JP6892394B2 - ノズルアセンブリおよび使用法 - Google Patents
ノズルアセンブリおよび使用法 Download PDFInfo
- Publication number
- JP6892394B2 JP6892394B2 JP2017558020A JP2017558020A JP6892394B2 JP 6892394 B2 JP6892394 B2 JP 6892394B2 JP 2017558020 A JP2017558020 A JP 2017558020A JP 2017558020 A JP2017558020 A JP 2017558020A JP 6892394 B2 JP6892394 B2 JP 6892394B2
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- JP
- Japan
- Prior art keywords
- nozzle
- pressurizing chamber
- particles
- container
- particle
- 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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Images
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- B—PERFORMING OPERATIONS; TRANSPORTING
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Description
本願は、それぞれ2015年6月4日に出願された米国仮特許出願第62/171,001号、米国仮特許出願第62/171,008号および米国仮特許出願第62/171,060号の優先権を主張するものであり、上記の出願はそれぞれその全体が参照により本明細書に組み込まれる。
引用される参考文献はいずれも、その全体が参照により本明細書に組み込まれる。本明細書で使用される単数形「a」、「an」および「the」は、文脈上そうでないことが明らかでない限り、複数形の指示対象を包含する。本明細書で使用される「および(ならびに」は、文脈上そうでないことが明らかでない限り、「または(もしくは、あるいは)」と互換的に使用される。本発明の任意の態様の実施形態はいずれも、文脈上そうでないことが明らかでない限り、組み合わせて用いることができる。
Phyton Biotech社(ブリティッシュコロンビア州、カナダ)からロット番号がそれぞれFP2−15004およびDT7−14025の未加工のパクリタキセルおよびドセタキセルを購入した。ともに未加工形態で特徴を明らかにした。Deco−PBM−V−0.41ミル(Deco社)を用いて両薬の粉砕を実施した。粉砕条件は両化合物とも以下の通りであった:
ボールサイズ=5mm
RPM=600
処理時間=60分
室温。
アセトンでパクリタキセルの65mg/ml溶液を調製した。晶析チャンバ内にBETE MicroWhirl(登録商標)フォグノズル(BETE Fog Nozzle社)と音響プローブ(Qsonica社、型番Q700)を約8mm離して配置した。沈殿したパクリタキセルナノ粒子を捕集するため、約100nmの穴を有するステンレス鋼メッシュフィルタを晶析チャンバに取り付けた。製造装置の晶析チャンバに超臨界二酸化炭素を入れ、約38℃、流速24kg/時で約1200psi(約8273kPa)にした。音響プローブを周波数20kHzで総出力の60%に調節した。パクリタキセルを含有するアセトン溶液を流速4.5mL/分で約36時間、ノズルから送り込んだ。作製されたパクリタキセルナノ粒子は、別個に3回実施した平均で、個数基準平均径が0.81μm、標準偏差が0.74μmであった。
エタノールでドセタキセルの79.32mg/ml溶液を調製した。加圧チャンバ内にノズルと音響プローブを約9mm離して配置した。沈殿したドセタキセルナノ粒子を捕集するため、約100nmの穴を有するステンレス鋼メッシュフィルタを加圧チャンバに取り付けた。製造装置の加圧チャンバに超臨界二酸化炭素を入れ、約38℃、流速68slpmで約1200psi(約8273kPa)にした。音響プローブを周波数20kHzで総出力の60%に調節した。ドセタキセルを含有するエタノールを流速2mL/分で約95分間、ノズルから送り込んだ。次いで、混合物をステンレス鋼メッシュフィルタに送り込み、沈殿したドセタキセルの凝集物および粒子を超臨界二酸化炭素から捕集した。ドセタキセルのナノ粒子の入ったフィルタを開け、生じた生成物をフィルタから回収した。
