Innovative Packaging Challenges for COVID-19 Drugs

Introduction

Understanding the Drug Characteristics

COVID-19 therapeutic research explored galectin-based carbohydrate molecules, known for modulating immune interactions. These compounds often require:

  • Stability at room temperature
  • Precise pH behavior
  • Ethanol washing and aseptic filling
  • Compatibility with glass vials, syringes, or cartridges

A detailed analysis of these characteristics is available in the main journal article (DOI link provided below).

Key Packaging Challenges Identified :

Delamination of Glass Containers

Glass delamination where thin flakes detach from a vial’s inner surfaceis a major risk for injectable drugs. High-pH formulations, phosphate buffers, and aggressive sterilization conditions increase this probability.

Main causes include:

  • High forming temperatures during vial manufacturing
  • High alkali content in glass
  • Long storage times and elevated temperatures
  • Interaction between Type I borosilicate glass and alkaline formulations

Potential Solutions:

  • Surface treatment using ammonium sulfate
  • Improved temperature control during glass forming
  • Switching to Alumino Silicate or COC/COP vials
  • Siliconization of inner vial surfaces

The U.S. Food & Drug Administration (FDA) highlights how inadequate container compatibility can lead to contamination and recalls, stressing the importance of selecting the right glass type for sensitive biologics.

Protein Adsorption on Glass & Rubber Surfaces :

Protein therapeutics are highly sensitive to surface interactions.

Major risks:

  • Loss of drug potency
  • Aggregation or denaturation
  • Adsorption to glass, rubber stoppers, or needle surfaces

Techniques to Reduce Adsorption:

  • Silicone oil coating
  • PEG/OEG-based coatings
  • Use of inert materials like COC/COP
  • Incorporation of stabilizers such as carbohydrates or amino acids

The American Association of Pharmaceutical Scientists (AAPS) emphasizes minimizing container–protein interactions to preserve drug efficacy.

Advanced Packaging Technologies:

Siliconization Advantages

  • Improved drainage
  • Lower plunger movement force
  • Reduced surface interaction with proteins

However, excessive silicone leads to droplet formation, which can trigger protein aggregation especially under stress conditions.

Alternatives to Glass Packaging:

COC/COP vials offer:

  • No metal ion release
  • High transparency
  • Low adsorption tendency
  • Superior puncture resistance

These materials help maintain stability in high-pH formulations that could otherwise degrade glass.

Challenges in Prefilled Syringes (PFS):

Syringeability Issues

Viscosity directly impacts injection force and user experience. According to the Hagen-Poiseuille relationship, thicker formulations require higher force.

Tungsten & Silicone Oil Interactions

Tungsten from syringe manufacturing may leach into formulations and promote protein aggregation. Silicone oil, although beneficial for lubrication, may cause sub-visible particle formation.

Rubber Components & Adhesives

Leachables from needle shields or adhesives can trigger:

  • Impurities
  • Protein instability
  • Needle clogging

A more detailed technical breakdown can be found in the main journal article URL within the study: A detailed analysis can be found in our main journal article url.

Further Reading and Resources

To further enhance research accessibility:

Implications for Global Healthcare

Proper packaging ensures that:

  • Drug stability remains intact throughout storage and transport
  • Patients receive safe, contaminant-free therapeutic products
  • Manufacturing processes comply with regulatory requirements

Call to Action

Disclaimer: This content is generated using AI assistance and should be reviewed for accuracy and compliance before considering this article and its contents as a reference. Any mishaps or grievances raised due to the reusing of this material will not be handled by the author of this article.