JP6594315B2 - 多相性骨移植片代用材料 - Google Patents
多相性骨移植片代用材料 Download PDFInfo
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- JP6594315B2 JP6594315B2 JP2016539077A JP2016539077A JP6594315B2 JP 6594315 B2 JP6594315 B2 JP 6594315B2 JP 2016539077 A JP2016539077 A JP 2016539077A JP 2016539077 A JP2016539077 A JP 2016539077A JP 6594315 B2 JP6594315 B2 JP 6594315B2
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- tricalcium phosphate
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- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 claims description 215
- 239000004568 cement Substances 0.000 claims description 128
- ZOMBKNNSYQHRCA-UHFFFAOYSA-J calcium sulfate hemihydrate Chemical compound O.[Ca+2].[Ca+2].[O-]S([O-])(=O)=O.[O-]S([O-])(=O)=O ZOMBKNNSYQHRCA-UHFFFAOYSA-J 0.000 claims description 78
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- AEMRFAOFKBGASW-UHFFFAOYSA-N Glycolic acid Chemical compound OCC(O)=O AEMRFAOFKBGASW-UHFFFAOYSA-N 0.000 claims description 38
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Description
i)硫酸カルシウム半水和物が、該微粒子組成物の総重量に基づくと少なくとも約50重量パーセントの濃度で存在する、硫酸カルシウム半水和物粉末、
ii)リン酸一カルシウム一水和物粉末、
iii)非多孔質β−リン酸三カルシウム粉末、および
iv)多孔質β−リン酸三カルシウム粉末
を含む微粒子組成物。
ii)リン酸一カルシウム一水和物粉末、
iii)約20ミクロン未満のメジアン粒径を有する非多孔質β−リン酸三カルシウム粉末であって、該リン酸一カルシウム一水和物粉末および該非多孔質β−リン酸三カルシウム粉末が、前記微粒子組成物の総重量に基づくと約3〜約20重量パーセントの複合濃度で存在する、非多孔質β−リン酸三カルシウム粉末、
iv)少なくとも約75ミクロンのメジアン粒径を有し、前記微粒子組成物の総重量に基づくと最大約20重量パーセントの濃度で存在する非多孔質β−リン酸三カルシウム顆粒、
v)前記微粒子組成物の総重量に基づくと最大約15重量パーセントの量の多孔質β−リン酸三カルシウム粉末、ならびに
vi)硫酸カルシウム半水和物の、硫酸カルシウム二水和物への変換を加速するのに適している促進剤であって、前記微粒子組成物の総重量に基づくと最大約1重量パーセントの濃度で存在する促進剤
を含む、任意の先述または後続の実施形態の微粒子組成物。
ii)リン酸一カルシウム一水和物粉末、
iii)約20ミクロン未満のメジアン粒径を有するβ−リン酸三カルシウム粉末であって、該リン酸一カルシウム一水和物粉末および該β−リン酸三カルシウム粉末が、前記微粒子組成物の総重量に基づくと約3〜約20重量パーセントの複合濃度で存在する、β−リン酸三カルシウム粉末、
