Mono (iron hydroxypyrone) and combination (iron hydroxypyrone and gi inflammation inhibiting agents) compositions for anaemia or h. pylori infections

Abstract

There is provided a composition or kit of parts comprising: one or more compounds capable of treating and/or preventing an inflammatory disease of the gastrointestinal tract: and an iron hydroxypyrone, for increasing the level of iron in a patient's bloodstream and/or treating and/or preventing anaemia such as iron deficiency anaemia. A composition comprising iron hydroxypyrone is also provided for administration to a subject: having or at risk of having achlorhydria; wherein the gastric pH of the subject is equal to or greater than about 4; or wherein the subject has an inflammatory disease of the gastrointestinal tract.

1 . A composition comprising: one or more compounds capable of treating and/or preventing an inflammatory disease of the gastrointestinal tract; and an iron hydroxypyrone, for increasing the level of iron in a patient's bloodstream. 
     
     
         2 . A composition comprising: one or more compounds capable of treating and/or preventing an inflammatory disease of the gastrointestinal tract; and an iron hydroxypyrone, for preventing and/or treating anaemia, such as iron deficiency anaemia. 
     
     
         3 . The composition according to  claim 1  or  claim 2 , wherein the inflammatory disease of the gastrointestinal tract requires a stomach acid reducing treatment regimen and/or wherein the one or more compounds or regimen optionally provides a gastric pH of equal to or greater than about 4, such as greater than 5 or 6, for example about 6.5 or above. 
     
     
         4 . The composition according to any one of  claims 1  to  3 , wherein the composition is for administration to a human or animal, preferably having an inflammatory disease of the gastrointestinal tract which preferably requires a stomach acid reducing treatment regimen. 
     
     
         5 . The composition according to any one of  claims 1  to  4 , wherein the composition is for administration to a human or animal, preferably having a gastrointestinal infection. 
     
     
         6 . The composition according to  claim 5  wherein the gastrointestinal infection is caused by  Helicobacter pylori.    
     
     
         7 . The composition according to any one of  claims 1  to  6  wherein the one or more compounds capable of treating and/or preventing an inflammatory disease of the gastrointestinal tract which preferably requires a stomach acid reducing treatment regimen comprise an acid reducing agent. 
     
     
         8 . The composition according to  claim 7 , wherein the acid reducing agent is selected from a proton pump inhibitor, an H 2  receptor antagonist, a substance capable of neutralising acids, or a combination thereof. 
     
     
         9 . The composition according to  claim 7 , wherein the acid reducing agent is selected from omeprazole, lansoprazole, pantoprazole, ranitidine, famotidine, nizatidine, cimetidine, aluminium hydroxide, magnesium carbonate, sodium or potassium bicarbonate, or calcium carbonate, or a combination thereof. 
     
     
         10 . The composition according to any one of  claims 1  to  9 , wherein the one or more compounds capable of treating and/or preventing an inflammatory disease of the gastrointestinal tract which preferably requires a stomach acid reducing treatment regimen comprises a cobalt compound. 
     
     
         11 . The composition according to  claim 10 , wherein the cobalt compound comprises a cobalt salt or a cobalt complex. 
     
     
         12 . The composition according to  claim 10 , wherein the cobalt compound comprises cobalt (II) gluconate or cobalt (II) chloride, or a combination thereof. 
     
     
         13 . The composition according to any one of  claims 1  to  12 , wherein the iron hydroxyprone comprises ferric trimaltol. 
     
     
         14 . The composition according to any one of  claims 1  to  12 , wherein the iron hydroxypyrone comprises a mixture of a ferrous or a ferric salt and a hydroxpyrone, preferably in the solid form. 
     
     
         15 . The composition according to  claim 14 , wherein the ferrous salt is an iron (II) carboxylate. 
     
     
         16 . The composition according to  claim 15 , wherein the iron (II) carboxylate is selected from iron (II) gluconate, iron (II) succinate or iron (Il) fumarate. 
     
     
         17 . A composition or kit of parts for increasing the level of iron in a patient's bloodstream comprising: one or more compounds capable of treating and/or preventing an inflammatory disease of the gastrointestinal tract; and an iron hydroxypyrone, wherein the iron hydroxypyrone comprises iron in the ferrous state. 
     
     
         18 . The composition according to  claim 17 , wherein the compound is a cobalt salt comprising cobalt gluconate. 
     
     
         19 . A composition or kit of parts for increasing the level of iron in a patient's bloodstream comprising: one or more compounds capable of treating and/or preventing an inflammatory disease of the gastrointestinal tract; and an iron hydroxypyrone with the proviso that when iron is in the ferric state, the compound is not a cobalt salt. 
     
