Towards Real Time Release testing: Dissolution prediction of tablets made using Continuous Direct Compression
21st November 2017 | 9AM EST | Pallavi Pawar of GlaxoSmithKline |WATCH FOR FREE
After 50 years of near-stagnation, pharmaceutical manufacturing is experiencing unprecedented scientific and technological innovation. There is a paradigm shift from testing product quality using lengthy off-line (and after-the-fact) assays to quality being tested during the process using online/ at-line measurements. This ability to evaluate and ensure quality of final product based on process data, geared towards making batch release decisions, is known as real time release testing (RTRt). A case study for predicting dissolution profiles of tablets made using CDC is presented. The methodology enables real-time release testing. Four different parameters were varied in the CDC line; API concentration, blender speed, feed frame speed, and compaction force, and their effect on tablet dissolution was investigated. Model dependent and model independent approaches were used to extract information from dissolution profiles. Multivariate regression was built between the information obtained from the NIR as the predictor variables and the dissolution profile parameters as the response. This enabled prediction of dissolution profiles for test samples made using CDC. Alternative RTRt approaches towards dissolution prediction will also be discussed.
Presented by Pallavi Pawar PhD, GlaxoSmithKline
Dr. Pallavi Pawar has been working as an Investigator (Pharma RnD) in the Product and Process Engineering team at GlaxoSmithKline (GSK) since September 2016. She supports the progression of GSK’s New Chemical Entity (NCE) portfolio by developing robust continuous formulation processes using state of the art technology, modeling, and statistical experimental design techniques. She works primarily in R&D labs, and as project advances through development, she is responsible for scale-up, culminating in tech transfer to commercial manufacturing facilities. She received her Ph.D. in Chemical Engineering from Rutgers University in May 2016 under the guidance of Dr. Fernando Muzzio. Her thesis focused on ‘Tools for Real Time Release Testing (Rtrt) In Batch and Continuous Tablet Manufacturing’. In it, she investigated non-destructive methods like Near IR spectroscopy to predict process and product performance, blend and content uniformity, hardness and dissolution of tablets, and compared this approach to traditional testing in both batch and continuous manufacturing mode. Her expertise is in powder handling, material characterization, and powder processing geared towards direct compaction of tablets. She has worked with batch and continuous unit operations including powder mixing, powder feeding, twin screw granulation, fluid bed drying, milling, and tablet compaction. She completed her Bachelor’s degree in Chemical Technology from Institute of Chemical Technology (UDCT), Mumbai in 2010.