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Claims for Patent: 8,501,164

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Claims for Patent: 8,501,164

Title:Nicotine lozenge compositions
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.
Inventor(s): Chen; Li-Lan (Parsippany, NJ)
Assignee: GlaxoSmithKline, LLC (Philadelphia, PA)
Application Number:12/990,049
Patent Claims: 1. 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; and b) an extragranular component blended with the master granule component comprising a nicotine active 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.

2. The oral lozenge composition of claim 1 wherein the master granules are obtained through wet or dry granulation.

3. The oral lozenge composition of claim 1 wherein the at least one dissolution modifier is selected from the group consisting of acacia, agar, alginic acid or a salt thereof, carbomer, carboxymethylcellulose, carrageenan, cellulose, chitosan, copovidone, cyclodextrins, ethylcellulose, gelatin, guar gum, hydroxyethyl cellulose, hydroxyethyl methylcellulose, hydroxypropyl cellulose, hypromellose, inulin, methylcellulose, pectin, polycarbophil or a salt thereof, polyethylene glycol, polyethylene oxide, polyvinyl alcohol, pullulan, starch, tragacanth, trehalose, xanthan gum and mixtures thereof.

4. The oral lozenge composition of claim 3 wherein the at least one dissolution modifier is selected from the group consisting of alginic acid or a salt thereof, polycarbophil or a salt thereof, xanthan gum and mixtures thereof.

5. The oral lozenge composition of claim 4 wherein the at least one dissolution modifier is selected from the group consisting of sodium alginate, calcium polycarbophil, xanthan gum and mixtures thereof.

6. The oral lozenge composition of claim 5 wherein the at least one dissolution modifier is xanthan gum.

7. The oral lozenge of claim 1 wherein the nicotine active is nicotine polacrilex.

8. The oral lozenge of claim 1 wherein the diluent is mannitol.

9. The oral lozenge of claim 1 further comprising at least one optional excipient selected from the group consisting of taste masking agents, sweetening agents, flavorants, chelating agents, antioxidants, glidants or colorants.

10. The oral lozenge of claim 1 wherein the unit weight of the oral lozenge is from about 100 mg to about 500 mg.

11. The oral lozenge of claim 10 wherein the oral lozenge dissolves in less than 15 minutes upon administration to the oral cavity.

12. 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 a nicotine active 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.

13. The nicotine containing lozenge composition with improved user compliance prepared by the process of claim 12 wherein the unit weight of the oral lozenge dosage form is from about 100 mg to about 500 mg.

14. The nicotine containing lozenge composition with improved user compliance prepared by the process of claim 13 wherein the unit weight of the oral lozenge dosage form is about 250 mg.

15. The nicotine containing lozenge composition with improved user compliance prepared by the process of claim 13 wherein the oral lozenge dosage form dissolves in less than 15 minutes upon administration to the oral cavity.

16. The nicotine containing lozenge composition with improved user compliance prepared by the process of claim 12 further comprising at least one optional excipient selected from the group consisting of taste masking agents, sweetening agents, flavorants, chelating agents, antioxidants, glidants or colorants.

17. 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 a nicotine active 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.

18. The oral lozenge composition of claim 1, wherein the ratio of nicotine active to total buffer is from about 3:1 to about 1:3 by total weight.

19. The oral lozenge composition of claim 1, wherein the ratio of alkaline buffering agent in the extragranular component to alkaline buffering agent in the master granule component is between about 5:1 to about 1:5.

20. The oral lozenge composition of claim 19, wherein the ratio of alkaline buffering agent in the extragranular component to alkaline buffering agent in the master granule component is about 1:1.

21. The oral composition of claim 1, wherein the total amount of alkaline buffering agent is from about 5 mg to about 20 mg.

22. The oral composition of claim 20, wherein the total amount of alkaline buffering agent is from about 8 mg to about 12 mg.
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