Claims for Patent: 8,309,126

Summary for Patent: 8,309,126

Title:	Dispersible bosentan tablet
Abstract:	The invention relates to dispersible tablets comprising the compound 4-tert-butyl-N-[6-(2-hydroxy-ethoxy)-5-(2-methoxy-phenoxy)-2-(pyrimidin-2- -yl)-pyrimidin-4-yl]-benzenesulfonamide.
Inventor(s):	Holman; Lovelace (Arlesheim, CH), Trenktrog; Timm (Binningen, DE)
Assignee:	Actelion Pharmaceuticals, Ltd. (Allschwill, CH)
Application Number:	13/154,588
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,309,126
Patent Claims:	1. A dispersible tablet composition comprising an active ingredient consisting of compound I of the formula ##STR00002## or a pharmaceutically acceptable salt or solvate thereof, and pharmaceutically acceptable excipients. 2. The dispersible tablet according to claim 1 comprising the following pharmaceutically acceptable excipients: a) at least one filler and b) at least one lubricant. 3. The dispersible tablet according to claim 2 further comprising at least one disintegrant. 4. The dispersible tablet according to any one of the preceding claims comprising at least one acidifying agent and/or at least one flavouring agent and/or at least one sweetening agent. 5. The dispersible tablet according to claim 1 comprising the following pharmaceutically acceptable excipients: one or more fillers in a total amount of 40 to 85% in weight based on the total weight of the dispersible tablet, one or more disintegrants in a total amount of 0.5 to 20% in weight based on the total weight of the dispersible tablet, one or more glidants in a total amount of 0.1 to 5% in weight based on the total weight of the dispersible tablet, one or more acidifying agents in a total amount of 0.5 to 13% in weight based on the total weight of the dispersible tablet, one or more flavouring agents in a total amount of 1 to 15% in weight based on the total weight of the dispersible tablet, one or more sweetening agents in a total amount of 0.1 to 10% in weight based on the total weight of the dispersible tablet, and one or more lubricants in a total amount of 0.05 to 7% in weight based on the total weight of the dispersible tablet. 6. The dispersible tablet according to any one of the preceding claims wherein compound I is in the monohydrate form. 7. The dispersible tablet according to any one of the preceding claims obtainable by using the method of direct compression. 8. A method for treating pulmonary arterial hypertension, comprising dispersing the dispersible tablet of claim 1 in aqueous media to form a suspension and administering the suspension to a patient in need thereof. 9. A process for the preparation of a dispersible tablet according to any one of claims 1 to 7, characterized in that the tablet is prepared by direct compression. 10. The dispersible tablet of claim 1, wherein the pharmaceutically acceptable excipients include a flavoring agent and/or a sweetener. 11. The dispersible tablet of claim 1 which disintegrates completely in water at 15-22.degree. C. in not more than 5 minutes.