Vetter dual-chamber delivery systems

Overview

Vetter’s patented dual-chamber technology offers an innovative and effective way to deliver drugs that require mixing and dilution immediately prior to application. Vetter dual-chamber syringes or cartridges can be used for lyophilized, liquid or powderdrugs.

The dual-chamber design eliminates the need for multiple needles or transfer devices,allowing different ingredients and solvents to be prefilled and stored separately, then easily mixed and administered as needed.

Background

Many recently approved parenteral drugs are based on biotechnological processes. More than 30 per cent of parenterals approved by the FDA in the past few years were lyophilized substances, according to Vetter’s research. These drugs are extremely sensitive to external influences, such as oxygen, sunlight, and pH values, which, along with other factors, can harm bioactivity.

For proteins and other recombinants, a simple and safe way to maintain bioactivity is to use a liquid formulation. However, simple dilution does not allow sufficient long-term stability for many drugs since water can act as both a medium and a reaction agent that can cause hydrolysis of proteins. In addition, water increases chemical and physical instability in reaction with other substances.

One answer is to remove as much water as possible from the liquid formulation to stabilize the substances, which can then be reconstituted with a diluent just before being injected.

In the lyophilization process, the dissolved substance is freeze dried, sublimating the water in a vacuum, with remaining moisture removed by raising the temperature slowly to turn the active substance and excipients into a solid amorphous or crystalline form. Depending on the formulation, the product will now remain stable for two to three years and can be reconstituted shortly before application.

Two different systems have become established for freeze-drying in primary packages: vials and dual-chamber systems.

Vials are less complex and are simpler to develop. On the other hand, they carry the disadvantage that administration of the drug is more complex,requiring the user to meter diluent from a second vial into a syringe and then add this to the lyophilized vial for reconstitution, before changing needle and administering the reconstituted drug to the patient. Another disadvantage is waste. At a volume of 1 mL of active substance, vial systems typically require overfill of 20 per cent or more to ensure accurate dosing.

Dual-chamber features

The Vetter dual-chamber system containsactive substance and the diluent in two separate chambers that remain unmixed until shortly before administration. The drug compound is lyophilized directly in-situ in the front chamber. After lyophilization, the diluent is filled into the second chamber. For administration, a simple “twist and push” forces the diluent through a glass bypass into the front chamber, where it is mixed with the active substance.

Dual-chamber systems reduce the overfill needed and increase precision in dosing because drug and diluent are premeasured. For example, in a dual-chamber lyophilization system in which the substance is lyophilized and reconstituted within the system, 1 mL of active substance requires an overfill of only six per cent, while 5 mL requires just three per cent overfill. Dual-chamber systems also decrease risk of medication error by eliminating need for multiple vials and needles.

Vetter offers two different dual-chamber solutions:

• Vetter Lyo-Ject® dual-chamber syringe
• Vetter Lyo-Ject® dual-chamber syringe is available in 1.0 ml, 2.5 ml, and 5.0 ml formats
• Vetter V-LK® dual-chamber cartridge
• V-LK® dual-chamber cartridge comes in a 1.0 ml format

Both systems are based on all-in-one designs that allow precise dosing and help to minimize reconstitution errors.

Innovative closure system and precision engineered stopper geometry allow little product loss, reducing overfill, residual volume and minimize packaging waste.

Drug delivery benefits:

Vetter dual-chamber systems offer multiple user advantages for delivery of sensitive injectable compounds, including:

• Simple administration: fewer steps required for preparation and injection in comparison with traditional vial/syringe combinations
• Increased patient safety: more precise dosing and minimized reconstitution errors
• High product security: all systems sealed during lyophilization process
• Versatility: cartridges designed for single- and multidose applications in pens
• Less waste: low residual volume with closure system and stopper geometry allows little product loss, reducing overfill, and minimize packaging waste
• Market differentiation: dual-chamber technology can provide a compound with greater end-user appeal and a powerful competitive edge

Resources

Click on Do dual-chamber syringes offer advantages over vials? to watch the video.
Click on Vetter dual-chamber syringe systems for more information.
Click on Vetter Pharma International GmbH to contact the company directly.