Stable montelukast solution
View Patent ↗A solution that is stable at 5° C. to 30° C. for at least 24 hours, comprising: (a) water, (b) montelukast sodium; (c) a carrier material for a fast disintegrating dosage form; and (d) a component selected from a strong base, a bicarbonate salt and mixtures thereof. The solution comprising montelukast sodium is stable under conditions that are typically encountered during certain phases of the manufacturing process of fast disintegrating dosage form that contain the montelukast sodium. The solution can be used to form fast disintegrating dosage form tablets. A method of preparing a fast disintegrating dosage form tablet including preparing such solution, and forming a tablet, and a fast disintegrating dosage form that is prepared from the montelukast sodium solution are also described.
1. A solution that is stable at a temperature between about 5° C. to about 30° C. for at least 24 hours, comprising:
(a) water;
(b) montelukast sodium;
(c) a carrier material for a fast disintegrating dosage form; and
(d) a component selected from a strong base, a bicarbonate salt and mixtures thereof, wherein the solution does not contain any solvent other than water.
2. The solution of claim 1 , further comprising:
(e) a saccharide.
3. The solution of claim 2 , wherein component (e) comprises mannitol.
4. The solution of claim 2 , wherein component (e) is mannitol.
5. The solution of claim 1 , wherein the molar ratio of component (b) to component (d) is from about 0.5:1 to about 10:1.
6. The solution of claim 1 , wherein the molar ratio of component (b) to component (d) is from about 0.75:1 to about 6:1.
7. The solution of claim 1 , wherein the component (d) is a strong base selected from an alkali metal hydroxides and alkaline earth metal hydroxides and mixtures thereof.
8. The solution of claim 7 , wherein the component (d) is sodium hydroxide.
9. The solution of claim 1 , having a pH of at least 9.0.
10. The solution of claim 1 , having a pH of at least 9.5.
11. The solution of claim 1 , wherein the component (d) is a bicarbonate salt selected from alkali metal bicarbonates, alkaline earth metal bicarbonates, ammonium bicarbonate and mixtures thereof.
12. The solution of claim 11 , wherein component (d) is sodium bicarbonate.
13. The solution of claim 1 , wherein the component (c) is selected from gelatins, alginates, hydroxyethyl cellulose, sodium carboxymethyl cellulose, microcrystalline cellulose, corn-syrup solids, pectin, carrageenan, agar, chitosan, locust bean gum, xanthan gum, guar gum, acacia gum, tragacanth, konjac flour, rice flour, wheat gluten, sodium starch glycolate, pullulan, modified starch, soy fiber protein, potato protein, papain, horseradish peroxidase, poly(vinyl alcohol), polyvinylpyrrolidone, and mixtures thereof.
14. The solution of claim 13 , wherein the component (c) comprises gelatin.
15. The solution of claim 13 , wherein the component (c) is gelatin.
16. The solution of claim 2 , wherein components (c) and (e) are each present in an amount of 1-6 wt %, based on the total weight of the solution.
17. The solution of claim 1 , that is stable at a temperature between about 5° C. to about 30° C. for at least 24 hours.
18. The solution of claim 1 , that is stable at a temperature between about 5° C. to about 30° C. for at least 48 hours.
19. A method of preparing a fast disintegrating dosage form tablet comprising steps of:
preparing the solution as claimed in claim 1 , and
forming a tablet from said solution.
20. The method of claim 19 , wherein said step of forming a tablet comprises lyophilization.
21. A fast disintegrating dosage form tablet prepared by the method of claim 19 .