Physically and chemically stable nicotine-containing particulate material
AssigneeNiconovum AB
InventorsHenri Hansson, Arne Kristensen
Life of this patent
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Abstract
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.
Claims16
1-60. (canceled)
A method for preparing a nicotine-containing particulate material comprising combining a crystalline cellulose with nicotine or a pharmaceutically acceptable salt, complex, or solvate thereof dissolved in a hydrophilic solvent such that the nicotine is at least partially retained inside voids of the crystalline cellulose.
The method according to claim 1, wherein the crystalline cellulose comprises microcrystalline cellulose (MCC).
The method according to claim 1, wherein the crystalline cellulose comprises particles with a mean size range of about 15 to about 250 μM.
The method according to claim 1, wherein the nicotine is sorbed in pores present in the crystalline cellulose.
The method according to claim 1, wherein the hydrophilic solvent comprises an alcohol or a combination thereof with water.
The method according to claim 1, wherein the prepared nicotine-containing particulate material comprises nicotine or a pharmaceutically acceptable salt, complex, or solvate thereof at a concentration of at the most about 20% w/w, said concentration being calculated as the nicotine base.
The method according to claim 1, wherein combining comprises mixing in a high shear mixer.
The method according to claim 1, comprising dissolving the nicotine or a pharmaceutically acceptable salt, complex, or solvate thereof in the hydrophilic solvent before combining with the crystalline cellulose.
The method according to claim 1, comprising drying the combined crystalline cellulose and nicotine or a pharmaceutically acceptable salt, complex, or solvate thereof.
The method according to claim 1, comprising coating at least a portion of the nicotine-containing particulate material.
The method according to claim 1, wherein the prepared nicotine-containing particulate material, when tested in an in vitro dissolution test, releases at least 90% w/w of the nicotine or the pharmaceutically acceptable salt, complex or solvate thereof within, at the most, about 30 minutes.
A method for preparing a nicotine-containing particulate material comprising:
- dissolving nicotine or a pharmaceutically acceptable salt, complex, or solvate thereof in a hydrophilic solvent comprising an alcohol or a combination thereof with water;
- combining the resultant solution with microcrystalline cellulose (MCC) in a high shear mixer;
- and
- drying the combination to form MCC particles having nicotine or a pharmaceutically acceptable salt, complex, or solvate thereof at a concentration of at the most about 7.5% w/w, said concentration being calculated as the nicotine base, at least partially retained inside voids of the MCC;
- wherein the dried combination is stable for at least 14 weeks when stored openly at 40° C. and 50% relative humidity.
Dependencies are inferred from the claim text.