Treament of t-cell mediated diseases

Abstract

The invention provides a method of treating T-cell mediated diseases and a method of inhibiting the activation of T-cells using certain diketopiperazines. The invention also provides methods of synthesizing diketopiperazines and pharmaceutical compositions comprising certain diketopiperazines. The invention further provides methods of making improved pharmaceutical compositions of proteins and peptides by either increasing or decreasing the content of diketopiperazines in the compositions and the resultant improved pharmaceutical compositions.

1 - 91 . (canceled) 
     
     
         92 . A pharmaceutical composition comprising an alanine-aspartic acid diketopiperazine (DA-DKP)-containing fraction of a solution of human albumin, wherein the DA-DKP-containing fraction is produced by separating human albumin from the human albumin solution, and wherein the composition is formulated for topical or transdermal administration in a dosage form selected from the group consisting of powders, sprays, ointments, pastes, creams, lotions, gels, solutions, patches, drops and inhalants. 
     
     
         93 . The composition of  claim 92 , wherein the DA-DKP-containing fraction is separated from the human albumin solution by passing the human albumin solution over an ultrafiltration membrane with a molecular weight cutoff that retains the DA-DKP-containing fraction. 
     
     
         94 . The composition of  claim 93 , wherein the molecular weight cutoff is less than 3000. 
     
     
         95 . The composition of  claim 92 , further comprising a component selected from the group consisting of caprylic acid, N-acetyl tryptophan and combinations thereof. 
     
     
         96 . The composition of  claim 92 , wherein the composition is formulated for topical or transdermal administration in a dosage form selected from the group consisting of ointments, pastes, creams, lotions, and gels. 
     
     
         97 . The composition of  claim 92 , wherein the composition is formulated for topical or transdermal administration in a cream dosage form. 
     
     
         98 . A method of treating a condition by topical or transdermal administration, comprising administering a pharmaceutical composition to a patient by topical or transdermal administration, wherein the pharmaceutical composition comprises an alanine-aspartic acid diketopiperazine (DA-DKP)-containing fraction of a solution of human albumin, wherein the DA-DKP-containing fraction is produced by separating human albumin from the human albumin solution, and wherein the composition is formulated for topical or transdermal administration in a dosage form selected from the group consisting of powders, sprays, ointments, pastes, creams, lotions, gels, solutions, patches, drops and inhalants. 
     
     
         99 . The method of  claim 98 , wherein the DA-DKP-containing fraction is separated from the human albumin solution by passing the human albumin solution over an ultrafiltration membrane with a molecular weight cutoff that retains the DA-DKP containing fraction. 
     
     
         100 . The method of  claim 99 , wherein the molecular weight cutoff is less than 3000. 
     
     
         101 . The method of  claim 98 , wherein the pharmaceutical composition further comprises a component selected from the group consisting of caprylic acid, N-acetyl tryptophan and combinations thereof. 
     
     
         102 . The method of  claim 98 , wherein the composition is formulated for topical or transdermal administration in a dosage form selected from the group consisting of ointments, pastes, creams, lotions, and gels. 
     
     
         103 . The method of  claim 98 , wherein the composition is formulated for topical or transdermal administration in a cream dosage form. 
     
     
         104 . A pharmaceutical product comprising:
 a. a composition comprising an alanine-aspartic acid diketopiperazine (DA-DKP)-containing fraction of a solution of human albumin, wherein the DA-DKP-containing fraction is produced by separating human albumin from the human albumin solution; and   b. a component selected from the group consisting of caprylic acid, N-acetyl tryptophan and combinations thereof;   wherein the product is in a cream dosage form.