Abstract Design of freeze-drying processes is often approached with a “trial and error”
experimental plan or, worse yet, the protocol used in the first laboratory run is adopted …

Near-infrared spectroscopy (NIRS) is a fast and non-destructive analytical method.
Associated with chemometrics, it becomes a powerful tool for the pharmaceutical industry …

Near-infrared (NIR) spectroscopy and imaging are fast and nondestructive analytical
techniques that provide chemical and physical information of virtually any matrix. In …

Various frameworks and methods, such as quality by design (QbD), real time release test
(RTRT), and continuous process verification (CPV), have been introduced to improve drug …

The existence of different solid-state forms such as polymorphs, solvates, hydrates, and
amorphous form in pharmaceutical drug substances and excipients, along with their …

Since the completion of the first edition of this book, major developments have occurred in
the pharmaceutical industry that have shaped the field of near-infrared (NIR) spectroscopy …

Physical characterization of formulations in frozen and freeze-dried solid states provides
indispensable information for rational development of freeze-dried pharmaceutical products …

Residual moisture content has a significant impact on the solid-state stability of
biopharmaceutical products. Protein degradation due to residual moisture is minimal at or …

The suitability of near infra-red spectroscopy (NIR) to follow changes in both the amorphous
and crystalline state of lactose at room temperature was investigated. Amorphous lactose …

Abstract Purpose. Near-infrared reflectance Spectroscopy (NIRS) was used to evaluate and
quantify the effect of compression force on the NIR spectra of tablets. Methods. Flat, white …