Prospects of standardization of inhalation medicinal forms in Russia

The spectrum of inhalation preparations constantly extends, in this connection such questions as increase of their quality, harmonization of requirements to domestic and import manufacturers and introduction of modern tool methods of standardization are extremely actual. Now the standard documentation regulating quality of preparations sometimes comprises superfluous quantity of indicators as manufacturers are compelled to fulfill requirements of OST 91500.05.001-00, SF XI and to follow own specifications broadcast from the European Pharmacopoeia, the Pharmacopoeia of the USA and so forth. Thus standard requirements to the inhalation preparations, "Aerosols" stated in the general article SF XI, no less than in OST, have currently become outdated and demand revision for the purpose of increase of a degree of quality and harmonization with leading foreign pharmacopoeias. In the review a quality monitoring of preparations for inhalations of domestic and import manufacture is considered, tendencies of development of standardization of the designated group of preparations are described. For inclusion in the State Pharmacopoeia of XII edition the general article «Medicinal forms for inhalations» is developed.