iv)約100〜約400ミクロンのメジアン粒径を有し、前記微粒子組成物の総重量に基づくと最大約12重量パーセントの濃度で存在するβ−リン酸三カルシウム顆粒、
v)前記微粒子組成物の総重量に基づくと最大約15重量パーセントの量の多孔質β−リン酸三カルシウム粉末であって、50重量%未満の最大約63ミクロンの粒径を有する粒子、および50重量%を上回る約63ミクロンよりも大きい粒径を有する粒子を含む多孔質β−リン酸三カルシウム粉末、ならびに
vi)硫酸カルシウム半水和物の、硫酸カルシウム二水和物への変換を加速するのに適している促進剤であって、前記微粒子組成物の総重量に基づくと最大約1重量パーセントの濃度で存在する促進剤
を含む、任意の先述または後続の実施形態の微粒子組成物。
本開示組成物の例示的な実施形態の1つは、表1において以下のように提供される。
本発明の組成物A(表1)を、比較用組成物(表2、それは、標準的な市販のPro-Dense(登録商標)組成物)と比較する。本発明の組成物Aは、作業時間(注入/送達時間)3〜5分、ビカット硬化時間(組成物が、破断なしではもはや変形不可能である時点)8〜12分、およびギルモア硬化時間(硬岩のような硬化が達成される時点)14〜17分を示す。比較用組成物は、作業時間3〜5分、ビカット硬化時間14〜19分、およびギルモア硬化時間30+分を示す。
本明細書中に記載するビカット硬化時間は、その全体が参照に本明細書に援用されるASTM C−472に全てしたがい、直径1mm、長さ5cmであり、かつ総重量300gを保有するビカット針を使用して測定する。試験される試料は、均質で流動可能なペーストが生ずるように混合すべきである。ビカット針落下試験に関する試料サイズは、およそ20mLのポリエチレンカップ中にケークとして軽く叩いて落とされる材料約3cc〜約5ccであり、水溶液が微粒子組成物と接触した1分後に、ビカット針の落下および取り外し以外は材料に攪拌を与えないように試料を取り扱う。カップは、ケークが高さ約1/4”〜約3/8”の大きさの短く平坦な円筒体となるような寸法を有する。
本発明の組成物A(「FastSet」として示される)および比較用組成物(「PRO-DENSE(登録商標)」として示される)の両方に関する放出力(組成物の溶液および粉末成分の混合の3分後に測定される)を図1に提供する。グラフ上の一番左のバーは、11ゲージの針によって注入された本発明の組成物Aを表し、真ん中のバーは、8ゲージの針によって注入された本発明の組成物Aを表し、グラフ上の一番右のバーは、11ゲージの針によって注入された比較用組成物を表す。本発明の組成物Aが、8ゲージおよび11ゲージの針によって、放出力の許容可能な値を有することがグラフにより示される。
本発明の組成物Aのダイアメトラル引張強さ(DTS)を試験して、図2において比較用組成物のDTSに対して比較する。図2に示すように、DTSは、硬化時間の24時間後、比較用組成物(「PRO-DENSE(登録商標)」として示される)よりも、本発明の組成物A(「FastSet」として示される)で幾らか高い。24時間時の比較用組成物と本発明の組成物Aとの間のDTSの差は、統計学的に有意である。
本発明の組成物Aおよび比較用組成物に関する溶解速度を下記方法論によって測定する。検体は、外径4.8mmおよび3.3mm長の円筒体のサイズへシリコーン型中で成形される。円筒状空隙を含むシリコーンの3mm厚のシートを型として使用する。円筒状空隙は、外径が4.8mm、および3.3mm長であり、空隙の円形面が平行になるように、およびシリコーンシートの表面と同じ平面で方向付けられる。
