Advantages of the Twin-Screw Extruder in Hot-Melt Extrusion

 

Exploring Proprietary Hot-Melt Extrusion

When it comes to producing a viable formulation for an active pharmaceutical ingredient with poor bioavailability, producers should consider proprietary hot-melt extrusion. HME is a well-established process that is easy to scale up with the appropriate mathematical models.

This blog explores hot-melt extrusion. Kindly scroll down and continue reading to learn more.  

At AbbVie, we handle your product as our own. The nature of your biological drug notwithstanding, you can count on us when it comes to aseptic fill-finish manufacturing. We will provide reliable and safe products that patients are ready to use. 

Hot-Melt Extrusion

Hot-melt extrusion was first developed for polymer processing in the plastics industry. Hot-melt extrusion is a flexible and well-established technology in the pharmaceutical industry. It aids the formulation of low-permeability, low-solubility drugs into a number of patient-friendly dose forms. This includes free-flowing granules, capsules, and tablets.

Hot-melt extrusion uses pressure and heat to melt a polymer before it is forced through an orifice at constant pressure. The ensuing extruder is then further processed into products that show uniform active pharmaceutical ingredient particle density and distribution. Hot-melt extrusion has become extensively used in drug product development. This is because of the additional flexibility it offers.

By choosing suitable polymeric matrix excipients, developers can create products that attain higher bioavailability compared to the traditional formulation. It also helps to achieve targeted delivery into the superior regions of the intestine when drugs have poor permeability and/or solubility.

Major Processing Advantages of Hot-Melt Extrusion

Here are some processing merits of hot-melt extrusion:

1. The process of hot-melt extrusion is independent of the compressibility features of the starting material.

2. Hot-melt extrusion allows the introduction of taste-masking practices.

3. Hot-melt extrusion is a solvent-less process

4. The Hot-melt extrusion process is a well-controlled, continuous process that is based on co-rotating twin-screw technology offering excellent blending characteristics. It results in an active pharmaceutical ingredient that is homogeneously dissolved or dispersed in the carrier matrix.

5. The Hot-melt extrusion process isn’t affected by any crystalline modifications of active pharmaceutical ingredients. This is because it is based on the amorphous solid distribution in a carrier matrix that provides elasticity in downstream processing and the capability to produce a range of formulation types.

How Can HME be Successful?

For hme services to be successful, the time in which the temperatures of the systems can be cooled down to degrees below the glass transition temperature is very critical. This is a factor that also affects the crystallization and aggregation of the active pharmaceutical ingredients. Drug formulations with targeted release kinetics are attained by a molecular scattering of the active substance present in the carrier matrix.

The choice of the screw design and process parameters determines the quality of the extruder. Here, small amounts of active pharmaceutical ingredients are adequate to evaluate the suitability of a Hot-melt extrusion process with respect to the quality and processability characteristics of the extrudate.

A systematic approach to Hot-melt extrusion regarding an understanding of the interplay between product and process allows for the production of stable amorphous solid dispersions and the quick scale-up of clinical production.