title: Development and evaluation of a novel dissolution apparatus for medicated chewing gum products.
abstract: A novel dissolution apparatus was developed for medicated chewing gum products. A prototype gum product containing phenylpropanolamine hydrochloride (PPA) was used to evaluate the apparatus. The apparatus consists of a conical Teflon base and a rotating, ribbed Teflon plunger suspended in a dissolution vessel. Parameters evaluated were rotation speed, plunger frequency, medium volume, medium type, medium sampling location, number of plunger ribs, and number of gum pieces. Samples were taken over a 20-min period and samples were analyzed by HPLC. Cumulative percentage released-versus-time profiles were obtained for each parameter evaluated. Statistical analysis of the gum product indicated that the only significant differences occurred at the lowest rotation speed and lowest plunger frequencies. A Level A correlation was found between the in vitro release profile for the 20-rpm and 30-cycles/min plunger frequency and the in vivo chew-out study.
authors.affiliation: Department of Pharmaceutics, University of Mississippi, University 38677.
authors.forename: J N
authors.initials: JN
authors.lastname: Rider
authors.forename: E L
authors.initials: EL
authors.lastname: Brunson
authors.forename: W G
authors.initials: WG
authors.lastname: Chambliss
authors.forename: R W
authors.initials: RW
authors.lastname: Cleary
authors.forename: A H
authors.initials: AH
authors.lastname: Hikal
authors.forename: P H
authors.initials: PH
authors.lastname: Rider
authors.forename: L A
authors.initials: LA
authors.lastname: Walker
authors.forename: C M
authors.initials: CM
authors.lastname: Wyandt
authors.forename: A B
authors.initials: AB
authors.lastname: Jones
mesh_terms: D002626:Chemistry, Pharmaceutical / Q000295:instrumentation; D002638:Chewing Gum / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid; D010665:Phenylpropanolamine / Q000032:analysis; D012995:Solubility
chemical_list: D002638:Chewing Gum; D010665:Phenylpropanolamine