3,5,3′-triiodothyronine sulfate as thyromimetic agent and pharmaceutical formulations thereof

摘要

The invention regards the use of triiodothyronine sulfate, commonly named T3S, as a medicament having thyromimetic activity for the treatment of pathologies due to organic deficiency of triiodothyronine (T3), as such or in association with thyroxine (T4), and pharmaceutical formulations for oral administration thereof.

主权项

1. A stable solid oral dosage composition comprising T3S as the active principle, in a quantity ranging from 1 to 1000 μg further comprising:
a) a diluent present at an amount from 50% to 99.99% by weight consisting of:
at least one alkaline inorganic salt selected from the group consisting of: trisodium phosphate, tri-calcium phosphate, calcium sulphate, calcium carbonate and magnesium carbonate, wherein said alkaline inorganic salt is present at an amount up to 35% of the total diluent w/w andmicrocrystalline cellulose of the alpha type; b) at least one disintegrant selected from the group consisting of: croscarmellose or salts thereof, crospovidone or salts thereof, polymethacrylates and maltodextrin or salts thereof; c) at least one glidant selected from the group consisting of: glycerol dibehenate silica derivatives, talc, and magnesium trisilicate; and d) at least one lubricant selected from the group consisting of silicates, hydrate silicon dioxide, hydrate colloidal silica; magnesium stearate; and zinc stearate.