Hot-melt extrusion formulation
In drug discovery and development, the pharmaceutical industry estimates that more than half of active pharmaceutical ingredients currently used are characterized as poorly water-soluble compounds. Such low solubility frequently leads to drug formulations with low bioavailability, which means that the drugs aren’t efficiently absorbed in the gastrointestinal tract and thus become less effective. One way of increasing the solubility and thus the bioavailability of drug products, especially oral solid dosage forms, is to produce them as amorphous solid dispersions (ASD). A chief method for doing so is hot-melt extrusion (HME).
Hot-melt extrusion formulations are ideal for pharmaceutical products, as the HME process is a solvent- and dust-free continuous process with remarkably few processing steps. With high reproducibility in a small laboratory footprint, HME has several advantages over products manufactured using spray dried dispersion formulations. Hot-melt extrusion and spray drying are the two most common methods of producing ASD formulas for oral solid dosage drugs.
Advantages of extrusion
Although pilot-scale spray dryers are routinely used for ASD production, their effectiveness is hampered by high solvent requirements, inconsistent product quality, and challenging scale-up. Hot-melt extrusion, on the other hand, is a continuous process which surpasses pharmaceutical spray drying in terms of flexibility, product quality, and process efficiency. The design of an extruder, typically with flexible screws that can be adjusted as needed, allows for a wide range of throughput and the development of a continuous process without the necessity to use solvents. This further translates into other advantages of extrusion, like easy scalability and full process automation, without ever compromising on quality.
A new article explores the future of hot-melt extrusion, and how it could possibly spray drying to a large degree. The advantages and challenges of this highly useful technology are covered in an interview with Dr. Thomas Quinten of Janssen Pharmaceutical Companies and Thermo Fisher Scientific’s Dirk Leister. The full article is now available for download, here.
In the article, the two experts discuss a variety of aspects related to hot-melt extrusion:
- ASD and its solubility
- Reaping the environmental advantages of HME
- The high-temperature challenges of HME/li>
- Changing the mindset of an industry slow to adopt alternative technologies
- The outlook for wider use of HME on a commercial scale
Additional resources on hot-melt extrusion
The aforementioned article is not the only place where you can get a more in-depth view of the advantages of hot-melt extrusion. Thermo Fisher Scientific recently hosted an online pharmaceutical e-symposium featuring talks about a variety of technologies like twin-screw granulation, microscopy, spectroscopy and more. Amongst the several webinars in the e-symposium was one entitled “Hot-melt extrusion, process monitoring, and final product verification, “presented by Dr.-Ing. Margarethe Richter, Applications Scientist at Thermo Fisher Scientific. You can learn more about that particular webinar here: Pharma e-Symposium: Advancements in Drug Development and Formulation. HME is obviously an effective and useful technology for the pharmaceutical industry, but the full extent of its benefits has yet to be realized.
Thobias Geissler is a Product Line Manager, Materials Characterization at Thermo Fisher Scientific
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