Claims for Patent: 12,246,006

Summary for Patent: 12,246,006

Title:	Single-dose packaged clotrimazole liquid composition
Abstract:	It relates to 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, and b) the container has a volume from 0.05 to 8 mL, with the condition that the water content of the composition is equal to or lower than 4% by weight with respect to the total composition weight. It also relates to a secondary packaging comprising one or more single-dose packaging units.
Inventor(s):	Maria Mar TERRAZ MENDOZA, Javier SANAGUSTÍN AQUILUÉ, Adolfo TÉLLEZ MOLINA, María Isabel DELGADO GAÑÁN
Assignee:	Laboratorios Salvat SA
Application Number:	US17/310,260
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 12,246,006
Patent 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. 2. The single-dose packaging unit according to claim 1, wherein the therapeutically effective amount of clotrimazole is from 0.1 to 5% by weight with respect to the total composition volume. 3. The single-dose packaging unit according to claim 1, wherein the polyethylene glycol is selected from the group consisting of PEG 200, PEG 300, PEG 400, PEG 600, and mixtures thereof. 4. The single-dose packaging unit according to claim 1, wherein the blow-fill-seal (BFS) container is made of a thermoplastic polymer selected from the group consisting of polyethylene (PE), low density polyethylene (LDPE), high density polyethylene (HDPE), polypropylene (PP) and mixtures thereof. 5. The single-dose packaging unit according to claim 1, which is sterile. 6. The single-dose packaging unit according to claim 1, wherein the water content of the composition is equal to or lower than 3% by weight with respect to the total composition weight. 7. A secondary packaging comprising one or more single-dose packaging units as defined in claim 1. 8. The secondary packaging according to claim 7, wherein an oxygen content inside the secondary packaging is equal to or lower than 10% by volume with respect to the total volume of gas. 9. The secondary packaging according to claim 7, wherein an oxygen content inside the secondary packaging is equal to or lower than 5% or equal to or lower than 2%, by volume with respect to the total volume of gas. 10. The secondary packaging according to claim 7, which is an aluminium foil complex overwrap pouch. 11. The secondary packaging according to claim 7, which comprises an inert gas. 12. The secondary packaging according to claim 7, wherein gas inside the secondary packaging is absent. 13. The single-dose packaging unit according to claim 4, wherein the thermoplastic polymer is low density polyethylene (LDPE). 14. The single-dose packaging unit according to claim 1, wherein the therapeutically effective amount of clotrimazole is from 0.1 to 5% by weight with respect to the total composition volume, and the blow-fill-seal (BFS) container is made of a thermoplastic polymer selected from the group consisting of polyethylene (PE), low density polyethylene (LDPE), high density polyethylene (HDPE), polypropylene (PP) and mixtures thereof. 15. The single-dose packaging unit according to claim 14, wherein the polyethylene glycol is selected from the group consisting of PEG 200, PEG 300, PEG 400, PEG 600, and mixtures thereof. 16. The single-dose packaging unit according to claim 15, wherein the water content of the composition is equal to or lower than 3% by weight with respect to the total composition weight. 17. The single-dose packaging unit according to claim 16, wherein the thermoplastic polymer is low density polyethylene (LDPE).