Elution-stabilized preparation

摘要

The invention provides a solid preparation which does not undergo the delay of elution of the active ingredient even after long-term storage. The solid preparation independently contains a teneligliptin-containing part containing teneligliptin or a salt thereof, or a solvate of teneligliptin or the salt thereof, in an amount 1.5- to 10-fold larger than that desired for the solid preparation.

主权项

1. A teneligliptin-containing solid preparation comprising (i) a teneligliptin-containing part containing teneligliptin hydrobromide hydrate, and (ii) a part other than the teneligliptin-containing part that does not comprise teneligliptin hydrobromide hydrate,
wherein the content of teneligliptin hydrobromide hydrate in the teneligliptin-containing part is 30 to 80 wt %, the part other than the teneligliptin-containing part comprises an excipient with a volume average particle diameter of 50 μm to 500 μm, and the teneligliptin-containing part is particulate or granular and discrete particles or granules of the teneligliptin-containing part are dispersed throughout the part other than the teneligliptin-containing part.