Development and evaluation of a novel dissolution apparatus for medicated chewing gum products.
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.
Rider
J N
JN
Department of Pharmaceutics, University of Mississippi, University 38677.
Brunson
E L
EL
Chambliss
W G
WG
Cleary
R W
RW
Hikal
A H
AH
Rider
P H
PH
Walker
L A
LA
Wyandt
C M
CM
Jones
A B
AB
D002626:Chemistry, Pharmaceutical / Q000295:instrumentation; D002638:Chewing Gum / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid; D010665:Phenylpropanolamine / Q000032:analysis; D012995:Solubility
D002638:Chewing Gum; D010665:Phenylpropanolamine