The modern requirements evaluation of leading world Pharmacopeias to eye drugs quality

L. M. Andryukova, E. G. Fetisova, S. V. Rusanova, V. K. Yakovenko, O. V. Dorovskyy


The whole system of drug quality standards is based on the national Pharmacopoeias, which regulate the basic requirements to quality of the certain dosage form, including ophthalmic drugs. The development of pharmaceutical science requires constant improvement and updating of drug quality standards. Among a number of other measures, this is ensured by introducing the necessary innovations and changes in existing national Pharmacopoeias. Recently, the general article for ophthalmic drugs included at the list of reviewed articles by leading world Pharmacopoeias.

Aim. Research and modern changes evaluation of the quality requirements to ophthalmic dosage form in Pharmacopeias of Ukraine, Europe andUSA compared to their previous versions.

Results. At the article is shown that in recent years there have been no significant changes in the European Pharmacopoeia general article for eye drugs; the changes in the State Pharmacopoeia of Ukraine general article for eye drugs concerned the national part; and more significant changes in the monographs associated with eye drugs occurred in United States Pharmacopeia (USP) that are bound with the structure improvement of the general article for pharmaceutical dosage form and, as a consequence, the introduction of the new separate general articles for ophthalmic drugs. The updated general article includes: the description and the routes of administration of ophthalmic products; all dosage forms that can be applied in the eye from the traditionally used to new that have emerged due to the development and improvement of modern technologies of ophthalmic drugs; quality and efficacy in vitro indexes of ophthalmic drugs.

Conclusions. The leading world Pharmacopoeias are not hardened dogmas. They constantly undergo modernization and improvement, taking into account the current level of knowledge, including the structure and the function of the human eye so as the new ophthalmic dosage forms, and make appropriate changes to the quality requirements. More detailed specification of the quality indexes of ophthalmic dosage forms with the acceptance criteria are given in USP, which enables developers to create the products that will allow patients to receive safe, effective and quality drugs. It has been expressed a view to take into account such changes in the national part of the domestic Pharmacopoeia.


dosage form; ophthalmic drugs; quality; quality indexes; State Pharmacopoeia of Ukraine; European Pharmacopoeia; United States Pharmacopeia


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