REQUIREMENTS FOR QUALITY OF SUPPOSITORIES AS A DOSAGE FORM IN ACCORDANCE WITH THE WORLD PHARMACOPOEIAS
DOI:
https://doi.org/10.11603/2312-0967.2019.3.10443Keywords:
suppositories, pessaries, quality control, pharmacopoeiasAbstract
The aim of the work. Comparative analysis of the world pharmacopoeias data for definition the indicators and their norms and also methods that determine the quality of suppositories as dosage form.
Materials and methods. Methods of information search, analysis of literary resources, comparison, generalization are used.
Results and discussion. Definition of suppositories as dosage form in the State Pharmacopoeia of Ukraine, State Pharmacopoeias of the Republics of Belarus and Kazakhstan, European and British Pharmacopoeias are given in general pharmacopoeia articles «Drugs for rectal use» and «Drugs for vaginal use» (as pessaries). The US Pharmacopoeia, Japanese Pharmacopoeia, and the State Pharmacopoeia of the Russian Federation contain a description of suppositories in general pharmacopoeia articles on dosage forms. During the analysis established that for the suppositories and pessaries the basic quality indicators: appearance, identification, uniformity of mass, disintegration, dissolution, melting point (for lipophilic bases), content of impurities, quantitative determination, microbiological quality are determined.
Conclusions. The analysis shows some differences of the data of pharmacopoeias regarding the quality control of suppositories and pessaries. This indicates the need to harmonize the requirements of pharmacopoeias for unification of quality control methods of suppositories and pessaries as widely used dosage forms.
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