Pharmaceutical compositions containing tadalafil and cyclodextrin

摘要

1. A solid pharmaceutical composition comprising a co-granulate of tadalafil with beta-cyclodextrin in a molar ratio greater than 1: 1 and at least one pharmaceutically acceptable extragranular ekstsipient.2. The composition of claim 1 wherein the extragranular excipient is a disintegrant, preferably croscarmellose natriya.3. A composition according to claim 2, wherein the amount of disintegrant is from 1 to 5 wt.% Of the total weight kompozitsii.4. A composition according to claims 1-3, wherein the starting substance tadalafil Cialis fraction comprises particles having a particle size d (0,9) 40 mikron.5. A composition according to claim 1, wherein the relative amount of the co-granulate tadalafil / beta-cyclodextrin in the composition is from about 30 to about 80 wt.%, Preferably from about 40 to about 60 wt.% Of the total weight kompozitsii.6. The composition of claim 1 wherein the co-granulate contains at least one other intragranular ekstsipient.7. A composition according to claim 6 wherein the intragranular excipient is solyubilizator.8. A composition according to claim 1, wherein the molar ratio between tadalafil and beta-cyclodextrin is less than 1: 8.9. A composition according to claim 8, wherein the molar ratio between tadalafil and beta-cyclodextrin is about 1: 1.25, 1: 1.3, 1: 1.5, 1: 2, 1: 2.5, 1: 3.10. Compressed tablet for oral administration of tadalafil, comprising a dosage amount of the composition according to any one pp.1-9.11. A tablet according to claim 10, comprising from 1 to 50 mg tadalafila.12. A tablet according to claim 10, wherein the dissolution rate of at least about 75 wt.% In about 15 minutes when tested by a paddle stirrer Ph. Eur. in 1000 mL aqueous medium containing 0.35% laurilsul