Affiliation:
1. Scientific Centre for Expert Evaluation of Medicinal Products
Abstract
Sea water and sea salt obtained from it are widely used as substances in the production of medicinal products. Complex chemical composition of sea water which contains various salts, calls for the development of a common quality standard for sea water-based medicines. The aim of the study was to analyse and summarise available data on the sources of sea water-based medicines, and on the current test methods, as well as to develop a unified approach to quality control. The paper summarises information on the use of sea water for medical purposes. It presents comparative data on the chemical composition of sea water obtained from different sources, manufacturing technologies of sea water-based medicines, and composition of medicines produced from sea water or sea salt. The paper summarises data on the use of sea water for the production of various dosage forms: drops, sprays, aerosols. The study revealed qualitative and quantitative differences in the content of major cations and anions in drug products. The authors analysed the use of various chemical and physico-chemical test methods for qualitative and quantitative characterisation of medicines. It was concluded that there is a need to harmonise quality control methods for sea water-based medicines.
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