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US 8,940,772 B2Granted
Nicotine lozenge composition
AssigneeGlaxoSmithKline LLC
InventorLi-Lan Chen
Life of this patent
Estimating the term…
Abstract
The present invention relates to nicotine lozenge compositions comprising reduced levels of buffering agents from traditional nicotine lozenges and which provide optimal oral pH and prompt nicotine absorption in a smaller, more convenient dosage form.
Claims20
An oral lozenge composition comprising:
- a) a master granule component comprising:
- at least one an alkaline buffering agent selected from the group consisting of sodium carbonate, sodium bicarbonate, potassium phosphate, potassium carbonate and potassium bicarbonate, and mixtures thereof;
- at least one dissolution modifier;
- and at least one diluent wherein the master granule component is obtained through wet or dry granulation;
- and
- b) an extragranular component blended with the master granule component comprising nicotine polacrilex and at least one alkaline buffering agent selected from the group consisting of sodium carbonate, sodium bicarbonate, potassium phosphate, potassium carbonate and potassium bicarbonate, and mixtures thereof.
3 more elements
A nicotine containing lozenge composition with improved user compliance prepared by the process of:
- a) granulating at least one alkaline buffering agent selected from the group consisting of sodium carbonate, sodium bicarbonate, potassium phosphate, potassium carbonate and potassium bicarbonate, and mixtures thereof, at least one dissolution modifier and at least one diluent into a master granulation,
- b) mixing said master granulation with nicotine polacrilex and an alkaline buffering agent selected from the group consisting of sodium carbonate, sodium bicarbonate, potassium phosphate, potassium carbonate and potassium bicarbonate, and mixtures thereof;
- and
- c) directly compressing said mixture into oral lozenge dosage forms.
1 more element
A nicotine containing lozenge composition which provides increased maximum pH in the oral cavity and fast nicotine absorption prepared by the process of:
- a) granulating at least one alkaline buffering agent selected from the group consisting of sodium carbonate, sodium bicarbonate, potassium phosphate, potassium carbonate and potassium bicarbonate, and mixtures thereof, at least one dissolution modifier and at least one diluent into a master granulation,
- b) mixing said master granulation with nicotine polacrilex and an alkaline buffering agent selected from the group consisting of sodium carbonate, sodium bicarbonate, potassium phosphate, potassium carbonate and potassium bicarbonate, and mixtures thereof;
- and
- c) directly compressing said mixture into an oral lozenge formulation.
1 more element
Dependencies are inferred from the claim text.