Stability Aspects of Packaging Materials

• Stability Aspects of Packaging Materials ensure protection against environmental factors like moisture, light, and oxygen, preserving drug potency.
• Stability Aspects of Packaging Materials also prevent interactions between the product and container, ensuring safety and efficacy.
• Packaging materials can significantly influence the stability of a pharmaceutical product.
• Improper packaging may lead to degradation, reduced potency, or contamination.

1. Moisture Transmission:

   • Plastics like LDPE may allow water vapor transmission, potentially degrading moisture-sensitive drugs.
   • Blister packs often use PVdC or aluminum foil to minimize moisture ingress.

2. Oxygen Permeability:

   • Certain drugs undergo oxidation in the presence of oxygen.
   • Oxygen barrier properties of packaging (e.g., multi-layer laminates, glass vials) are crucial for products prone to oxidative degradation.

3. Light Transmission:

   • Some drugs degrade when exposed to UV or visible light.
   • Amber glass or opaque containers can help protect light-sensitive products.

4. Chemical Interactions:

   • Leaching of plasticizers, stabilizers, or metal ions can compromise product safety or efficacy.
   • Container surface treatments or linings can help mitigate interaction.

5. Physical Stability:

   • Glass delamination (formation of flakes inside vials).
   • Changes in container integrity during shipping or storage (e.g., denting of metal cans).

6. Temperature and Humidity:

   • Extreme temperatures or high humidity can accelerate degradation.
   • Packaging must maintain integrity under typical transportation and storage conditions.

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