本開示組成物の第2の例示的な実施形態は、下記の通りに提供され、比較用組成物に対する本発明の組成物の特性化および評価の目的で具体的に調製した。表6で言及されるような「本発明の粉末組成物A」は、表1で言及されるような「本発明の組成物A」に匹敵するが、表6に言及されるような「本発明の粉末組成物A」は、「本発明の組成物A」のMCPMおよびグリコール酸/生理食塩水を含まないことに留意されたい。表7は、本発明の粉末組成物A、MCPM、およびグリコール酸/生理食塩水の相対混合量を示し、「本発明の組成物A」を提供する。
本発明の粉末組成物A、MCPMおよびグリコール酸/生理食塩水を混合して、得られたペーストをペレット型上へ広げ、室温で最低8時間乾燥させて、ペレットを得た。次に、ペレットを40℃で5時間炉乾燥し、すり鉢とすりこぎを使用して、分析用に粉末へと砕いた。
pH決定に関しては、本発明Aの粉末および液体成分のゆるいスラリーを連続して5分間混合した。5分が終わった時点で、pHを記録した。3つの別個のスラリーを、このように調製および試験して、平均pH5.52、標準偏差0.02が得られた。本発明の組成物AのpHは、2標本T−検定に基づいて、比較用組成物のpHと有意に異ならないと決定された(p=0.074)。
性能特性実験に関しては、本発明の粉末組成物AおよびMCPMを一緒に混合し、グリコール酸/生理食塩水を混合機に添加し、材料を22〜25”の真空下で30秒間、激しく混合して、本発明の組成物Aを得た。
Claims (90)
- 水溶液との混合時に骨移植片代用セメントを形成するのに適している微粒子組成物であって、
i)硫酸カルシウム半水和物が、該微粒子組成物の総重量に基づくと少なくとも約50重量パーセントの濃度で存在する、硫酸カルシウム半水和物粉末、
ii)リン酸一カルシウム一水和物粉末、
iii)非多孔質β−リン酸三カルシウム粉末、および
iv)多孔質β−リン酸三カルシウム粉末
を含む微粒子組成物。 - 前記硫酸カルシウム半水和物が、前記微粒子組成物の総重量に基づくと少なくとも約70重量パーセントの濃度で存在する、請求項1に記載の微粒子組成物。
- 前記硫酸カルシウム半水和物粉末が、二峰性の粒子分布を有する、請求項1に記載の微粒子組成物。
- 前記硫酸カルシウム半水和物粉末が、約5〜約20ミクロンのメジアン粒径を有する、請求項3に記載の微粒子組成物。
- 前記非多孔質β−リン酸三カルシウム粉末が、約20ミクロン未満のメジアン粒径を有する、請求項1に記載の微粒子組成物。
- 前記多孔質β−リン酸三カルシウム粉末が、二峰性の粒径分布を示す、請求項1に記載の微粒子組成物。
- 前記多孔質β−リン酸三カルシウム粉末が、50重量%未満の最大約63ミクロンの粒径を有する粒子、および50重量%を上回る約63ミクロンよりも大きい粒径を有する粒子を含む、請求項6に記載の微粒子組成物。
- 前記多孔質β−リン酸三カルシウム粉末が、約25重量%の最大約63ミクロンの粒径を有する粒子、および約75重量%の約63ミクロンよりも大きい粒径を有する粒子を含む、請求項6に記載の微粒子組成物。
- 少なくとも約75ミクロンのメジアン粒径を有する非多孔質β−リン酸三カルシウム顆粒をさらに含む、請求項1に記載の微粒子組成物。
- 前記非多孔質β−リン酸三カルシウム顆粒が、約75〜約1,000ミクロンのメジアン粒径を有する、請求項9に記載の微粒子組成物。
- 前記非多孔質β−リン酸三カルシウム顆粒が、前記微粒子組成物の総重量に基づくと最大約20重量パーセントの濃度で存在する、請求項9に記載の微粒子組成物。
- 前記非多孔質β−リン酸三カルシウム顆粒が、前記微粒子組成物の総重量に基づくと最大約12重量パーセントの濃度で存在する、請求項9に記載の微粒子組成物。
- 前記硫酸カルシウム半水和物が、α−硫酸カルシウム半水和物である、請求項1に記載の微粒子組成物。
- 前記硫酸カルシウム半水和物粉末が、前記硫酸カルシウム半水和物粉末の総容量に基づくと約30〜約60容量パーセントの約1.0〜約3.0ミクロンのモードを有する粒子、および約40〜約70容量パーセントの約20〜約30ミクロンのモードを有する粒子を含む二峰性の粒子分布を有する、請求項1に記載の微粒子組成物。
