JP2016521155A - ホットメルト断片化押出機およびプロセス - Google Patents
ホットメルト断片化押出機およびプロセス Download PDFInfo
- Publication number
- JP2016521155A JP2016521155A JP2016505932A JP2016505932A JP2016521155A JP 2016521155 A JP2016521155 A JP 2016521155A JP 2016505932 A JP2016505932 A JP 2016505932A JP 2016505932 A JP2016505932 A JP 2016505932A JP 2016521155 A JP2016521155 A JP 2016521155A
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- JP
- Japan
- Prior art keywords
- extruder
- thread
- twin screw
- fragmentation
- rotating twin
- 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.)
- Granted
Links
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Images
Classifications
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
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Abstract
Description
1. ステアリン酸
2. ポリエチレンオキシド(PEO)
3. Kollidon(登録商標)SR(ポリ酢酸ビニルおよびポビドン)
4. 炭酸カルシウム
5. Klucel(商標)JF(ヒドロキシプロピルセルロース)
6. Ethocel(商標)N7(エチルセルロース)
7. タルク
試験は、2つの異なるスクリュ構成F1およびF2を有し、それぞれのDo/Diが1.71である、本明細書の譲受人により製造された2軸スクリュ押出機Omega 20を使用して行った。F1およびF2のスクリュ構成は共に、表1に提示し、それぞれ図5および図6に示した。図5および図6には単一のシャフトが示されているが、押出機構成は、相補的な要素を有する1対のシャフトを有する。F2スクリュ構成は、F2が様々なニュートラルニーディングブロック構成を有し、その結果、F1に比べて良好な断片化をもたらす点において、F1とは異なる。両方の構成は、断片化領域で混合要素を使用する。特許文献2に記載される混合要素(DSE)は、断片化領域の先頭に位置する(バレルC4)。冷却も、バレルC4で開始する。
RSE−右回転スクリュ要素
RFV−右回転ショベル要素
RFN−右回転遷移要素
LSE−左回転スクリュ要素
DSE−動的撹拌要素
RKB−45度食い違い角 右回転ニーディングブロック
NKB−90度食い違い角 (ニュートラル)ニーディングブロック
ケトプロフェンの融点は約90℃であることが公知である。バレル内の溶融領域の温度は、試験13では60℃に維持される(即ち、APIの融点よりも低い。)。セフロキシムアキセチルは、Tgが70℃よりも高い非晶質薬物である。
試験5、7、8、9、10、11、および15では、平均粒径が1mmより大きかった。
表2に列挙した試験により調製した組成物のそれぞれの粒度分布は、Malvern MasterSizer 2000を使用して決定した。試験のそれぞれで得られた断片の平均粒径も、表2に列挙した。
試験5、6、7、8、9、10、11、14、15、16、17、18は、添加剤のみを、単独で、およびその他の添加剤と組み合わせて使用して実行した。
断片を形成するための共回転2軸スクリュ押出機であって、経口投薬に適切な1種もしくは複数の添加剤、または経口投薬に適切な1種もしくは複数の添加剤を1種もしくは複数の活性医薬成分と一緒に受け取るための取入領域と、少なくとも1種の添加剤を軟化させて、粘性集塊または溶融体を形成するための溶融領域と、粘性集塊を同時に断片化しかつ冷却して、冷却された断片にするための断片化領域と、冷却された断片を押出機から回収するための押出機出口とを含む押出機。
共回転2軸スクリュ押出機内で断片を形成する方法であって:
a.経口投薬に適切な1種または複数の添加剤を押出機に供給するステップと;
