Hot Melt Extrusion (HME) Formulation Services
HME is a cutting-edge drug development technology that helps pharmaceutical companies create new medications that are highly soluble and bioavailable. Our experts leverage the science and strategy behind HME formulation to enhance drug solubility and delivery.
The HME process uses heat and pressure to combine polymers with active pharmaceutical ingredients (API). During this process, the combined material is pressed through a die to form a tablet, capsule, or granule. Typically, this is done with two twin screw extruders, which press the active ingredient into the polymer and resulting in a polymer matrix.
HME is part of our end-to-end development and manufacturing process. By incorporating HME early in development, we help our clients address solubility and bioavailability challenges on a small scale, before moving to clinical trials or large-scale commercial manufacturing and distribution.
The Advantages of HME in Drug Formulation for API Solubility Enhancement
Using a hot melt extruder offers many benefits when formulating new pharmaceutical products. The most notable advantage this technology offers is the ability to take poorly soluble drug compounds and incorporate them safely and effectively in new products.
For example, there are many compounds that have medical potential, but do not dissolve effectively in liquid or absorb properly in the body. HME technology combines these compounds with a polymer that is soluble and bioavailable for efficient drug delivery.
HME technology also helps pharmaceutical companies develop sustained and modified release drugs. With this process, you can combine unstable compounds with specific polymers that facilitate a longer delivery period within the body. This means the therapeutic effects of the drug will last longer with each dose.
Finally, HME is also very effective for developing drugs with taste-masking properties. Some active drug ingredients have very bitter or unpleasant flavors, but the HME process coats these ingredients with a polymer. The polymer acts as a barrier between the taste buds and the active ingredients, making the drug more palatable. This is particularly helpful when creating drugs for children, seniors, and other sensitive patient groups.
In addition to its versatility, HME also has the benefit of being very efficient. The process is highly automated, requiring little manual input, and finished compounds don’t require any post-procedure drying, which keeps manufacturing times reasonable. On top of that, the HME process can be done continuously, which improves drug uniformity and maintains quality.
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Hot Melt Extrusion (HME)