光遮蔽法およびレーザー回折法の両方により粒子径を解析した。光遮蔽法にはParticle Sizing Systems AccuSizer 780 SISシステムを用い、レーザー回折法にはShimadzu SALD−7101を用いた。水に溶かした0.10%(w/v)ドデシル硫酸ナトリウム(SDS)を分散剤に用いてパクリタキセルナノ粒子を解析した。isopar Gを分散剤に用いてドセタキセルナノ粒子を解析した。
200〜300mgの質量既知の分析物を30mLの試料管に加えた。次いで、充填した試料管をPorous Materials社のSORPTOMETER(登録商標)、BET−202Aモデルに装填した。次いで、BETWIN(登録商標)ソフトウェアパッケージを用いて自動試験を実施した後、各試料の表面積を算出した。
パクリタキセルまたはドセタキセルの粒子調製物をプラスチック秤量用漏斗から風袋を測定した10mLメスシリンダーに室温で加えた。薬物の質量を0.1mgの位まで測定し、体積を0.1mLの位まで測定し、密度を算出した。
パクリタキセル
約50mgの原料(すなわち、未加工パクリタキセル、粉砕パクリタキセルまたはパクリタキセル粒子)と約1.5グラムの1mmガラスビーズをバイアル内で約1時間転がすことによってビーズを原料で覆った。ビーズをステンレス鋼メッシュ容器に移し、37℃、pH7、50/50(v/v)のメタノール/水溶媒の入った溶解浴および75rpmで稼働するUSP装置II(パドル)に入れた。10分後、20分後、30分後、60分後および90分後、5mL量を取り出し、0.22μmフィルタでろ過し、U(V/V)is分光光度計を用いて227nmで分析した。試料の吸光度値を溶解溶媒で調製した標準溶液のものと比較して、溶解した原料の量を求めた。
約50mgの原料(すなわち、未加工ドセタキセル、粉砕ドセタキセルまたはドセタキセル粒子)を37℃、pH7、15/85(v/v)のメタノール/水溶媒の入った溶解浴および75rpmで稼働するUSP装置II(パドル)に直接入れた。5分後、15分後、30分後、60分後、120分後および225分後、5mL量を取り出し、0.22μmフィルタでろ過し、UV/VIS分光光度計を用いて232nmで分析した。試料の吸光度値を溶解溶媒で調製した標準溶液のものと比較して、溶解した原料の量を求めた。
上記のプロトコルおよびその変形形態(すなわち、ノズル、フィルタ、音響エネルギー源、流速などを変えたもの)を用いて作製した粒子のBET表面積は、22〜39m2/gの範囲であった。図1に、本発明の方法を用いて作製した例示的粒子を示す。比較により、未加工パクリタキセルのBET表面積は7.25m2/gと測定され(図2)、米国特許第5833891号および同第5874029号の方法に従って作製したパクリタキセル粒子は11.3〜15.58m2/gの範囲であった。本発明の方法を用いて得られた例示的粒子径を表1に示す。
Claims (21)
- 加圧チャンバを画定し、遠位端と近位端とを備えた容器と、
前記容器の前記近位端にある前記加圧チャンバの注入口と、
前記加圧チャンバの内部に位置するノズルであって、前記加圧チャンバの前記注入口と流体連通している注入管を備え、出口開口部を備え、前記容器の前記近位端と前記ノズルの前記出口開口部との間の距離を変化させるよう調節可能であり、前記容器の縦軸と前記ノズルの縦軸との間の角度を変化させるよう調節可能であるノズルと、
前記加圧チャンバ内に位置し、かつ、前記ノズルの前記出口開口部から離れて位置する音響エネルギー源と、
前記容器の前記遠位端にある前記加圧チャンバの出口と
を備えた、ノズルアセンブリ。 - 前記音響エネルギー源は、前記ノズルの前記出口開口部と当該音響エネルギー源との間の距離、及び/又は、当該音響エネルギー源と前記ノズルの前記縦軸との間の角度を変化させるように調節可能である、請求項1に記載のノズルアセンブリ。
- 前記加圧チャンバの前記注入口が、第一のリザーバおよび第二のリザーバと流体連通している、請求項1または2のいずれか1項に記載のノズルアセンブリ。
- 前記容器の前記近位端に前記加圧チャンバの第二の注入口をさらに備え、
前記加圧チャンバの前記注入口が第一のリザーバと流体連通し、前記加圧チャンバの前記第二の注入口が第二のリザーバと流体連通している、請求項1または2に記載のノズルアセンブリ。 - 前記ノズルの前記出口開口部が前記ノズルの内部に渦を生じさせる、請求項1〜4のいずれか1項に記載のノズルアセンブリ。
- 前記ノズルの前記注入管が、1.5875mm〜6.35mmの範囲の内径を有する、請求項1〜5のいずれか1項に記載のノズルアセンブリ。
- 前記ノズルと連結され、前記容器の前記近位端と前記ノズルの前記出口開口部との間の距離を変化させるよう構成されているモータ
をさらに備えた、請求項1〜6のいずれか1項に記載のノズルアセンブリ。 - 前記モータがさらに、前記容器の縦軸と前記ノズルの縦軸との間の角度を変化させるよう構成されている、請求項7に記載のノズルアセンブリ。
