Composition comprising crustacean gastrolith components and its use

Abstract

Provided is a formulation containing amorphous or microcrystalline calcium carbonate finely interspersed with organic matter in a ratio of 10 parts of the carbonate per 1 to 3 parts of the organic matter, wherein the organic matter consists of chitin and polypeptide. The formulation is efficient in treating various pathological conditions, including proliferative diseases, neurological disorders, and musculoskeletal disorders.

1 - 39 . (canceled) 
   
   
       40 . A method for treating a condition associated with calcium metabolism or calcium signaling selected from the group consisting of pain, proliferative diseases, neurological disorders, immunologic disorders, cardiovascular diseases, pulmonary diseases, nutritional disorders, reproductive disorders, musculoskeletal disorders, and dental problems, comprising orally administering a pharmaceutical formulation comprising calcium carbonate (CaCO3) finely mixed with an organic matter (Om) essentially consisting of chitin and polypeptide (Pp), wherein said Om and said CaCO3 are present in a ratio of from 1/10 to 3/10, and said Pp and chitin are present in a ratio of from 1/100 to 1/10. 
   
   
       41 . A method according to  claim 40 , wherein said treating comprises mitigating the symptoms. 
   
   
       42 . A method according to  claim 40 , wherein said proliferative disease is selected from sarcomas, carcinomas, lymphomas and melanomas. 
   
   
       43 . A method according to  claim 42 , wherein said carcinoma is breast carcinoma or bronchogenic carcinoma. 
   
   
       44 . A method according to  claim 40 , wherein said treating comprises slowing down or inhibiting the cell proliferation in a tumor. 
   
   
       45 . A method according to  claim 40 , wherein said pain is selected from postoperative pain, pain after injury, pain associated with cancer, and neuropathic pain. 
   
   
       46 . A method according to  claim 40 , wherein said neurologic disorder is selected from demyelinating diseases, dementias, and movement disorders. 
   
   
       47 . A method according to  claim 40 , wherein said condition is a degenerative disease selected from multiple sclerosis, Alzheimer's disease, and Parkinson's disease. 
   
   
       48 . A method according to  claim 40 , wherein said condition comprises a bone associated disorder selected from the group consisting of bone marrow disorder, fracture, and osteoporosis. 
   
   
       49 . A method according to  claim 40 , wherein said condition is a neurodegenerative disorder. 
   
   
       50 . A method according to  claim 40 , comprising treating degenerative disorders, comprising orally administering a composition of matter containing an Om finely mixed with CaCO3, said Om essentially consisting of chitin and Pp, wherein said Om and CaCO3 are present in a ratio of from 1/10 to 3/10, and wherein said Pp and chitin are present in a ratio of from 1/100 to 1/10. 
   
   
       51 . A method according to  claim 40 , comprising managing pain, comprising orally administering a composition of matter containing an Om finely mixed with CaCO3, said Om essentially consisting of chitin and Pp, wherein said Om and CaCO 3  are present in a ratio of from 1/10 to 3/10, and wherein said Pp and chitin are present in a ratio of from 1/100 to 1/10. 
   
   
       52 . A method according to  claim 40 , wherein said composition is administered orally in daily doses of from about 0.5 to about 3 g. 
   
   
       53 . A method of preparing said pharmaceutical formulation of  claim 40 , comprising
 i) providing a material containing amorphous or microcrystalline CaCO3 and organic matter (Om), wherein the mass ratio Om/CaCO3 is between 1/10 and 3/10, and wherein said Om consists essentially of chitin and Pp, the mass ratio Pp/chitin being between 1/100 and 1/10; and   ii) adjusting water content in the mixture to be from 10 to 30 wp per 100 wp CaCO3.   
   
   
       54 . A method according to  claim 53 , wherein said material containing CaCO3 and Om in step i) is obtained from biological source. 
   
   
       55 . A method of according to  claim 53 , wherein said material containing CaCO3 and Om in step i) is an artificial mixture of the components. 
   
   
       56 . A method of according to  claim 54 , wherein said source is an organ or a body part of a crustacean. 
   
   
       57 . A method of according to  claim 53 , comprising
 i) providing a material containing CaCO3, and Om consisting essentially of chitin and Pp, wherein the mass ratio Om/CaCO3 is between 1/10 and 3/10, and the mass ratio Pp/chitin is between 1/100 and 1/10;   ii) optionally adjusting water content in the mixture up to 30 wp per 100 wp CaCO3;   iii) optionally adjusting the content of inorganic salts other than CaCO3 in the mixture up to 40 wp per 100 wp of CaCO3; and   iv) homogenizing the mixture to obtain a fine dispersion.   
   
   
       58 . A method of according to  claim 54 , comprising
 i) selecting crayfish, monitoring and optionally inducing the formation of gastrolith;   ii) harvesting developed gastroliths;   iii) drying said gastroliths in hot air until only about 20 parts of water per 100 parts of CaCO3 is retained; and   iv) grinding said dried gastroliths.   
   
   
       59 . A method of according to  claim 57 , comprising
 i) dispersing calcium hydroxide in water;   ii) optionally admixing sodium and/or potassium phosphate;   iii) saturating the dispersion with carbon dioxide while adding chitin and polypeptide;   iv) centrifuging the suspension;   v) discarding a part of the supernatant; and   vi) drying the part of the dispersion containing the sediment until only about 20 parts of water per 100 parts of CaCO3 is retained.