	US 12,246,006 B2
	Single-dose packaged clotrimazole liquid composition
Maria Mar Terraz Mendoza, Esplugues de Llobregat (ES); Javier Sanagustín Aquilué, Esplugues de Llobregat (ES); Adolfo Téllez Molina, Esplugues de Llobregat (ES); and María Isabel Delgado Gañán, Esplugues de Llobregat (ES)
Assigned to LABORATORIOS SALVAT, S.A., Esplugues de Llobregat (ES)
Appl. No. 17/310,260
Filed by LABORATORIOS SALVAT, S.A., Esplugues De Llobregat (ES)
PCT Filed Feb. 18, 2020, PCT No. PCT/EP2020/054250 § 371(c)(1), (2) Date Jul. 27, 2021, PCT Pub. No. WO2020/169611, PCT Pub. Date Aug. 27, 2020.
Claims priority of application No. 19382120 (EP), filed on Feb. 19, 2019.
Prior Publication US 2022/0133695 A1, May 5, 2022
Int. Cl. A61K 31/4174 (2006.01); A61J 1/14 (2023.01); A61K 9/08 (2006.01); A61K 47/10 (2017.01)

CPC A61K 31/4174 (2013.01) [A61J 1/1468 (2015.05); A61K 9/08 (2013.01); A61K 47/10 (2013.01)]

17 Claims

1. A single-dose packaging unit which is a blow-fill-seal (BFS) container which comprises a sterile pharmaceutical or veterinary liquid composition which is a solution, wherein:

a) the composition comprises a therapeutically effective amount of clotrimazole or a pharmaceutically or veterinary acceptable salt thereof, together with one or more pharmaceutically or veterinary acceptable excipients or carriers, wherein clotrimazole is the single active ingredient of the composition, and a solubilizing agent which is polyethylene glycol, and

b) the container has a volume from 0.05 to 8 mL, with the condition that a water content of the composition is equal to or lower than 4% by weight with respect to the total composition weight.