JP2016533775A - キトサンペースト創傷手当て材 - Google Patents
キトサンペースト創傷手当て材 Download PDFInfo
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- JP2016533775A JP2016533775A JP2016518431A JP2016518431A JP2016533775A JP 2016533775 A JP2016533775 A JP 2016533775A JP 2016518431 A JP2016518431 A JP 2016518431A JP 2016518431 A JP2016518431 A JP 2016518431A JP 2016533775 A JP2016533775 A JP 2016533775A
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- Prior art keywords
- paste
- phosphate
- kit
- chitosan
- kit according
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Abstract
Description
本願は、2013年10月24日に「キトサンステント材ペースト(CHITOSAN STENTING PASTE)」の名称で出願されている米国特許出願第14/061,993号及び2014年6月30日に「キトサンペースト創傷手当て材(CHITOSAN PASTE WOUND DRESSING)」の名称で出願されている米国特許出願第14/319,901号からの優先権を主張するものであり、また本願と同日に出願されている「キトサンステント材ペースト」という名称の国際特許出願第(弁理士整理番号C04881WO01)号に関係しており、それら各々の開示をここに参考文献として援用する。
[0011]次の詳細な説明は、一部の特定の実施形態を説明しており、制限を課す意味に取られてはならない。本明細書の中の全ての重さ、量、及び比は、別途特に指摘されていない限り重量によるものである。以下に示されている用語の意味は次の通りである。
[0015]「生体分解性の」という用語が物質に関して使用されている場合、それは、当該物質が生体内で分解又は侵食してより小さい化学的又は物理的な種を形成するという意味である。その様な分解プロセスは、酵素的、化学的、又は物理的であってもよい。
[0019]「不透明な」という用語が材料に関して使用されている場合、それは、普通の頭上にある照明が約4mm厚の材料層を透過されないことを意味する。
[0021]「ペースト」という用語が物質に関して使用されている場合、それは、当該物質が見るからに均質、無孔、不透明な材料であって、例えば歯磨きペーストと同様の柔らかで延ばしたり広げたりできる粘稠度を有している材料であることを意味する。不透明ゲルはペーストであるとされる。自由に流動する乾燥した固体粒子の集合体、延ばせない固形物、多孔質スポンジ、透明ゲル、液体、又は噴霧可能な組成物は、ペーストではないということになる。
[0025]「薄い」という用語が組織又は他の身体構造の上の保護的な層に関して使用されている場合、それは、約2ミリメートル未満の平均厚さを有しているという意味である。
[0027]「張度」という用語が外的物質に対する細胞の応答に関して使用されている場合、それは、所与の膜を横断して浸透力を働かせる容量を有する溶質濃度の総和を指す。細胞膜を横断することのできない溶質が浸透力を働かせる。細胞膜に関しては物質の溶質濃度に依存して張度は「高張性」、「低張性」、又は「等張性」と呼称されることもある。「高張性」は細胞膜の外により高い溶質濃度を有する物質を指す。そういうものとして、当該物質が細胞膜に接触したとき、細胞内の水は細胞から外へ出て行き細胞膜の外の溶質濃度を平衡させる傾向を有することになる。「低張性」は細胞膜の外により低い溶質濃度を有する物質を指す。そいうものとして、細胞の外からの水は細胞の中へ入ってゆき、細胞内部の溶質濃度の平衡を図ろうとして腫脹を引き起こす。「等張性」は物質の溶質濃度が物質が接触することになる細胞と同じであることを指す。そいうものとして、それは細胞と生理学的一体にあると考えられ、故に水の純流動は無い。
[0062]PBS錠剤を水に溶かし、1N NaOHを使用してpHをpH11−12へ調節して、3X PBS(pH11−12)溶液を調製した。グリセロールを使用する場合には、グリセロールをPBS溶液に添加してPBS/グリセロール溶液を形成した。PBS溶液か又はPBS/グリセロール溶液の何れかへ、乾燥成分、つまりは、30−400kDa分子量キトサン又はグリセロールリン酸二ナトリウム塩水和物の固体の可変量を添加し、室温で混合してペーストを形成した。次いでペーストをガンマ線滅菌した。調合物全てがペーストを形成し、室温ではペーストのまま留まった。表1は総液体体積中の成分の割合を示している。表1は、各調合物についての滅菌後の浸透圧重量モル濃度、粘度、及び接着度の値も示している。
[0064]表2からの調合物4、調合物5、及び調合物6を評価し、4つの一般的な菌種(黄色ブドウ球菌、表皮ブドウ球菌、大腸菌、及び緑膿菌)に対するそれらの抗微生物活性を抑制域スクリーニング技法を使用して判定した。
[0068]調合物6を、米国薬局方(USP)の抗微生物効力試験を施行するための指針第<51>章及び微生物回収率の妥当性確認第<1227>章に従って評価したところ、一般的な有機体に対する抗微生物効能が治療適用区域に典型的に見られることを確定した。測定された抗微生物性を下の表5に示している。
[0069]調合物4及び調合物6をE−ビーム滅菌又はガンマ線滅菌し、ISO指針10993−5医療装置の生物学的評価−第5部:試験管内細胞毒性の試験、に従って潜在的細胞毒性効果について評価した。調合物4及び調合物6を37℃の純水(PW)の中で24時間抽出した。PW抽出物を強度が2倍の最小必須媒体(2X MEM)と50%の濃度へ混合した。陰性対照(高密度ポリエチレン)及び試薬対照(例えばPW)を同様に調製した。陽性対照(天然ゴムラテックス、カルバミン酸亜鉛促進剤、酸化亜鉛、及び二酸化チタン、を含んでいるラテックス手袋粉無)を37℃の強度1倍のMEM(1X MEM)の中で24時間抽出した。L−929マウス繊維芽細胞を有する哺乳類細胞培養単層の三重反復試験に各抽出物(調合物14、調合物16、陽性対照、陰性対照、及び試薬対照)を投与し、37℃で5%CO2存在下に48時間培養した。培養に続いて、それら単層を異常細胞形態学及び細胞変性について顕微鏡(100X)で検査した。
実施形態1.
