Claims for Patent: 10,300,041

Summary for Patent: 10,300,041

Title:	Liquid oral simvastatin compositions
Abstract:	Aqueous suspensions for oral administration are disclosed that include simvastatin having a d.sub.90 of simvastatin particles of less than about 100 .mu.m as the active agent. The aqueous suspension also includes simvastatin as about 20 mg to about 80 mg per 5 ml of the aqueous suspension, a suspending agent as about 20 mg to about 50 mg of the aqueous suspension, a wetting agent, an antimicrobial preservative, an antifoaming agent, water, and a buffering system providing the aqueous suspension with a pH of about 6.4 to about 7. Methods of making such a suspension and methods of treatments in orally administering the same are also disclosed.
Inventor(s):	Driver; Phillip (Keighley, GB)
Assignee:	Rosemont Pharmaceuticals LTD (GB)
Application Number:	15/423,710
Patent Claims:	1. An aqueous suspension which is suitable for oral administration comprising: simvastatin particles having a d.sub.90 of less than about 100 .mu.m present in a concentration of about 20 mg to about 80 mg per 5 ml of the aqueous suspension; a suspending agent, selected from the group consisting of silicates, salts of carboxymethylcellulose, methyl cellulose, hydroxypropylmethylcellulose, sodium alginate, polyvinyl-pyrrolidone, gums, and combinations thereof, present in a concentration of about 20 mg to about 50 mg per 5 ml of the aqueous suspension; a wetting agent; an antimicrobial preservative; an antifoaming agent; water; and a buffering system providing the aqueous suspension with a pH of about 6.4 to about 7. 2. The aqueous suspension of claim 1, wherein the antifoaming agent is simethicone. 3. The aqueous suspension of claim 1, wherein the antimicrobial preservative consists of one or more hydroxybenzoates. 4. The aqueous suspension of claim 1, wherein the antimicrobial preservative is present in a concentration in a range of about 5 mg to about 20 mg per 5 ml of the aqueous suspension. 5. The aqueous suspension of claim 1, wherein the simvastatin is present in a concentration in the range of about 20 mg to about 40 mg per 5 ml of aqueous suspension. 6. The aqueous suspension of claim 1, wherein the buffering system comprises a phosphate and/or a citrate. 7. The aqueous suspension of claim 6, wherein the buffering system comprises a citrate in a concentration of about 2 mg to about 10 mg per 5 ml of aqueous suspension and a phosphate in a concentration of about 5 mg to about 20 mg per 5 ml of aqueous suspension. 8. The aqueous suspension of claim 1, wherein the suspending agent consists of magnesium aluminum silicate and sodium carmellose. 9. The aqueous suspension of claim 1, wherein the wetting agent is present in a concentration of about 0.01 mg to about 0.2 mg per 5 ml of the aqueous suspension. 10. The aqueous suspension of claim 9, wherein the wetting agent is an ionic surfactant comprising a sulfate moiety. 11. The aqueous suspension of claim 1, further comprising one or more of an antioxidant, a sweetener, a flavor, or a processing aid. 12. An aqueous suspension which is suitable for oral administration comprising: simvastatin particles having a d.sub.90 of less than about 30 .mu.m present in a concentration of about 20 mg to about 40 mg per 5 ml of the aqueous suspension; a suspending agent, selected from the group consisting of silicates, salts of carboxymethylcellulose, methyl cellulose, hydroxypropylmethylcellulose, sodium alginate, polyvinyl-pyrrolidone, gums, and combinations thereof, present in a concentration of about 20 mg to about 50 mg per 5 ml of the aqueous suspension; a wetting agent is present in a concentration of about 0.01 mg to about 0.2 mg per 5 ml of the aqueous suspension; an antimicrobial preservative; an antifoaming agent; water; and a buffering system providing the aqueous suspension with a pH of about 6.4 to about 7. 13. The aqueous suspension of claim 12, wherein the antifoaming agent is simethicone. 14. The aqueous suspension of claim 12, wherein the antimicrobial preservative consists of one or more hydroxybenzoates. 15. The aqueous suspension of claim 12, wherein the antimicrobial preservative is present in a concentration in a range of about 5 mg to about 20 mg per 5 ml of the aqueous suspension. 16. The aqueous suspension of claim 12, wherein the buffering system comprises a phosphate and/or a citrate. 17. The aqueous suspension of claim 16, wherein the buffering system comprises a citrate in a concentration of about 2 mg to about 10 mg per 5 ml of aqueous suspension and a phosphate in a concentration of about 5 mg to about 20 mg per 5 ml of aqueous suspension. 18. The aqueous suspension of claim 12, wherein the suspending agent consists of magnesium aluminum silicate and sodium carmellose. 19. The aqueous suspension of claim 12, wherein the wetting agent is an ionic surfactant comprising a sulfate moiety. 20. The aqueous suspension of claim 12, further comprising one or more of an antioxidant, a sweetener, a flavor, or a processing aid.