PEDIATRIC POWDER FOR ORAL SUSPENSION CONTAINING ANTIVIRAL AGENT AND METHOD FOR THE PREPARATION THEREOF
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 includesDry blending of Drug:Ion Exchange Resin in a ratio 1:0.8 to form a blend;...
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| creator | SAMARA, VASILIKI GOTZAMANIS, GEORGE KOUTRI, IOANNA DIAKIDOU, AMALIA FOUSTERIS, MANOLIS KARAVAS, EVANGELOS GEORGOUSIS, ZAHARIAS KOUTRIS, EFTHYMIOS KAKOURIS, ANDREAS KALASKANI, ANASTASIA KALANTZI, LIDA |
| description | 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 includesDry 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 μm, 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. |
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| title | PEDIATRIC POWDER FOR ORAL SUSPENSION CONTAINING ANTIVIRAL AGENT AND METHOD FOR THE PREPARATION THEREOF |
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