eBook: Formulation Technologies and Strategies for Successful New Product Development - 22

coating solutions from stock Parteck® COAT excipient
and plasticizer solutions. For each test, 50 µl of a
coating solution was placed in a DSC aluminum
pan and dried overnight. The dried material was
then weighed, the pan closed, and the DSC analysis
performed. Triethyl
citrate, triacetin, PEG 1000,
and several polyols were found to exhibit strong
plasticizing effects
Next, the effect of different types of plasticizers at
different concentrations on the tablet surface was
explored by determining the surface roughness
using a laser scanning microscope. Triethyl citrate
and triacetin were found to dramatically reduce
the surface roughness when incorporated into
formulations at 30% of the solids content. Sorbitol
and mannitol were also found to have a positive
effect. Of the PEGs evaluated, PEG 1000 provided
the greatest decrease in roughness.
Continuous Processing Potential
with Parteck® COAT Excipient
Continuous manufacturing is recognized to provide
significant benefits in improved product quality
and consistency while reducing the manufacturing
footprint and also potentially the cost. To be
successful, however, inline, real-time monitoring is
essential to ensure ongoing performance.
For tablet coating processes, we are evaluating
the use of optical coherence tomography (OCT) in
collaboration with RCPE and Phyllon, a company
commercializing this technology. OCT provides
valuable insights into the coating process, including
the coating thickness and its homogeneity (structure)
and surface roughness as the film is forming. With
this system, it is possible to target a specific coating
thickness rather than relying solely on assumptions
of appropriate weight gain and back-calculations to
determine spraying time.
With our team of SAFC® formulation experts and
extensive portfolio of excipients, including Parteck®
COAT excipient, we are well positioned to develop
coatings suited for continuous coating operations.
Indeed, we are currently automating the tablet
coating process using OCT to determine the layer
thickness and are achieving robust results even at
large scale.
Comprehensive Coating Formulation
Support
Parteck® COAT PVA is our latest addition to our
extensive SAFC® excipient portfolio. Parteck® M
mannitol and Parteck® SI sorbitol excipients are ideal
for the formulation of tablet cores that can then be
coated with Parteck® COAT films formulated with
MilliporeSigma plasticizers, anti-tacking agents, and
pigments and colorants.
With this wide range of products, our SAFC®
portfolio is able to support customers through
each step of the tablet formulation development
process. Importantly, because these products are
developed in-house, we have a deep understanding
of their behaviors and how they can best be used in
formulation development. Furthermore, all of these
excipients are Emprove® qualified with high levels
of documentation for reduced risk and smoother
regulatory filings.
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eBook: Formulation Technologies and Strategies for Successful New Product Development

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