Proliposomal testosterone formulations

Abstract

Novel testosterone formulations are disclosed where testosterone is incorporated into a phospholipid/cholesterol system to produce a proliposomal powder dispersion. The proliposomal powder dispersions of the invention may be formulated with pharmaceutically acceptable excipients to form pharmaceutical compositions. Enterically coated oral dosage forms are disclosed as are methods of treatment for testosterone replacement therapy.

1 - 15 . (canceled) 
     
     
         16 . A proliposomal powder dispersion comprising:
 (a) testosterone,   (b) distearoyl phosphatidylcholine (DSPC) or dimyristoyl phosphatidylcholine (DMPC), and   (c) dimyrsitoyl phosphatidyl glycerol sodium (DMPG)   
       wherein (a), (b) and (c) are present in weight ratios of (a):(b):(c) from (2):(0.7-1):(0.3-1). 
     
     
         17 . The proliposomal powder dispersion of claim  1 , comprising
 (a) testosterone,   (b) DSPC, and   (c) DMPG,   
       wherein the weight ratios of (a):(b):(c) are 2:1:1. 
     
     
         18 . The proliposomal powder dispersion of claim  1  comprising
 (a) testosterone, 
 (b) DMPC, and 
 (c) DMPG, 
 
       wherein the weight ratios of (a):(b):(c) are 2:1:1. 
     
     
         19 . The proliposomal powder dispersion of claim  1  comprising
 (a) testosterone, 
 (b) DMPC, and 
 (c) DMPG, 
 
       wherein the weight ratios of (a):(b):(c) are 2:0.7:0.3. 
     
     
         20 . An oral dosage form comprising a proliposomal powder dispersion of claim  1 , wherein the oral dosage form is a capsule or a tablet. 
     
     
         21 . The oral dosage form of  claim 20 , further comprising at least one pharmaceutically acceptable excipient. 
     
     
         22 . The oral dosage form of  claim 21 , wherein the at least one pharmaceutically excipient is microcrystalline cellulose. 
     
     
         23 . The oral dosage form of  claim 20 , further comprising a delayed release coating. 
     
     
         24 . The oral dosage form of  claim 20 , wherein the testosterone is present in an amount ranging from 100 to 260 mg.