title: Real-time imaging as an emerging process analytical technology tool for monitoring of fluid bed coating process.
abstract: A direct imaging system (EyeconTM) was used as a Process Analytical Technology (PAT) tool to monitor fluid bed coating process. EyeconTMgenerated real-time onscreen images, particle size and shape information of two identically manufactured laboratory-scale batches. EyeconTMhas accuracy of measuring the particle size increase of ±1 μm on particles in the size range of 50-3000 μm. EyeconTMcaptured data every 2 s during the entire process. The moving average of D90 particle size values recorded by EyeconTMwere calculated for every 30 min to calculate the radial coating thickness of coated particles. After the completion of coating process, the radial coating thickness was found to be 11.3 and 9.11 μm, with a standard deviation of ±0.68 and 1.8 μm for Batch 1 and Batch 2, respectively. The coating thickness was also correlated with percent weight build-up by gel permeation chromatography (GPC) and dissolution. GPC indicated weight build-up of 10.6% and 9.27% for Batch 1 and Batch 2, respectively. In conclusion, weight build-up of 10% can also be correlated with 10 ± 2 μm increase in the coating thickness of pellets, indicating the potential applicability of real-time imaging as an endpoint determination tool for fluid bed coating process.
authors.affiliation: a Pharma Research Department , Wockhardt Research Centre , Aurangabad , Maharashtra , India.
authors.forename: Venkata Ramana
authors.initials: VR
authors.lastname: Naidu
authors.affiliation: a Pharma Research Department , Wockhardt Research Centre , Aurangabad , Maharashtra , India.
authors.forename: Rucha S
authors.initials: RS
authors.lastname: Deshpande
authors.affiliation: a Pharma Research Department , Wockhardt Research Centre , Aurangabad , Maharashtra , India.
authors.forename: Moinuddin R
authors.initials: MR
authors.lastname: Syed
authors.affiliation: b Department of Chemical Technology , Dr. Babasaheb Ambedkar Marathwada University , Aurangabad , Maharashtra , India.
authors.forename: Pravin S
authors.initials: PS
authors.lastname: Wakte
mesh_terms: D002850:Chromatography, Gel; D004339:Drug Compounding / Q000295:instrumentation / Q000379:methods*; D004867:Equipment Design; D005079:Excipients / Q000737:chemistry; D061848:Optical Imaging / Q000295:instrumentation / Q000379:methods*; D010316:Particle Size; D004364:Pharmaceutical Preparations / Q000737:chemistry; D013607:Tablets / Q000737:chemistry*
chemical_list: D005079:Excipients; D004364:Pharmaceutical Preparations; D013607:Tablets
keywords: EyeconTM; Fluid bed coating; pellet size and shape; process analytical technology; quality by design; real-time imaging