ORIGINAL ARTICLES   

Minerva Biotecnologica 2007 March;19(1):7-15

Copyright © 2007 EDIZIONI MINERVA MEDICA

language: English

Design and development of oral paediatric reverse water-in-oil microemulsions as carriers for ranitidine hydrochloride

Smola M. ^{1, 2}, Zhao M. ¹, Vandamme T. F. ¹, Sokolowski A. ²

¹ Département de Chimie Bioorganique Faculté de Pharmacie Université Louis Pasteur, Illkirch, France 2 Faculty of Chemical Engineering Wroclaw University of Technology, Wroclaw, Poland

Aim. The main purpose of this study was to prepare an oral paediatric drug delivery system containing ranitidine hydrochloride.
Methods. Due to the existence of several constraints (bitter taste of the drug, necessity to administer orally liquids to children, poor stability of the drug in aqueous solutions) to formulate oral appropriate paediatric formulations, reverse water-in-oil microemulsions have been evaluated as carriers.
Results. The optimum formulation of reverse water-in-oil (w/o) microemulsion containing ranitidine hydrochloride was obtained based on the study of pseudo ternary phase diagrams. The optimum w/o microemulsion consisted of 10% ranitidine hydrochloride, 30.4% Labrafil® M 1944 CS, polysorbate 80 as the surfactant, propylene glycol as the co-surfactant with a surfactant/cosurfactant ratio of 2. The mean droplet size of the aqueous phase in the w/o microemulsion was 200 nm. The influence of other excipients, i.e. sweeteners on the physicochemical properties of the reverse microemulsions was also examined.
Conclusion. The results of the present study will be helpful for the preparation of oral liquid dosage forms of ranitidine hydrochloride with an acceptable taste.