STEER is a globally recognised player in the pharmaceutical industry for melt extrusion, with installations in reputed pharmaceutical multinational organisations.
Pharmaceutical compounding with hot melt extrusion
Pharmaceutical compounding using hot melt extrusion (HME) involves achieving a homogenous solid dispersion or solution by mixing and/or melting API with one or more excipients such as polymers, lipids, surfactants, diluents, lubricants, glidants, plasticisers and other modifiers for the purpose of stabilisation, bioavailability enhancement, controlled release or tastemasking and improved delivery especially in oral and transdermal systems.
It is important to avoid drug degradation that could result in related substances or impurities, and to achieve the required morphology or structure in the compounded mass. Applications in information technology have grown sharply with the improvement in the process capability of the CPU. Likewise, applications in pharmaceutical technology are influenced by the process capability of the extruder processing zone (EPZ) of the co-rotating twin-screw compounder.
Our pharma extruders are built to comply with cGMP and offer easy cleaning and removal. STEER has a fully trained team to provide complete validation (DQ, IQ, OQ, PQ, PLC validation and risk assessment) support to our pharma customers.
The use of HME provides substantial cost advantage and is the way forward to bring down the total cost of healthcare.
STEER is proud that every one of its customer trials has been a success and has helped customers to shrink their development timelines and open many new avenues.
Hot melt extrusion systems
STEER’s OMEGA PHARMA is a modular twin-screw extruder designed for pharmaceutical applications. This hot melt extrusion system is ideal for mixing, homogenising and degassing. It is a highly flexible system, with continuous operation process capability and high energy efficiency. It conforms to GMP standards and its clamshell design enables easy cleaning.
The OMICRON 12 PHARMA is a co-rotating twin-screw extruder, developed specifically for the pharma industry. It enables outstanding dispersive and distributive mixing, and can produce material at a very low output rate to help reduce the cost of new product development. Its design enables easy cleaning, scale up and changeover.
The modular OMEGA 30P features co-rotating, fully wiping twin-screws and clamshell barrels. Its key applications are mixing, homogenising and drying. Its continuous operation capabilities, flexibility and outstanding energy efficiency make it an idea pharma extruder.
Scalable melt extruders
STEER scalable melt extruders, ranging from lab scale to production models, have been running successfully for the past 3-5 years in various plants across the world. At STEER, we fully understand the needs of pharmaceutical R&D; our smallest 10 Dia scalable extruder (to handle 10g-15g batches) comes complete with scalable upstream and downstream options, such as chill roll unit, volumetric feeder and cutter.
STEER has designed the extruder to offer flexibility to perform operations for applications like melt extrusion, melt granulation, taste masking, sustained release, gas injection and liquid injection.
Please contact STEER to find out more.