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Related Concept Videos

Sublimation01:03

Sublimation

Sublimation is the direct transformation of a solid to a gaseous state. For instance, at standard pressure and room temperature, solid carbon dioxide sublimes to gaseous carbon dioxide. The phase diagram depicts the conditions required for sublimation. This process occurs at the solid-gas phase boundary and is not observed above the triple point of the substance. The reverse of sublimation is called deposition, where a gaseous substance condenses directly into a solid. Sublimation and...
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Microfluidic Production of Lysolipid-Containing Temperature-Sensitive Liposomes
09:51

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Published on: March 3, 2020

Recent advances and further challenges in lyophilization.

Julia Christina Kasper1, Gerhard Winter, Wolfgang Friess

  • 1Department of Pharmacy, Pharmaceutical Technology and Biopharmaceutics, Ludwig-Maximilians-Universitaet Muenchen, Munich, Germany.

European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V
|June 12, 2013
PubMed
Summary

Lyophilization (freeze-drying) is expanding in pharmaceuticals, with recent advances in formulations, container systems, and freezing techniques. New insights challenge traditional methods and emphasize process analytical technology (PAT) and quality by design (QbD) for future equipment development.

Keywords:
AdvancesChallengesCollapseFormulationFreeze-dryingLyophilizationPharmaceutical applicationsQuality by designStability

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Area of Science:

  • Pharmaceutical Science
  • Chemical Engineering
  • Materials Science

Background:

  • Lyophilization (freeze-drying) is a critical process in pharmaceutical manufacturing.
  • The field has seen continuous development and expansion entering the 21st century.
  • Understanding and optimizing lyophilization is essential for drug stability and efficacy.

Purpose of the Study:

  • To review recent advancements in pharmaceutical lyophilization.
  • To discuss emerging challenges and future directions in the field.
  • To explore novel formulation and container system strategies.

Main Methods:

  • Literature review of recent developments in lyophilization.
  • Analysis of novel formulation aspects and container systems.
  • Discussion of the critical role of the freezing step and temperature considerations.

Main Results:

  • Expanded pharmaceutical applications of lyophilization have been identified.
  • Novel formulation and container systems are emerging.
  • The importance of the freezing step and challenging established lyophilization dogmas are highlighted.
  • Process Analytical Technology (PAT) and Quality by Design (QbD) are increasingly important.

Conclusions:

  • Lyophilization technology continues to evolve with new applications and techniques.
  • Future developments require reconsideration of traditional approaches and equipment design.
  • Integration of PAT and QbD principles is crucial for optimizing lyophilization processes.