Abstract: A powder including Valaciclovir or pharmaceutical acceptable salt or derivative thereof and an ion exchange resin. The Valaciclovir is in complex with the ion exchange resin forming Drug-Resin complex (DRC) particles, and each DRC particle comprises hydrogen bonds between the ion exchange resin and a cationic center of Valaciclovir. The ratio of Valaciclovir to the ion exchange resin in the DRC particle is 1:0.5. The powder further includes a suspending agent and a pH agent, and the suspending agent forms a film around each DRC particle and the film decreases interparticle attraction. The powder is configured to be reconstituted with an aqueous diluent as suspension for oral administration.

Abstract: A process for preparing a powder for reconstitution as a suspension includes the following steps: First, complexing Valaciclovir with an ion exchange resin and forming Drug-Resin complex (DRC) particles. The complexing includes Dry blending of Drug:Ion Exchange Resin in a ratio 1:0.8 to form a blend; Kneading the blend with water in a ratio of Drug:Ion Exchange Resin:Water 1:0.8:0.5 to form a wet mass; Drying of the wet mass at 40° C. Next, milling of the Drug-Resin complex particles until particle size gets less than 250 ?m, and then dry mixing of the Drug-Resin complex particles with excipients to form an internal phase. The excipients of the internal phase comprise a suspending agent and a pH agent, and the suspending agent forms a film around each DRC particle and the film decreases interparticle attraction. Next, mixing the internal phase with excipients of an external phase to form the powder, and then sifting the powder to eliminate any clumps.

Abstract: The present invention relates to a pediatric powder for reconstitution as suspension for oral administration comprising a therapeutically effective amount of an antiviral agent or pharmaceutical acceptable salt or derivative thereof, in particular Valaciclovir in complex with an ion exchange resin in a specific ratio in order to obtain a palatable and child-friendly product. It also relates to a process for the preparation thereof.

Abstract: The present invention relates to a pediatric chewable tablet comprising a therapeutically effective amount of an anti-viral agent or pharmaceutical acceptable salt or derivative thereof, in particular Valaciclovir in complex with an ion exchange resin in a specific ratio in order to obtain a palatable and child-friendly product. It also relates to a process for the preparation thereof.