Becton Dickinson France

Tzvetelina Chevolleau

Jean-Bernard Hamel

Benoit Fremon

Sébastien Jouffray

The invention relates to a method for reducing an amount of sub visible particles in a pharmaceutical composition contained in a medical injection device comprising a container () including a barrel () lubricated with a lubricant coating () in contact with the pharmaceutical composition, and a stopper () in sliding engagement within the barrel (), the container comprising a region () extending distally from the distal end () of the barrel which is not accessible to the stopper. During formation of said lubricant coating () on the inner wall of the barrel, the method comprises limiting lubricant from being deposited into said region () extending distally from the distal end () of the barrel.

Method for reducing an amount of subvisible particles in a pharmaceutical composition

Disclosed herein is a method to evaluate the stability of a protein-based formulation including a protein, a peptide and/or a protein derivative and a buffer relative to a lubricant of a lubricated container in which the formulation is intended to be stored, including: a) Evaluating a decrease over time of interfacial tension between the buffer and the lubricant, b) Evaluating a decrease over time of interfacial tension between the protein-based formulation and the lubricant, c) Identifying at least one component of the protein-based formulation interacting with the lubricant by comparing the decrease evaluated in step b) with the decrease evaluated in step a).

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Saint Egreve, France

Tzvetelina Chevolleau