Self-modeling curve resolution (SMCR) analysis of near-infrared (NIR) imaging data of pharmaceutical tablets.
The idea of quality by design (QbD) has been proposed in pharmaceutical field. QbD is a systematic approach to control the product performance based on the scientific understanding of the product quality and its manufacturing process. In the present study, near-infrared (NIR) imaging is utilized as a tool to achieve this concept. A practical use of a chemometrics technique called self-modeling curve resolution (SMCR) is demonstrated with NIR imaging analysis of pharmaceutical tablets containing two ingredients, a soluble active ingredient, pentoxifylline (PTX), and an insoluble excipient, palmitic acid. Concentration profiles obtained by SMCR reveal that the homogenous distribution of chemical ingredients strongly depends on the grinding time and that its process plays a central role in quantitative control, say sustained-release of PTX. In addition, pure component spectra by SMCR indicate a sequential change of specific NIR peak intensities following the increase of the grinding time. The spectra change shows a molecular structure change related to its crystallinity during grinding process. Accordingly, this study clearly demonstrates that NIR imaging combined with SMCR can be a powerful tool to reveal chemical or physical mechanism induced by the manufacturing process of pharmaceutical products and that it may be a solid solution for QbD of pharmaceutical products.
Technology Research & Development Center, Dainippon Sumitomo Pharma Co., Ltd. Osaka 554-0022, Japan.
Kimie
K
Awa
Takehiro
T
Okumura
Hideyuki
H
Shinzawa
Makoto
M
Otsuka
Yukihiro
Y
Ozaki
D007259:Infrared Rays; D019308:Palmitic Acid / Q000737:chemistry; D010431:Pentoxifylline / Q000737:chemistry; D004364:Pharmaceutical Preparations / Q000737:chemistry*; D011786:Quality Control; D012995:Solubility; D013607:Tablets / Q000737:chemistry*; D013997:Time Factors; D014961:X-Ray Diffraction
D004364:Pharmaceutical Preparations; D013607:Tablets; D019308:Palmitic Acid; D010431:Pentoxifylline