US 12,453,732 B2
Pediatric powder for oral suspension containing antiviral agent and method for the preparation thereof
Evangelos Karavas, Pallini Attikis (GR); Efthymios Koutris, Pallini Attikis (GR); Vasiliki Samara, Pallini Attikis (GR); Ioanna Koutri, Pallini Attikis (GR); Anastasia Kalaskani, Pallini Attikis (GR); Lida Kalantzi, Pallini Attikis (GR); Andreas Kakouris, Pallini Attikis (GR); Amalia Diakidou, Pallini Attikis (GR); George Gotzamanis, Pallini Attikis (GR); Zaharias Georgousis, Pallini Attikis (GR); and Manolis Fousteris, Pallini Attikis (GR)
Assigned to PHARMATHEN S. A., Pallini-Attikis (GR)
Filed by PHARMATHEN S.A., Pallini-Attikis (GR)
Filed on Jul. 13, 2022, as Appl. No. 17/863,638.
Application 17/863,638 is a continuation of application No. 15/326,476, filed on Jan. 14, 2017, granted, now 11,969,429.
Prior Publication US 2022/0339159 A1, Oct. 27, 2022
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/522 (2006.01); A61K 9/00 (2006.01); A61K 9/14 (2006.01); A61K 9/16 (2006.01)
CPC A61K 31/522 (2013.01) [A61K 9/0053 (2013.01); A61K 9/0095 (2013.01); A61K 9/141 (2013.01); A61K 9/145 (2013.01); A61K 9/1629 (2013.01); A61K 9/1652 (2013.01)] 10 Claims
 
1. A process for preparing a suspension from a powder comprising Valaciclovir or pharmaceutical acceptable salt or derivative thereof and an ion exchange resin, the process comprising the following steps:
(a) Complexing Valaciclovir with the ion exchange resin and forming Drug-Resin complex (DRC) particles, wherein each DRC particle comprises hydrogen bonds between the ion exchange resin and a cationic center of Valaciclovir, and wherein the ratio of Valaciclovir to the ion exchange resin within the DRC particle is 1:0.5-1:0.8;
(b) Mixing the Drug-Resin complex particles with a suspending agent, which is xanthan gum, and optionally a pH agent, and wherein the suspending agent forms a film around each DRC particle and the film decreases interparticle attraction; and
wherein the powder is reconstituted with an aqueous diluent to form a homogenous suspension for oral administration and wherein the powder comprises a dissolution profile where more than 95% of Valaciclovir is released from complexation with the ion exchange resin at 10 minutes when suspended in 900 ml HCl 0.1N.