title: Monitoring blend potency in a tablet press feed frame using near infrared spectroscopy.
abstract: A near-infrared (NIR) probe was installed into the feed frame of a rotary tablet press to monitor API concentration as a function of time. A series of step change experimental trials were completed, where a placebo blend was initially charged into the feed frame, and an active blend was layered above. The compression process was initiated, and process parameters, such as mass throughput rate, and feed frame paddle wheel speed were systematically varied. For the range of mass throughput rates studied, excellent correlations were shown between the NIR signal and weight corrected tablet potency from stratified tablet samples. A similar correlation was demonstrated for higher feed frame paddle wheel speeds. However, for lower feed frame paddle wheel speeds, a bias was observed between weight corrected tablet potency and the NIR signal. This finding suggests that compression process parameters, such as paddle wheel rotational speed and NIR probe location, must be optimized for different tablet press geometries to ensure that the NIR process signal can be related to tablet potency. This emerging application of Process Analytical Technology (PAT) may be used to identify powder segregation events during discharge of powder from an intermediate bulk container (IBC) or as a development tool to further understand powder mixing dynamics occurring within the feed frame. This may also be used as a diagnostic tool for fault detection during tablet compression. Finally, this PAT application may also be integrated with the tablet press control system as a gating or reject device for sub or super-potent tablets or enable Real-Time-Release testing (RTRt) through the continuous monitoring of the potency and homogeneity of powder circulating within the feed frame.
authors.affiliation: Pfizer Inc., Eastern Point Road, Groton, CT 06340, USA. howard.w.ward@pfizer.com
authors.forename: Howard W
authors.initials: HW
authors.lastname: Ward
authors.forename: Daniel O
authors.initials: DO
authors.lastname: Blackwood
authors.forename: Mark
authors.initials: M
authors.lastname: Polizzi
authors.forename: Hugh
authors.initials: H
authors.lastname: Clarke
mesh_terms: D005079:Excipients / Q000737:chemistry*; D004364:Pharmaceutical Preparations / Q000737:chemistry; D011208:Powders; D019265:Spectroscopy, Near-Infrared / Q000379:methods*; D013607:Tablets; D013678:Technology, Pharmaceutical / Q000379:methods*; D013997:Time Factors
chemical_list: D005079:Excipients; D004364:Pharmaceutical Preparations; D011208:Powders; D013607:Tablets