Characterization of Solid-State Drug Polymorphs and Real-Time Evaluation of Crystallization Process Consistency by Near-Infrared Spectroscopy

@article{Qi2018CharacterizationOS,
  title={Characterization of Solid-State Drug Polymorphs and Real-Time Evaluation of Crystallization Process Consistency by Near-Infrared Spectroscopy},
  author={Shu Y Qi and Ye Tian and Wen-bo Zou and Chang-qin Hu},
  journal={Frontiers in Chemistry},
  year={2018},
  volume={6}
}
Herein, we aimed to develop a strategy for evaluating the consistency of pharmaceutically important crystallization processes in real time, focusing on two typical cases of polymorphism. Theoretical analysis using a combination of 13C solid-state nuclear magnetic resonance spectroscopy with other polymorphism analysis techniques identified a number of marker signals, the changes of which revealed the presence of two or more structural orientations (lattices and/or molecular conformations) in… 
2 Citations

Figures and Tables from this paper

A Strategy to Assess Quality Consistency of Drug Products
TLDR
A strategy with strong practicality, comprehensiveness and visualization to demonstrate the quality consistency of a specific product is established, not only conducive to the improvement of quality standards, but to the retrospective investigation of manufacturing processes which ultimately allowed maintenance of product consistency.

References

SHOWING 1-10 OF 23 REFERENCES
Chemometrics‐assisted solid‐state characterization of pharmaceutically relevant materials. Polymorphic substances
Analytical techniques for quantification of amorphous/crystalline phases in pharmaceutical solids.
TLDR
The present review provides a compilation of the theoretical and practical aspects of existing techniques, thereby facilitating the selection of an appropriate technique to accomplish various objectives of quantification of amorphous systems.
Estimation of the Degree of Crystallinity of Cefazolin Sodium by X-Ray and Infrared Methods
TLDR
The X-ray procedure appears to be superior since it can differentiate among the three solid CEZ forms, whereas IR could distinguish between only crystalline and amorphous CEZ, reproducibly.
Application of Solid-State NMR to Reveal Structural Differences in Cefazolin Sodium Pentahydrate From Different Manufacturing Processes
Solid-state Nuclear magnetic resonance, thermogravimetric analysis, X-ray diffraction, and Fourier-transform infrared spectroscopy were combined with theoretical calculation to investigate different
Applications of solid‐state NMR to pharmaceutical polymorphism and related matters *
  • R. Harris
  • Materials Science
    The Journal of pharmacy and pharmacology
  • 2007
TLDR
A range of applications are discussed, with particular emphasis on information about crystallography, for which NMR can address problems that cannot be readily solved by diffraction techniques (such as dynamic disorder and non‐stoichiometric hydration).
The contribution of Raman spectroscopy to the analysis of phase transformations in pharmaceutical compounds.
Solid-state NMR studies of form I of atorvastatin calcium.
TLDR
A possible structure of Form I of atorvastatin calcium (ATC-I), derived from solid-state NMR data and density functional theory calculations of various structures, is proposed for this important active pharmaceutical ingredient (API).
NIR spectroscopy as a PAT tool for solid dosage continuous manufacturing
TLDR
This presentation will discuss different case studies for which the implementation of NIR spectrometers of low wavelength ranges aided in formulation, process trouble-shooting and ultimately, how these were used as PAT tools for the continuous manufacturing of tablets and orodispersible polymer fi lms.
Process analytical technology : spectroscopic tools and implementation strategies for the chemical and pharmaceutical industries
Contributors. Preface. List of Abbreviations. Process Analytical Chemistry: Introduction and Historical Prespective. Dr. Ernest Baughman. Implementation of Process Analytical Technologies. Dr. Gert
Solid form screening--a review.
...
...