Introducing the Alba® Primary Packaging Platform. Part 1: Particle Release Evaluation

PDA Journal of Pharmaceutical Science and Technology
Alberto ChillonDaniele Zuccato

Abstract

The sensitivity of drugs to one or more elements of the primary packaging is a serious concern for the pharmaceutical industry. Biologics in particular are highly sensitive, leading to a higher risk of incompatibility and stability test failures as worst-case scenarios. This potential incompatibility-and the consequent formulation instability due to the interactions between the drug and the primary container surface-may have multiple causes: the intrinsic nature of the container surface, leachables coming from the materials used, substances coming from the production process, silicone oil droplets, or other particles. The Alba primary packaging platform was designed in order to have the same interface between the drug and the glass container surface on the different primary packaging containers to minimize the emergence of instabilities at later stages during the formulation development. The Alba containers are internally treated with an innovative cross-linked coating based on silicone oil lubricant, and the additional rubber components have been selected to minimize the possible differences between the container typologies. This paper shows in deep detail the subvisible particle release reduction and the comparability of the ...Continue Reading

Citations

Mar 13, 2021·AAPS PharmSciTech·Ashwin C ParenkyMohammed Shameem

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