Child health and development | News | 2007 | Production of zinc tablets and zinc oral solutions - Guidelines for programme managers and pharmaceutical manufacturers

Production of zinc tablets and zinc oral solutions - Guidelines for programme managers and pharmaceutical manufacturers

Print PDF

Guidelines on the production of zinc tablets and oral solutions are now available on-line, to assist policy makers and programme managers in the selection and procurement of quality zinc products for use in the prevention and treatment of diarrhoeal diseases in children below five years old. In fact, zinc supplementation has recently been recommended as an adjunct to oral rehydration salts in the management of diarrhoeal diseases in children under-5 and zinc has been included in the 14th Edition of the WHO Model List of Essential Medicines. There is a need to have a product which contains the recommended dose of zinc (only zinc) and formulations which mask the strong metallic after-taste. Zinc sulphate tablets and zinc oral solutions should be manufactured according to the principles of Good Manufacturing Practices (GMP) and comply with the specifications described in the relevant pharmacopeial monographs.

The guidelines focus on zinc sulphate as this is the most widely used zinc salt, other forms including zinc gluconate or zinc acetate, all water-soluble zinc salts. The guidelines describe the specifications for tablets and oral solutions, the evaluation of their acceptability, product formulation and production, registration, quality assurance and inclusion in the National Essential Medicine List, which guides the selection of medicines for procurement and standard treatment guidelines.