eBook: Formulation Technologies and Strategies for Successful New Product Development - 37

Figure 1. In vitro dissolution profiles of ibuprofen tablets
made with ODT excipient systems A-E.
of the excipient combinations (Figure 2). These
factors influence how well water penetrates the
tablet, leading to different speeds of action of the
superdisintegrants contained therein.
Although the major pharmacopeias do not account
for particle structure in excipient monographs -
instead focusing on the chemical parameters of
the individual components - particle morphology
plays a major role in the performance of solid dosage
forms. It remains likely that the particule structure of
excipients results in differences in galenic behavior.
Other factors are also involved as well. For example,
some excipients contain polymers known to have
retarding effects; swelling starch can produce a
similar result. Formulators should, therefore, evaluate
ODT excipient systems on additional criteria beyond
a simple disintegration test to find the most suitable
excipient system for their respective API and desired
final product performance.
Simpler Can Be Better
In addition to evaluating the varying performance of
different ODT excipient systems, it is also important
to consider their complexity. Most ODT excipient
systems on the market contain several binders
Figure 2. Surface area and pore volume of ODT excipient systems A-E.
and a superdisintegrant. The higher the number of
components, the greater the work involved when
implementing quality-by-design development
approaches and for regulatory registration
ODT excipient systems comprising just two
components present a lower burden. Parteck®
ODT excipient, for instance, is a combination
of D-mannitol (a binder) and croscarmellose
sodium (a superdisintegrant). Croscarmellose
sodium is the sodium salt of a cross linked, partly
O-(carboxymethylated) cellulose. Both are well
accepted by regulatory authorities, which may
help to accelerate the registration process for
ODT formulations.
As a result, the morphology of the Parteck® ODT
excipient system is
rough and structured when
viewed under a scanning electron microscope
(SEM) (Figure 3). This microstructure leads to good
compression behavior, and thus high tablet strength
is achievable with low compression forces.
37

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