RT Journal Article
SR Electronic
T1 Introducing the Alba® Primary Packaging Platform. Part 2: Inorganic Extractables Evaluation
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP pdajpst.2018.009423
DO 10.5731/pdajpst.2018.009423
A1 Chillon, Alberto
A1 Zuccato, Daniele
YR 2019
UL http://journal.pda.org/content/early/2019/01/15/pdajpst.2018.009423.abstract
AB 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 worst-case scenario. 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. 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 details the reduction of the inorganic extractable release and the comparability of the performances of different containers, obtained using such technology. The improvement has been demonstrated stressing the containers with different extract solutions: Alba coated containers show a strong reduction of inorganic extractables and of corrosion degree compared to a spray-on siliconized and bulk products. The containers included in the Alba platform present comparable results and this represents a strong advantage during the drug formulation development, facilitating the transition from a container to another.