TY - JOUR
T1 - Topologically directed confocal Raman imaging (TD-CRI)
T2 - Advanced Raman imaging towards compositional and micromeritic profiling of a commercial tablet components
AU - Muthudoss, Prakash
AU - Kumar, Satheesh
AU - Ann, Eddy Yii Chung
AU - Young, Kwok Jia
AU - Chi, Rayce Lim Rui
AU - Allada, Ravikiran
AU - Jayagopal, Balaji
AU - Dubala, Anil
AU - Babla, Irfan B.
AU - Das, Samir
AU - Mhetre, Sandeep
AU - Saraf, Isha
AU - Paudel, Amrit
N1 - Funding Information:
PM acknowledges interaction on image processing with Saurabh Sahane, The Machine Learning Company, Maharashtra, India. PM acknowledges interaction on statistics with Hussain Ali, Christ University, Bangalore, India. There is no conflict of interest and there was no financial assistance for this work.
Publisher Copyright:
© 2022 Elsevier B.V.
PY - 2022/2/20
Y1 - 2022/2/20
N2 - Particle size distribution (PSD), spatial location and particle cluster size of ingredients, polymorphism, compositional distribution of a pharmaceutical product are few of the most important attributes in establishing the drug release-controlling microstructural and solid state properties that would be used to (re)design or reproduce similar products. There are numerous solid-state techniques available for PSD analysis. Laser diffraction (LD) is mostly used to study PSD of raw materials. However, a constraint of LD is the interference between the active pharmaceutical ingredients (API) and excipients, where it is very challenging to measure API size in a tablet. X-ray powder diffraction (XRPD) is widely employed in establishing the polymorphism of API and excipients. This research examined a commercial osmotic tablet in terms of extracting solid state properties of API and functional excipient by Raman Imaging. Establishing repeatability, reproducibility, and sample representativeness when the samples are non-uniform and inhomogeneous necessitates multiple measurements. In such scenarios, when employing imaging-based techniques, it can be time-consuming and tedious. Advanced statistical methodologies are used to overcome these disadvantages and expedite the characterization process. Overall, this study demonstrates that Raman imaging can be employed as a non-invasive and effective offline method for assessing the solid-state characteristics of API and functional excipients in complex dosage forms like osmotic tablets.
AB - Particle size distribution (PSD), spatial location and particle cluster size of ingredients, polymorphism, compositional distribution of a pharmaceutical product are few of the most important attributes in establishing the drug release-controlling microstructural and solid state properties that would be used to (re)design or reproduce similar products. There are numerous solid-state techniques available for PSD analysis. Laser diffraction (LD) is mostly used to study PSD of raw materials. However, a constraint of LD is the interference between the active pharmaceutical ingredients (API) and excipients, where it is very challenging to measure API size in a tablet. X-ray powder diffraction (XRPD) is widely employed in establishing the polymorphism of API and excipients. This research examined a commercial osmotic tablet in terms of extracting solid state properties of API and functional excipient by Raman Imaging. Establishing repeatability, reproducibility, and sample representativeness when the samples are non-uniform and inhomogeneous necessitates multiple measurements. In such scenarios, when employing imaging-based techniques, it can be time-consuming and tedious. Advanced statistical methodologies are used to overcome these disadvantages and expedite the characterization process. Overall, this study demonstrates that Raman imaging can be employed as a non-invasive and effective offline method for assessing the solid-state characteristics of API and functional excipients in complex dosage forms like osmotic tablets.
KW - Bootstrapping
KW - Cluster size distribution
KW - Compositional distribution
KW - Control chart
KW - Non-parametric statistical tests
KW - Osmotic drug delivery systems
KW - Particle size distribution
KW - Polymorphism
KW - Raman imaging
KW - Solid-state properties
KW - Spatial location
UR - http://www.scopus.com/inward/record.url?scp=85122591298&partnerID=8YFLogxK
U2 - 10.1016/j.jpba.2022.114581
DO - 10.1016/j.jpba.2022.114581
M3 - Article
C2 - 35026592
AN - SCOPUS:85122591298
SN - 0731-7085
VL - 210
JO - Journal of Pharmaceutical and Biomedical Analysis
JF - Journal of Pharmaceutical and Biomedical Analysis
M1 - 114581
ER -