- 前記多孔質β−リン酸三カルシウム粉末が、約5〜約15重量パーセントの濃度で存在する、請求項1に記載の微粒子組成物。
- 前記非多孔質β−リン酸三カルシウム粉末が、前記非多孔質β−リン酸三カルシウム粉末の総容量に基づくと約30〜約70容量パーセントの約2.0〜約6.0ミクロンのモードを有する粒子、および約30〜約70容量パーセントの約40〜約70ミクロンのモードを有する粒子を含む二峰性の粒径分布を有する、請求項1に記載の微粒子組成物。
- 前記非多孔質β−リン酸三カルシウム粉末が、前記非多孔質β−リン酸三カルシウム粉末の総容量に基づくと約50〜約65容量パーセントの約4.0〜約5.5ミクロンのモードを有する粒子、および約35〜約50容量パーセントの約60〜約70ミクロンのモードを有する粒子を含む二峰性の粒径分布を有する、請求項1に記載の微粒子組成物。
- 硫酸カルシウム半水和物の、硫酸カルシウム二水和物への変換を加速するのに適している促進剤をさらに含む、請求項1に記載の微粒子組成物。
- 前記促進剤が、硫酸カルシウム二水和物粒子、硫酸カリウム粒子および硫酸ナトリウム粒子から成る群から選択され、前記促進剤が、任意選択によりスクロースでコーティングされる、請求項18に記載の微粒子組成物。
- 前記促進剤が、前記微粒子組成物の総重量に基づくと最大約1重量パーセントの濃度で存在する、請求項18に記載の微粒子組成物。
- i)二峰性の粒子分布および約5〜約20ミクロンのメジアン粒径を有する硫酸カルシウム半水和物粉末であって、該硫酸カルシウム半水和物が、前記微粒子組成物の総重量に基づくと少なくとも約70重量パーセントの濃度で存在する、硫酸カルシウム半水和物粉末、
ii)リン酸一カルシウム一水和物粉末、
iii)約20ミクロン未満のメジアン粒径を有する非多孔質β−リン酸三カルシウム粉末であって、該リン酸一カルシウム一水和物粉末および該非多孔質β−リン酸三カルシウム粉末が、前記微粒子組成物の総重量に基づくと約3〜約20重量パーセントの複合濃度で存在する、非多孔質β−リン酸三カルシウム粉末、
iv)少なくとも約75ミクロンのメジアン粒径を有し、前記微粒子組成物の総重量に基づくと最大約20重量パーセントの濃度で存在する非多孔質β−リン酸三カルシウム顆粒、
v)前記微粒子組成物の総重量に基づくと最大約15重量パーセントの量の多孔質β−リン酸三カルシウム粉末、ならびに
vi)硫酸カルシウム半水和物の、硫酸カルシウム二水和物への変換を加速するのに適している促進剤であって、前記微粒子組成物の総重量に基づくと最大約1重量パーセントの濃度で存在する促進剤
を含む、請求項1に記載の微粒子組成物。 - i)二峰性の粒子分布および約5〜約20ミクロンのメジアン粒径を有するα−硫酸カルシウム半水和物粉末であって、該硫酸カルシウム半水和物が、前記微粒子組成物の総重量に基づくと少なくとも約70重量パーセントの濃度で存在し、該硫酸カルシウム半水和物粉末が、該硫酸カルシウム半水和物粉末の総容量に基づくと約30〜約60容量パーセントの約1.0〜約3.0ミクロンのモードを有する粒子、および約40〜約70容量パーセントの約20〜約30ミクロンのモードを有する粒子を含む二峰性の粒子分布を有する、α−硫酸カルシウム半水和物粉末、
ii)リン酸一カルシウム一水和物粉末、
iii)約20ミクロン未満のメジアン粒径を有するβ−リン酸三カルシウム粉末であって、該リン酸一カルシウム一水和物粉末および該β−リン酸三カルシウム粉末が、前記微粒子組成物の総重量に基づくと約3〜約20重量パーセントの複合濃度で存在する、β−リン酸三カルシウム粉末、
iv)約100〜約400ミクロンのメジアン粒径を有し、前記微粒子組成物の総重量に基づくと最大約12重量パーセントの濃度で存在するβ−リン酸三カルシウム顆粒、
v)前記微粒子組成物の総重量に基づくと最大約15重量パーセントの量の多孔質β−リン酸三カルシウム粉末であって、50重量%未満の最大約63ミクロンの粒径を有する粒子、および50重量%を上回る約63ミクロンよりも大きい粒径を有する粒子を含む多孔質β−リン酸三カルシウム粉末、ならびに
