How To Mill Hot Melt Extrusion Without Destroying Product Quality
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HME (hot melt extrusion) is a validated method
for increasing the bioavailability of poorly soluble APIs. Unlike other
formulation methods, hot melt extrusion does not require the use of solvents.
Hot melt extrusion is more cost-effective since it uses continuous
manufacturing and can be utilized for abuse deference and taste masking. In
line with your commercialization strategy, this could result in a
higher-quality, more marketable pharmaceutical product.
Today, proprietary hot melt extrusion manufacturing has
found a position in pharmaceutical manufacturing, where it is used to make
pellets, granules, implants, ophthalmic inserts, and prolonged release tablets,
among other things. Polymers can be formed into a film via hot melt extrusion,
which eliminates the need for traditional solvent-casting procedures.
Pharmaceutical companies are primarily interested
in developing bio-enhanced formulations, generating solid solutions from water
soluble pharmaceuticals, and mass producing drugs in the form of pellets,
beads, and transdermal systems via hot melt extrusion.
HME services are becoming more
popular in the pharmaceutical sector as more pharmacological components,
particularly Pharmaceutical APIs, become insoluble or unstable during standard
wet granulation processing.
The procedure of hot melt extrusion
A powder combination of API and polymers is fed
into a heated processing zone within the extruder during the hot melt extrusion
(HME) process. The intense shear and mixing action of twin screws disperses the
API into a polymer matrix. The mixture is driven through a hole to form an
extrudate, which is then quickly cooled to solidify. The extrudate can be
easily molded into tablet form if necessary. However, before moving on to the
solid dosage manufacturing procedures, extrudates are usually further processed
(i.e. milled) into a powder.
How to grind the HME with care
Because melt granulation is a size-enlargement
process, the resultant material is frequently outside of the optimal particle
size range for direct injection into compression machines like tablet presses.
As a result, it has to be processed further.
When milling the extrudate, it's important to
have a powder with appropriate flow characteristics and the right bulk density
for a high-quality tablet. As a result, equipment selection is critical, as it
will have a substantial impact on the end product's quality.
Fitz mills can be supplied with chilled water
jackets that are placed in key spots to reduce the heat of impact. Because the
collision of the process material and the blades performs the majority of the
size reduction, the sizing screen can be substantially larger than the target
particle top size. Blinding and the aforementioned extrusion effect are avoided
because of the big aperture screen.
As a result, a stable milling technique for
heat-sensitive melt-extruded or melt-agglomerated materials has been developed.
Conclusion
Hot Melt Extrusion adds variety and flexibility
to the manufacturing process, making it a great alternative to traditional
methods like spray drying. Raw material selection, screw design, and
post-extrusion equipment all aid in determining the best method for various
dosage forms.
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