US 12,458,645 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 Mar. 15, 2024, as Appl. No. 18/606,678.
Application 18/606,678 is a continuation of application No. 15/326,476, granted, now 11,969,429, previously published as PCT/EP2015/001239, filed on Jun. 19, 2015.
Claims priority of application No. PCT/EP2014/001951 (WO), filed on Jul. 17, 2014; and application No. PCT/EP2015/001239 (WO), filed on Jun. 19, 2015.
Prior Publication US 2024/0216382 A1, Jul. 4, 2024
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)] 11 Claims
 
1. A powder comprising Valaciclovir or pharmaceutical acceptable salt or derivative thereof and an ion exchange resin, wherein Valaciclovir is in complex with the ion exchange resin 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 in the DRC particle is 1:0.5, and wherein the powder further comprises 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 configured to be reconstituted with an aqueous diluent to form a homogeneous 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.