Claims for Patent: 8,633,194

Summary for Patent: 8,633,194

Title:	Pharmaceutical composition of piperazine derivatives
Abstract:	The present invention relates to a liquid composition containing an active substance belonging to the family of substituted benzhydryl piperazines with reduced amounts of preservatives.
Inventor(s):	Fanara; Domenico (Wanze, BE), Scouvart; Jean (Brussels, BE), Poulain; Claire (Brussels, BE), Deleers; Michel (Linkebeek, BE)
Assignee:	UCB Pharma, S.A. (Brussels, BE)
Application Number:	10/599,451
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,633,194
Patent Claims:	1. A liquid pharmaceutical composition comprising (i) levocetirizine or a pharmaceutically acceptable salt of levocetirizine, and (ii) a preservative mixture consisting essentially of a mixture of methyl parahydroxybenzoate and propyl parahydroxybenzoate in a ratio of 9/1 expressed in weight, said mixture being present in an amount of more than 0 and up to 0.75 mg/ml of the composition, wherein said composition is substantially free of bacteria. 2. The liquid pharmaceutical composition according to claim 1, wherein the composition is aqueous. 3. The liquid pharmaceutical composition according to claim 1, wherein the amount of the p-hydroxybenzoate esters is in the range of 0.0001 to 0.75 mg/ml of the composition. 4. The liquid pharmaceutical composition according to claim 1, wherein the composition is in the form of oral solutions, nasal drops, eye drops or ear drops. 5. The liquid pharmaceutical composition according to claim 1, wherein the pharmaceutically acceptable salt of levocetirizine is a hydrochloride salt. 6. The liquid pharmaceutical composition according to claim 5, wherein the hydrochloride salt of levocetirizine is present in amount of 0.5 mg/ml and the mixture of methyl p-hydroxybenzoate and propyl p-hydroxybenzoate is present in amount of 0.75 mg/ml. 7. The liquid pharmaceutical composition according to claim 1, which composition comprises levocetirizine or a pharmaceutically acceptable salt that is at least 95% by weight of the levorotatory enantiomer of cetirizine. 8. A method of making a liquid pharmaceutical composition according to claim 1 comprising mixing levocetirizine or a pharmaceutically acceptable salt thereof with a mixture of methyl p-hydroxybenzoate and propyl p-hydroxybenzoate, wherein the methyl p-hydroxybenzoate and propyl p-hydroxybenzoate are present in a ratio of 9:1. 9. The method according to claim 8, comprising mixing a pharmaceutically acceptable salt of levocetirizine with a mixture of methyl p-hydroxybenzoate and propyl p-hydroxybenzoate, wherein the methyl p-hydroxybenzoate and propyl p-hydroxybenzoate are present in a ratio of 9:1. 10. The method according to claim 9, wherein the pharmaceutically acceptable salt of levocetirizine is a hydrochloride salt. 11. The composition of claim 1, wherein the composition is in the form of an oral solution comprising 0.50 mg/ml levocetirizine dihydrochloride, 0.675 mg/ml methyl p-hydroxybenzoate, and 0.075 mg/ml propyl p-hydroxybenzoate. 12. The composition of claim 1, wherein the composition is in the form of a solution of oral drops comprising 5.0 mg/ml levocetirizine dihydrochloride, 0.3375 mg/ml methyl p-hydroxybenzoate, and 0.0375 mg/ml propyl p-hydroxybenzoate.