Suspension for oral administration comprising amorphous tolvaptan
AssigneeOtsuka Pharmaceutical Co., Ltd.
InventorsAkitsuna AKAGI, Kai SUZUKI, Atsuya NAKAMURA, Toru NISHIBAYASHI
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AssigneeOtsuka Pharmaceutical Co., Ltd.
InventorsAkitsuna AKAGI, Kai SUZUKI, Atsuya NAKAMURA, Toru NISHIBAYASHI
Estimating the term…
This invention provides a suspension for oral administration comprising particles containing amorphous tolvaptan that can inhibit or delay crystallization of amorphous tolvaptan over time in the suspension, and stably maintain high solubility of tolvaptan and excellent absorbability of tolvaptan from the gastrointestinal tract; and a solid formulation for oral administration that can be suspended to prepare the suspension for oral administration at the time of use. This invention relates to a suspension for oral administration, in particular, a syrup, comprising (a) particles containing amorphous tolvaptan, (b) hydroxypropyl methylcellulose (HPMC), and (c) a solvent, wherein the amount of the HPMC (b) is 0.1 to 25% by weight based on the total weight of the suspension for oral administration.
A suspension for oral administration, comprising:
A method for producing a suspension for oral administration, the method comprising uniformly dispersing particles containing amorphous tolvaptan in an aqueous suspension containing HPMC or an aqueous solution containing HPMC.
Use of a suspension comprising (a) particles containing amorphous tolvaptan, (b) hydroxypropyl methylcellulose (HPMC), and (c) a solvent for the production of a drug for preventing, reducing, or treating hyponatremia, polycystic kidney disease, body fluid retention in heart failure, or body fluid retention in liver cirrhosis.
Dependencies are inferred from the claim text.