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Primary Packaging Solutions for Intravitreal Administration of Ophthalmic Drugs – Critical Features of Prefillable Syringes

One of the probably most sensational organs of the human body are the eyes. Visual perception, reception and processing of optical stimuli from our environment take place via the eyes. Therefore, it is even worse for affected persons when this is negatively influenced by diseases or degeneration. Due to the increasingly aging society and the increased prosperity worldwide, the number of chronic and age-related diseases in the field of eye diseases is also rising. According to WHO, at least 1 billion people suffer from eye disease. One of the most prominent retinal diseases is macular degeneration, in which the central visual acuity of an eye is partially or completely lost. Another 500,000 – 600,000 patients with diabetes mellitus suffer from eye damage as a secondary disease, the so-called diabetic retinopathy. The advent of novel drug technologies such as gene therapies or RNAi-based approaches are opening treatment options in the field of genetic diseases (e.g. retinitis pigmentosa), among others.

Prefilled Syringes (PFS) Used in Ophthalmology

PFS used in the area of ophthalmology is primarily used for cataract surgeries in the anterior eye area or with vascular endothelial growth inhibitors to treat inter alia wet macular degeneration intravitreally. In the case of cataract surgeries, the injection of viscous hyaluronic acid prevents the collapse of the anterior chamber and simplifies the insertion of artificial intraocular lenses. For macular degeneration, monoclonal antibodies (mAbs) or recombinant fusion proteins are injected into the vitreous body to inhibit the adverse growth of blood vessels and in this way maintain the sight of the patient. The hyaluronic acids used for cataract operations are highly viscous but are not especially sensitive to potential chemical interactions. Conversely, the monoclonal antibodies (mAbs) and recombinant fusion proteins used for the therapy are biotechnologically manufactured and often sensitive to drug-container interactions over shelf-life. Both therapies are very different, although the eye is treated in both cases. Prefilled syringes have proven themselves over the last years very well as a primary packaging solution, making drug delivery in the area of ophthalmology more user-friendly and decreasing risks regarding dosing and administration. In ophthalmology, they are injected with fine needles repeatedly at intervals of several weeks directly into the interior of the eye (Figure 1). In these cases, low dosage volume requires highly precise syringe dimensions and scaling. Both treatment areas are subject to strict requirements regarding the allowed particle load.

Our whitepaper “Pre-fillable syringes – critical features for ophthalmological applications” provides an overview of the requirements of PFS used in this therapeutic area as well as highlighting the benefits associated by using PFS instead of the conventional way of vials and Polypropylene syringes. Lowest particle levels to ensure compliance with USP <789>and also reduce risk for the drug product and patients is one of the key benefits for PFS with baked-on siliconisation (BOS) and silicone-free syringes in Glass and COP compared to polypropylene syringes commonly used for repacking.

 

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