Liquid composition comprising ibuprofen and phenylephrine
The present invention relates to a liquid pharmaceutical composition for oral administration in the form of suspension which comprises the combination of ibuprofen and phenylephrine, or a pharmaceutically acceptable salt thereof, as active substances, and hypromellose, xanthan gum, liquid maltitol, glycerine and water. The composition is stable, has good organoleptical properties and shows excellent pharmacokinetic profile, providing quick absorption of the drugs. The present invention also relates to the use of the composition for treating the symptoms of flu and common cold, particularly in adults and in children over 7 years.
1 . A liquid pharmaceutical composition for oral administration in the form of suspension which comprises:
a) Ibuprofen in an amount comprised between 2% w/v and 10% w/v;
b) phenylephrine or a pharmaceutically acceptable salt thereof, in an amount comprised between 0.005% w/v and 2% w/v, expressed as equivalent amount of phenylephrine hydrochloride;
c) hypromellose, in an amount comprised between 0.1% w/v and 5% w/v;
d) xanthan gum, in an amount comprised between 0.05% w/v and 4% w/v;
e) liquid maltitol;
f) glycerine; and
g) water.
2 . The composition according to claim 1 , wherein phenylephrine is in the form of a salt selected from phenylephrine hydrochloride, phenylephrine hydrobromide and phenylephrine bitartrate.
3 . The composition according to claim 2 , wherein phenylephrine is in the form of phenylephrine hydrochloride.
4 . The composition according to claim 1 , wherein the amount of ibuprofen is comprised between 3% w/v and 5% w/v.
5 . The composition according to claim 1 , wherein the amount of phenylephrine or a pharmaceutically acceptable salt thereof is comprised between 0.08% w/v and 0.2% w/v, expressed as equivalent amount of phenylephrine hydrochloride.
6 . The composition according to claim 1 , wherein the amount of hypromellose is comprised between 0.2% w/v and 2% w/v.
7 . The composition according to claim 1 , wherein the amount of xanthan gum is comprised between 0.1% w/v and 2% w/v.
8 . The composition according to claim 1 , wherein the amount of liquid maltitol is comprised between 30% w/v and 70% w/v.
9 . The composition according to claim 1 , wherein the amount of glycerine is comprised between 5% w/v and 15% w/v.
10 . The composition according to claim 1 , wherein said composition comprises a pH adjusting agent to adjust the pH of the composition to a value comprised between 2 and 6.
11 . The composition according to claim 1 , wherein said composition comprises a preservative.
12 . The composition according to claim 1 , wherein said composition comprises a sweetening agent selected from acesulfame potassium, alitame, neohesperidin dihydrochalcone, neotame, saccharin, saccharin sodium, sucralose, thaumatin, and mixtures thereof.
13 . The composition according to claim 1 , wherein said composition comprises sodium chloride.
14 . A process for preparing the composition of claim 1 , wherein said process comprises the following steps:
(i) mixing hypromellose, xanthan gum and one part of the liquid maltitol with one part of total water to obtain a homogeneous mixture;
(ii) separately mixing ibuprofen, phenylephrine or a pharmaceutically acceptable salt thereof, glycerine and the rest of liquid maltitol with another part of total water, to obtain a homogeneous mixture;
(iii) adding the mixture of step (ii) to the mixture of step (i);
(iv) adding the rest of water.
15 . A method of treating symptoms of flu and common cold, comprising administering a therapeutically effective dose of the composition according to claim 1 to a patient in need thereof.
16 . The composition according to claim 1 , wherein the amount of hypromellose is comprised between 0.4% w/v and 0.6% w/v.
17 . The composition according to claim 1 , wherein the amount of xanthan gum is comprised between 0.3% w/v and 0.6% w/v.
18 . The composition according to claim 1 , wherein the amount of liquid maltitol is comprised between 45% w/v and 55% w/v.
19 . The composition according to claim 1 , wherein the amount of glycerine is comprised between 9% w/v and 11% w/v.
20 . The composition according to claim 1 , wherein said composition comprises a mixture of saccharin sodium and thaumatin as sweetening agent.