Uses of Proprietary Hot Melt Extrusion

Hot melt extrusion is the act of introducing pressure and heat to dissolve a polymer and make it go through an orifice in an ongoing process. Hot melt extrusion is a well-known processing method for polymers as far back as the thirties. With the evolution of technology, hot melt extrusion has found use in the healthcare industry, where it is used in many applications.

In this blog, we shall highlight the uses of proprietary hot melt extrusion in the pharmaceutical industry. Continue reading to learn more.

 

The Uses of Proprietary Hot Melt Extrusion

There are two most common reasons for using hot melt extrusion in the pharmaceutical world, highlighted and discussed below;

1. HME is Used to Improve the Bioavailability and Solubility of an API

For BCS class II and IV active pharmaceutical ingredients, poor solubility is a result of a steady crystalline form that cannot be penetrated by water. The amorphous form of an active pharmaceutical ingredient is usually more soluble because not much energy is needed for dissolution.

This resulted in the development of solid dispersions to distribute the active pharmaceutical ingredient in a carrier polymer, inhibiting it from crystallizing.

Because hot melt extrusion involves continuous mixing, it is suitable for dispersing the active pharmaceutical ingredient into a polymer carrier. Feeding polymer and active pharmaceutical ingredients into an extruder cause extrudate that contains soluble, uniformly dispersed, and stable soluble.

2. HME is Used to Control the Delivery of an Active Pharmaceutical Ingredient

Drug-eluting devices, also known as implantable drug-eluting systems, offer they can site-specific, localized drug delivery, thereby minimizing side effects and improving the effectiveness of the treatment.

These systems commonly provide active pharmaceutical ingredients over a long period to deliver continuous therapeutic effects with great patient compliance. This period can vary greatly depending on the product.

Whether a drug-eluting system requires to deliver for years or weeks, many of these products rely upon hot melt extrusion to disperse active pharmaceutical ingredients in a polymer matrix that delivers uniform, sustained drug release.

Conclusion

Hot melt extrusion is a well-developed processing technique that can leverage process analytical technology. Hence, it is possible to highly reproducible and customized dispersions using this technique. Hot melt extrusion can produce drug-eluting systems with different release profiles, and this depends on the type of die that is used.

Simple extrusion of a solid profile produces matrix-type systems. These usually follow first-order kinetics release, commonly with an initial burst of the drug. On the other hand, reservoir systems may use a tubing die that is filled with the drug.

Some reservoir systems utilize a higher multi-layer extrusion method. Here, a core loaded with drug is, at the same time, extruded. These systems achieve almost zero-order release kinetics where the rate of drug-release does not change over time.

AbbVie Contract manufacturing offers HME services in both Europe and the United States. We are leading in the pharmaceutical industry with more than three decades of hot melt extrusion development experience. Contact us today for your HME solutions.