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Arzneiformen-Entwicklung

Arzneiformen-Entwicklung


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About the Book

Fur die galenische Entwicklung von Arzneizubereitungen stehen zwei Wege zur Wahl: der experimentorientierte und der wissensbasierte. Bei der experimentorientierten Entwicklung wird von galenisch meist unvollstandig charakterisierten Arzneistoffen und Hilfsstoffen ausgegangen und nach dem Prinzip "Versuch und Irrtum" experi mentell nach geeigneten Rezepturen gesucht. Diese Methode, die auf Gluckstreffer setzt, fuhrt nur dann rasch zum Erfolg, wenn es sich um einen niedrig dosierten und galenisch unproblematischen Arznei stoff handelt. Ausserdem wird auf diese Weise U.u. nur eine gerade eben geeignete und keine optimierte Rezeptur erhalten. Bei der wissensbasierten Entwicklung sind Arzneistoff, Hilfsstoffe und Verfahren (letztere nur einmal) genauer zu charakterisieren, be vor das galenische Fachwissen uber Abhangigkeiten und Zusammen hange zur Anwendung kommt. Hierbei werden zunachst theoretisch optimierte Rezepturen abgeleitet, die anschliessend experimentell zu uberprufen sind. Uber den Stellenwert "gerade noch geeigneter" und "optimierter" Rezepturen kann diskutiert werden, dennoch muss das Ziel: optimale Produkteigenschaften, wie sie Gesetzgeber und fir meninterne Standards verlangen, im Vordergrund stehen. Grundlage der wissensbasierten Entwicklung ist das in den letzten Jahrzehnten gewonnene galenische Fachwissen, das allerdings selek tiert und strukturiert sein muss. Die relativ vielen Rechenoperationen in diesem Buch sind eine Folge der Zielsetzung, optimale Stoffmengen, Prozessbedingungen und Produkteigenschaften quantitativ prognos tizieren zu konnen. Aber selbst bei einer nur qualitativen Betrachtung liefern die Formeln wichtige Informationen uber die massgebenden Ein flussgrossen einer Zielgrosse. Da vollstandige wissensbasierte Ent wicklungen einen relativ grossen rechnerischen Aufwand erfordern konnen, empfiehlt es sich als Hilfsmittel ein entsprechendes handels ubliches Expertensystem (z. B. die Software "Entwicklungssysteme") heranzuziehen."
About the Author:

Herbert Stricker

studierte Chemie an der Technischen Hochschule München, Promotion am Institut für Chemische Technologie. 1964-80 Tätigkeit in der pharmazeutischen Industrie. 1980-97 Leiter und Ordinarius des Institutes für Pharmazeutische Technologie und Biopharmazie an der Universität Heidelberg. Schwerpunkte der Tätigkeit und Forschung: Biopharmazie (Pharmakokinetik, Freigabekinetik, Modellentwicklung), Haltbarkeit von Arzneimitteln, Arzneiformenentwicklung (u.a. Liposomen, Implantate, Retardformen). Seit der Emeritierung 1997 Geschäftsführer einer Firma für galenische Software.


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Product Details
  • ISBN-13: 9783642623936
  • Publisher: Springer
  • Publisher Imprint: Springer
  • Height: 242 mm
  • No of Pages: 305
  • Series Title: Springer-Lehrbuch
  • Sub Title: Feste Zubereitungen
  • Width: 193 mm
  • ISBN-10: 364262393X
  • Publisher Date: 30 Aug 2012
  • Binding: Paperback
  • Language: German
  • Returnable: Y
  • Spine Width: 0 mm
  • Weight: 750 gr


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