     
         20 . The composition according to  claim 18 , wherein the compound is a substance capable of neutralising an acid. 
     
     
         21 . The composition according to any one of  claims 17  to  20 , wherein the inflammatory disease of the gastrointestinal tract requires a stomach acid reducing treatment regimen. 
     
     
         22 . The composition according to any one of  claims 1  to  21 , which is a pharmaceutical composition comprising a pharmaceutically acceptable diluent or carrier and wherein the composition is adapted for oral administration. 
     
     
         23 . A composition comprising an iron hydroxypyrone, for administration to a subject having, or at risk of having, achlorhydria. 
     
     
         24 . A composition comprising an iron hydroxypyrone for administration to a subject, wherein the gastric pH of the subject is equal to or greater than about 4, such as greater than 5 or 6, for example about 6.5 or above. 
     
     
         25 . A composition comprising an iron hydroxypyrone for administration to a subject, wherein the subject has an inflammatory disease of the gastrointestinal tract and preferably the gastric pH of the subject is equal to or greater than about 4, such as greater than 5 or 6, for example about 6.5 or above. 
     
     
         26 . The composition according to  claim 24  or  claim 25  wherein the subject has or is at risk of having achlorhydria. 
     
     
         27 . The composition according to any one of  claims 23  to  26  wherein the subject has been, will be, or is being administered an acid reducing regimen or one or more compounds capable of treating and/or preventing an inflammatory disease of the gastrointestinal tract. 
     
     
         28 . The composition according to any one of  claims 23  to  26 , further comprising one or more compounds capable of treating and/or preventing an inflammatory disease of the gastrointestinal tract or an acid reducing regimen. 
     
     
         29 . The composition of  claim 27  or  claim 28 , wherein the inflammatory disease of the gastrointestinal tract requires a stomach acid reducing treatment regimen. 
     
     
         30 . The composition according to any one of  claims 23  to  29 , wherein the composition is for increasing the level of iron in a patient's bloodstream and/or for preventing and/or treating anaemia such as iron deficiency anaemia. 
     
     
         31 . The composition according to  claim 23  or  claim 26 , wherein the achlorhydria is associated with an inflammatory disease of the gastrointestinal tract. 
     
     
         32 . The composition according to  claim 23  or  claim 26  , wherein the achlorhydria is associated with atrophic gastritis or a gastrointestinal infection, such as caused by  Helicobacter pylori.    
     
     
         33 . The composition according to any one of  claims 23  to  32  as defined in any one of  claims 3  to  22 . 
     
     
         34 . The composition according to any one of  claims 1  to  33 , wherein the iron hydroxypyrone is administered at the same time, before or after one or more compounds capable of treating and/or preventing an inflammatory disease of the gastrointestinal tract, or the acid reducing regimen, preferably the iron hydroxypyrone is administered at the same time or subsequent to the one or more compounds or the acid reducing regimen. 
     
     
         35 . The composition according to any one of  claims 1  to  34 , wherein the composition is administered by oral administration. 
     
     
         36 . The composition according to any one of  claims 1  to  35 , wherein the composition is for the absorption of iron. 
     
     
         37 . A method for increasing the level of iron in a patient's bloodstream and/or for preventing and/or treating anaemia, such as iron-deficiency anaemia, which comprises the step of administering to a subject: one or more compounds capable of treating and/or preventing an inflammatory disease of the gastrointestinal tract; and an iron hydroxypyrone. 
     
     
         38 . Use of one or more compounds capable of treating and/or preventing an inflammatory disease of the gastrointestinal tract which preferably requires a stomach acid reducing treatment regimen, and an iron hydroxypyrone, in the manufacture of a medicament for increasing the level of iron in a patient's bloodstream and/or for preventing and/or treating anaemia such as iron deficiency anaemia. 
     
     
         39 . Use of an iron hydroxypyrone in the manufacture of a medicament for administration to a subject having, or at risk of having, achlorhydria. 
     
     
         40 . Use of an iron hydroxypyrone in the manufacture of a medicament for administration to a subject, wherein the gastric pH of the subject is equal to or greater than about 4, such as greater than 5 or 6, for example about 6.5 or above. 
     
     
         41 . Use of an iron hydroxypyrone in the manufacture of a medicament for administration to a subject, wherein the subject has an inflammatory disease of the gastrointestinal tract and preferably the gastric pH of the subject is equal to or greater than about 4, such as greater than 5 or 6, for example about 6.5 or above.