METHOD FOR STORING LINAGLIPTIN HYDRATE-CONTAINING FORMULATION, LINAGLIPTIN HYDRATE-CONTAINING FORMULATION STORED BY THE SAME, AND EVALUATION METHOD
To provide methods for storing a linagliptin hydrate-containing formulation in which linagliptin hydrate maintains Form C after production, or to provide linagliptin hydrate-containing formulations stored by the storage method, and further to provide methods for evaluating that the linagliptin hydra...
Gespeichert in:
| Hauptverfasser: | , |
|---|---|
| Format: | Patent |
| Sprache: | eng ; jpn |
| Schlagworte: | |
| Online-Zugang: | Volltext bestellen |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| Zusammenfassung: | To provide methods for storing a linagliptin hydrate-containing formulation in which linagliptin hydrate maintains Form C after production, or to provide linagliptin hydrate-containing formulations stored by the storage method, and further to provide methods for evaluating that the linagliptin hydrate contained in the linagliptin hydrate-containing formulation maintains Form C.SOLUTION: According to one embodiment of the present invention, there is provided a method for storing a linagliptin hydrate-containing formulation, which maintains an equilibrium relative humidity of the linagliptin hydrate-containing formulation in terms of 25°C of 10% or more and 45% or less.SELECTED DRAWING: Figure 1
【課題】製造後において、リナグリプチン水和物がＦｏｒｍ Ｃを維持するリナグリプチン水和物含有製剤の保管方法を提供する。または、その保管方法で保管されたリナグリプチン水和物含有製剤を提供する。さらに、リナグリプチン水和物含有製剤に含まれるリナグリプチン水和物がＦｏｒｍ Ｃを維持していることを評価する方法を提供する。【解決手段】本発明の一実施形態によると、本発明の一実施形態によると、リナグリプチン水和物含有製剤の２５℃に換算した平衡相対湿度を、１０％以上４５％以下に維持する、リナグリプチン水和物含有製剤の保管方法が提供される。【選択図】図１ |
|---|