Compositions and Methods for Preservation of Materials in the Amorphous State

Abstract

The present disclosure provides methods and compositions including a sugar and a choline hydrogen phosphate salt for preservation and stabilization of materials in the amorphous state. The compositions and methods suppress the formation of crystals in materials in the amorphous state.

1 . A method for preservation of a biomaterial comprising:
 combining the biomaterial with a preservative composition comprising a sugar or sugar alcohol and a salt comprising choline hydrogen phosphate (HPO 4   −2 ) to form a mixture, wherein the salt in the preservative composition comprises a greater percentage of HPO 4   −2  than of choline dihydrogen phosphate (H 2 PO 4   − ); and   converting the preservative composition around, within, or around and within the biomaterial to an amorphous state.   
     
     
         2 . The method of  claim 1 , wherein the sugar is selected from the group consisting of: sucrose, glucose, fructose, and trehalose. 
     
     
         3 . The method of  claim 1 , wherein the sugar comprises trehalose. 
     
     
         4 . The method of  claim 1 , wherein the biomaterial is selected from the group consisting of: living tissues, living cells, live viruses, peptides, nucleic acids, biomolecules, and combinations of these. 
     
     
         5 . The method of  claim 1 , wherein converting the material to the amorphous state comprises processes selected from the group consisting of: cooling the material to a temperature less than the glass transition temperature of the composition, dehydration, or a combination of both cooling and dehydrating. 
     
     
         6 . The method of  claim 5 , wherein the cooling or dehydration is selected from the group consisting of: freezing, freeze-drying, vitrification, cryopreservation, heat drying, microwave drying, lyophilization, use of a desiccant, air-flow drying, spin drying, spray drying, and combinations thereof. 
     
     
         7 . The method of  claim 1 , wherein the preservative composition forms an amorphous state matrix around the biomaterial. 
     
     
         8 . The method of  claim 1 , wherein the preservative composition suppresses crystal formation in the amorphous state preservative composition around biomaterial for a greater amount of time as compared to a biomaterial preserved with a comparative composition having the same formulation as the preservative composition except for having a greater amount of choline dihydrogen phosphate (H 2 PO 4   − ). 
     
     
         9 . The method of  claim 1 , wherein the preservative composition has a salt:sugar ratio of about 0.1 to about 2.0. 
     
     
         10 . A preservative composition comprising:
 a sugar or sugar alcohol and a salt comprising choline hydrogen phosphate (HPO 4   −2 ), wherein the choline hydrogen phosphate comprises 50% or more of the salt.   
     
     
         11 . The preservative composition of  claim 10 , having a salt:sugar ratio of about 0.2 or greater 
     
     
         12 . The preservative composition of  claim 10 , having a salt:sugar ratio of about 0.5 or greater. 
     
     
         13 . The preservative composition of  claim 10 , having a salt:sugar ratio of about 0.1 to about 2.0. 
     
     
         14 . The preservative composition of  claim 10 , wherein the composition has a pH of about 7.0 or greater. 
     
     
         15 . The preservative composition of  claim 10 , wherein the composition has a pH of about 7.0 to about 10.0. 
     
     
         16 . The preservative composition of  claim 10 , wherein the sugar is selected from the group consisting of: sucrose, glucose, fructose, and trehalose. 
     
     
         17 . The preservative composition of  claim 10 , wherein the sugar comprises trehalose. 
     
     
         18 . The preservative composition of  claim 10 , wherein the salt comprises about 50% or less weight percent choline dihydrogen phosphate (H 2 PO 4   − ). 
     
     
         19 . A composition comprising:
 a living biomaterial, and   a preservative composition comprising a sugar or sugar alcohol and a salt comprising 50% or more of choline hydrogen phosphate (HPO 4   −2 ),   wherein the preservative composition is in an amorphous state and wherein the amount of time to formation of crystals in the presence of moisture is increased over the amount of time to crystal formation in a comparative composition comprising a greater percentage of choline dihydrogen phosphate (H 2 PO 4   − ) than HPO 4   −2 .   
     
     
         20 . The composition of  claim 19 , wherein the sugar is trehalose.