eBook: Formulation Technologies and Strategies for Successful New Product Development - 27

Figure 3. Compression profile (A) and disintegration time (B) of Parteck® Delta M compared to β-mannitol showing
increased tablet hardness and disintegration for tablets based on Parteck® Delta M excipient.
considered to be a major contributing factor to
improved compaction behavior.2
The larger surface
area is associated with higher compressibility, which
enables the production of harder tablets with shorter
disintegration times.
MilliporeSigma is currently the only excipient
supplier offering the delta (δ) polymorphic form
of D(-)-mannitol for pharmaceutical applications.
Parteck® Delta M excipient was specifically designed
for use in wet granulation. While monographed as
a standard mannitol, Parteck® Delta M excipient
transforms into the β polymorph during granulation,
creating an increased surface area and a porous
structure, resulting in increased compressibility.
Differences in the compression profile (A) and
disintegration (B) of wet granulated Parteck® Delta
M excipient compared with standard β-mannitol are
shown in Figure 3. Significantly faster disintegration
was also observed for formulations based on Parteck®
Delta M excipient compared with corresponding
formulations with the β modification and correlated
with the measured Brunauer-Emmett-Teller (BET)
surface areas (Figure 4) .
Mannitol was granulated with 10% water and dried,
and granules larger than 1 mm were removed. The
Figure 4. Surface area of δ- versus β-mannitol granulate
produced by wet granulation
27

eBook: Formulation Technologies and Strategies for Successful New Product Development

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