Stabilized products, processes and devices for preparing same

Abstract

Disclosed is a multi-compartment medical device useful in the storage, processing and extended shelf life of perishable products, especially pharmaceutical, food and biological products. Particular biological materials processed according to the present methods are human blood and blood products (RBCs). Also disclosed are processes for preserving food, pharmaceutical and biological products for long-term storage and extended shelf life employing a process that reduces the hydration level of the material to less than native hydration levels of the specific product. The invention further provides stabilized biological products, such as in the form of glassified beads, prepared using a two-phase system according to the described processes that may be rehydrated and prepared for clinical use, and having essentially no loss of biological and/or pharmacological activity.

1 . A container suitable for processing a composition comprising a material of interest comprising: 
 a. a first compartment suitable for containing the material in an essentially hydrated state, said first compartment comprising a first inlet port and an outlet port;    b. a second compartment comprising a moisture absorbing material;    c. a barrier material separating said first compartment and said second compartment, wherein a surface portion of said barrier material comprises a moisture permeable membrane,    wherein said barrier material comprises a membrane or series of membranes suitable for permitting selective traverse of moisture contained in said material from the first compartment into said second compartment, and said membrane is essentially non-permeable to said moisture absorbing material in said second compartment.    
     
     
         2 . The container of  claim 1  wherein the material of interest is further defined as a biological product comprising red blood cells, and wherein the moisture permeable barrier is further described as permeable to liquid components and as essentially non-permeable to non-liquid components of said blood product.  
     
     
         3 . The container of  claim 1  wherein the material of interest is further defined as comprising a pharmaceutical agent.  
     
     
         4 . The container of  claim 1  wherein the first compartment further comprises a second inlet port suitable for permitting a dilute into said first compartment.  
     
     
         5 . The container of  claim 1  wherein the moisture absorbing material of said second compartment is further defined as comprising polyethylene glycol, dextran, polyalcohol, polyacrylamide, or a mixture thereof.  
     
     
         6 . The container of  claim 2  wherein the first container comprises a calcium chelator.  
     
     
         7 . The container of  claim 1  wherein the second compartment further comprises a second outlet port suitable for permitting the expulsion of the moisture absorbing material out of the second compartment.  
     
     
         8 . The container of  claim 1  further defined as comprising a sample storage unit comprising a first compartment and a second compartment, wherein said first compartment is in communication with said second compartment though a tubing connection, said second compartment comprising a diluent suitable for rehydrating the processed perishable product in said first compartment.  
     
     
         9 . The container of  claim 1  wherein the barrier is further defined as comprising a membrane comprising cellulose nitrate, mixed cellulose ester, cellulose acetate, nylon, polyethersulfone, or a combination thereof.  
     
     
         10 . A process for stabilizing a material to form a stabilized product, said process comprising a two (2) phase system including an aqueous phase and a non-aqueous phase, said process comprising: 
 a. preparing a first aqueous phase comprising an aqueous solution of the material of interest in a sufficient volume of water to provide a first aqueous phase solution, wherein said material is at a relatively high concentration;    b. preparing a second phase comprising the step of dispersing the first aqueous phase solution in a non-aqueous suspending solvent to form a water-in-oil emulsion;    c. agitating said water-in-oil emulsion so as to provide for formation of particles; and    d. collecting the stabilized product particles, wherein the stabilized product particles are further defined as comprising a stabilized material having a water activity (a w ) of less than about 0.9.    
     
     
         11 . The process of  claim 10  wherein the second phase suspending solvent is further defined as comprising decanol.  
     
     
         12 . The process of  claim 10  wherein the stabilized material is further defined as having a water activity (a w ) of between about 0.1 to about 0.9.  
     
     
         13 . The process of  claim 10  further comprising the step of preparing a reconstituted material of said stabilized product particles by suspending said particles in a sufficient amount of an aqueous buffer, wherein the reconstituted stabilized product particles are released into an aqueous phase to provide the reconstituted product.  
     
     
         14 . The process of  claim 10  wherein the material comprises a pharmaceutical agent.  
     
     
         15 . A pharmaceutical composition comprising a pharmaceutical agent prepared by the process of  claim 14 .  
     
     
         16 . A process for preparing a stabilized composition comprising having a reduced water activity (a w ) level comprising: 
 a. placing a composition comprising a hydrated material of interest in a device comprising a first container and a material permeable to moisture; and    b. drawing out the moisture of said material of interest through the permeable material to provide a stabilized material having a reduced water activity (a w ) level,    wherein the water activity (a w ) level of said stabilized material is less than the water activity level of the unprocessed material, and wherein said stabilized material is essentially free of contact to any desiccating material.    
     
     
         17 . The process of  claim 16  wherein the stabilized material comprises red blood cells, platelets, plasma, viruses, bone marrow, progenitor cells or any fractionated or component part thereof.  
     
     
         18 . The process of  claim 16  wherein the water activity (a w ) level of the stabilized material is between about 0.1 to about 0.9.  
     
     
         19 . The process of  claim 16  wherein the water activity (a w ) level of the stabilized material is less than 0.9.  
     
     
         20 . A pharmaceutical product comprising a pharmaceutically active ingredient prepared by the process of  claim 16.