Extractable/leachable substances from plastic materials used as pharmaceutical product containers/devices

Area of Science:

• Pharmaceutical Science
• Materials Science
• Analytical Chemistry

Background:

• Plastic packaging materials, including DEHP-plasticized PVC and polyolefins, are widely used in the pharmaceutical industry.
• The potential for organic and inorganic substances to leach from these materials into pharmaceutical products is a significant concern.
• Understanding leachable profiles is crucial for ensuring drug product safety and quality.

Purpose of the Study:

• To review and synthesize information on leachable substances originating from pharmaceutical plastic packaging.
• To cover the identification and quantification of leachables from materials such as DEHP-plasticized PVC and polyolefins.
• To assess reported levels of leachables in both real and simulated pharmaceutical products.

Main Methods:

• Literature review of scientific publications and regulatory documents.
• Analysis of studies reporting the identification of leachable substances.
• Compilation and assessment of data on leachable substance concentrations.

Main Results:

• Identified a range of organic and inorganic leachables from various pharmaceutical plastic packaging materials.
• Reported varying levels of these leachables, influenced by factors like plastic type, contact time, and storage conditions.
• Highlighted the presence of leachables in both simulated and actual pharmaceutical products.

Conclusions:

• Leachable substances from pharmaceutical plastic packaging are prevalent and require careful monitoring.
• Accurate identification and quantification methods are essential for risk assessment.
• Continued research and regulatory scrutiny are necessary to ensure patient safety regarding pharmaceutical leachables.