Solid oral dosage form for breast symptoms

Abstract

The invention is a solid oral dosage form that is designed to deliver a supraphysiological dose of molecular iodine of 3 to 60 mg per day. The solid oral dosage form is designed to have a low risk of thyroid related adverse clinical events for patients with deficiencies of certain minerals. The solid oral dosage form includes a source of iodine, a reactive agent, and calcium or iron. The solid oral dosage form may include one or more of selenium, vitamin A, vitamin D, zinc, gamma-linolenic acid, vitamin B1, and magnesium. The solid dosage form may further comprise an enteric coating that coats ingredients that are absorbed predominantly from the intestines, such as vitamin A and D, and does not coat the source of iodine and the reactive agent.

It is claimed: 
     
         1 . A solid oral dosage form, comprising
 a source of iodine comprising iodide,   a reactive agent selected from the group comprising an iodate salt, hydrogen peroxide, a source of iodate, and a source of hydrogen peroxide,   selenium,   a metal ion selected from calcium and iron, and   a pH control agent such that the effective pH of the solid oral dosage form is between 7.0 and 12.0,
 wherein
 (i) the source of iodine is unreactive when in the solid oral dosage form, 
 (ii) the total iodine in the solid oral dosage form is 3 to 60 milligrams, 
 (iii) the source of iodine reacts with the reactive agent in simulated gastric fluid, 
 (iv) the solid oral dosage form, when placed in simulated gastric fluid for a period of up to 2 hours, generates a ratio of molecular iodine to total iodine in the range of 0.8 to 1.0 by weight. 
 
   
     
     
         2 . The solid oral dosage form of  claim 1 , wherein the reaction between the source of iodine and the reactive agent in (iii) is an oxidation-reduction reaction. 
     
     
         3 . The solid oral dosage form of  claim 1 , wherein the ratio of the source of iodine to the reactive agent is within ±20% of the ideal ratio for creating a ratio of molecular iodine to total iodine within the range 0.97 to 1.0. 
     
     
         4 . The solid oral dosage form of  claim 3 , wherein the source of iodine and the reactive agent are mixed in a homogeneous distribution within the solid oral dosage form. 
     
     
         5 . The solid oral dosage form of  claim 1 , comprising 10 to 500 milligrams of calcium. 
     
     
         6 . The solid oral dosage form of  claim 5 , comprising vitamin A. 
     
     
         7 . The solid oral dosage form of  claim 1 , comprising 0.2 to 20 milligrams of iron. 
     
     
         8 . The solid oral dosage form of  claim 7 , comprising vitamin D. 
     
     
         9 . The solid oral dosage form of  claim 1 , wherein the solid oral dosage form comprises calcium, iron, and selenium. 
     
     
         10 . The solid oral dosage form of  claim 9 , comprising vitamin A and vitamin D. 
     
     
         11 . The solid oral dosage form of  claim 10 , further comprising an enteric coating, wherein the enteric coating coats the vitamin A and the vitamin D. 
     
     
         12 . The solid oral dosage form of  claim 11 , wherein the enteric coating coats no more than 20% of the source of iodine and the reactive agent. 
     
     
         13 . The solid oral dosage form of  claim 10 , comprising a means for physically separating the vitamin A or vitamin D from the source of iodine within the solid dosage form. 
     
     
         14 . The solid oral dosage form of  claim 1 , further comprising one or more ingredients selected from the group of gamma-linolenic acid, vitamin B1, magnesium, and zinc. 
     
     
         15 . The solid oral dosage form of  claim 1 , wherein the total iodine in the solid oral dosage form is 6 to 50 milligrams. 
     
     
         16 . The solid oral dosage form of  claim 1 , wherein the solid oral dosage form comprises L-selenomethionine. 
     
     
         17 . The solid oral dosage form of  claim 1 , wherein the solid oral dosage form does not comprise gamma-linolenic acid. 
     
     
         18 . A method for treating fibrocystic breast condition, comprising:
 ingesting on an empty stomach a solid oral dosage form that comprises 3 to 60 milligrams of iodine, a metal ion selected from calcium and iron, and wherein the solid oral dosage form reacts in simulated gastric fluid within 2 hours to generate molecular iodine with a ratio of molecular iodine to total iodine in the range of 0.8 to 1.0 by weight, and   repeating said ingesting daily for at least 28 days.   
     
     
         19 . The method of  claim 18 , wherein the solid oral dosage form further comprises selenium. 
     
     
         20 . The method of  claim 18 , wherein the solid oral dosage form further comprises vitamin A or vitamin D. 
     
     
         21 . The method of  claim 18 , wherein the solid oral dosage form comprises 6 to 50 milligrams of iodine.