Method for making cetirizine tablets
View Patent ↗In one aspect, the present invention features a method of producing a tablet including cetirizine including the steps of: (i) mixing cetirizine, a polyol, and a solvent for the cetirizine to form a cetirizine:polyol complex, wherein the solvent comprises water and an alkalizing agent and has a pH from about 2 to about 7; (ii) isolating particles of the cetirizine:polyol complex from the mixture; and (iii) forming the particles into a tablet.
1. A method of producing a tablet comprising cetirizine, said method comprising the steps of:
(i) mixing cetirizine, a polyol, an alkalizing agent and a solvent for said cetirizine to form a cetirizine:polyol complex, wherein said solvent comprises water and said mixture has a pH from about 2.5 to about 4;
(ii) isolating particles of said cetirizine:polyol complex from said mixture; and
(iii) forming said particles into a tablet; wherein said polyol is a cyclodextrin.
2. A method of claim 1 , wherein said polyol is beta-cyclodextrin.
3. A method of claim 1 , wherein said alkalizing agent is selected from the group consisting of sodium bicarbonate and sodium citrate.
4. A method of claim 1 , wherein said cetirizine is cetirizine dihydrochloride.
5. A method of claim 1 , wherein said cetirizine is levocetirizine dihydrochloride.
6. A method of claim 1 , wherein said polyol and cetirizine are mixed together prior to being mixed with said solvent.
7. A method of claim 1 , wherein said polyol, cetirizine, and alkalizing agent are mixed together prior to being mixed with said solvent.
8. A method of claim 1 , wherein said polyol, cetirizine, and solvent are mixed via a fluidized bed process.
9. A method of claim 1 , wherein said polyol, cetirizine, and solvent are mixed via a high-shear granulation process.
10. A method of claim 1 , wherein said polyol, cetirizine, and solvent are mixed via a spray drying process.
11. A method of claim 1 ,wherein said method further comprising the step of blending said particles with a tablet matrix prior to forming said tablet.
12. A method of claim 11 , wherein said tablet matrix comprises a polyol.
13. A method of claim 12 , wherein said polyol comprised within said tablet matrix is selected from the group consisting of mannitol, sucrose, sorbitol, xylitol, erythritol, and dextrose.
14. A method of claim 1 ,wherein said tablet is orally disintegrating tablet matrix.
15. A method of claim 1 , wherein said tablet is formed by compressing said particles.
16. A method of claim 1 , wherein said tablet is formed by a lyophilizing said particles.
17. A method of claim 2 , wherein said polyol, cetirizine, and alkalizing agent are mixed together prior to being mixed with said solvent.
18. A method of claim 2 , wherein said alkalizing agent is selected from the group consisting of sodium bicarbonate and sodium citrate.
19. A method of claim 17 , wherein said alkalizing agent is selected from the group consisting of sodium bicarbonate and sodium citrate.
20. A method of claim 19 , wherein said cetirizine is cetirizine dihydrochloride.