vi)硫酸カルシウム半水和物の、硫酸カルシウム二水和物への変換を加速するのに適している促進剤であって、前記微粒子組成物の総重量に基づくと最大約1重量パーセントの濃度で存在する促進剤
を含む、請求項1に記載の微粒子組成物。 - 生物活性剤をさらに含む、請求項1〜22のいずれか一項に記載の微粒子組成物。
- 前記生物活性剤が、海綿骨片、増殖因子、抗生物質、殺虫剤、化学療法剤、抗ウイルス薬、鎮痛薬、および抗炎症剤から成る群から選択される、請求項23に記載の微粒子組成物。
- 前記生物活性剤が、骨髄穿刺液である、請求項23に記載の微粒子組成物。
- 前記生物活性剤が、線維芽細胞増殖因子、血小板由来増殖因子、骨形態形成タンパク質、骨形成タンパク質、トランスフォーミング増殖因子、LIM石灰化タンパク質、類骨誘導因子、アンギオゲニン、エンドセリン、成長分化因子、ADMP−1、エンドセリン、肝細胞増殖因子およびケラチノサイト増殖因子、ヘパリン結合増殖因子、ヘッジホッグタンパク質、インターロイキン、コロニー刺激因子、上皮増殖因子、インスリン様増殖因子、サイトカイン、オステオポンチンおよびオステオネクチンから成る群から選択される増殖因子である、請求項23に記載の微粒子組成物。
- 約3〜約8分の、水溶液との混合時のビカット硬化時間を有する、請求項1〜22のいずれか一項に記載の微粒子組成物。
- 約6〜約20分の、水溶液との混合時のギルモア硬化時間を有する、請求項1〜22のいずれか一項に記載の微粒子組成物。
- 前記多孔質β−リン酸三カルシウム粉末の孔径が、約100ミクロン〜約400ミクロンの範囲内である、請求項1〜22のいずれか一項に記載の微粒子組成物。
- 前記多孔質β−リン酸三カルシウム粉末が、相互接続された多方向多孔性を特徴とする、請求項1〜22のいずれか一項に記載の微粒子組成物。
- 前記多孔質β−リン酸三カルシウム粉末が、少なくとも約50%の総多孔性を有する、請求項1〜22のいずれか一項に記載の微粒子組成物。
- 請求項1〜22のいずれか一項に記載の微粒子組成物を、水溶液と混合することにより形成される反応生成物を含む骨移植片代用セメントであって、該反応生成物が、硫酸カルシウム二水和物、ブルシャイト、および多孔質β−リン酸三カルシウム成分を含む、骨移植片代用セメント。
- 非多孔質β−リン酸三カルシウム顆粒を含む、請求項32に記載の骨移植片代用セメント。
- 既定の形状で成形される、請求項32に記載の骨移植片代用セメント。
- 前記既定の形状が、ペレット、顆粒、くさび形、ブロックおよびディスクから成る群から選択される、請求項34に記載の骨移植片代用セメント。
- 前記水溶液がカルボン酸を含む、請求項32に記載の骨移植片代用セメント。
- 前記カルボン酸がヒドロキシカルボン酸である、請求項36に記載の骨移植片代用セメント。
- 前記ヒドロキシカルボン酸がグリコール酸である、請求項37に記載の骨移植片代用セメント。
- 前記カルボン酸が、pH約6.5〜約7.5に中和される、請求項36に記載の骨移植片代用セメント。
- 前記水溶液が、塩化ナトリウムをさらに含む、請求項36〜39のいずれか一項に記載の骨移植片代用セメント。
- 骨移植片代用キットであって、請求項1〜22のいずれか一項に記載の微粒子組成物を封入している1つまたは複数の容器、滅菌水溶液を封入している別個の容器、および該キットを使用する方法について記載している取扱説明書を含む骨移植片代用キット。
- 前記微粒子組成物および前記水溶液を混合するのに適している混合装置をさらに含む、請求項41に記載の骨移植片代用キット。
- 骨移植片代用セメント混合物を骨欠損の部位へ送達するのに適している送達デバイスをさらに含む、請求項42に記載の骨移植片代用キット。
- 前記送達デバイスが、Jamshidi針を含む、請求項43に記載の骨移植片代用キット。
