Muñoz CA, Rodríguez CJE, Lagarto PA, Núñez GR, Gil AJM

Language: Spanish
References: 7
Page: 184-190
PDF size: 85.55 Kb.

ABSTRACT

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 Researcha nd 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 physicalchemical 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.

REFERENCES

1. Vademecum Internacional. [CD-ROM]. 45 ed. Madrid: Medicom; 2004.

2. NUM-ZIT Sulfato de Cinc gotas orales. Laboratorios Master. [citedo 4 Nov 2012]. Available from: http://www.farmaciasahumada.cl/stores/fasa/html

3. Suplemento alimenticio formulado a base de Selenito de Sodio. Sulfato de Cinc y Vitamina E (SELZIVIT). [citado 4 Nov 2012]. Disponible en: http://www.info_comercializadoramd.com

4. The United Stated Pharmacopoeia 24 and National Formulary 19 (USP 24-NF 19). Microbial Limit tests (61) [CD-ROM]. Rockville: The United States Pharmacopeial Convention, Inc; 2001.

5. The United Pharmacopoeia 24 and National Formulary 19 (USP24-NF 19). Antimicrobial effectiveness testing (51) [CD-ROM]. Rockville: The United States Pharmacopeial Convention, Inc; 2001.

6. OECD Guideline for Testing of Chemical 423. Acute Oral Toxicity-Acute Toxic Class Method. Paris: Organization for Economic Cooperation and Development; 2001.

7. Rodríguez Chanfrau JE, Gil Apan JM, Núñez Gomero R. Sulfato de cinc 0.9 % solución. Técnica de fabricante Nº 0502. La Habana, Cuba: CIDEM; 2005.