RT Journal Article
SR Electronic
T1 Replacing the Emulsion for Bake-on Siliconization of Containers—Comparison of Emulsion Stability and Container Performance in the Context of Protein Formulations
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 89
OP 108
DO 10.5731/pdajpst.2021.012640
VO 76
IS 2
A1 Moll, Fabian
A1 Bechtold-Peters, Karoline
A1 Mellman, James
A1 Sigg, JÜrgen
A1 Friess, Wolfgang
YR 2022
UL http://journal.pda.org/content/76/2/89.abstract
AB Pre-filled syringes have simplified parenteral administration of protein drugs. To ensure an easy and consistent movement of the plunger, the inner glass container surface is typically siliconized. For bake-on siliconization, emulsions are sprayed on and heat treated. Due to the European Union regulation REACh (Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals) the use of certain emulsion components, partially constituting the gold standard LiveoTM 365 35% Dimethicone NF Emulsion (LiveoTM 365), becomes restricted and LiveoTM 366 35% Dimethicone NF Emulsion (LiveoTM 366) has been introduced as an alternative. This change may affect the handling properties as well as the silicone layer formed. The purpose of these studies was to identify any differences that may influence the stability and safety of the final drug/device combination product to enable the use of the new emulsion. We compared silicone emulsions LiveoTM 365 and LiveoTM 366 and dilutions focusing on 1) their general physical stability, 2) the thermal degradation process of the emulsions and their components, and 3) the resulting silicone layer concerning chemistry, morphology, and functionality. The results were linked to the assessment of the final product regarding particle formation and short-term stability. A comparison of the emulsions LiveoTM 365 and LiveoTM 366 for bake-on siliconization is presented to support the transition of the latter as it becomes mandatory with REACh. Our studies show that the two emulsions do not significantly differ with respect to handling and stability, the resultant silicone layer characteristics as well as its functionality. We conclude that the transition to the new emulsion will not significantly impact the final product or the layer performance upon storage and with respect to particle formation.