Claims for Patent: 8,765,150

Summary for Patent: 8,765,150

Title:	Riluzole aqueous suspensions
Abstract:	Physically and chemically stable aqueous oral suspensions of riluzole and manufacturing methods thereof. The suspensions contain riluzole in particle form and at least a wetting agent, preferably a surfactant. Riluzole is present in amounts from about 0.1% to about 20% w/v and has an average particle size lower than 200 .mu.m. The suspensions are devoid of the known local (mouth) anaesthetic effects of riluzole.
Inventor(s):	Artico; Roberta (Milan, IT), Adami; Marco (Milan, IT), Barbareschi; Daniele (Milan, IT), Moscoso; Jaime (Alcoendas, ES), Oldoni; Tiziano (Milan, IT), Mascagni; Paolo (Milan, IT)
Assignee:	Italfarmaco SpA (Milan, IT)
Application Number:	13/138,047
Patent Claims:	1. An aqueous oral suspension which comprises riluzole or a pharmaceutically acceptable salt thereof, a mixture of at least an anionic surfactant and at least a non-ionic surfactant, and at least a suspending agent comprising magnesium aluminum silicate in an amount from about 0.2% to about 5.0% w/v and xanthan gum in an amount from about 0.1% to about 3.0% w/v, wherein said anionic surfactant is sodium lauryl sulphate present in an amount of from about 0.0001% to about 1% w/v, and said non-ionic surfactant is a polyethyleneglycol ether and wherein riluzole or said pharmaceutically acceptable salt thereof is present in an amount from about 0.1% to about 20% w/v. 2. The suspension according to claim 1, wherein riluzole or said pharmaceutically acceptable salt thereof is present in an amount of from about 0.2% to about 10% w/v. 3. The suspension according to claim 1, wherein riluzole or said pharmaceutically acceptable salt thereof is in particle form. 4. The suspension according to claim 3, wherein the average size of the particles of riluzole or said pharmaceutically acceptable salt thereof is lower than 200 .mu.m. 5. The suspension according to claim 4, wherein said average particle size is from about 75 .mu.m to about 25 .mu.m. 6. The suspension according to claim 1, wherein said mixture of at least an anionic surfactant and at least a non-ionic surfactant is present in amounts from about 0.005% to about 2% w/v. 7. The suspension according to claim 1, wherein riluzole or said pharmaceutically acceptable salt thereof is present in an amount lower than 1.0% w/v. 8. The suspension according to claim 1, wherein riluzole or said pharmaceutically acceptable salt thereof is present in an amount lower than 10% w/v. 9. A method of treating amyotrophic lateral sclerosis in a patent in need of such treatment, said method comprising administering to said patient an effective amount of a suspension according to claim 1. 10. The suspension according to claim 2, wherein riluzole or said pharmaceutically acceptable salt thereof is present in an amount of from about 0.3% to about 6% w/v. 11. The suspension according to claim 4, wherein said average particle size is from about 50 .mu.m to about 10 .mu.m. 12. The suspension according to claim 6, wherein said mixture of at least an anionic surfactant and at least a non-ionic surfactant is present in amounts from about 0.01% to about 0.5% w/v. 13. The suspension according to claim 1, wherein said sodium lauryl sulphate is present in an amount of from about 0.0005 to about 0.5% w/v. 14. The suspension according to claim 1, wherein said sodium lauryl sulphate is present in an amount of from about 0.001 to about 0.1% w/v. 15. The suspension according to claim 7 wherein riluzole or said pharmaceutically acceptable salt thereof is present in an amount of from 0.3% to 0.8% w/v. 16. The suspension according to claim 8, wherein riluzole or said pharmaceutically acceptable salt thereof is present in an amount lower than 5% w/v. 17. The suspension according to claim 8, wherein riluzole or said pharmaceutically acceptable salt thereof is present in an amount from about 0.3% to about 4.0% w/v. 18. The suspension according to claim 1, wherein said polyethylenglycol ether is PEG 25 cetostearyl ether.