Abstract
Solid dispersion formulations and drug in polymer matrices are increasingly
being used by the pharmaceutical industry to enhance the solubility, or
bio-availability, of active pharmaceutical ingredients (APIs). The degree of
solubility or bio-availability enhancement, as well as properties such as chemical
stability and physical characteristics, will be dependent on the homogeneity of the
drug in polymer matrix. The use of Raman spectroscopy to assess homogeneity has
traditionally been limited by the time required to acquire images from a
statistically representative sample area. This may be overcome by employing a more
rapid one-dimensional Raman line-mapping approach and using a statistical analysis
to extract the critical information. This approach has been termed “lean” Raman
imaging and allows a large area of sample to be probed in a relatively short space
of time. This paper discusses the use of “lean” Raman imaging to assess two
performance-indicating parameters of a drug in polymer formulation, sedimentation of
the API within a capsule formulation and phase separation of the individual
components. The development of a screening method, using Raman line mapping to allow
rapid measurement of sedimentation of the API, is discussed. This method requires
less than half an hour per capsule for data collection and processing. In addition,
the development of a “lean” Raman mapping technique, using single line scans to
assess drug and polymer domain sizes, is detailed. This technique employs a simple
peak ratio approach coupled with statistical analysis to provide a measure of the
degree of drug and polymer segregation without the need for acquisition of high
pixel density images or multivariate analysis. The Raman mapping data is compared
with both the dissolution profiles and processing parameters of the samples tested
and a strong correlation is shown between formulation homogeneity and dissolution
behavior.
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