Multi-layer nicotine-containing pharmaceutical composition
AssigneeNiconovum USA, Inc.
InventorsDonna Walker Duggins, John-Paul Mua, Darrell Eugene Holton, Jr., Daniel Verdin Cantrell
Life of this patent
Estimating the term…
Abstract
The invention provides a multi-layered pharmaceutical composition comprising two or more formulations with varying properties. In some embodiments, the pharmaceutical compositions provide combinations of different organoleptic properties within the same product. In certain embodiment, these combinations allow for a modified release profile of active ingredients as the user enjoys the pharmaceutical composition. The invention further provides methods for making and using the pharmaceutical composition.
Claims20
A multi-layered pharmaceutical composition comprising two or more formulations having different organoleptic properties, wherein the formulations are selected from the group consisting of:
- i) a dissolvable formulation comprising a sugar substitute in an amount of at least about 80% by weight and a sugar alcohol syrup;
- ii) a meltable formulation comprising a lipid having a melting point of about 36° C. to about 45° C.;
- iii) a pastille formulation comprising a polysaccharide filler;
- iv) a pastille formulation comprising a sugar alcohol and a natural gum binder component;
- v) a chewable formulation comprising a binder, an emulsifier, and a lipid having a melting point of about 36° C. to about 45° C.;
- and
- vi) a hard coating formulation comprising a binder, a sugar substitute, and a sugar alcohol syrup;
- wherein at least one fat nulation further comprises one or more nicotinic compounds.
-25 (canceled)
A process for preparing a multi-layered pharmaceutical composition, comprising:
- preparing a first formulation by combining one or more nicotinic compounds with one or more components selected from the group consisting of binders, lipid components, polysaccharide fillers, sugar substitutes, sugar alcohol syrups, flavorants, sweeteners, emulsifiers, disintegration aids, humectants, buffering agents, and mixtures thereof to form a first nicotinic compound-containing mixture and forming the first nicotinic compound-containing mixture into a desired form;
- preparing a second formulation by combining one or more nicotinic compounds with one or more components selected from the group consisting of binders, lipid components, polysaccharide fillers, sugar substitutes, sugar alcohol syrups, flavorants, sweeteners, emulsifiers, disintegration aids, humectants, buffering agents, and mixtures thereof to form a second nicotinic compound-containing mixture and forming the second nicotinic compound-containing mixture into a desired form;
- and applying the second formulation to the first formulation,
- wherein the formulations are selected from the group consisting of:
- i) a dissolvable formulation comprising a sugar substitute in an amount of at least about 80% by weight and a sugar alcohol syrup;
- ii) a meltable formulation comprising a lipid having a melting point of about 36° C. to about 45° C.;
- iii) a pastille formulation comprising a polysaccharide filler;
- iv) a pastille formulation comprising a sugar alcohol and a natural gum binder component;
- v) a chewable formulation comprising a binder, an emulsifier, and a lipid having a melting point of about 36° C. to about 45° C.;
- and
- vi) a hard coating formulation comprising a binder, a sugar substitute, and a sugar alcohol syrup.
Dependencies are inferred from the claim text.