Abstract

MUNOZ CERNADA, Adriana et al. Design of formulation of Zinc sulphate 10 mg Zn²⁺/5 mL oral solution for pediatric use. Rev Cubana Farm [online]. 2014, vol.48, n.2, pp. 184-190. ISSN 0034-7515.

Introduction: the zinc sulphate solution is orally administered for pediatric purposes, in prophylaxis and treatment of zinc deficiency resulting from inadequate diet or malabsorption. It is also used in children to manage low weight and height. Objective: design of a formulation of oral zinc sulphate solution at 10 mg Zn²⁺/5 mL for pediatric use. Methods: results of the physical-chemical stability studies, microbiology evaluation and toxicological test were shown for selected formulation. Three pilot scale-up batches and one industrial batch were prepared. The chemical stability under accelerated conditions and shelf-life studies were conducted on the basis of a compleximetric titration with EDTA method developed in the Center of Research and Development of Drugs (CIDEM). Results: a colorless, translucent and sweet liquid formulation, free of foreign matters, was obtained. In the orally administered tolerance test made in rats, no signs of significant toxicity attributable to the administration of the formulation at the study dose were observed. The other parameters evaluated in the physical-chemical stability of the shelf life study proved to be satisfactory. Conclusions: the solution was chemically, physically and microbiologically stable at a temperature of 32 ± 2 ºC for a 24 month period. When comparing the results of the pilot scale-up batch and those of the industrial batch, they were similar. This showed that the developed technology is feasible at industrial scale.

Keywords : zinc sulphate; stability; pharmaceutical solution; compleximetric titration.

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