リン酸塩含有溶液中に溶解させた水溶性キトサン又はその誘導体と潤滑剤又は湿潤剤とを備えるペースト組成物を備えている滅菌包装体内ペーストにおいて、組成物は、室温ではペーストであり、少なくとも4のpH、約1Pa.s.から約15Pa.s.の粘度、を有しており、ペーストは手術部位へ接着し少なくとも1日間の滞留時間を有している、滅菌包装体内ペースト。
リン酸塩含有溶液中に溶解させた水溶性キトサン又はその誘導体と潤滑剤又は湿潤剤とを備えるペースト組成物を備えている創傷手当て材において、組成物は、室温ではペーストであり、少なくとも4のpH、約1Pa.s.から約15Pa.s.の粘度、を有しており、ペーストは手術部位へ接着し少なくとも1日間の滞留時間を有している、創傷手当て材。
水溶性キトサンは塩を備えている、実施形態1又は実施形態2。
実施形態4.
水溶性キトサンは塩酸塩を備えている、実施形態1から実施形態3の何れかの実施形態。
水溶性キトサンは総ペースト重量の約3重量%から約20重量%である、実施形態1から実施形態4の何れかの実施形態。
水溶性キトサンは総ペースト重量の約15重量%から約18重量%である、実施形態1から実施形態5の何れかの実施形態。
リン酸塩含有溶液はリン酸緩衝生理食塩水(PBS)である、実施形態1から実施形態6の何れかの実施形態。
リン酸塩含有溶液は9から12の間のpHを有している、実施形態1から実施形態7の何れかの実施形態。
潤滑剤又は湿潤剤はグリセロールを備えている、実施形態1から実施形態8の何れかの実施形態。
4から7のpHを有している実施形態1から実施形態9の何れかの実施形態。
実施形態11.
滞留時間は少なくとも3日間である、実施形態1から実施形態10の何れかの実施形態。
引っ張り試験機を1mm/秒の分離速度で作動させて使用し、ペーストの試料を間にして約4.4ニュートンの圧縮力を用いて互いに圧縮されている2つのコラーゲン被覆ゴム製半球体を分離させる場合に、約5グラムから約80グラムの間の力が必要になる接着強度を有している実施形態1から実施形態15の何れかの実施形態。
グリセロールリン酸を更に備えている実施形態1から実施形態12の何れかの実施形態。
浸透圧重量モル濃度低減剤を更に備えている実施形態1から実施形態13の何れかの実施形態。
浸透圧重量モル濃度低減剤はヒドロキシル官能性セルロース又はアルキル修飾型セルロースを備えている、実施形態14。
ヒドロキシル官能性セルロース又はアルキル修飾型セルロースは、ヒドロキシプロピルセルロース、メチルセルロース、又はヒドロキシエチルセルロースである、実施形態15。
浸透圧重量モル濃度は約270mOsm/kgから約2000mOsm/kgである、実施形態14から実施形態16の何れかの実施形態。
無細胞毒性である実施形態1から実施形態17の何れかの実施形態。
実施形態19.
1又はそれより小さい細胞毒性評点を有している実施形態18。
滅菌包装体は電子ビーム滅菌又はガンマ線滅菌されている、実施形態1から実施形態19の何れかの実施形態。
滅菌エネルギーは約12kGyから約40kGyである、実施形態20。
実施形態22.
