CURRENT APPROACHES TO PREPARING PHARMACOPOEIAL ARTICLES REGULATING THE QUALITY OF PARENTERAL AND OPHTHALMIC DRUGS

By using parenteral and ophthalmic drugs presented by liquid dosage forms as an example, the authors propose the approaches to preparing pharmacopoeial articles and normative documents, which are based on the relationship between the physicochemical properties of a formulation (its aggregate state, dispersion), a method of application of a drug, and requirements for its quality. The paper shows the great importance of a number of indicators for controlling the quality of parenteral and ophthalmic drugs, as well as the necessity of complying them with the declared normalizable values of the efficiency and safety of their medical application. It provides a rationale for compiling a list of the major quality indices for liquid dosage forms, normalizable values and pharmaceutical analysis methods and procedures used for their determination, which are included in the pharmacopoeial articles and normative documents.