Pharmaceutical Composition Comprising Lumateperone

    公开(公告)号:US20240374527A1

    公开(公告)日:2024-11-14

    申请号:US18655810

    申请日:2024-05-06

    Abstract: The present invention relates to a pharmaceutical composition for oral administration comprising: a) about 5% w/w to about 40% w/w of lumateperone or pharmaceutically acceptable salt thereof; b) about 50% w/w to about 95% w/w of at least one diluent; c) about 1% w/w to about 10% w/w of at least one disintegrant; d) about 0.1% w/w to about 2% w/w of at least one glidant; and e) about 0.5% w/w to about 5% w/w of a lubricant selected from the group consisting of sodium stearyl fumarate, stearic acid, and combinations thereof, wherein the amount of nitrosamine impurity after exposure of the pharmaceutical composition to 40° C./75% RH for a period of six months is less than the FDA acceptable intake limit of the nitrosamine impurity based on maximum daily dose of lumateperone.

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