title: PAT-Based Control of Fluid Bed Coating Process Using NIR Spectroscopy to Monitor the Cellulose Coating on Pharmaceutical Pellets.
abstract: Current endeavor was aimed towards monitoring percent weight build-up during functional coating process on drug-layered pellets. Near-infrared (NIR) spectroscopy is an emerging process analytical technology (PAT) tool which was employed here within quality by design (QbD) framework. Samples were withdrawn after spraying every 15-Kg cellulosic coating material during Wurster coating process of drug-loaded pellets. NIR spectra of these samples were acquired using cup spinner assembly of Thermoscientific Antaris II, followed by multivariate analysis using partial least squares (PLS) calibration model. PLS model was built by selecting various absorption regions of NIR spectra for Ethyl cellulose, drug and correlating the absorption values with actual percent weight build up determined by HPLC. The spectral regions of 8971.04 to 8250.77 cm-1, 7515.24 to 7108.33 cm-1, and 5257.00 to 5098.87 cm-1were found to be specific to cellulose, where as the spectral region of 6004.45 to 5844.14 cm-1was found to be specific to drug. The final model gave superb correlation co-efficient value of 0.9994 for calibration and 0.9984 for validation with low root mean square of error (RMSE) values of 0.147 for calibration and 0.371 for validation using 6 factors. The developed correlation between the NIR spectra and cellulose content is useful in precise at-line prediction of functional coat value and can be used for monitoring the Wurster coating process.
authors.affiliation: Wockhardt Research Centre, Aurangabad, Maharashtra, India. VNaidu@wockhardt.com.
authors.forename: Venkata Ramana
authors.initials: VR
authors.lastname: Naidu
authors.affiliation: Wockhardt Research Centre, Aurangabad, Maharashtra, India.
authors.forename: Rucha S
authors.initials: RS
authors.lastname: Deshpande
authors.affiliation: Wockhardt Research Centre, Aurangabad, Maharashtra, India.
authors.forename: Moinuddin R
authors.initials: MR
authors.lastname: Syed
authors.affiliation: Wockhardt Research Centre, Aurangabad, Maharashtra, India.
authors.forename: Piyush
authors.initials: P
authors.lastname: Deoghare
authors.affiliation: Wockhardt Research Centre, Aurangabad, Maharashtra, India.
authors.forename: Dharamvir
authors.initials: D
authors.lastname: Singh
authors.affiliation: Department of Chemical Technology, Dr. Babasaheb Ambedkar Marathwada University Aurangabad, Maharashtra, India.
authors.forename: Pravin S
authors.initials: PS
authors.lastname: Wakte
mesh_terms: D002138:Calibration; D002482:Cellulose / Q000031:analogs & derivatives* / Q000138:chemical synthesis; D004339:Drug Compounding / Q000379:methods*; D004343:Drug Implants / Q000138:chemical synthesis*; D005079:Excipients; D015999:Multivariate Analysis; D019265:Spectroscopy, Near-Infrared / Q000379:methods*
chemical_list: D004343:Drug Implants; D005079:Excipients; C013517:ethyl cellulose; D002482:Cellulose
keywords: NIR spectroscopy; multi-variate model; partial least square regression model; process analytical technology; wurster coating