HME Basics: Overview of Hot Melt Extrusion Process

Hot Melt Extrusion (HME) has gained widespread recognition over the last three decades. It has already established itself in a wide range of manufacturing activities and pharmaceutical research breakthroughs.

Hot melt extrusion (HME) is a manufacturing technology that has traditionally been used in the plastic and food sectors but is currently gaining traction in the pharmaceutical industry due to its increased flexibility. This is because HME allows the continuous production of a wide range of dosage formulations, including solid dose form, which is especially important for poorly soluble active pharmaceutical ingredients (APIs).

HME services have found use in the healthcare sector as the technology has progressed. It is used in various applications, including:

● Manufacturing of medical devices,

● Production of drug-eluting systems, and

● Mixing of active pharmaceutical ingredients (APIs) with polymers

The hot melt extrusion process is solvent-free, unlike other preparation selections. Hot melt extrusion is more cost-effective than continuous processing. 

How Hot Melt Extrusion Works

Extrusion is a continuous process that incorporates conveying, melting, blending, kneading, and degassing. The various components involved are continually added into the extruder's processing portion or "barrel" in a highly regulated manner. Material transportation and mixing are controlled by co-rotating screw shafts, which also influence the duration spent in each zone.

Different temperature profiles can be used in each zone to match the polymer and API processing needs. Air or other gasses can be removed from the molten mass by means of a vacuum element to deliver a bubble-free ejection of molten residue through a spout after the dispensation section. When the molten residue cools, a solid product is created. 

Benefits of Using Hot Melt Extrusion

Pharmaceutical hot melt extrusion aims to spread an active medicinal ingredient uniformly in a carrier polymer. Some of the benefits of using HME in a pharmaceutical setting are as follows:

Improved Solubility and Bioavailability

Poor solubility results from a stable crystalline state that water cannot penetrate effectively. Because less energy is required for dissolution, the amorphous form of an active pharmaceutical ingredient (API) is frequently more soluble. Solid dispersions were developed to spread the API in a carrier polymer and prevent it from forming. These formless solid dispersals can be developed using hot melt extrusion.

When opposed to spray drying, proprietary hot melt extrusion technology offers the benefit of being solvent-free, continuous, and scalable.

Controlled Drug Delivery

The advantages of implantable drug-eluting systems which are also identified as drug-eluting strategies) over traditional oral drug distribution methods are many. They can, for example, administer drugs to particular locations, boost therapeutic effectiveness and reduce side effects. These systems usually provide API over a longer period of time to ensure a continuous therapeutic impact and improved patient compliance. 

Mask bitter tastes

Bitter APIs have also been investigated using proprietary hot melt extrusion. The API is mixed with a taste buds masking agent. The interaction of the polymer and API protects the tongue from the API's bitter flavor.

Conclusion

The use of hot-melt extrusion technology to make various medication delivery devices is becoming increasingly popular. It's a valuable formulation tool for increasing solubility and bioavailability and creating drug-eluting systems for long-term release. 

AbbVie Contract Manufacturing has decades of experience with HME. We offer a wide range of HME services and are always available to handle any drug manufacturing.