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Stability Aspects of Packaging Materials

  • 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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