Device for evaluation of pharmaceutical compositions

Abstract

A membrane-permeation test for evaluating pharmaceutical compositions is described. The method comprises the following steps: (1) providing a microporous membrane having a plurality of pores, the membrane having a feed side and a permeate side, wherein the feed side of the membrane is in fluid communication with the feed solution, and wherein the permeate side of the membrane is in fluid communication with a permeate solution; (2) administering a pharmaceutical composition to an aqueous solution to form a feed solution; and (3) measuring the concentration of drug in the permeate solution; wherein the feed side of the membrane is hydrophilic, and/or wherein the permeate solution comprises an organic fluid.

1 - 15 . (canceled) 
   
   
       16 . A device for evaluating a pharmaceutical composition comprising a drug, said device comprising
 (1) a feed reservoir for containing a feed solution,   (2) a permeate reservoir for containing a permeate solution, and   (3) a hydrophobic microporous membrane having a hydrophilic feed side and a permeate side, wherein said hydrophilic feed side has a contact angle for a drop of water of less than about 70° and said permeate side has a contact angle for a drop of water of greater than about 90°,   
     wherein said membrane separates said feed reservoir from said permeate reservoir. 
   
   
       17 . The device of  claim 16  wherein said hydrophobic microporous membrane is made from a polymer selected from the group consisting of polypropylene, polyethylene, polytetrafluoroethylene, polyvinylidine difluoride, and polysulfone. 
   
   
       18 . The device of  claim 17  wherein said hydrophobic microporous membrane has a nominal pore size ranging from about 0.05 μm to about 0.45 μm. 
   
   
       19 . The device of  claim 18  wherein said hydrophobic microporous membrane is a polypropylene membrane having a nominal pore size of about 0.1 μm. 
   
   
       20 . The device of  claim 19  wherein said polypropylene membrane has been treated to render said feed side of said membrane hydrophilic. 
   
   
       21 . The device of  claim 20  wherein said polypropylene membrane has been treated using a cold plasma. 
   
   
       22 . A multi-well plate for evaluating a pharmaceutical composition comprising a drug, said multi-well plate comprising (1) a filter plate, and (2) an acceptor plate, wherein said filter plate has a plurality of filter wells, and said acceptor plate has a plurality of acceptor wells, wherein said filter wells mate with said acceptor wells, wherein the bottom of each of said filter wells comprises a hydrophobic microporous membrane having a hydrophilic feed side and a permeate side, and wherein said hydrophilic feed side has a contact angle for a drop of water of less than about 70° and said permeate side has a contact angle for a drop of water of greater than about 90°. 
   
   
       23 . The multi-well plate of  claim 22  wherein said hydrophobic microporous membrane is made from a polymer selected from the group consisting of polypropylene, polyethylene, polytetrafluoroethylene, polyvinylidine difluoride, and polysulfone. 
   
   
       24 . The multi-well plate of  claim 23  wherein said hydrophobic microporous membrane has a nominal pore size ranging from about 0.05 μm to about 0.45 μm. 
   
   
       25 . The multi-well plate of  claim 24  wherein said hydrophobic microporous membrane is a polypropylene membrane having a nominal pore size of about 0.1 μm. 
   
   
       26 . The multi-well plate of  claim 25  wherein said polypropylene membrane has been treated to render said feed side of said membrane hydrophilic. 
   
   
       27 . The device of  claim 26  wherein said polypropylene membrane has been treated using a cold plasma.