Claims for Patent: 9,474,303

Summary for Patent: 9,474,303

Title:	Translucent smokeless tobacco product
Abstract:	A smokeless tobacco product is provided that includes a tobacco material in the form of a tobacco extract, a particulate tobacco material, or a combination thereof. In some embodiments, the smokeless tobacco product is substantially translucent. Methods for making and using the smokeless tobacco product are also provided. The smokeless tobacco product can include isomalt, maltitol syrup, particulate tobacco, and a translucent tobacco extract prepared by ultrafiltration.
Inventor(s):	Holton, Jr.; Darrell (Clemmons, NC)
Assignee:	R.J. Reynolds Tobacco Company (Winston-Salem, NC)
Application Number:	13/614,673
Patent Claims:	1. A smokeless tobacco product comprising: a. a tobacco material comprising an ultrafiltered, translucent tobacco extract consisting of compounds having a molecular weight of less than about 5,000 Da; b. a sugar substitute in an amount of at least about 80% by weight of the smokeless tobacco product; and c. a sugar alcohol syrup, wherein the smokeless tobacco product is orally dissolvable and substantially translucent. 2. The smokeless tobacco product of claim 1, wherein the sugar substitute is a non-hygroscopic sugar alcohol capable of forming a glassy matrix. 3. The smokeless tobacco product of claim 1, wherein the sugar substitute is isomalt. 4. The smokeless tobacco product of claim 1, wherein the sugar substitute is present in an amount of at least about 85% by weight of the smokeless tobacco product. 5. The smokeless tobacco product of claim 1, wherein the sugar substitute is present in an amount of at least about 90% by weight of the smokeless tobacco product. 6. The smokeless tobacco product of claim 1, wherein the sugar alcohol syrup is maltitol syrup. 7. The smokeless tobacco product of claim 1, wherein the ultrafiltered, translucent tobacco extract is a heat-treated tobacco extract that has been treated prior to inclusion in the smokeless tobacco product by heating the tobacco extract in an aqueous solution comprising lysine, cysteine, asparaginase, or hydrogen peroxide. 8. The smokeless tobacco product of claim 7, wherein the aqueous solution further comprises NaOH. 9. The smokeless tobacco product of claim 1, wherein the ultrafiltered, translucent tobacco extract is characterized by a percent light transmittance of at least about 30% at visible light wavelengths greater than about 600 nm. 10. The smokeless tobacco product of claim 1, wherein the ultrafiltered, translucent tobacco extract is characterized by a percent light transmittance of at least about 40% at visible light wavelengths greater than about 600 nm. 11. The smokeless tobacco product of claim 1, wherein the ultrafiltered, translucent tobacco extract is characterized by a percent light transmittance of at least about 50% at visible light wavelengths greater than about 600 nm. 12. The smokeless tobacco product of claim 1, wherein the tobacco material further comprises a particulate tobacco material. 13. The smokeless tobacco product of claim 12, wherein the weight ratio of the ultrafiltered, translucent tobacco extract to the particulate tobacco is from about 5:1 to about 1:10. 14. The smokeless tobacco product of claim 1, further comprising one or more components selected from the group consisting of flavorants, sweeteners, salts, and combinations thereof. 15. The smokeless tobacco product of claim 14, comprising one or more of the following: a flavorant in an amount from about 0.1 to about 15 percent by weight of the smokeless tobacco product; sucralose in the amount from about 0.01 to about 2 percent by weight of the smokeless tobacco product; and sodium chloride in the amount from about 0.5 to about 10 percent by weight of the smokeless tobacco product. 16. The smokeless tobacco product of claim 1, further comprising a throat irritation mitigant. 17. The smokeless tobacco product of claim 16, wherein the throat irritation mitigant is selected from the group consisting of sodium citrate, honey, ginger, pectin, capsaicin, camphor, dextromethorphan, echinacea, zinc gluconate, peppermint oil, spearmint oil, eucalyptus oil, glycerin, organic acids, and combinations or extracts thereof. 18. The smokeless tobacco product of claim 1, comprising: a. at least about 1.0 percent by weight of the ultrafiltered, translucent tobacco extract; b. a non-hygroscopic sugar alcohol capable of forming a glassy matrix in an amount of at least about 85% by weight; and c. a sugar alcohol syrup in an amount sufficient to slow recrystallization of the non-hygroscopic sugar alcohol. 19. The smokeless tobacco product of claim 1, comprising: a. at least about 0.5 percent by weight of the ultrafiltered, translucent tobacco extract; b. at least about 1.0 percent by weight of a particulate tobacco material; c. a non-hygroscopic sugar alcohol capable of forming a glassy matrix in an amount of at least about 85% by weight; and d. a sugar alcohol syrup in an amount sufficient to slow recrystallization of the non-hygroscopic sugar alcohol. 20. A method of preparing the translucent smokeless tobacco product of claim 1, comprising: (i) mixing an ultrafiltered, translucent tobacco extract, a non-hygroscopic sugar alcohol capable of forming a glassy matrix in a melted state, and a sugar alcohol syrup to form a mixture; and (ii) cooling the mixture to room temperature to form a solid smokeless tobacco product exhibiting translucency. 21. The method of claim 20, further comprising forming the ultrafiltered, translucent tobacco extract by subjecting a tobacco extract to ultrafiltration. 22. The method of claim 21, wherein the subjecting step removes components having a molecular weight above about 5,000 Da from the tobacco extract. 23. The method of claim 20, further comprising subjecting the ultrafiltered, translucent tobacco extract to treatment with a non-imprinted polymer adapted for the removal of tobacco-specific nitrosamines. 24. The method of claim 20, further comprising heat-treating the ultrafiltered, translucent tobacco extract by heating the tobacco extract in an aqueous solution comprising lysine, cysteine, asparaginase, or hydrogen peroxide. 25. The method of claim 24, wherein the aqueous solution further comprises NaOH. 26. The method of claim 20, wherein the translucent smokeless tobacco product has an acrylamide content of less than about 500 ppb. 27. The method of claim 20, wherein the mixing step comprises heating the non-hygroscopic sugar alcohol to a temperature above the hard crack stage in the absence of the ultrafiltered, translucent tobacco extract, and then mixing the translucent tobacco extract into the non-hygroscopic sugar alcohol at a temperature below the hard crack stage. 28. The method of claim 27, wherein the hard crack stage is about 145.degree. C. to about 155.degree. C. and the non-hygroscopic sugar alcohol is heated at a temperature between the hard crack stage and about 171.degree. C. 29. The method of claim 20, further comprising introducing the mixture into a plurality of molds to create individual product units prior to the cooling step. 30. The method of claim 20, wherein the mixing step further comprises adding particulate tobacco to the mixture.

Details for Patent 9,474,303

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Recordati Rare Diseases, Inc.	ELSPAR	asparaginase	For Injection	101063	01/10/1978		2031-09-22