What are HME Services?

 

Hot-melt extrusion (HME) is a well-known applied process in the plastics industry. HME services have recently been feasible to produce various dosage forms and drug delivery systems. Hot-melt extruded dosage forms are complex mixtures of active drugs, processing aids, and functional excipients.

HME continuous manufacturing has numerous advantages in terms of production and speeding up new drug development cycles.

What is Hot Melt Extrusion?

The most common oral solid dose form in the pharmaceutical industry is tablets and capsules. Tablets and capsules containing tiny particles of the active ingredient dissolve faster.

By employing HME services, even the processing of poorly soluble carrier/active substance combinations is no longer a big issue in the pharmaceutical sector. 

Hot-melt extrusion is a cost-effective method for creating solid molecular dispersions that outperform solvent-based methods like spray drying and co-precipitation. Proprietary hot melt extrusion has been shown to give sustained, modified, and targeted drug delivery by embedding drugs in a polymeric carrier. It is used to create controlled drug release dosage forms using conventional and non-conventional polymeric materials.

How Hot Melt Extrusion is Used

Hot-melt extrusion is used for the following:

● Covering up the bitter taste of an active ingredient.

● Development of controlled-release dosage formulations.

● Polymer-drug solutions/dispersions formation: These include:

● A higher rate of drug dissolution

● Higher drug solubility

● Creating dosage formulations with a controlled release (including implants).

These are some of the ways proprietary hot melt extrusion is used:

The Process of Hot Melt Extrusion

Hot-melt extrusion is driving raw materials through a die at a raised temperature with a spinning screw into a product of even shape. The procedure is anhydrous as it requires fewer processing stages because it is a continuous operation, uses no organic solvents, does not compress the actives, and improves bioavailability by dispersing the drug at the molecular level in the final dosage forms.

The extrusion method includes converting the API and excipients under controlled conditions to produce a product with a homogeneous shape and density (such as a fast-dissolving film or tablet).

Extrudate should be managed into the preferred dosage form after extrusion, e.g., intravaginal rings, mini-matrices, tablets, granules, films, pellets, and porous matrices.

Advantages of using HME Services

Hot-melt extrusion offers several advantages over typical pharmaceutical processing processes, including:

● Better content uniformity.

● Improved bioavailability of poorly soluble substances.

● Clinically beneficial dosage forms.

● Processing without the use of solvents or water

● Few processing steps

● Sustained, modified, and targeted release capabilities.

● There are no criteria for active ingredients compressibility, and the entire operation is straightforward, continuous, and efficient.

● Uniform dispersion of fine particles occurs.

● Excellent stability at different pH and moisture levels.

● Because they are non-swellable and water-insoluble, they are safe to use in people.

● Reduced number of unit operations.

● A wide range of performance dose forms is produced.

● Creation of a variety of geometries

These advantages are a simplification of multi-stage, complex operations.

Conclusion

Hot-melt extrusion is a rapidly evolving technology platform for addressing challenging formulation difficulties, particularly in the solubilization area.

AbbVie Contract Manufacturing offers various proprietary hot melt extrusion solutions for the pharmaceutical industry. We have numerous items that can satisfy the needs of customers depending on the intended process.