Novel pharmaceutical dosage forms comprising valganciclovir hydrochloride

Abstract

The present invention provides novel solid pharmaceutical dosage forms for oral administration, after being constituted in water. The solid dosage forms comprise a therapeutically effective amount of valganciclovir hydrochloride and a non-hygroscopic organic acid present in an amount sufficient to stabilize the valganciclovir hydrochloride in a predetermined amount of water. The present invention also provides novel liquid pharmaceutical dosage forms for oral administration after constituting the solid pharmaceutical dosage form with water. A non-hygroscopic bulking agent may optionally be included in the above dosage form. These novel pharmaceutical dosage forms are useful in the treatment or control of viruses such as herpes simplex virus and cytomegalovirus. The present invention also provides a method for treating these diseases employing the solid and liquid pharmaceutical dosage forms and a method for preparing these pharmaceutical dosage forms.

1 .- 10 . (canceled) 
     
     
         11 . A liquid pharmaceutical dosage form for oral administration comprising:
 (a) a therapeutically effective amount of valganciclovir hydrochloride;   (b) a predetermined amount of water; and   (c) fumaric acid present in an amount sufficient to stabilize the valganciclovir hydrochloride in the predetermined amount of water; wherein the valganciclovir hydrochloride is present in an amount of about 50 mg/mL.   
     
     
         12 .- 15 . (canceled) 
     
     
         16 . The liquid dosage from according to  claim 11 , wherein the non-hygroscopic organic acid is present in the liquid dosage form in an amount sufficient to lower the pH to 3.8 or below. 
     
     
         17 . The liquid dosage form according to  claim 11 , further comprising an effective amount of a non-hygroscopic bulking agent. 
     
     
         18 . The liquid dosage form according to  claim 17 , wherein the non-hygroscopic bulking agent is selected from the group consisting of mannitol and lactose. 
     
     
         19 . The liquid dosage form according to  claim 18 , wherein the non-hygroscopic bulking agent is mannitol. 
     
     
         20 . The liquid dosage form according to  claim 17 , wherein the non-hygroscopic bulking agent is present in an amount up to about 90% by weight of the total composition. 
     
     
         21 .- 25 . (canceled)