LAUSR

BACKGROUND In many countries, the hypertension in the pediatric population is considered an important risk of mortality and morbidity. In this sense, it is important to design and develop new pharmaceutical forms for pediatric patients with hypertension. The development of orodispersible mini-tablets (ODMTs) for paediatric use has gained importance within recent years the WHO authorities set up regulations for developing suitable and palatable dosage forms for paediatric patients. OBJECTIVE The aim of this study was to design and develop orodispersible mini tablets of enalapril maleate for pediatric use. METHODS Five pharmaceutical formulations were designed. The effects of different co-processed excipients and active pharmaceuthical ingredient at different doses were study. Lactose co-processed excipients selected were Tablettose® 80, MicroceLac® 100 and StarLac®. The micromeritic properties were evaluated for all the physical mixtures. The mini tablets were obtained by direct compression and quality control parameters were determined in accordance with United States Pharmacopeia. RESULTS Three OMDTs with StarLac® provide good results of hardness, flowability and fast disintegration. One of them, with 0.1 mg of enalapril maleate, showed the best results for the official parameters of hardness (4.0 kp), friability (< 1%), disintegration time (28 s), drug content uniformity (103.6 %) and the best wetting time (23 s). CONCLUSION The orodispersible mini tablets with StarLac® showed good officially quality parameters. One of them showed the best wetting time and doses for pediatric patients. This formulation could be considered eligible to be elaborated on an industrial scale.