実施形態1から実施形態21の何れかの実施形態から形成されている創傷手当て材。
104 プランジャ
106 バレル
108 先端
116 患者の脚
118 外部創傷
120 ペースト
200 計量分配シリンジ
202 外科医の右手
204 プランジャ
206 シリンジバレル
208 一直線の先端
210 曲げることのできる先端
220 不透明な塊
Claims (20)
- 創傷を治療するための方法において、
創傷へ、リン酸塩含有溶液中に溶解させた水溶性キトサン又はその誘導体を備えているペースト組成物を塗布する段階であって、前記組成物は、室温ではペーストであり、少なくとも4のpH、約1Pa.s.から約15Pa.s.の粘度、及び少なくとも1日間の滞留時間、を有している、ペースト組成物を塗布する段階、を備えている、
創傷を治療するための方法。 - リン酸塩含有溶液中に溶解させた水溶性キトサン又はその誘導体を備えているペースト組成物の、創傷を治療するための使用において、前記組成物は、室温ではペーストであり、少なくとも4のpH、約1Pa.s.から約15Pa.s.の粘度、及び少なくとも1日間の滞留時間、を有している、ペースト組成物の使用。
- 創傷を治療するためのキットにおいて、リン酸塩含有溶液中に水溶性キトサン又はその誘導体を備えるペースト組成物であって、室温ではペーストであり、少なくとも4のpH、約1Pa.s.から約15Pa.s.の粘度、及び少なくとも1日間の滞留時間、を有しているペースト組成物、を収容している滅菌包装体と、前記ペースト及び前記キットの、創傷を治療するための使用を説明する取扱説明書と、を備えているキット。
- 前記水溶性キトサンは塩酸塩を備えている、請求項1に記載の方法、請求項2に記載の使用、又は請求項3に記載のキット。
- 前記水溶性キトサンは総ペースト重量の約3重量%から約20重量%である、何れかの上記請求項に記載の方法、使用、又はキット。
- 前記水溶性キトサンは総ペースト重量の約15重量%から約18重量%である、何れかの上記請求項に記載の方法、使用、又はキット。
- 前記水溶性キトサンは約5kDaから約2000kDaの数平均分子量を有している、何れかの上記請求項に記載の方法、使用、又はキット。
- 前記水溶性キトサンは約30kDaから約400kDaの数平均分子量を有している、何れかの上記請求項に記載の方法、使用、又はキット。
- 前記リン酸塩含有溶液はリン酸緩衝生理食塩水である、何れかの上記請求項に記載の方法、使用、又はキット。
- 前記リン酸塩含有溶液は3Xリン酸緩衝生理食塩水である、何れかの上記請求項に記載の方法、使用、又はキット。
- 前記リン酸塩含有溶液は9から12のpHを有している、何れかの上記請求項に記載の方法、使用、又はキット。
- 前記リン酸塩含有溶液はグリセロールリン酸を備えている、何れかの上記請求項に記載の方法、使用、又はキット。
- 潤滑剤又は湿潤剤を更に備えている何れかの上記請求項に記載の方法、使用、又はキット。
- 前記潤滑剤又は湿潤剤はグリセロールである、請求項12に記載の方法、使用、又はキット。
- 前記潤滑剤又は前記湿潤剤は総ペースト重量の約1重量%から約10重量%である、請求項12に記載の方法、使用、又はキット。
- 前記ペーストは滅菌されている、何れかの上記請求項に記載の方法、使用、又はキット。
- 前記滅菌は電子ビーム放射又はガンマ線放射である、請求項15に記載の方法、使用、又はキット。
- 前記ペーストは、引っ張り試験機を1mm/秒の分離速度で作動させて使用し、前記ペーストの試料を間にして約4.4ニュートンの圧縮力を用いて互いに圧縮されている2つのコラーゲン被覆ゴム製半球体を分離させる場合に、約5グラムから約80グラムの間の力が必要になる接着強度を有している、何れかの上記請求項に記載の方法、使用、又はキット。
- 前記ペーストは1又はそれより小さい細胞毒性評点を有する無細胞毒性である、何れかの上記請求項に記載の方法、使用、又はキット。
- すぐに使用できる状態をした組成物として包装されている何れかの上記請求項に記載の方法、使用、又はキット。
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US14/319,901 | 2014-06-30 | ||
US14/319,901 US9192574B2 (en) | 2013-10-24 | 2014-06-30 | Chitosan paste wound dressing |
PCT/US2014/062041 WO2015061612A1 (en) | 2013-10-24 | 2014-10-23 | Chitosan paste wound dressing |
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AU2014340006B2 (en) | 2018-06-28 |
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CA2927357A1 (en) | 2015-04-30 |
JP6397491B2 (ja) | 2018-09-26 |
JP6491647B2 (ja) | 2019-03-27 |
CA2926401A1 (en) | 2015-04-30 |
JP2016534050A (ja) | 2016-11-04 |
WO2015061612A1 (en) | 2015-04-30 |
CA2926401C (en) | 2019-08-20 |
EP3060265A1 (en) | 2016-08-31 |
US20150119358A1 (en) | 2015-04-30 |
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