Actual Questions of Standartization of Gas-Forming Solid Medical Forms

Gas-forming (effervescent) solid medical forms may be submitted in the form of powders, granules and tablets. The analysis of effervescent range of medicines, registered in Russian Federation has shown that at present the domestic phapmaceutical market is represented by 64 items of effervescent medicines, of which 63 are the tablets and and one form is granules. It should be noted that almost all of them are made abroad.

The analysis of the requirements for the quality of gas-forming solid medical forms has shown that they do not always reflect specificity of structure and technology of this category of medical forms.

Offered specific qualities that could be recommended for inclusion in regulatory documentation for effervescent medicines, namely: solubility, in minutes, organoleptic properties of the water solution, dissolution time, pH of 1 % water solution, residual moisture.

These quality indicators can be presented in the relevant sections of the State Pharmacopoeia of 12 edirions, containing general pharmacopoeial articles «Tablets», «Powders», «Granules» and used in the design and quality control of solid effervescent medicines.