FIELD: chemical-pharmaceutical industry and technology. SUBSTANCE: invention relates to pharmaceutical composition for making sustained-release tablets, in part, for sublingual use and to methods of their making. Pharmaceutical composition has 98.1-99.8 wt.-% of nonagglomerated drug particles covered by polymeric envelope (microcapsules) including 97.6-99 wt.-% of drug and 1-2.4 wt.-% of film-forming substance, 0.1-1.0 wt.-% of lubricating agent and 0.1-0.9 wt.-% of water. Raising agent that is a drug taken in the amount 0.1-10 wt. -% of obtained mixture mass is added to the composition. Method of preparing the composition involves preliminary preparing crystals covered by polymeric envelope (microcapsules) by application on nonagglomerated drug particles consisting of binding agent and addition of lubricating and raising components. In the process of making microcapsules and/or their intermediate storage the moisture content in envelope is 0.5 wt.-%, not above, and before addition of lubricating and raising components microcapsules are wetted with water to concentration 0.1-0.9 wt.-%. Prepared composition can be controlled by degradation time being without use of additional accessory substances. EFFECT: improved method of preparing. 8 cl, 8 tbl, 4 ex
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Authors
Dates
2001-08-10—Published
2000-11-28—Filed