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Introducing the Alba® Primary Packaging Platform. Part 2: Inorganic Extractables Evaluation.

Alberto Chillon1, Daniele Zuccato2

  • 1SGLab Advanced Technology, Nuova Ompi S.r.l., via Molinella 17, 35017 Piombino Dese (PD), Italy; and.

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The Alba primary packaging platform significantly reduces inorganic extractables and corrosion in drug containers. This innovative coating ensures consistent drug stability and simplifies formulation development by minimizing interactions between drugs and packaging.

Keywords:
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Area of Science:

  • Pharmaceutical Packaging Technology
  • Drug Stability and Compatibility
  • Materials Science in Healthcare

Background:

  • Drug sensitivity to primary packaging materials is a critical concern, especially for biologics, increasing risks of incompatibility and formulation instability.
  • Interactions between drug formulations and container surfaces can stem from intrinsic material properties, leachables, manufacturing residues, or particulate contamination.
  • Existing primary packaging solutions often present challenges in ensuring consistent drug-container interfaces across different formats.

Purpose of the Study:

  • To introduce and evaluate the Alba primary packaging platform designed to minimize drug-container interactions and enhance formulation stability.
  • To demonstrate the reduction in inorganic extractables and mitigation of corrosion achieved with Alba technology compared to conventional treatments.
  • To highlight the comparability of performance across different Alba containers, facilitating seamless drug formulation development.

Main Methods:

  • Internal treatment of Alba containers with an innovative cross-linked silicone oil-based coating.
  • Selection of rubber components to minimize variability between container types.
  • Stress testing of containers using various extract solutions to quantify inorganic extractables and assess corrosion levels.

Main Results:

  • Alba-coated containers exhibited a significant reduction in inorganic extractables compared to spray-on siliconized and bulk products.
  • A notable decrease in the degree of corrosion was observed in Alba-treated containers.
  • Containers within the Alba platform demonstrated comparable performance, indicating high consistency.

Conclusions:

  • The Alba primary packaging platform effectively minimizes inorganic extractables and corrosion, enhancing drug stability.
  • The consistent performance across Alba containers offers a significant advantage for pharmaceutical formulation development and scale-up.
  • Alba technology represents an advancement in primary packaging, addressing critical concerns for sensitive drug formulations, particularly biologics.