Oral Rehydration Salts
Production of the new ORS
Acute diarrhoeal diseases are among the leading causes of mortality in infants and young children in many developing countries. In most cases, death is caused by dehydration. Dehydration from diarrhoea can be prevented by giving extra fluids at home, or it can be treated simply, effectively, and cheaply in all age-groups and in all but the most severe cases by giving patients by mouth an adequate glucose-electrolyte solution called Oral Rehydration Salts (ORS) solution.
Since 2003, WHO and UNICEF are recommending the use of a new ORS formulation of improved effectiveness when compared to the old formulation. A revised monograph for ORS, describing this new formula, was adopted by the WHO Expert Committee on Specifications for Pharmaceutical Preparations at its meeting in October 2005 for inclusion in the fourth edition of The International Pharmacopoeia.
The document entitled "Oral Rehydration Salts - Production of the new ORS", based on the above-mentioned revised monograph, updates an earlier document (WHO/CDD/SER/85.8), and provides information on the manufacture of the new ORS. It has been prepared to assist national authorities in establishing the local manufacture of a product of pharmaceutical quality, in order that they may become self-reliant in meeting the needs of their national diarrhoeal diseases control activities. It is emphasized that the methods recommended in the document are meant to serve as guidelines, and that they need to be adapted to meet local requirements and conditions, provided they follow the principles of Good Manufacturing Practices for pharmaceutical products (WHO Technical Report Series, No 908, 2003).