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Reconstitution Systems

Lyophilization (“freeze-drying”) is the process of dehydrating a material (at low temperature and reduced pressure) to extend shelf life. Many biologic drug products are offered in lyophilized form. Important to subsequent administration is efficient reconstitution (i.e., rehydration). This section presents papers on the chemistry, products and processes of both lyophilization and reconstitution.

Overcoming Challenges in the Reconstitution of a High-Concentration Protein Drug Product. 
L.-F. H. Lin and R. Bunnell.  BioPharm International, 26 (3) (2013)

Abstract:

This article discusses strategies to reduce reconstitution time for protein drug products that are highly concentrated, including modification to methods of lyophilization and reconstitution.  Model protein had a molecular weight of 210,000 and drug product had a concentration 40 – 80 mg/mL.  Accelerated methods had no effect on protein aggregation as demonstrated by size-exclusion high-performance liquid chromatography (SE–HPLC), Fourier-transform infrared (FTIR) spectroscopy, or sodium dodecyl sulfate polyacrylamide gel electrophoresis (SDS–PAGE).

Link: http://www.biopharminternational.com/overcoming-challenges-reconstitution-high-concentration-protein-drug-product


Guide to Inspections of Lyophilizaton of Parenterals

Abstract:

This article discusses the process of lyophilization in general, and considerations for inspection of lyophilization operations.

Link: http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074909.htm


Reconstitution of a Powdered Medication (Video)

Abstract:

This video shows the basic process of reconstituting a lyophilized product with water using only a vial and syringe.

Link: https://www.youtube.com/watch?v=8ECYuiHFObU


Basic Principles of Freeze Drying. 
J. Barley

Abstract:

This article gives an overview of the process of lyophilization and the types of equipment employed.

Link: http://www.spscientific.com/freeze-drying-lyophilization-basics/


Controlling Ice Nucleation During the Freezing Step of Lyophilization - Lyophilization Technologies for Controlled Nucleation. 

Adeline Siew.  Pharmaceutical Technology 37 (5) (May 2, 2013)

Abstract:

This article discusses the issues that can result from uneven ice nucleation across multiple vials in a lyophilization chamber, and temperature variation strategies that can address them.

Link: http://www.pharmtech.com/controlling-ice-nucleation-during-freezing-step-lyophilization?id=&sk=&date=&pageID=2


Pharmaceutical Lyophilization (Videos)

Abstract:

This link comprises 4 videos that show an actual large scale lyophilization process, including animated schematic diagrams describing the process unit operations.

Link: https://www.youtube.com/watch?v=9iS0usklM58&index=3&list=PLYpkT00AUL3ZJNbRsbVRwU0Iy6AOetQ5J