b.少なくとも1種の添加剤を軟化または溶融させて、粘性集塊または溶融体を形成するステップと;
c.粘性集塊または溶融体を同時に断片化しかつ冷却して、冷却された断片を得るステップと;
d.冷却された断片を押出機から収集するステップと
を含む方法。
Claims (17)
- 断片を形成するための共回転2軸スクリュ押出機であって、
経口投薬に適切な1種もしくは複数の添加剤、または経口投薬に適切な1種もしくは複数の添加剤を1種もしくは複数の活性医薬成分と一緒に受け取るための取入領域と、
少なくとも1種の添加剤を軟化させて、粘性集塊または溶融体を形成するための溶融領域と、
前記粘性集塊を同時に断片化しかつ冷却して、冷却された断片にするための断片化領域と、
前記冷却された断片を該押出機から回収するための押出機出口とを備える、共回転2軸スクリュ押出機。 - 前記断片化領域が、ミリング、混合、または断片化要素を含む、請求項1に記載の共回転2軸スクリュ押出機。
- 前記断片化領域が、リード「L」で表面に螺旋状に形成された一続きのねじ山を有する少なくとも1つの混合要素を備え、
前記ねじ山は、少なくとも1回、リード「L」の何分の1かで整数ローブねじ山から非整数ローブねじ山に変形し、かつリード「L」の何分の1かで元の整数ローブねじ山に変形するか、または、前記ねじ山は、少なくとも1回、リード「L」の何分の1かで非整数ローブねじ山から整数ローブねじ山に変形し、かつリード「L」の何分の1かで元の非整数ローブねじ山に変形する、請求項1に記載の共回転2軸スクリュ押出機。 - 前記混合要素が、前記断片化領域の先頭に位置する、請求項3に記載の共回転2軸スクリュ押出機。
- 前記添加剤が、脂肪酸、ベヘン酸グリセリル、およびワックスからなる群から選択される、請求項1に記載の共回転2軸スクリュ押出機。
- 前記脂肪酸が、ステアリン酸である、請求項5に記載の共回転2軸スクリュ押出機。
- 前記溶融領域の温度が、前記粘性集塊または溶融体の形成を可能にするために、少なくとも1種の添加剤の軟化温度、ガラス転移温度Tgまたは融点よりも高い、請求項1から請求項6のいずれかに記載の共回転2軸スクリュ押出機。
- 前記断片化領域に冷却システムが設けられ、
前記断片化領域の温度が、前記粘性集塊または溶融体を冷却するために、少なくとも1種の添加剤の軟化温度、ガラス転移温度Tgまたは融点以下である、請求項1から請求項7のいずれかに記載の共回転2軸スクリュ押出機。 - 前記冷却が、前記断片化領域の全体にわたって均一である、請求項1に記載の共回転2軸スクリュ押出機。
- 前記断片化領域が、前記押出機出口に向かって増大する冷却勾配を有する、請求項1に記載の共回転2軸スクリュ押出機。
- 共回転2軸スクリュ押出機内で断片を形成する方法であって、
a.経口投薬に適切な1種または複数の添加剤を前記押出機に供給するステップと、
b.少なくとも1種の添加剤を軟化または溶融させて、粘性集塊または溶融体を形成するステップと、
c.前記粘性集塊または溶融体を同時に断片化しかつ冷却して、冷却された断片を得るステップと、
d.前記冷却された断片を前記押出機から収集するステップと
を含む方法。 - 経口投薬に適切な1種または複数の添加剤を、1種または複数の活性医薬成分と一緒に、前記押出機に供給するステップを含む、請求項11に記載の方法。
- 前記添加剤が、脂肪酸、ベヘン酸グリセリル、およびワックスからなる群から選択される、請求項11または請求項12に記載の方法。
- 前記脂肪酸が、ステアリン酸である、請求項13に記載の方法。
- 同時に行われる断片化および冷却が、ミリング、混合、または断片化要素によって実現される、請求項11または請求項12に記載の方法。
- 前記同時に行われる断片化および冷却が、リード「L」で表面に螺旋状に形成された一続きのねじ山を有する少なくとも1つの混合要素によって実現され、
前記ねじ山は、少なくとも1回、リード「L」の何分の1かで整数ローブねじ山から非整数ローブねじ山に変形し、かつリード「L」の何分の1かで元の整数ローブねじ山に変形するか、または、前記ねじ山は、少なくとも1回、リード「L」の何分の1かで非整数ローブねじ山から整数ローブねじ山に変形し、かつリード「L」の何分の1かで元の非整数ローブねじ山に変形する、請求項11または請求項12に記載の方法。 - 前記混合要素が、前記断片化領域の先頭に位置する、請求項16に記載の方法。
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