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: 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 water dispersible mini-tablets of Enalapril or a pharmaceutically acceptable salt thereof for use in the treatment of hypertension in a pediatric population. The pediatric population is defined as 0 to 18 years of age. The water dispersible mini-tablets of Enalapril further include a disintegrant, a diluent, a lubricant and a glidant. The active ingredient is distributed evenly in the mini-tablet and the disintegrant comprises Crospovidone. The mini-tablet has a diameter of 3 mm and disintegrates in less than 15 seconds in water.

Abstract: The present invention relates to an oral applicable therapeutic dosage form, in particular an orodispersible film comprising Enalapril or pharmaceutically acceptable salts thereof for use in the treatment of hypertension in a pediatric population. The pediatric population is defined from 1 to 18 years of age. The present invention also provides a method of manufacturing of such a dosage form.

Abstract: The present invention relates to an oral applicable therapeutic dosage form, in particular an orodispersible film comprising Enalapril or pharmaceutically acceptable salts thereof for use in the treatment of hypertension in a pediatric population. The pediatric population is defined from 1 to 18 years of age. The present invention also provides a method of manufacturing of such a dosage form.

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.

Abstract: The present invention relates to water dispersible mini-tablets of Enalapril or a pharmaceutically acceptable salt thereof for use in the treatment of hypertension in a pediatric formulation. The pediatric formulation is defined as 0 to 18 years of age. The present invention also provides a method of manufacturing of such dosage form.

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 an oral applicable therapeutic dosage form, in particular an orodispersible film comprising Enalapril or pharmaceutically acceptable salts thereof for use in the treatment of hypertension in a pediatric population. The pediatric population is defined from 1 to 18 years of age. The present invention also provides a method of manufacturing of such a dosage form.