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.
Claims56
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%.
A dosage form comprising 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) nicotine sorbed in the porous structure in a concentration of 0.1 to 8% (w/w),
- wherein the amount of particulate material contained in the dosage form corresponds to an effective amount of nicotine of from 0.5 to 6 mg nicotine 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%.
A pharmaceutically acceptable, nicotine-containing, composition comprising a particulate microcrystalline excipient material for relatively fast release of the nicotine upon contact with a human subject, the particulate microcrystalline excipient material comprising a combination of:
- i) a particulate microcrystalline excipient having a suitable porous structure and bulk density for allowing nicotine to sorb in the porous structure of the excipient upon contact;
- and
- ii) at least 0.5 mg of nicotine sorbed within the porous structure, and wherein the nicotine is sorbed within the porous structure of the particulate microcrystalline excipient at a concentration 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%.
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 crystalline excipient having suitable porous structure and bulk density for allowing nicotine to sorb in the porous structure of the excipient upon contact;
- and
- b) a nicotine compound sorbed within the porous structure, wherein the nicotine compound is nicotine or a pharmaceutically acceptable salt, complex or solvate thereof, and wherein at least 90% w/w of the nicotine compound in said particulate excipient is released when said excipient is placed in 1 liter of phosphate buffer at pH 7.4, at 37° C., for 30 minutes in a dissolution apparatus of USP, paddle.
Dependencies are inferred from the claim text.