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Untersuchungen zur Gefriertrocknung von Doxorubicin-beladenen HSPC/Cholesterol- Liposomen

Untersuchungen zur Gefriertrocknung von Doxorubicin-beladenen HSPC/Cholesterol- Liposomen

          
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About the Book

Das Ziel dieser Arbeit liegt in der Erarbeitung eines Lyophilisationsprotokolls, um die Lagerstabilitat von Doxorubicin (DXR)-beladenen Liposomen zu verbessern. Die Schwerpunkte liegen dabei in der Uberprufung der geeigneten Einfriergeschwindigkeit, der Optimierung der Primartrocknung und der Konzentration des Lyoprotektors. Daruber hinaus wird zusatzlich versucht, durch verschiedene Rehydrierungsmodelle und den Zusatz von PEG die Stabilitat der DXR-beladenen Liposomen wahrend der Lyophilisation zu verbessern. Im ersten Teil der Arbeit werden zunachst DXR und Idarubicin (IDA)-beladene Liposomen mit verschiedenen Lipidkompositionen hergestellt und hinsichtlich ihrer Lagerstabilitat bei Kuhlschrank-Temperatur (2 8 °C) und bei 37 °C bei verschiedenen pH Werten (entsprechend den moglichen Zielkompartimenten der Liposomen im Korper) uberpruft. Dabei zeigt sich, dass DXR-beladene Liposomen im Allgemeinen eine hohere Einschlusseffizienz (EE) (> 80%) aufweisen als IDA-beladene Liposomen. Hinzu kommt, dass die Lagerstabilitat der Liposomen mit DXR erkennbar stabiler ist als bei Verwendung von IDA. Da dieser Effekt auch bei Stabilitatsmessungen bei 37 °C auftritt, werden schließlich DXR-beladene HSPC/Cholesterol (Chol)- Liposomen fur die Lyophilisationsversuche eingesetzt. Nach einem ersten Lyophilisationsdurchlauf zeigt sich, dass fur die Stabilisierung der Praparation wahrend der Lyophilisation sowohl die Einstellung der Primartrocknungstemperatur ( 20 °C) als auch die Konzentrationen der eingesetzten Zucker (Saccharose, Trehalose, Mannitol) verandert werden mussen. Saccharose scheint als Lyoprotektor fur die Praparation geeignet zu sein. In folgenden DSC-Untersuchungen konnen Annahmen uber die Glasubergangsstufen der DXR-beladenen HSPC/Chol-Liposomen getroffen werden. Die Lyophilisation unter den neu gewahlten Lyophilisationsbedingungen fuhrt zu einer deutlichen Verbesserung der EE. Gleichzeitig wird der Einfluss der Sterilfiltration auf HSPC/Chol-Liposomen wahrend der Lyophilisation getestet. Dabei stellt sich heraus, dass die EE sterilfiltrierter DXR-beladener Liposomen niedriger als die EE der unsterilen Praparation liegt. In weiteren Untersuchungen zeigt sich, dass die zur Stabilisierung der Praparation beste Saccharosekonzentration vorliegt, wenn HBS (10 mM HEPES, 140 mM NaCl) mit Saccharose anstelle von NaCl isotonisiert wird. Außerdem fuhrt eine schnelle Abkuhlrate (Flussigstickstoff) zur Verbesserung der EE der sterilfiltrierten Praparation. Auch verdeutlichen verschiedene Reyhydrierungsmodelle, dass die einmalige Zugabe des gesamten sublimierten Wassers zu den hochsten EE-Werte fuhrt. Der Zusatz von mPEG2000-DSPE zeigt sich als ein vielversprechender Ansatz zur Verbesserung der EE und der Großenverteilung der Praparation vor und nach der Lyophilisation. Mit der erfolgreichen Gefriertrocknung von anti-GD2-funktionalisierten HSPC/Chol-Liposomen besteht auch auf diesem Gebiet die Moglichkeit, die Lagerstabilitat solcher Praparationen verbessern zu konnen.


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Product Details
  • ISBN-13: 9783954042036
  • Publisher: Cuvillier Verlag
  • Binding: Paperback
  • Language: German
  • Width: 276 mm
  • ISBN-10: 3954042037
  • Publisher Date: 1/1/2012
  • Height: 210 mm
  • Weight: 11 gr

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