Custom pharmaceutical extrusion: powering the next generation of drug delivery systems

Pharmaceutical extrusion is a critical enabler in the manufacture of advanced drug delivery systems, from long-acting injectables to solid implants. While extrusion is a well-established process in industries such as plastics and food, its application in the pharmaceutical sector, particularly for novel products, presents unique technical challenges. These challenges often demand more than standard equipment, they require bespoke automation and precision engineering.

At 3P innovation, we specialise in developing custom extrusion solutions tailored to complex pharmaceutical applications. Whether you're working with temperature-sensitive biologics, sticky or high-viscosity materials, or cutting-edge drug delivery formats, our team delivers fit-for-purpose systems that meet both process and product requirements.

Understanding pharmaceutical extrusion

Extrusion is a versatile manufacturing process that enables materials to be shaped into highly controlled forms, making it ideal for applications such as implants, rods, and long-acting injectable formats.

Two common extrusion methods are:

• Hot-melt extrusion: The material is heated until molten and then forced through a die. As it cools, it solidifies into the desired shape. Ideal for controlled-release formulations, drug-loaded implants, and polymer-based injectables.

• Cold/wet extrusion: Suited to temperature-sensitive actives, this method uses a solvent or binder to shape the material at low temperatures. After extrusion, the product is dried to remove moisture and stabilise the final structure.

Each method requires tailored process control to manage variables like shear, temperature, pressure, and moisture content, especially when dealing with novel or high-potency drugs.

Critical process considerations in custom extrusion

1. Material feeding and extruder selection
Material behaviour determines whether a ram-die, single-screw, or twin-screw extruder is most appropriate. Continuous vs. batch feeding, homogeneity, and mixing dynamics must all be accounted for.

2. Shaping, curing and solidification
Post-extrusion curing is often as critical as the extrusion itself. Air cooling is typical in pharma, but more complex products may require solvent exchange, skin formation control, or multi-stage drying.

3. Cutting and downstream handling
Cutting methods (fly, crush, shear, laser) must be matched to the material properties and desired final form. Equally important is orientation and transfer of the product downstream without compromising shape or integrity.

4. Precision inspection
Accurate dosing and dimensional control are non-negotiable. We integrate inspection technologies, such as multi-plane imaging, laser measurement, and high-resolution microscopy, to verify consistency in real time.

Why aseptic extrusion is a game-changer

Aseptic extrusion is an emerging frontier in pharma. Unlike traditional methods, aseptic extrusion prevents contamination and ensures product sterility, making it ideal for long-acting injectables and implants, temperature-sensitive biologics and vaccines and customised drug delivery forms requiring precise control.

Given the complexity of maintaining sterility throughout the extrusion process, off-the-shelf solutions are insufficient. 3P innovation’s expertise in custom aseptic automation ensures that even the most challenging pharmaceutical products can be extruded with precision and sterility. With decades of experience in pharmaceutical engineering, 3P innovation stands at the forefront of aseptic extrusion automation. 

Want to learn more? Contact us today to explore how our custom aseptic extrusion solutions can transform your pharmaceutical manufacturing processes.