Pharmaceutical composition for oral administration

摘要

A pharmaceutical composition containing, as the active ingredient, 4-{[(1R,2s,3S,5s,7s)-5-hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide, of which the solubility in an acidic pH region is different from that in a neutral pH region, with rapid disintegration property and rapid drug dissolution property as well as the expectation of a good drug dosing compliance, is provided. The pharmaceutical composition for oral administration of the present invention contains 4-{[(1R,2s,3S,5s,7s)-5-hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide or a pharmaceutically acceptable salt thereof, and a hydrophilic lubricant, and is useful as a pharmaceutical composition for oral administration with rapid disintegration property and rapid drug dissolution property as well as the expectation of a good drug dosing compliance.

主权项

1. A tablet for oral administration, comprising 4-{[(1R,2s,3S,5s,7s)-5-hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide or a pharmaceutically acceptable salt thereof, and a hydrophilic lubricant, wherein the hydrophilic lubricant is one, or two or more selected from the group consisting of sodium stearyl fumarate, polyethylene glycol, and sodium lauryl sulfate, wherein the content of 4-{[(1R,2s,3S,5s,7s)-5-hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide or a pharmaceutically acceptable salt thereof to the tablet for oral administration is about 30% by weight to about 60% by weight, wherein the content of the hydrophilic lubricant to the tablet for oral administration is 1% by weight to 10% by weight, and a hydrophilic substance wherein the hydrophilic substance is a sugar alcohol.