Paracetamol liquid suspensions
Pharmaceutical liquid suspensions containing paracetamol wherein the suspensions are formulated with paracetamol particles having a d50 of less than or equal to 10 μm and a d90 of less than or equal to 35 μm such that browning discoloration is reduced during prolonged storage.
1. A pharmaceutical composition comprising a liquid suspension having paracetamol particles with a d50 of less than or equal to 10 μm and a d90 of less than or equal to 35 μm,
wherein the composition is substantially dye-free and substantially free of reducing sugars.
2. The pharmaceutical composition according to claim 1 , wherein the paracetamol concentration is 24 mg/ml.
3. The pharmaceutical composition according to claim 1 , wherein the paracetamol concentration is 32 mg/ml.
4. The pharmaceutical composition according to claim 1 , wherein the paracetamol concentration is 48 mg/ml.
5. A pharmaceutical composition according to claim 1 comprising a high intensity sweetener selected from sucralose, aspartame, saccharin, acesulfame, cyclamate, and pharmaceutically acceptable salts thereof.
6. A pharmaceutical composition according to claim 5 wherein the high intensity sweetener is sucralose.
7. A pharmaceutical composition according to claim 1 comprising a polyhydric alcohol sweetener selected from sorbitol, mannitol, xylitol erythritol, maltitol and a combination of at least two or more thereof.
8. A pharmaceutical composition according to claim 7 wherein the polyhydric alcohol sweetener is a combination of sorbitol and maltitol.
9. A pharmaceutical composition according to claim 1 comprising an antimicrobial preservative selected from methyl paraben, propyl paraben, sodium methyl paraben, sodium ethyl paraben, sodium propyl paraben and a combination of two or more thereof.
10. A pharmaceutical composition according to claim 9 wherein the antimicrobial preservative is a combination of methyl paraben and propyl paraben.
11. A pharmaceutical composition according to claim 1 comprising a thickening agent which is xanthan gum.
12. A pharmaceutical composition according to claim 1 comprising a humectant selected from glycerine, sorbitol, polyethylene glycol, propylene glycol and a combination of two or more thereof.
13. A pharmaceutical composition according to claim 12 wherein the humectant is glycerine.
14. The pharmaceutical composition according to claim 1 , wherein the composition has a total color differences parameter ΔE* value after 27-months storage at 15-20° C. of less than 10 according to CIELAB color parameters.
15. A pharmaceutical composition comprising a liquid suspension having:
2.0-5.0% wt./v paracetamol;
0.50-1.00% wt./v xanthan gum;
10-20% wt./v glycerine;
10-20% wt./v sorbitol 70% solution;
50-60% wt./v maltitol;
0.020-0.030% wt./v anhydrous citric acid;
0.20-0.30% wt./v sodium citrate dihydrate;
0.20-0.40% wt./v sucralose; and
q.s. to 100% wt./v water,
wherein the paracetamol is present as suspended particles with a d50 of less than or equal to 10 μm and a d90 of less than or equal to 35 μm, and
wherein the composition is substantially dye-free and substantially free of reducing sugars.
16. The pharmaceutical composition of claim 15 , wherein the composition has a total color differences parameter ΔE* value after 27-months storage at 15-20° C. of less than 10 according to CIELAB color parameters.
17. The pharmaceutical composition of claim 15 , wherein the composition further comprises 0.01-0.20% wt./v methyl paraben, 0.01-0.065% wt./v propyl paraben, or a combination of both.
18. The pharmaceutical composition of claim 15 , wherein the composition further comprises 0.005-0.015% wt./v EDTA.
19. The pharmaceutical composition of claim 15 further comprising a flavoring agent.