Method for administering insulin to the buccal region

Abstract

A mixed micellar pharmaceutical formulation includes a micellar pharmaceutical agent, an alkali metal C8 to C22 alkyl sulfate, alkali metal salicylate, a pharmaceutically acceptable edetate and at least one absorption enhancing compound. The absorption enhancing compounds are selected from the group consisting of lecithin, hyaluronic acid, pharmaceutically acceptable salts of hyaluronic acid, octylphenoxypolyethoxyethanol, glycolic acid, lactic acid, chamomile extract, cucumber extract, oleic acid, linolenic acid, borage oil, evening primrose oil, trihydroxy oxo cholanyiglycine, glycerin, polyglycerin, lysine, polylysine, triolein and mixtures thereof. Each absorption enhancing compound is present in a concentration of from 1 to 10 wt:/wt. % of the total formulation, and the total concentration of absorption enhancing compounds are less than 50 wt./wt. % of the formulation. Methods for administering insulin and heparin to the buccal region are also disclosed.

1 - 25 . (canceled) 
     
     
         26 . An oral transmucosal pharmaceutical chewing gum composition, the composition comprising:
 a pharmaceutical agent,   water,   an alkali metal C8 to C22 alkyl sulphate in a concentration of from 1 to 10 wt./wt. % of the total formulation,   a pharmaceutically acceptable edetate in a concentration of from 1 to 10 wt./wt. % of the total formulation,   at least one alkali metal salicylate in a concentration of from 1 to 10 wt./wt. % of the total formulation,   and at least one absorption enhancing compound, said absorption enhancing compound being selected from the group consisting of lecithin, hyaluronic acid, pharmaceutically acceptable salts of hyaluronic acid, octylphenoxypolyethoxyethanol, glycolic acid, lactic acid, chamomile extract, cucumber extract, oleic acid, linolenic acid, borage oil, evening primrose oil, menthol, trihydroxy oxo cholanylglycine and pharmaceutically acceptable salts of trihydroxy oxo cholanylglycine, glycerin, polyglycerin, lysine, polylysine, polidocanol alkyl ethers and analogues of polidocanol alkyl ethers, triolein and mixtures thereof, wherein the amount of each absorption enhancing compound is present in a concentration of from 1 to 10 wt./wt. % of the total formulation, and the total concentration of absorption enhancing compounds are less than 50 wt./wt. % of the formulation, and   an effective amount of a chewing gum base.   
     
     
         27 . The composition of  claim 26 , wherein the pharmaceutical agent is selected from the group consisting of insulin, heparin, low molecular weight heparin, hirulog, hirugen, huridine, interferons, interleukins, cytokines, mono and polyclonal antibodies, chemotherapeutic agents, vaccines, glycoproteins, bacterial toxoids, hormones, calcitonins, insulin like growth factors (IGF), glucagon like peptides (GLP-1), large molecule antibiotics, protein based thrombolytic compounds, platelet inhibitors, DNA, RNA, gene therapeutics antisense oligonucleotides, steroids, hypnotics and pain killers. 
     
     
         28 . The composition of  claim 27 , wherein the pharmaceutical agent is insulin. 
     
     
         29 . The composition of  claim 26 , wherein the chewing gum base comprises at least one ingredient chosen from guar gum, powdered acacia, carrageenan, beeswax and xanthan gum. 
     
     
         30 . The composition of  claim 26 , in which one of the absorption enhancing compounds is lecithin. 
     
     
         31 . The composition of  claim 30 , wherein the lecithin is selected from the group consisting of sphingomyelin, cephalin, lysolecithin and mixtures thereof. 
     
     
         32 . The composition of  claim 26 , wherein the alkali metal C8 to C22 alkyl sulphate is sodium lauryl sulphate. 
     
     
         33 . The composition of  claim 26 , wherein the alkali metal salicylate is sodium salicylate. 
     
     
         34 . The composition of  claim 26 , comprising an absorption enhancing compound selected from the group consisting of hyaluronic acid, pharmaceutically acceptable salts of hyaluronic acid and mixtures thereof, the concentration such absorption enhancing compound being from about 1 to about 5 wt./wt. %. 
     
     
         35 . The composition of  claim 34 , comprising sodium hyaluronate. 
     
     
         36 . The composition of  claim 26 , comprising oleic acid. 
     
     
         37 . The composition of  claim 26 , comprising gamma-linoleic acid. 
     
     
         38 . The composition of  claim 26 , comprising menthol. 
     
     
         39 . The composition of  claim 26 , comprising phosphatidylcholine. 
     
     
         40 . The composition of  claim 26 , comprising insulin, sodium lauryl sulphate, sodium salicylate, a pharmaceutically acceptable edetate, sodium hyaluronate, oleic acid, gamma-linoleic acid, menthol and phosphatidylcholine.