title: In-line non-invasive turbidimetry as a tool to ensure content uniformity in the betamethasone filling process.
abstract: The filling process of liquid suspensions is a difficult operation,mainly due to drug settling. Small variations during the process may lead to serious deviations in the API content uniformity of the finished product, particularly if the drug settles fast. Real-time non-invasive monitoring of liquid suspensions is a useful approach to ensure an acceptable API content in the finished product. The aim of this study was to develop a method based on non-invasive turbidity measurements for in-line determinations of betamethasone content uniformity during the filling process of injections. Owing to the constructive features of the developed system, the determinations were performed in a non-destructive and non-invasive way, thus allowing the analysis of the whole batch and minimizing the risk of contaminating the product. The results obtained by the method proposed in this study demonstrated that non-invasive turbidimetry is a powerful tool for continuous monitoring of the filling process of betamethasone injections, within the Quality by Design framework (FDA, 2009).
authors.affiliation: Departamento de Investigación y Desarrollo, Hitec S.R.L., San Blas 2655, C1416EFU Buenos Aires, Argentina; Departamento de Química, Facultad de Ingeniería, Universidad de Buenos Aires, Paseo Colón 850, C1063ACV Buenos Aires, Argentina. Electronic address: cmuzzio@fi.uba.ar.
authors.forename: Cristian R
authors.initials: CR
authors.lastname: Muzzio
authors.affiliation: Departamento de Investigación y Desarrollo, Hitec S.R.L., San Blas 2655, C1416EFU Buenos Aires, Argentina.
authors.forename: Martín A
authors.initials: MA
authors.lastname: Tomé
authors.affiliation: Departamento de Investigación y Desarrollo, Hitec S.R.L., San Blas 2655, C1416EFU Buenos Aires, Argentina.
authors.forename: Rodolfo J
authors.initials: RJ
authors.lastname: Díaz
authors.affiliation: Departamento de Investigación y Desarrollo, Química Montpellier S.A., Virrey Liniers 673, C1220AAC Buenos Aires, Argentina.
authors.forename: Germán C Fernández
authors.initials: GC
authors.lastname: Otero
authors.affiliation: Departamento de Investigación y Desarrollo, Química Montpellier S.A., Virrey Liniers 673, C1220AAC Buenos Aires, Argentina.
authors.forename: Pablo C
authors.initials: PC
authors.lastname: Campiutti
authors.affiliation: Departamento de Investigación y Desarrollo, Química Montpellier S.A., Virrey Liniers 673, C1220AAC Buenos Aires, Argentina.
authors.forename: Héctor L
authors.initials: HL
authors.lastname: Cuevas
authors.affiliation: Departamento de Investigación y Desarrollo, Hitec S.R.L., San Blas 2655, C1416EFU Buenos Aires, Argentina.
authors.forename: Nicolás G
authors.initials: NG
authors.lastname: Dini
mesh_terms: D001623:Betamethasone / Q000737:chemistry*; D004339:Drug Compounding / Q000379:methods*; D009391:Nephelometry and Turbidimetry; D010316:Particle Size; D011786:Quality Control; D013535:Suspensions
chemical_list: D013535:Suspensions; D001623:Betamethasone
keywords: Content uniformity; In-line; Injectables; Process analytical technology; Suspensions; Turbidimetry