Formulations of (+)-2-[1-(3-ethoxy-4-methoxy-phenyl)-2-methanesulfonyl-ethyl]-4-acetylaminoisoindoline-1,3-dione

Abstract

Pharmaceutical compositions and single unit dosage forms of (+)-2-[1-(3-ethoxy-4-methoxy-phenyl)-2-methanesulfonyl-ethyl]-4-acetylaminoisoindoline-1,3-dione, or a pharmaceutically acceptable stereoisomer, prodrug, salt, solvate, hydrate, or clathrate thereof, are provided herein. Also provided are methods of treating, managing, or preventing various diseases or disorders.

What is claimed is: 
     
         1 . A pharmaceutical composition comprising compound A: 
       
         
           
           
               
               
           
         
         or a pharmaceutically acceptable salt thereof; a filler; a disintegrant; and a lubricant. 
       
     
     
         2 . The pharmaceutical composition of  claim 1 , wherein the compound of formula (A) is present at an amount of about 5% to about 25 by weight of the total composition. 
     
     
         3 . The pharmaceutical composition of  claim 1 , wherein the filler is lactose. 
     
     
         4 . The pharmaceutical composition of  claim 3 , wherein the lactose is present at an amount of about 20% to 85% by weight of the total composition. 
     
     
         5 . The pharmaceutical composition of  claim 3 , wherein the composition further comprises cellulose as a filler. 
     
     
         6 . The pharmaceutical composition of  claim 5 , wherein the cellulose is present at an amount of about 10% to about 50% by weight of the total composition. 
     
     
         7 . The pharmaceutical composition of  claim 1 , wherein the disintegrant is croscarmellose. 
     
     
         8 . The pharmaceutical composition of  claim 7 , wherein the croscarmellose is present at an amount of about 2% to about 8% by weight of the total composition. 
     
     
         9 . The pharmaceutical composition of  claim 1 , wherein the lubricant is magnesium stearate. 
     
     
         10 . The pharmaceutical composition of  claim 9 , wherein the magnesium stearate is present at an amount of about 0.25% to about 5% of the total composition. 
     
     
         11 . The pharmaceutical composition of  claim 1 , wherein the composition is coated with a coating formulation. 
     
     
         12 . The pharmaceutical composition of  claim 1 , wherein the coating formulation comprises one or more excipients, wherein the excipient is a coating agent, a binder, a lubricant, a stabilizing agent, a plasticizer, an adhesive, a glidant, a diluent, or a combination thereof. 
     
     
         13 . The pharmaceutical composition of  claim 12 , wherein the excipient is polyvinyl alcohol. 
     
     
         14 . The pharmaceutical composition of  claim 13 , wherein the polyvinyl alcohol is present at an amount of about 35% to about 45% by weight of the total coating formulation. 
     
     
         15 . The pharmaceutical composition of  claim 12 , wherein the excipient is polyethylene glycol. 
     
     
         16 . The pharmaceutical composition of  claim 15 , wherein the polyethylene glycol is present at an amount of about 20% to about 25% by weight of the total coating formulation. 
     
     
         17 . The pharmaceutical composition of  claim 12 , wherein the excipient is talc. 
     
     
         18 . The pharmaceutical composition of  claim 17 , wherein the talc is present at an amount of about 10% to about 15% by weight of the total coating formulation. 
     
     
         19 . The pharmaceutical composition of  claim 12 , wherein the excipients are one or more coloring agents. 
     
     
         20 . The pharmaceutical composition of  claim 19 , wherein the coloring agents are present at an amount of about 25% to about 30% by weight of the total coating formulation. 
     
     
         21 . A tablet comprising:
 (A) a core composition, wherein the core composition comprises:   
       
         
           
           
               
               
           
         
          or a pharmaceutically acceptable salt thereof, at an amount of about 10% by weight of the total core composition; 
         (ii) lactose at an amount of about 60% by weight of the total core composition; 
         (iii) microcrystalline cellulose at an amount of about 26.25% by weight of the total core composition; 
         (iv) croscarmellose at an amount of about 3% by weight of the total core composition; and 
         (v) magnesium stearate at an amount of about 0.75% by weight of the total core composition; and 
         (B) a coating formulation, wherein the coating formulation comprises:
 (i) polyvinyl alcohol at an amount of about 40% by weight of the total coating formulation; 
 (ii) polyethylene glycol at an amount of about 20% by weight of the total coating formulation; 
 (iii) talc at an amount of about 15% by weight of the total coating formulation; and 
 (iv) a mixture of coloring agents at an amount of about 25% by weight of the total coating formulation. 
 
       
     
     
         22 . A method of treating, preventing or managing a disease or disorder comprising administering to a patient the pharmaceutical composition of  claim 1 , wherein the disease or disorder is psoriasis, arthritis, dermatitis, acne, dermatomyositis, ulcerative colitis, Behcet's disease, Crohn's disease, sarcoidosis, uveitis, rosacea or lichen planus. 
     
     
         23 . The method of  claim 22 , wherein the psoriasis is plaque-type psoriasis. 
     
     
         24 . The method of  claim 22 , wherein the arthritis is psoriatic arthritis, rheumatoid arthritis, osteoarthritis or acute gouty arthritis. 
     
     
         25 . The method of  claim 22 , wherein the dermatitis is atopic dermatitis or contact dermatitis. 
     
     
         26 . The method of  claim 22 , wherein the sarcoidosis is chronic cutaneous sarcoidosis. 
     
     
         27 . A method of treating, preventing or managing a disease or disorder comprising administering to a patient the pharmaceutical composition of  claim 21 , wherein the disease or disorder is psoriasis, arthritis, dermatitis, acne, dermatomyositis, ulcerative colitis, Behcet's disease, Crohn's disease, sarcoidosis, uveitis, rosacea or lichen planus. 
     
     
         28 . The method of  claim 27 , wherein the psoriasis is plaque-type psoriasis. 
     
     
         29 . The method of  claim 27 , wherein the arthritis is psoriatic arthritis, rheumatoid arthritis, osteoarthritis or acute gouty arthritis. 
     
     
         30 . The method of  claim 27 , wherein the dermatitis is atopic dermatitis or contact dermatitis. 
     
     
         31 . The method of  claim 27 , wherein the sarcoidosis is chronic cutaneous sarcoidosis.