- 前記微粒子組成物の一部が、第1のシリンジに封入され、前記微粒子組成物の一部が、第2のシリンジに封入され、各シリンジの内容物が混合され得るように、前記キットが、該第1および第2のシリンジを接続するのに適しているシリンジコネクターをさらに含む、請求項41に記載の骨移植片代用キット。
- 前記微粒子組成物の少なくとも一部を含有する少なくとも1つのシリンジ、および前記シリンジを、前記滅菌水溶液を封入している前記容器に接続するのに適しているバイアルアダプターをさらに含む、請求項41に記載の骨移植片代用キット。
- 水溶液との混合時に骨移植片代用セメントを形成するのに適している微粒子組成物であって、
i)硫酸カルシウム半水和物が、該微粒子組成物の総重量に基づくと少なくとも約50重量パーセントの濃度で存在する、硫酸カルシウム半水和物粉末、および
ii)粉末、顆粒、または粉末と顆粒との混合物の形態の多孔質β−リン酸三カルシウム微粒子
を含み、
前記多孔質β−リン酸三カルシウムが、約5〜約15重量パーセントの濃度で当該微粒子組成物中に存在する、
微粒子組成物。 - 前記硫酸カルシウム半水和物が、前記微粒子組成物の総重量に基づくと少なくとも約70重量パーセントの濃度で存在する、請求項47に記載の微粒子組成物。
- 前記硫酸カルシウム半水和物粉末が、二峰性の粒子分布を有する、請求項47又は48に記載の微粒子組成物。
- 前記硫酸カルシウム半水和物粉末が、約5〜約20ミクロンのメジアン粒径を有する、請求項49に記載の微粒子組成物。
- 前記多孔質β−リン酸三カルシウム微粒子が、二峰性の粒径分布を示す、請求項47又は48に記載の微粒子組成物。
- 前記多孔質β−リン酸三カルシウム微粒子が、50重量%未満の最大約63ミクロンの粒径を有する粒子、および50重量%を上回る約63ミクロンよりも大きい粒径を有する粒子を含む、請求項51に記載の微粒子組成物。
- 前記多孔質β−リン酸三カルシウム微粒子が、約25重量%の最大約63ミクロンの粒径を有する粒子、および約75重量%の約63ミクロンよりも大きい粒径を有する粒子を含む、請求項51に記載の微粒子組成物。
- 前記硫酸カルシウム半水和物が、α−硫酸カルシウム半水和物である、請求項47又は48に記載の微粒子組成物。
- 前記硫酸カルシウム半水和物粉末が、前記硫酸カルシウム半水和物粉末の総容量に基づくと約30〜約60容量パーセントの約1.0〜約3.0ミクロンのモードを有する粒子、および約40〜約70容量パーセントの約20〜約30ミクロンのモードを有する粒子を含む二峰性の粒子分布を有する、請求項47又は48に記載の微粒子組成物。
- 前記多孔質β−リン酸三カルシウム微粒子が、該微粒子組成物の総重量に基づくと約5〜約15重量パーセントの濃度で存在する、請求項47又は48に記載の微粒子組成物。
- 前記多孔質β−リン酸三カルシウム微粒子が、約100ミクロン〜約400ミクロンの範囲内の孔径を有する、請求項47又は48に記載の微粒子組成物。
- 前記多孔質β−リン酸三カルシウム微粒子が、相互接続された多方向多孔性を特徴とする、請求項47又は48に記載の微粒子組成物。
- 前記多孔質β−リン酸三カルシウム微粒子が、少なくとも約50%の総多孔性を有する、請求項47又は48に記載の微粒子組成物。
- 微粒子組成物であって、
i)二峰性の粒子分布および約5〜約20ミクロンのメジアン粒径を有する硫酸カルシウム半水和物粉末、および
ii)前記微粒子組成物の総重量に基づくと最大約15重量パーセントの量の多孔質β−リン酸三カルシウム微粒子であって、50重量%未満の最大約63ミクロンの粒径を有する粒子、および50重量%を上回る約63ミクロンよりも大きい粒径を有する粒子を含む多孔質β−リン酸三カルシウム微粒子
を含む、微粒子組成物。 - 前記硫酸カルシウム半水和物が、前記微粒子組成物の総重量に基づくと少なくとも約70重量パーセントの濃度で存在する、請求項60に記載の微粒子組成物。
