Orally-administrable compositions comprising stable amorphous calcium carbonate

Abstract

The present invention provides orally-administrable compositions comprising stable amorphous calcium carbonate (ACC). The compositions are preferably prepared as solid dosage forms such as tablets, capsules and powders. The present invention further provides methods for supplementing oral calcium intake in subjects and as well as methods for treating osteoporosis, osteomalacia and related diseases.

1 . A method for optimizing the harvesting of crayfish gastroliths, wherein said method comprises the steps of:
 a) selecting crayfish having weights within a pre-determined range;   b) monitoring gastrolith development using digital X-ray imaging;   c) optionally inducing gastrolith formation by physiological and endocrinological means;   d) calculating a Molting Mineralization Index (MMI) for each crayfish, wherein the MMI is the ratio of gastrolith width to carapace length; and   e) harvesting those crayfish having an MMI greater than a pre-determined value.   
     
     
         2 . The method according to  claim 1 , wherein the pre-determined value in step (e) indicates that the crustacean is about 2 days before its molt. 
     
     
         3 . The method according to  claim 1 , wherein step (c) is performed by manipulating the X organ sinus gland complex, controlling the level of ecdysteroids or a combination thereof. 
     
     
         4 . The method according to  claim 1 , wherein the crayfish is of the  Cherax  genus. 
     
     
         5 . The method according to  claim 4 , wherein the crayfish is  Cherax quadricarinatus.    
     
     
         6 . The method according to  claim 5 , wherein the pre-determined weight range in step (a) is 25-80 g, and the pre-determined MMI value is 0.1. 
     
     
         7 . A process for preparing an orally administrable composition comprising stable amorphous calcium carbonate, wherein said process comprises the steps of harvesting gastroliths from crayfish according to the method of  claim 1 , grinding said gastroliths to forma powder, and formulating said powder into an orally-administrable dosage form. 
     
     
         8 . The process according to  claim 7 , wherein said orally-administrable dosage form is a solid dosage form selected from the group consisting of tablets, capsules, powders, granulates, lozenges and pastilles. 
     
     
         9 . The process according to  claim 7 , wherein said orally-administrable dosage form is a liquid dosage form selected from a liquid suspension or a gel. 
     
     
         10 . The process according to  claim 7 , further comprising mixing the powder with an excipient selected from the group consisting of diluents, binders, fillers, lubricants, glidants and disintegrants. 
     
     
         11 . A method for optimizing the harvesting of crayfish gastroliths using digital X-ray imaging (DXI), wherein said method comprises the steps of:
 a) selecting crayfish having weights within a pre-determined range;   b) monitoring gastrolith development using digital X-ray imaging;   c) optionally inducing gastrolith formation by physiological and endocrinological means;   d) obtaining a background-corrected digital image from the raw X-ray image obtained in step (b) and estimating therefrom the number of days remaining until optimal gastrolith development;   e) classifying the crayfish according to their stage of gastrolith development; and   f) harvesting those crayfish classified in step (e) as having optimally-developed gastroliths.   
     
     
         12 . The method according to  claim 11 , wherein step (c) is performed by manipulating the X organ sinus gland complex, controlling the level of ecdysteroids or a combination thereof. 
     
     
         13 . The method according to  claim 11 , wherein step (e) comprises using a mathematical technique based on nonlinear functions that normalize the raw X-ray image. 
     
     
         14 . The method according to  claim 11 , wherein the crayfish is of the  Cherax  genus. 
     
     
         15 . The method according to  claim 14 , wherein the crayfish is  Cherax quadricarinatus.    
     
     
         16 . The method according to  claim 15 , wherein the pre-determined weight range in step (a) is 30-40 g. 
     
     
         17 . A process for preparing an orally administrable composition comprising stable amorphous calcium carbonate, wherein said process comprises the steps of harvesting gastroliths from crayfish according to the method of  claim 11 , grinding said gastroliths to form a powder, and formulating said powder into an orally-administrable dosage form. 
     
     
         18 . The process according to  claim 17 , wherein said orally-administrable dosage form is a solid dosage form selected from the group consisting of tablets, capsules, powders, granulates, lozenges and pastilles. 
     
     
         19 . The process according to  claim 17 , wherein said orally-administrable dosage form is a liquid dosage form selected from a liquid suspension or a gel. 
     
     
         20 . The process according to  claim 17 , further comprising mixing the powder with an excipient selected from the group consisting of diluents, binders, fillers, lubricants, glidants and disintegrants.