- 請求項1〜8のいずれか1項に記載の1つまたは複数のノズルアセンブリと、
1つまたは複数のノズルアセンブリと連通している1つまたは複数の粒子ろ過システムと、
前記1つまたは複数の粒子ろ過システムと連通している1つまたは複数の粒子捕集装置と
を含む、粒子作製システム。 - 前記1つまたは複数の粒子ろ過システムが、少なくとも1つの高圧収集フィルタシステムと前記収集フィルタの下流に直列した少なくとも1つの低圧捕集フィルタシステムとを含む直列粒子ろ過システムを含む、請求項9に記載の粒子作製システム。
- 少なくとも2つの粒子収集フィルタと、2つの粒子捕集フィルタと、2つの捕集装置とを含む、請求項10に記載の粒子作製システム。
- 前記1つまたは複数の粒子捕集装置が、
チャンバを画定し、遠位端と近位端とを備えた捕集容器と、
前記捕集容器の前記近位端から伸長し、前記チャンバと流体連通している、入口と、
前記捕集容器の前記近位端から伸長している出口であって、前記入口が前記チャンバと流体連通し、前記出口が前記チャンバと前記出口との間に位置する多孔性材料を備えた出口と
を備えている、請求項9〜11のいずれか1項に記載の粒子作製システム。 - 前記捕集装置内で捕集された1つまたは複数の粒子を測定するよう構成された試料採取システムをさらに含む、請求項9〜12のいずれか1項に記載の粒子作製システム。
- (i)加圧チャンバを画定し、遠位端と近位端とを備えた容器と、(ii)前記容器の前記近位端にある前記加圧チャンバの第一の注入口と、(iii)前記加圧チャンバの内部に位置するノズルであって、前記加圧チャンバの前記第一の注入口と流体連通している注入管を備え、出口開口部を備え、前記容器の前記近位端と前記ノズルの前記出口開口部との間の距離を変化させるよう調節可能であり、前記容器の縦軸と前記ノズルの縦軸との間の距離を変化させるよう調節可能であるノズルと、(iv)前記加圧チャンバ内に位置し、かつ、前記ノズルの前記出口開口部から離れて位置する音響エネルギー源と、(v)前記容器の前記遠位端にある前記加圧チャンバの出口とを備えたノズルアセンブリを準備する段階と、
前記加圧チャンバ内の前記音響エネルギー源を前記ノズルの前記出口開口部に近接させて配置する段階と、
前記加圧チャンバ内で第一の流体および第二の流体を受け取る段階であって、前記第一の流体が前記ノズルの前記出口開口部を通って前記音響エネルギー源上に移動し、前記第二の流体が前記加圧チャンバの第二の注入口を通って移動し、それにより前記加圧チャンバ内に複数の粒子が生じる段階と、
前記加圧チャンバの前記出口から前記複数の粒子を受け取る段階と、
捕集装置内で前記複数の粒子を捕集する段階と、
前記複数の粒子のうちの1つまたは複数の粒子のサイズを求める段階と
を含む、粒子を形成する方法。 - 前記1つまたは複数の粒子の所望のサイズと、前記1つまたは複数の粒子について求めたサイズとの間の差を求める段階をさらに含む、請求項14に記載の方法。
- 前記求めた差に応じて、前記容器の前記近位端と前記ノズルの前記出口開口部との間の距離および前記容器の縦軸と前記ノズルの縦軸との間の角度のうちの少なくとも一方を調節する段階をさらに含む、請求項15に記載の方法。
- 前記ノズルを通る第一の流体の流速が0.5mL/分〜30mL/分の範囲である、請求項14〜16のいずれか1項に記載の方法。
- 前記音響エネルギー源から前記音響エネルギー源の最大音響エネルギー出力の10%〜100%の振幅を有する音響エネルギーが発生する、請求項14〜17のいずれか1項に記載の方法。
- 命令を記憶したコンピュータ読取り可能媒体であって、1つまたは複数のプロセッサによって実行されたとき、
前記加圧チャンバ内で第一の流体および第二の流体を受け取る段階であって、前記第一の流体が前記ノズルの前記出口開口部を通って前記音響エネルギー源上に移動し、前記第二の流体が前記加圧チャンバの第二の注入口を通って移動し、それにより前記加圧チャンバ内に複数の粒子が生じる段階と、
前記加圧チャンバの前記出口から前記複数の粒子を受け取る段階と、
捕集装置内で前記複数の粒子を捕集する段階と、
前記複数の粒子のうちの1つまたは複数の粒子のサイズを求める段階と
を含む操作を請求項1〜8のいずれか1項に記載のノズルアセンブリに操作を実行させる、
コンピュータ読取り可能媒体。 - 前記操作が、
前記1つまたは複数の粒子の所望のサイズと、前記1つまたは複数の粒子について求めたサイズとの間の差を求める段階
をさらに含む、請求項19に記載のコンピュータ読取り可能媒体。 - 前記操作が、
前記求めた差に応じて、前記容器の前記近位端と前記ノズルの前記出口開口部との間の距離および前記容器の縦軸と前記ノズルの縦軸との間の角度のうちの少なくとも一方を調節する段階
をさらに含む、請求項20に記載のコンピュータ読取り可能媒体。
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