[Preparation of ondansetron hydrochloride osmotic pump tablets and their in vitro drug release].
OBJECTIVE
To prepare ondansetron hydrochloride osmotic pump tablets (OND-OPT) and investigate their in vitro drug release behavior.


METHODS
OND-OPT were prepared with a single punch press and pan coating technique. Osmotic active agents and plasticizer of coating film were chosen by drug release tests. The effects of the number, position and direction of drug release orifice on release behavior were investigated. The relation between drug release duration and thickness of coating film, PEG content of coating film and size of drug release orifice was established by uniform design experiment. The surface morphological change of coating film before and after drug release test was observed by scanning electron microscopy. The osmotic pumping release mechanism of OND-OPT was confirmed by drug release test with high osmotic pressure medium.


RESULTS
Lactose-mannitol (1:2) was chosen as osmotic active agents and PEG400 as plasticizer of coating film. The direction of drug release orifice had great effect on the drug release of OND-OPT without HPMC, and had no effect on the drug release of OND-OPT with HPMC. The OND-OPT with one drug release orifice at the centre of the coating film on one surface of tablet released their drug with little fluctuation. The drug release duration of OND-OPT correlated with thickness of coating film and PEG content of coating film, and didn't correlate significantly with the size of drug release orifice. OND-OPT released their drug with osmotic pumping mechanism predominantly.


CONCLUSIONS
OND-OPT are able to realize ideal controlled drug release.
Zheng
Hang-sheng
HS
Department of Pharmaceutics, School of Pharmacy, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China. henderson2000@163.com
Bi
Dian-zhou
DZ
D000932:Antiemetics / Q000737:chemistry*; D003692:Delayed-Action Preparations; D004337:Drug Carriers; D016503:Drug Delivery Systems; D065347:Hypromellose Derivatives; D007785:Lactose; D008353:Mannitol; D008747:Methylcellulose / Q000031:analogs & derivatives; D017294:Ondansetron / Q000737:chemistry*; D009997:Osmotic Pressure; D011092:Polyethylene Glycols; D012995:Solubility; D013607:Tablets; D047392:beta-Cyclodextrins
D000932:Antiemetics; D003692:Delayed-Action Preparations; D004337:Drug Carriers; D013607:Tablets; D047392:beta-Cyclodextrins; D065347:Hypromellose Derivatives; D008353:Mannitol; D011092:Polyethylene Glycols; D017294:Ondansetron; D008747:Methylcellulose; D007785:Lactose