Detection of component segregation in granules manufactured by high shear granulation with over-granulation conditions using near-infrared chemical imaging

Recent advancement of chemical imaging in pharmaceutical quality control: From final product testing to industrial utilization

“…PLS is a quantitative method that has been successfully applied in the many pharmaceutical analysis. 14,32,33 Other relevant algorithms include t partial least squares 2 (PLS2) and classical least squares (CLS).…”

“…To detect over-granulation condition and explain the internal mechanism, an NIR-CI study has been completed. 32 The study contained nine batches on a scale of 5 kg under di®erent granulation times and impeller speeds. Long granulation time and fast impeller speed were used to simulate over-granulation condition.…”

Vapor Phase Alkyne Coating of Pharmaceutical Excipients: Discrimination Enhancement of Raman Chemical Imaging for Tablets

“…In the field of pharmaceutical science, the particle size as well as dispersion of active pharmaceutical ingredients (APIs) or excipients in solid formulations have been reported using chemical imaging. Common methods used to obtain chemical information at a certain point include vibrational spectroscopy such as infrared (IR), 1,2 near-infrared, [3][4][5] Raman, or terahertz 6,7 spectroscopy. Of these methods, Raman chemical imaging appears to be superior in many aspects.…”

Composition limits in granulation with active component in the binder

“…This is the case, for example in pharmaceutical granulation, where a mixture of active pharmaceutical ingredient crystals together with other formulation components (excipients) that act as disintegrants, fillers, and so forth, is granulated by means of a relatively small quantity of a liquid, which can be either water or aqueous solution of a polymer . In this case, it is usually required to add as little binder as is necessary to achieve the desired granule properties and not to over‐granulate the batch . However, there are also situations where the active component of the formulation is contained in the binder or formed from the binder by a chemical reaction, while the primary solid particles simultaneously play the role of a reactant and a carrier or structurant.…”