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Effects of syringe material and silicone oil lubrication on the stability of pharmaceutical proteins.

ABSTRACT: Currently, polymer-based prefillable syringes are being promoted to the pharmaceutical market because they provide an increased break resistance relative to traditionally used glass syringes. Despite this significant advantage, the possibility that barrel material can affect the oligomeric state of the protein drug exists. The present study was designed to compare the effect of different syringe materials and silicone oil lubrication on the protein aggregation. The stability of a recombinant fusion protein, abatacept (Orencia), and a fully human recombinant immunoglobulin G1, adalimumab (Humira), was assessed in silicone oil-free (SOF) and silicone oil-lubricated 1-mL glass syringes and polymer-based syringes in accelerated stress study. Samples were subjected to agitation stress, and soluble aggregate levels were evaluated by size-exclusion chromatography and verified with analytical ultracentrifugation. In accordance with current regulatory expectations, the amounts of subvisible particles resulting from agitation stress were estimated using resonant mass measurement and dynamic flow-imaging analyses. The amount of aggregated protein and particle counts were similar between unlubricated polymer-based and glass syringes. The most significant protein loss was observed for lubricated glass syringes. These results suggest that newly developed SOF polymer-based syringes are capable of providing biopharmaceuticals with enhanced physical stability upon shipping and handling.

SUBMITTER: Krayukhina E

PROVIDER: S-EPMC4359023 | biostudies-literature | 2015 Feb

REPOSITORIES: biostudies-literature

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Effects of syringe material and silicone oil lubrication on the stability of pharmaceutical proteins.

Krayukhina Elena E Tsumoto Kouhei K Uchiyama Susumu S Fukui Kiichi K

Journal of pharmaceutical sciences 20140924 2

Currently, polymer-based prefillable syringes are being promoted to the pharmaceutical market because they provide an increased break resistance relative to traditionally used glass syringes. Despite this significant advantage, the possibility that barrel material can affect the oligomeric state of the protein drug exists. The present study was designed to compare the effect of different syringe materials and silicone oil lubrication on the protein aggregation. The stability of a recombinant fus ...[more]

PMID: 25256796

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Project description:Wetting plays a major role in the close interactions between liquids and solid surfaces, which can be tailored by modifying the chemistry as well as the structures of the surfaces' outermost layer. Several methodologies, such as chemical vapor deposition, physical vapor deposition, electroplating, and chemical reactions, among others, have been adopted for the alteration/modification of such interactions suitable for various applications. However, the fabrication of low-contact line-pinning hydrophobic surfaces via simple and easy methods remains an open challenge. In this work, we exploit one-step and multiple-step silicone oil (5-100 cSt) grafting on smooth silicon substrates (although the technique is suitable for other substrates), looking closely at the effect of viscosity as well as the volume and layers (one to five) of oil grafted as a function of the deposition method. Remarkably, the optimization of grafting of silicone oil fabrication results in non-wetting surfaces with extremely low contact angle hysteresis (CAH) below 1° and high contact angles (CAs) of ∼108° after a single grafting step, which is an order of magnitude smaller than the reported values of previous works on silicone oil-grafted surfaces. Moreover, the different droplet-surface interactions and pinning behavior can additionally be tailored to the specific application with CAH ranging from 1 to 20° and sliding angles between 1.5 and 60° (for droplet volumes of 3 μL), depending on the fabrication parameters adopted. In terms of roughness, all the samples (independent of the grafting parameters) showed small changes in the root-mean-square roughness below 20 nm. Lastly, stability analysis of the grafting method reported here under various conditions shows that the coating is quite stable under mechanical vibrations (bath ultrasonication) and in a chemical environment (ultrasonication in a bath of ethanol) but loses its low-pinning characteristics when exposed to saturated steam at T ∼ 99 °C. The findings presented here provide a basis for selecting the most appropriate and suitable method and parameters for silicone oil grafting aimed at low pinning and low hysteresis surfaces for specific applications.

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Effects of syringe material and silicone oil lubrication on the stability of pharmaceutical proteins.

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Effects of syringe material and silicone oil lubrication on the stability of pharmaceutical proteins.

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