Tablettable chewing gums
The invention relates to certain nicotine chewing gums that provide for a high rate of buccal absorption and high plasma concentrations, in particular over the first 10 minutes after administration, in a subject willing to quit smoking.
1. A method for the relief from nicotine craving comprising administering to the oral cavity and chewing a chewing gum comprising a coated core, the core comprising:
a compressible chewing gum base that is suitable for tableting at ambient temperature, at least one nicotine active selected from the group consisting of pharmaceutically acceptable salts of nicotine and pharmaceutically acceptable , cellulose-free, nicotine complexes and resins,
at least one buffering agent in homogeneous mixture with the nicotine active, said at least one buffering agent comprising particles comprising a core of sodium bicarbonate and an outer layer of sodium carbonate,
whereby the core is tableted, and
a coating free of nicotine active comprising 80-95 % maltitol and 0.5-3 % peppermint oil (based on total coating mass).
2. The method of claim 1 , wherein the at least one nicotine active is selected from the group consisting of pharmaceutically acceptable salts of nicotine.
3. The method of claim 1 , wherein the at least one nicotine active in an amount corresponding to from 0.2 to 8 mg of nicotine free base.
4. The method of claim 1 , wherein the coating comprises a binder selected from the group consisting of arabic gum, tragacanth gum, guar gum, acacia gum , xanthan gum , alginic acid, salts of alginic acid, gellan gum , glucomannan gum, carrageenan gum , karaya gum, locust bean gum, tara gum , gelatin and any mixtures thereof.
5. The method of claim 1 , wherein the coating comprises a coating-plastifying substance selected from the group consisting of glycerol, polyethylene glycol, propylene glycol, povidone (polyvinyl pyrrolidone), copovidone (vinyl pyrrolidone vinyl acetate copolymer), hydroxypropyl cellulose, hydroxypropyl methylcellulose, hydroxypropyl methylcellulose phthalate, diethyl phthalate, dibutyl phthalate, diacetin, triacetin , triethyl citrate, dibutyl citrate, acetyl tributyl citrate, acetyl triethyl citrate , 2 pyrrolidone and any mixtures thereof.
6. The method of claim 1 , wherein rapid nicotine release means releasing in an in-vitro dissolution testing method (40 ml buffer pH 7.4, chewing jaw distance 1.6 mm - 20° rotation, 50 chewing movements per minute) at least 60% in 5 minutes (250 chews) , at least 70% in 10 minutes (500 chews) and more than 80% in 30 minutes (1500 chews) of the total nicotine content.
7. The method of claim 1 , wherein rapid nicotine release means in-vivo delivering to the mouth of a patient at least 80% of the original amount of nicotine originally being present in said chewing gum over a time period of 30 min starting with administering said chewing gum.
8. The method of claim 1 , wherein the coating additionally comprises a binder comprising a gum.
9. The method of claim 1 , wherein the coating additional comprises a coating-plastifying substance comprising glycerol.