Drug manufacturing is the process of industrial-scale
synthesis of
pharmaceutical drugs by
pharmaceutical companies. The process of drug manufacturing can be broken down into a series of
unit operations, such as
milling,
granulation,
coating,
tablet pressing, and others.
Unit operations
Formulation and pre-formulation development
Before a drug can be manufactured at any scale, much work goes into
the actual formulation of the drug. Formulation development scientists
must evaluate a compound for uniformity, stability and many other
factors. After the evaluation phase, a solution must be developed to
deliver the drug in its required form such as solid, semi-solid,
immediate or controlled release, tablet, capsule
Powder blending
In the pharmaceutical industry, a wide range of excipients may be
blended together to create the final blend used to manufacture the solid
dosage form. The range of materials that may be blended (excipients,
API), presents a number of variables which must be addressed to achieve
products of acceptable blend uniformity. These variables may include the
particle size distribution (including aggregates or lumps of material),
particle shape (spheres, rods, cubes, plates, and irregular), presence
of moisture (or other volatile compounds), and particle surface
properties (roughness, cohesivity).
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Milling
During the drug manufacturing process,
milling is often
required in order to reduce the average particle size in a drug powder.
There are a number of reasons for this, including increasing homogeneity
and dosage uniformity, increasing
bioavailability, and increasing the solubility of the drug compound.
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Granulation
Granulation can be thought of as the opposite of milling; it is the
process by which small particles are bound together to form larger
particles, called
granules. Granulation is used for several
reasons. Granulation prevents the "demixing" of components in the
mixture, by creating a granule which contains all of the components in
their required proportions, improves flow characteristics of powders
(because small particles do not flow well), and improves compaction
properties for tablet formation.
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Hot melt extrusion
Hot melt extrusion is utilized in pharmaceutical solid oral dose
processing to enable delivery of drugs with poor solubility and
bioavailability. Hot melt extrusion has been shown to molecularly
disperse poorly soluble drugs in a polymer carrier increasing
dissolution rates and bioavailability. The process involves the
application of heat, pressure and agitation to mix materials together
and 'extrude' them through a die. Twin-screw high shear extruders blend
materials and simultaneously break up particles. The resulting particles
can be blended and compressed into tablets or filled into capsules.
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