Putting nir to good use in tablet formulation and manufacture

Abstract

According to market research, the global OSD formulation market is anticipated to grow by an annual compound rate of 6.5%, reaching a value of US$926.3 billion (€826 billion) by the end of 2027 (1). In the granulation process stages, a process analytical technology (PAT) approach based on NIR sensors allows for the simultaneous determination of multiple parameters by measuring on-line residual moisture and particle enlargement during all phases of the granulation process by achieving the desired quality attribute phase-by-phase and not at a predetermined time. The major benefits provided by the technique are that it is a fast, non-destructive method allowing users to overcome the issues of a potentially long, drawn-out analysis as well as the small sample size that is commonplace in standard dissolution tests. [...]dissolution can be predicted to a certain level of reliability through calibration model development (e.g., partial least squares) when API content is variable.