- 前記多孔質β−リン酸三カルシウム微粒子が、約100ミクロン〜約400ミクロンの範囲内の孔径を有する、請求項60又は61に記載の微粒子組成物。
- 前記多孔質β−リン酸三カルシウム微粒子が、相互接続された多方向多孔性を特徴とする、請求項60又は61に記載の微粒子組成物。
- 前記多孔質β−リン酸三カルシウム微粒子が、少なくとも約50%の総多孔性を有する、請求項60又は61に記載の微粒子組成物。
- 水溶液との混合時に骨移植片代用セメントを形成するのに適している微粒子組成物であって、
i)硫酸カルシウム半水和物が、該微粒子組成物の総重量に基づくと少なくとも約50重量パーセントの濃度で存在する、硫酸カルシウム半水和物粉末、
ii)リン酸一カルシウム一水和物粉末、
iii)非多孔質β−リン酸三カルシウム粉末、および
iv)粉末、顆粒、または粉末と顆粒との混合物の形態の多孔質β−リン酸三カルシウム微粒子
を含み、
前記多孔質β−リン酸三カルシウム微粒子が、約5〜約15重量パーセントの濃度で当該微粒子組成物中に存在する、
微粒子組成物。 - 前記硫酸カルシウム半水和物が、該微粒子組成物の総重量に基づくと少なくとも約70重量パーセントの濃度で存在する、請求項65に記載の微粒子組成物。
- 前記硫酸カルシウム半水和物粉末が、二峰性の粒子分布を有する、請求項65に記載の微粒子組成物。
- 前記硫酸カルシウム半水和物粉末が、約5〜約20ミクロンのメジアン粒径を有する、請求項67に記載の微粒子組成物。
- 前記非多孔質β−リン酸三カルシウム粉末が、約20ミクロン未満のメジアン粒径を有する、請求項65に記載の微粒子組成物。
- 前記多孔質β−リン酸三カルシウム微粒子が、二峰性の粒径分布を示す、請求項65に記載の微粒子組成物。
- 前記多孔質β−リン酸三カルシウム微粒子が、50重量%未満の最大約63ミクロンの粒径を有する粒子、および50重量%を上回る約63ミクロンよりも大きい粒径を有する粒子を含む、請求項70に記載の微粒子組成物。
- 前記多孔質β−リン酸三カルシウム微粒子が、約25重量%の最大約63ミクロンの粒径を有する粒子、および約75重量%の約63ミクロンよりも大きい粒径を有する粒子を含む、請求項70に記載の微粒子組成物。
- 前記多孔質β−リン酸三カルシウム微粒子が、少なくとも約75ミクロンのメジアン粒径を有する、請求項65に記載の微粒子組成物。
- 前記多孔質β−リン酸三カルシウム微粒子が、約75〜約1,000ミクロンのメジアン粒径を有する、請求項73に記載の微粒子組成物。
- 前記多孔質β−リン酸三カルシウム微粒子が顆粒の形態である、請求項65に記載の微粒子組成物。
- 前記多孔質β−リン酸三カルシウム顆粒が、前記微粒子組成物の総重量に基づくと最大約5〜約12重量パーセントの濃度で存在する、請求項75に記載の微粒子組成物。
- 前記硫酸カルシウム半水和物が、α−硫酸カルシウム半水和物である、請求項65に記載の微粒子組成物。
- 前記硫酸カルシウム半水和物粉末が、前記硫酸カルシウム半水和物粉末の総容量に基づくと約30〜約60容量パーセントの約1.0〜約3.0ミクロンのモードを有する粒子、および約40〜約70容量パーセントの約20〜約30ミクロンのモードを有する粒子を含む二峰性の粒子分布を有する、請求項65に記載の微粒子組成物。
- 前記多孔質β−リン酸三カルシウム微粒子が、約5〜約15重量パーセントの濃度で存在する粉末の形態である、請求項65に記載の微粒子組成物。
- 前記非多孔質β−リン酸三カルシウム粉末が、前記非多孔質β−リン酸三カルシウム粉末の総容量に基づくと約30〜約70容量パーセントの約2.0〜約6.0ミクロンのモードを有する粒子、および約30〜約70容量パーセントの約40〜約70ミクロンのモードを有する粒子を含む二峰性の粒径分布を有する、請求項65に記載の微粒子組成物。
