Gastric emptying of non-disintegrating solid drug delivery systems in fasted state: relevance to drug dissolution.
BACKGROUND
Knowledge of gastric emptying (GE) of solid drug delivery systems (DDS) is meaningful for the development of new DDS as it enables the design of in vitro dissolution experiments with conditions close to those in vivo in order to predict drug plasma concentration profiles with high reliability.


METHODS
Gastric emptying of non-disintegrating pellets, tablets and mini-tablets in the fasted state is described on the basis of various studies performed in the last 30 years, which have evaluated the emptying process mostly by gamma scintigraphy. Different influences on GE and mathematical models describing GE kinetics of single and multiunit dosage forms are represented. A discussion on the implementation of these data in the development of drug dissolution testing procedures is given.


RESULTS
Readers will gain an insight into the kinetics and mechanisms of GE processes. Some suggestions on the use of the obtained knowledge in biopharmaceutical testing of DDS are also given.


CONCLUSIONS
Gastric emptying of non-disintegrating solid DDS is a very important process, which might influence drug dissolution, bioavailability and the plasma concentration profile. It is reasonable to consider this process in biopharmaceutical testing of these DDS.
Locatelli
Igor
I
University of Ljubljana, Faculty of Pharmacy, Askerceva cesta 7, SI-1000 Ljubljana, Slovenia.
Nagelj Kovacic
Natasa
N
Mrhar
Ales
A
Bogataj
Marija
M
D004304:Dosage Forms; D016503:Drug Delivery Systems; D005215:Fasting; D005746:Gastric Emptying; D006801:Humans; D012995:Solubility; D013607:Tablets / Q000008:administration & dosage
D004304:Dosage Forms; D013607:Tablets