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Related Experiment Videos

Lyophilization closures for protein based drugs.

F DeGrazio1, K Flynn

  • 1West Company, Phoenixville, Pennsylvania.

Journal of Parenteral Science and Technology : a Publication of the Parenteral Drug Association
|March 1, 1992
PubMed
Summary

Lyophilization stoppers absorb and release moisture, potentially degrading drugs. This study compares moisture absorption in different rubber formulations to mitigate product degradation.

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Area of Science:

  • Pharmaceutical Science
  • Materials Science

Background:

  • Rubber formulations used as lyophilization stoppers exhibit variable moisture absorption and release.
  • Moisture release from stoppers can lead to drug degradation, particularly in low cake weight products.
  • Stopper formulation components, including polymers and fillers, influence water absorption during autoclaving.

Purpose of the Study:

  • To compare the moisture absorption characteristics of low and high absorbent rubber formulations.
  • To investigate the impact of stopper moisture release on dry-fill pharmaceutical products.
  • To provide data for selecting appropriate rubber formulations for lyophilization stoppers.

Main Methods:

  • Comparative analysis of moisture absorption in different rubber stopper formulations.
  • Evaluation of moisture release from stoppered vials containing dry product.
  • Characterization of rubber formulation components and their interaction.

Main Results:

  • Significant variations in moisture absorption capacities were observed among different rubber formulations.
  • The composition of rubber formulations directly impacts their water absorption levels.
  • Moisture release from certain formulations was quantified and discussed in relation to product stability.

Conclusions:

  • Rubber stopper formulation selection is critical for preventing moisture-related drug degradation.
  • Understanding and controlling moisture absorption is essential for ensuring the shelf-life of lyophilized products.
  • Further research into novel rubber formulations with optimized moisture properties is warranted.

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