Dosage form containing two or more active pharmaceutical ingredients in different physical forms

摘要

A dosage form for administration of two or more active pharmaceutical ingredients to a subject, comprising a first pharmaceutical composition comprising a first active pharmaceutical ingredient and optionally one or more pharmaceutically acceptable excipients in a first physical form selected from the group consisting of powder, granule, pellet, bead or mini-tablet form, and at least a second pharmaceutical composition comprising a second active pharmaceutical ingredient and optionally one or more pharmaceutically acceptable excipients in a second physical form selected from the group consisting of granule, pellet, bead, mini-tablet or tablet form, wherein the composition is characterized in that said first and second physical forms are selected to be different to minimize interactions between said first and second pharmaceutical compositions and to allow separation of said first and second pharmaceutical compositions for analysis on the basis of size difference.

主权项

1. A dosage form for administration of two active pharmaceutical ingredients to a subject, said dosage form consisting essentially of a first pharmaceutical composition comprising a first active pharmaceutical ingredient and optionally one or more pharmaceutically acceptable excipients in a first physical form selected from the group consisting of powder, granule, pellet, bead or mini-tablet form, and a second pharmaceutical composition comprising a second active pharmaceutical ingredient and optionally one or more pharmaceutically acceptable excipients in a second physical form physically separate from the first physical form within the dosage form selected from the group consisting of granule, pellet, bead, mini-tablet or tablet form,
wherein the first active pharmaceutical ingredient is fluoxetine or a pharmaceutically acceptable salt thereof and the second active pharmaceutical ingredient is olanzapine or a pharmaceutically acceptable salt thereof, and wherein said first and second physical forms are selected to be different to minimize formation of impurities between said first and second pharmaceutical compositions and to allow separation of said first and second pharmaceutical compositions for analysis on the basis of size difference.