Patent ID: 8889109

Claim:
A stable solid pharmaceutical dosage form for oral administration, after being constituted in water, comprising: (a) a therapeutically effective amount of valganciclovir hydrochloride; and (b) a non-hygroscopic organic acid present in an amount sufficient to stabilize the valganciclovir hydrochloride in a predetermined amount of water, wherein the solid pharmaceutical dosage form has a stability of 99% or greater for at least 12 months storage at 25 degrees C. and 60% relative humidity for recovery of valganciclovir hydrochloride, wherein the dosage form has the following composition: Unit Weight Components mg/120 mg Valganciclovir HCl 55.15 1 Povidone K30 2.00 Fumaric Acid 2.00 Sodium Benzoate 1.00 Sodium Saccharin 0.25 Mannitol 57.80 Tutti-Frutti Flavor 1.80 1 Equivalent to 50 mg of valganciclovir (as free base) on a dry basis.