title: Reflectance infrared spectroscopy for in-line monitoring of nicotine during a coating process for an oral thin film.
abstract: A process analytical method using reflectance infrared spectrometry was developed for the in-line monitoring of the amount of the active pharmaceutical ingredient (API) nicotine during a coating process for an oral thin film (OTF). In-line measurements were made using a reflectance infrared (RI) sensor positioned after the last drying zone of the coating line. Real-time spectra from the coating process were used for modelling the nicotine content. Partial least squares (PLS1) calibration models with different data pre-treatments were generated. The calibration model with the most comparable standard error of calibration (SEC) and the standard error of cross validation (SECV) was selected for an external validation run on the production coating line with an independent laminate. Good correlations could be obtained between values estimated from the reflectance infrared data and the reference HPLC test method, respectively. With in-line measurements it was possible to allow real-time adjustments during the production process to keep product specifications within predefined limits hence avoiding loss of material and batch.
authors.affiliation: LTS Lohmann Therapie-Systeme AG, Andernach, Germany; Department of Pharmaceutics and Biopharmacy, Philipps University Marburg, Germany. Electronic address: Florian.Hammes@ltslohmann.de.
authors.forename: Florian
authors.initials: F
authors.lastname: Hammes
authors.affiliation: LTS Lohmann Therapie-Systeme AG, Andernach, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Hille
authors.affiliation: Department of Pharmaceutics and Biopharmacy, Philipps University Marburg, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Kissel
mesh_terms: D002138:Calibration; D004304:Dosage Forms; D004339:Drug Compounding / Q000379:methods; D016018:Least-Squares Analysis; D009538:Nicotine / Q000737:chemistry*; D019265:Spectroscopy, Near-Infrared
chemical_list: D004304:Dosage Forms; D009538:Nicotine
keywords: Active pharmaceutical ingredient (API) determination; In-line monitoring; Oral thin film (OTF); Process analytical technology (PAT); Reflectance infrared spectroscopy