- 前記非多孔質β−リン酸三カルシウム粉末が、前記非多孔質β−リン酸三カルシウム粉末の総容量に基づくと約50〜約65容量パーセントの約4.0〜約5.5ミクロンのモードを有する粒子、および約35〜約50容量パーセントの約60〜約70ミクロンのモードを有する粒子を含む二峰性の粒径分布を有する、請求項65に記載の微粒子組成物。
- i)二峰性の粒子分布および約5〜約20ミクロンのメジアン粒径を有する硫酸カルシウム半水和物粉末であって、該硫酸カルシウム半水和物が、前記微粒子組成物の総重量に基づくと少なくとも約70重量パーセントの濃度で存在する、硫酸カルシウム半水和物粉末、
ii)リン酸一カルシウム一水和物粉末、
iii)約20ミクロン未満のメジアン粒径を有する非多孔質β−リン酸三カルシウム粉末であって、該リン酸一カルシウム一水和物粉末および前記非多孔質β−リン酸三カルシウム粉末が、前記微粒子組成物の総重量に基づくと約3〜約20重量パーセントの複合濃度で存在する、非多孔質β−リン酸三カルシウム粉末、
iv)前記微粒子組成物の総重量に基づくと約5から約15重量パーセントの多孔質β−リン酸三カルシウム微粒子、および
v)硫酸カルシウム半水和物の、硫酸カルシウム二水和物への変換を加速するのに適している促進剤であって、前記微粒子組成物の総重量に基づくと最大約1重量パーセントの濃度で存在する促進剤
を含む、請求項65に記載の微粒子組成物。 - i)二峰性の粒子分布および約5〜約20ミクロンのメジアン粒径を有するα−硫酸カルシウム半水和物粉末であって、該硫酸カルシウム半水和物が、前記微粒子組成物の総重量に基づくと少なくとも約70重量パーセントの濃度で存在し、該硫酸カルシウム半水和物粉末が、該硫酸カルシウム半水和物粉末の総容量に基づくと約30〜約60容量パーセントの約1.0〜約3.0ミクロンのモードを有する粒子、および約40〜約70容量パーセントの約20〜約30ミクロンのモードを有する粒子を含む二峰性の粒子分布を有する、α−硫酸カルシウム半水和物粉末、
ii)リン酸一カルシウム一水和物粉末、
iii)約20ミクロン未満のメジアン粒径を有するβ−リン酸三カルシウム粉末であって、前記リン酸一カルシウム一水和物粉末および該β−リン酸三カルシウム粉末が、前記微粒子組成物の総重量に基づくと約3〜約20重量パーセントの複合濃度で存在する、β−リン酸三カルシウム粉末、
iv)約100〜約400ミクロンのメジアン粒径を有し、前記微粒子組成物の総重量に基づくと約5〜約12重量パーセントの濃度で存在する多孔質β−リン酸三カルシウム顆粒、
v)硫酸カルシウム半水和物の、硫酸カルシウム二水和物への変換を加速するのに適している促進剤であって、前記微粒子組成物の総重量に基づくと最大約1重量パーセントの濃度で存在する促進剤
を含む、請求項65に記載の微粒子組成物。 - 生物活性剤をさらに含む、請求項65〜83のいずれか一項に記載の微粒子組成物。
- 前記生物活性剤が、海綿骨片、増殖因子、抗生物質、殺虫剤、化学療法剤、抗ウイルス薬、鎮痛薬、および抗炎症剤から成る群から選択される、請求項84に記載の微粒子組成物。
- 約3〜約8分の、水溶液との混合時のビカット硬化時間を有する、請求項65〜85のいずれか一項に記載の微粒子組成物。
- 約6〜約20分の、水溶液との混合時のギルモア硬化時間を有する、請求項65〜85のいずれか一項に記載の微粒子組成物。
- 前記多孔質β−リン酸三カルシウム微粒子の孔径が、約100ミクロン〜約400ミクロンの範囲内である、請求項65〜85のいずれか一項に記載の微粒子組成物。
- 前記多孔質β−リン酸三カルシウム粉末が、少なくとも約50%の総多孔性を有する、請求項79に記載の微粒子組成物。
- 請求項65〜89のいずれか一項に記載の微粒子組成物を、水溶液と混合することにより形成される反応生成物を含む骨移植片代用セメントであって、該反応生成物が、硫酸カルシウム二水和物、ブルシャイト、および多孔質β−リン酸三カルシウム成分を含む、骨移植片代用セメント。
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