B1 (ko) | 2021-04-09 |
JP6108500B2 (ja) | 2017-04-05 |
EP2874598A1 (en) | 2015-05-27 |
KR20150032577A (ko) | 2015-03-26 |
EP2874598B1 (en) | 2017-11-22 |
WO2014013286A1 (en) | 2014-01-23 |
US20190151213A1 (en) | 2019-05-23 |
CA2879011A1 (en) | 2014-01-23 |
CN104507453B (zh) | 2018-02-16 |
CN104507453A (zh) | 2015-04-08 |
US20150216781A1 (en) | 2015-08-06 |
US10182977B2 (en) | 2019-01-22 |
US20160338925A1 (en) | 2016-11-24 |
AU2018203692B2 (en) | 2020-01-02 |
ES2660023T3 (es) | 2018-03-20 |
DK2874598T3 (en) | 2018-03-05 |
AU2019283808B2 (en) | 2021-07-01 |
KR20200000494A (ko) | 2020-01-02 |
AU2012385702A1 (en) | 2015-02-05 |
US20200093720A1 (en) | 2020-03-26 |
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