ORALLY DISINTEGRATING TABLETS WITH A HIGH DISSOLUTION RATE ALONG WITH VERY GOOD MECHANICAL PROPERTIES AND PROCESS FOR OBTAINING THEM

摘要

The tablets comprise: at least 59.5% spray-dried mannitol; active ingredient below or equal to 10%, where at least 90% in weight of the active ingredient has a particle size below 100 µm; microcrystalline cellulose 10-18%, with an average particle size of 50 µm and where at least 99% in weight of microcrystalline cellulose has a particle size below 250 µm; sodium croscarmellose 1-4%; and a lubricant agent 0.5-2%; where, unless specified otherwise, the percentages are expressed in weight of the total weight of the tablet. And also a process comprising: sieving and mixing of components except for the lubricant agent; mixing of all components; and direct compression of the final mixture. The tablets of the invention give lower disintegration times as well as good perception on the tongue after disintegration, and overcome the problem of insufficient mechanical resistance for packaging and transport operations.