Composition comprising solanum glaucophyllum for preventing and/or treating hypocalcaemia and for stabilizing blood calcium levels

Abstract

The present invention provides a pharmaceutical and/or veterinary composition comprising a retard release formulation of a Solarium glaucophyllum preparation. The composition further preferably comprises a calcium source. The composition of the invention is suitable to prevent and/or treat hypocalcaemia. Furthermore, the composition is suitable to prevent milk fever in cows. Advantageously, the composition is administered only once before calving so as to prevent the occurrence of milk fever in cows.

1 . A pharmaceutical or veterinary composition comprising a slow release formulation comprising a  Solanum glaucophyllum  preparation and a calcium source, the slow release formulation completely releases 1,25-(OH) 2  vitamin D3-glycosides contained in the preparation over a time period that is equal to or greater than 4 hours. 
     
     
         2 . The composition of  claim 1 , wherein the composition comprises dolomite. 
     
     
         3 . The composition of  claim 1 , wherein the composition has a density of at least 1.2 kg/l (g/ml). 
     
     
         4 . The composition of  claim 1 , wherein the  S. glaucophyllum  preparation is selected from the group consisting of comminute and/or powdered dry leaves of  Solanum glaucophyllum,  an extract prepared from  S. glaucophyllum  leaves, and a combination of both. 
     
     
         5 . The composition of  claim 1 , wherein the composition comprises a second formulation comprising a  S. glaucophyllum  preparation, the second formulation is an instant release formulation releasing the active principle completely before the expiration of 4 hours, and the slow release formulation being a first formulation releasing the active principle completely after 4 hours. 
     
     
         6 . The composition of  claim 1 , wherein the release period is determined by immersion of the formulation into water at 37° C. and determining the time until all 1,25-(OH)2 vitamin D 3 -gycosides are dissolved in the water. 
     
     
         7 . The composition of  claim 1 , wherein in the preparation of  S. glaucophyllum  glycosides of 1,25-(OH) 2  vitamin D 3  are the only active form of vitamin D 3  present in the preparation and/or in that alkaloids typical for  Solanum  species are absent. 
     
     
         8 . The composition of  claim 5 , wherein the second formulation comprises the  S. glaucophyllum  preparation and one or more excipient, which rapidly releases the active principle following contact with water and/or digestive liquids. 
     
     
         9 . The composition of  claim 1 , wherein the slow release formulation comprises the  S. glaucophyllum  preparation and at least one excipient, which exhibits slow release characteristics. 
     
     
         10 . The composition of  claim 9 , wherein the slow release characteristics are obtained by including the extract in a matrix or by coating the preparation containing the extract with an excipient that releases the active principle in a slow release manner. 
     
     
         11 . The composition of  claim 10 , wherein the matrix comprises components that are not readily soluble in water so that the matrix is eroded completely over a time frame of greater than 4 hours. 
     
     
         12 . The composition of  claim 10 , wherein the coating comprises an excipient, which is resistant to the digestive liquid of the stomach, but which is decomposed when in contact with bile and/or with pancreatic juice. 
     
     
         13 . The composition of  claim 1 , which is provided in a form selected from the group consisting of a bolus, a capsule, a granular composition, a pellet, a tablet, a gel, a powder and a compacted powder. 
     
     
         14 . A method for treating and/or preventing hypocalcaemia comprising administering to a patient in need of same a pharmaceutical or veterinary composition comprising a slow release formulation comprising a  Solanum glaucophyllum  preparation and a calcium source, the slow release formulation completely releases 1,25-(OH) 2  vitamin D 3 -glycosides contained in the preparation over a time period that is equal to or greater than 4 hours. 
     
     
         15 . A method for treating and/or preventing parturient paresis and/or milk fever comprising the step of administering to a patient in need of same a pharmaceutical or veterinary composition comprising a slow release formulation comprising a  Solanum glaucophyllum  preparation and a calcium source, the slow release formulation completely releases 1,25-(OH) 2  vitamin D 3 -glycosides contained in the preparation over a time period that is equal to or greater than 4 hours. 
     
     
         16 . A method for increasing the level of calcium in blood and/or for normalizing blood calcium levels and/or for maintaining normal or healthy calcium levels in blood and/or for avoiding deficiencies of calcium in blood comprising the step of administering to a patient in need of same a pharmaceutical or veterinary composition comprising a slow release formulation comprising a  Solanum glaucophyllum  preparation and a calcium source, the slow release formulation completely releases 1,25-(OH) 2  vitamin D 3 -glycosides contained in the preparation over a time period that is equal to or greater than 4 hours. 
     
     
         17 . The composition of  claim 15 , which is administered as a single administration dose to a gestating mammal before giving birth. 
     
     
         18 . The method of  claim 15 , wherein the patient is a livestock mammal. 
     
     
         19 - 20 . (canceled) 
     
     
         21 . The composition of  claim 16 , which is administered as a single administration dose to a gestating mammal before giving birth. 
     
     
         22 . The method of  claim 16 , wherein the patient is a livestock mammal. 
     
     
         23 . The composition of  claim 14 , which is administered as a single administration dose to a gestating mammal before giving birth. 
     
     
         24 . The method of  claim 14 , wherein the patient is a livestock mammal. 
     
     
         25 . The composition of  claim 10 , wherein the excipient of the coating releases the active principle by diffusion through the coating and/or by way of enzymatic decomposition in specific compartments of the digestive tract.