title: Process development for spray drying of sticky pharmaceuticals; case study of bioadhesive nicotine microparticles for compressed medicated chewing gum.
abstract: Spray drying of pharmaceutical compounds with sticky properties is a challenging task and may require substantial time and resources. By including small-scale studies of single droplet drying kinetics a relatively high number of experiments with less material is allowed. This means one can construct a more robust design space according to Quality by Design (QbD) formulation development principles. In the current study we present a case study on the development of spray dried microparticles comprising nicotine bitartrate and hypromellose or alginate polymer, for incorporation into medicated chewing gum. By illustration of initial studies on single droplet drying kinetics, subsequent characterization of microparticles, and final characterization of compressed chewing gum this paper summarizes the entire development process.
authors.affiliation: Department of Pharmacy, Faculty of Health and Medical Sciences, University of Copenhagen, Universitetsparken 2, 2100 Copenhagen, Denmark.
authors.forename: Camilla
authors.initials: C
authors.lastname: Sander
authors.forename: Henrik Stillhof
authors.initials: HS
authors.lastname: Nielsen
authors.forename: Susanne Roslev
authors.initials: SR
authors.lastname: Søgaard
authors.forename: Celina
authors.initials: C
authors.lastname: Støving
authors.forename: Mingshi
authors.initials: M
authors.lastname: Yang
authors.forename: Jette
authors.initials: J
authors.lastname: Jacobsen
authors.forename: Jukka
authors.initials: J
authors.lastname: Rantanen
mesh_terms: D000464:Alginates / Q000737:chemistry; D002638:Chewing Gum; D003890:Desiccation / Q000379:methods; D016503:Drug Delivery Systems; D020723:Glucuronic Acid / Q000737:chemistry; D006603:Hexuronic Acids / Q000737:chemistry; D065347:Hypromellose Derivatives; D008353:Mannitol / Q000737:chemistry; D008747:Methylcellulose / Q000031:analogs & derivatives / Q000737:chemistry; D009538:Nicotine / Q000737:chemistry*; D013678:Technology, Pharmaceutical / Q000379:methods*
chemical_list: D000464:Alginates; D002638:Chewing Gum; D006603:Hexuronic Acids; D065347:Hypromellose Derivatives; D008353:Mannitol; D009538:Nicotine; D020723:Glucuronic Acid; D008747:Methylcellulose