Multi-layer nicotine-containing pharmaceutical composition

1. A multi-layered pharmaceutical composition comprising two formulations having different organoleptic properties, wherein the formulations include:

i) a translucent, dissolvable formulation comprising a sugar substitute in an amount of at least about 80% by weight and a sugar alcohol syrup in an amount of from about 0.1% to about 2% by weight, wherein the sugar substitute is a non-hygroscopic sugar alcohol forming a glassy matrix; and

ii) a meltable formulation comprising a lipid having a melting point of about 36° C. to about 45° C.

wherein at least one formulation further comprises one or more nicotinic compounds.

2. The multi-layered pharmaceutical composition of claim 1 , wherein the translucent, dissolvable formulation and the meltable formulation each comprise one or more nicotinic compounds.

3. The multi-layered pharmaceutical composition of claim 1 , wherein the one or more nicotinic compounds are independently in the form of a free base, a salt, a complex, or a solvate.

4. The multi-layered pharmaceutical composition of claim 3 , wherein the one or more nicotinic compounds comprise nicotine polacrilex.

5. The multi-layered pharmaceutical composition of claim 1 , wherein the one or more nicotinic compounds comprise a nicotinic compound sorbed onto a porous particulate carrier.

6. The multi-layered pharmaceutical composition of claim 5 , wherein the porous particulate carrier comprises microcrystalline cellulose.

7. The multi-layered pharmaceutical composition of claim 1 , wherein the form of the pharmaceutical composition is a core formulation surrounded by one or more continuous layers or a core formulation coated by one or more discontinuous layers so as to form a layered or side-by-side configuration of the two or more formulations.

8. The multi-layered pharmaceutical composition of claim 1 , wherein the sugar substitute of the translucent, dissolvable formulation comprises isomalt and wherein the sugar alcohol syrup of the translucent, dissolvable formulation comprises maltitol syrup.

9. The multi-layered pharmaceutical composition of claim 1 , wherein the translucent, dissolvable formulation comprises a nicotinic compound.

10. The multi-layered pharmaceutical composition of claim 1 , wherein the lipid of the meltable formulation has a melting point of about 38° C. to about 41° C.

11. The multi-layered pharmaceutical composition of claim 1 , wherein the lipid of the meltable formulation is an animal or plant derived fat, wax, or oil.

12. The multi-layered pharmaceutical composition of claim 1 , wherein the meltable formulation comprises a nicotinic compound; the lipid in an amount of from about 10% to about 50% by weight; and further comprises a filler in an amount of from about 20% to about 40% by weight, based on the meltable formulation.

13. The multi-layered pharmaceutical composition of claim 1 , wherein the meltable formulation comprises a nicotinic compound; the lipid in an amount of about 30% by weight or greater; and further comprises a filler in an amount of about 30% by weight or greater, based on the meltable formulation.

14. A process for preparing a multi-layered pharmaceutical composition according to claim 1 , comprising:

preparing a translucent, dissolvable formulation by combining one or more nicotinic compounds with a sugar substitute and a sugar alcohol syrup to form a first nicotinic compound-containing mixture;

preparing a meltable formulation by combining one or more nicotinic compounds with a lipid component to form a second nicotinic compound-containing mixture;

and either forming the translucent, dissolvable formulation into a desired form and applying the meltable formulation to the translucent, dissolvable formulation,

or forming the meltable formulation into a desired form and applying the translucent, dissolvable formulation to the meltable formulation.

15. The process of claim 14 , wherein the translucent, dissolvable formulation is formed into a desired form by pouring the first nicotinic compound-containing mixture into a mold.

16. The process of claim 14 , wherein the meltable formulation is applied by spray coating, dip coating, or by forming the meltable formulation into a sheet that is applied to the translucent, dissolvable formulation as a sandwiched coating.

17. The process of claim 16 , wherein the spray coating or dip coating is conducted at a temperature such that the translucent, dissolvable formulation is maintained in substantially intact form.

18. A method for treating a human subject having a condition, disease, or disorder responsive to stimulation of nicotinic acetylcholinergic receptors, comprising orally administering an effective amount of a multi-layered pharmaceutical composition according to claim 1 to said human subject.

19. The method of claim 18 , wherein said administering step comprises administering the multi-layered pharmaceutical composition to a human subject as a smoking cessation aid.