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The unique
spectral imaging characteristics of combining Teraview’s terahertz pulsed imaging
(TPI™) and terahertz pulsed spectroscopy (TPS)
offers the pharmaceutical industry new ways to improve
tablet integrity and performance, aids the discovery
of new polymorphs and improves information on hydration
state and crystallinity.
TeraView's
TPI™ technologies
are fundamentally suited to the testing of complex
tablet and coating forms. Consistent with the FDA’s
Process Analytical Technologies (PAT) initiatives,
Terahertz pulsed imaging and spectroscopy are particularly
applicable to Pharmaceutical Development, Manufacturing,
Root Cause Analysis and Product Quality Testing. Their
application facilitates improved process control and
production consistency across plants and geographies. In
contrast to traditional analysis, TeraView’s
three dimensional terahertz pulsed imaging (3D TPI™)
provides nondestructive, direct analysis of both matrix
and coating attributes which influence bioavailability
as determined by dissolution testing. 3D TPI™ analysis
of intact dosage forms yields unique information about
the following Critical Quality Attributes:
- Identification of separation of layers of multilayered
solid dosage forms
- Identification of cracks, dislocations and localized
chemical/physical structure in cores
- Estimation of API and excipient homogeneity in
formulations and cores
- Estimation
of coating thickness, uniformity and coverage for
single/multi-layer coating formulations
- Estimation of
API and excipient homogeneity in formulations
and coatings
Teraview’s
Terahertz Pulsed Spectroscopy (TPS) is particularly
useful for probing molecular structure without
concern for thermal effects apparent with more traditional
techniques. TPS measurements
performed in both transmittance and reflectance geometries
with minimal or no sample preparation elucidates
solid state crystalline structure for:
- Polymorph detection/screening
- Salt selection/crystallization
studies
- API/excipient compatibility for product
formulation
- Quantitative/qualitative analysis
of API and excipients
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