title: Predicting the dissolution behavior of pharmaceutical tablets with NIR chemical imaging.
abstract: Near infrared chemical imaging (NIRCI) is a common analytical non-destructive technique for the analysis of pharmaceutical tablets. This powerful process analytical technology provides opportunity to chemically understand the sample, and also to determine spatial distribution and size of ingredients in a tablet. NIRCI has been used to link disintegrant, excipients and active pharmaceutical ingredient (API) to tablet dissolution, as disintegrants play an important role in tablet disintegration, resulting in API dissolution. This article describes a specific methodology to predict API dissolution based on disintegrant chemical information obtained with NIRCI. First, several tablet batches with different disintegrant characteristics were produced. Then, NIRCI was successfully used to provide chemical images of pharmaceutical tablets. A PLS regression model successfully predicted dissolution profiles. These results show that NIRCI is a robust and versatile technique for measuring disintegrant properties in tablet formulations and predicting their effects on dissolution profiles. Thus, NIRCI could routinely complement and eventually replace dissolution testing by monitoring a critical material attribute: disintegrant content.
authors.affiliation: Pfizer Industrial Research Chair on Process Analytical Technology in Pharmaceutical Engineering, Department of Chemical & Biotechnological Engineering, Université de Sherbrooke, Sherbrooke, Quebec, Canada; Faculty of Pharmacy, Université Montpellier I, France.
authors.forename: Ketsia
authors.initials: K
authors.lastname: Yekpe
authors.affiliation: Pfizer Industrial Research Chair on Process Analytical Technology in Pharmaceutical Engineering, Department of Chemical & Biotechnological Engineering, Université de Sherbrooke, Sherbrooke, Quebec, Canada. Electronic address: nicolas.abatzoglou@usherbrooke.ca.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Abatzoglou
authors.affiliation: Faculty of Pharmacy, Université Montpellier I, France.
authors.forename: Bernard
authors.initials: B
authors.lastname: Bataille
authors.affiliation: Pfizer Industrial Research Chair on Process Analytical Technology in Pharmaceutical Engineering, Department of Chemical & Biotechnological Engineering, Université de Sherbrooke, Sherbrooke, Quebec, Canada.
authors.forename: Ryan
authors.initials: R
authors.lastname: Gosselin
authors.affiliation: Faculty of Pharmacy, Université Montpellier I, France.
authors.forename: Tahmer
authors.initials: T
authors.lastname: Sharkawi
authors.affiliation: Pfizer Industrial Research Chair on Process Analytical Technology in Pharmaceutical Engineering, Department of Chemical & Biotechnological Engineering, Université de Sherbrooke, Sherbrooke, Quebec, Canada; Process Analytical Science Group, Pfizer, Saint-Laurent, Quebec, Canada.
authors.forename: Jean-Sébastien
authors.initials: JS
authors.lastname: Simard
authors.affiliation: Pfizer Industrial Research Chair on Process Analytical Technology in Pharmaceutical Engineering, Department of Chemical & Biotechnological Engineering, Université de Sherbrooke, Sherbrooke, Quebec, Canada; Process Analytical Science Group, Pfizer, Saint-Laurent, Quebec, Canada.
authors.forename: Antoine
authors.initials: A
authors.lastname: Cournoyer
mesh_terms: D002482:Cellulose / Q000737:chemistry; D065546:Drug Liberation; D007052:Ibuprofen / Q000737:chemistry; D016018:Least-Squares Analysis; D011205:Povidone / Q000737:chemistry; D012995:Solubility; D019265:Spectroscopy, Near-Infrared / Q000379:methods*; D013607:Tablets / Q000737:chemistry*
chemical_list: D013607:Tablets; D002482:Cellulose; D011205:Povidone; C109691:microcrystalline cellulose; D007052:Ibuprofen
keywords: Disintegrant; Dissolution testing; Kollidon CL; Multivariate data analysis; Near infrared chemical imaging; Quality by design