Impact of Formulation Variables on Silicone Oil Distribution and Functionality of Prefilled Syringe System

Galen H. Shi; Sharon L. Shinkle; Ganapathy Gopalrathnam; Xia Dong; Jeffrey D. Hofer; Eric C. Jensen; Natarajan Rajagopalan

doi:10.5731/pdajpst.2017.008169

Abstract

The interior surface of prefilled syringes is typically coated with silicone oil for lubrication to aid in free plunger movement. This article discusses the impact and interaction of formulation variables with silicone oil within the interior surface of the barrel. Characterization techniques including syringe glide force, break loose force, ZebraSci imaging, contact angle, ICP, and RapID were used in assessing the interactions. Data indicate formulation variables of pH, buffer and tonicity agent type and concentration and surfactant can impact silicone oil distribution of prefilled syringes leading to changes in functional properties of the syringe over time. Syringe samples containing acetate and histidine buffers showed an increase in glide force at accelerated temperature conditions, but the change was minimal at 5°C. The samples with the highest glide force correlate with the presence of sodium acetate buffer in combination with mannitol. Sodium chloride appeared to have lesser impact on glide force than mannitol. Samples with higher glide force appeared to exhibit a change in the silicone oil layer of the syringe, as observed with ZebraSci imaging, as well as significant reduction in surface hydrophobicity, as demonstrated through contact angle measurement. These data indicate the morphology of the siliconized surface may be changing over time in contact with different formulation variables.

Received July 18, 2017.
Accepted October 10, 2017.

PDA members receive access to all articles published in the current year and previous volume year. Institutional subscribers received access to all content. Log in below to receive access to this article if you are either of these.

If you are neither or you are a PDA member trying to access an article outside of your membership license, then you must purchase access to this article (below). If you do not have a username or password for JPST, you will be required to create an account prior to purchasing.

Full issue PDFs are for PDA members only.

Note to pda.org users

The PDA and PDA bookstore websites (www.pda.org and www.pda.org/bookstore) are separate websites from the PDA JPST website. When you first join PDA, your initial UserID and Password are sent to HighWirePress to create your PDA JPST account. Subsequent UserrID and Password changes required at the PDA websites will not pass on to PDA JPST and vice versa. If you forget your PDA JPST UserID and/or Password, you can request help to retrieve UserID and reset Password below.