Taste masked active pharmaceutical powder compositions and processes for making them

摘要

A taste masked particulate pharmaceutical formulation include a core that comprises an active pharmaceutical ingredient; at least a partial nanoparticle material layer on the core that comprises a nanoparticle material with a median particle size not greater than 100 nm; a first polymer layer that is at least partially water soluble and a second polymer layer that is water insoluble. The active pharmaceutical ingredient is completely released in 30 minutes in the USP Dissolution Test. A process of making the particulate pharmaceutical formulation using sequential fluidized bed coating steps under controlled conditions is also described.

主权项

1. A process for preparing a taste masked particulate pharmaceutical formulation from core particles that comprise an active pharmaceutical ingredient and at least a partial coating of nanoparticle material that has a median particle size not greater than 100 nm, comprising steps of:
1) coating the core particles in a fluidized bed with a first polymer layer; and 2) coating the first polymer layer of the core particles with a water insoluble second polymer layer in a fluidized bed in the presence of a nanoparticle material with a median particle size not greater than 100 nm; andwherein the first polymer layer is at least partially water soluble.