Physically and chemically stable nicotine-containing particulate material

摘要

A nicotine-containing particulate material for release of nicotine, the material comprising a combination of nicotine or a pharmaceutically acceptable salt, complex or solvate thereof and a microcrystalline cellulose. The particulate material is stable upon storage and releases nicotine relatively fast. The particulate material can be used in the manufacture of nicotine containing pharmaceutical composition, wherein the release of nicotine can be designed to be relatively fast so as to obtain a fast onset of action.

主权项

1. A pharmaceutically acceptable, nicotine-containing, particulate material for relatively fast release of the nicotine upon contact with a human subject, the material comprising a combination of:
a) a particulate microcrystalline excipient having suitable porous structure and bulk density for allowing nicotine to sorb in the porous structure of the excipient upon contact; and b) at least 0.5 milligrams of nicotine sorbed within the porous structure, the particulate material having a concentration of nicotine of 0.1 to 8% (w/w), and wherein the nicotine sorbed within the porous structure is chemically and/or physically stable for at least 22 weeks when stored at a temperature of 40° C. and a relative humidity of 50%.