Claims for Patent: 9,597,289

Summary for Patent: 9,597,289

Title:	Liquid oral simvastatin compositions
Abstract:	A suspension which is suitable for oral administration, comprising simvastatin, at least one suspending agent, and at least one preservative, wherein at least 90 wt % of the particles of simvastatin are less than 100 .mu.m in diameter. The present invention also includes uses of the suspension and methods of making the suspension.
Inventor(s):	Driver; Phillip (Keighley, GB)
Assignee:	ROSEMONT PHARMACEUTICALS LTD. (Leeds, GB)
Application Number:	12/298,451
Patent Claims:	1. An aqueous suspension which is suitable for oral administration, wherein 5 ml of suspension comprises: TABLE-US-00005 Amount Constituent (mg/5 ml) Purified Water Q.S. Magnesium Aluminium silicate 20 Propylene glycol 75 Methyl hydroxybenzoate 8 Ethyl hydroxybenzoate 2 Propyl hydroxybenzoate 0.8 Carmellose sodium 10 Simethicone 1 Citric Acid Monohydrate 3.75 Disodium Hydrogen Phosphate anhydrous 11.25 Sodium Lauryl sulphate 0.05 Simvastatin having d.sub.90 .ltoreq. 20 .mu.m 20. 2. The suspension of claim 1 wherein the suspension additionally contains: Acesulfame K 2.5 mg/5 ml Flavour 15 mg/5 ml. 3. An aqueous suspension which is suitable for oral administration, wherein 5 ml of suspension comprises: TABLE-US-00006 Amount Constituent (mg/5 ml) Purified Water Q.S. Magnesium Aluminium silicate 20 Propylene glycol 75 Methyl hydroxybenzoate 9 Ethyl hydroxybenzoate 2 Propyl hydroxybenzoate 0.8 Carmellose sodium 10 Simethicone 1 Citric Acid Monohydrate 3.75 Disodium Hydrogen Phosphate anhydrous 11.25 Sodium Lauryl sulphate 0.05 Simvastatin having d.sub.90 .ltoreq. 20 .mu.m 20. 4. The suspension of claim 3 wherein the suspension additionally contains: Acesulfame K 2.5 mg/5 ml Flavour 15 mg/5 ml. 5. An aqueous suspension which is suitable for oral administration, wherein 5 ml of suspension comprises: TABLE-US-00007 Amount Constituent (mg/5 ml) Purified Water Q.S. Magnesium Aluminium silicate 20 Propylene glycol 75 Methyl hydroxybenzoate 8 Ethyl hydroxybenzoate 2 Propyl hydroxybenzoate 0.8 Carmellose sodium 10 Simethicone 2 Citric Acid Monohydrate 3.75 Disodium Hydrogen Phosphate anhydrous 11.25 Sodium Lauryl sulphate 0.10 Simvastatin having d.sub.90 .ltoreq. 20 .mu.m 40. 6. The suspension of claim 5 wherein the suspension additionally contains: Acesulfame K 2.5 mg/5 ml Flavour 15 mg/5 ml. 7. An aqueous suspension which is suitable for oral administration, wherein 5 ml of suspension comprises: TABLE-US-00008 Amount Constituent (mg/5 ml) Purified Water Q.S. Magnesium Aluminium silicate 20 Propylene glycol 75 Methyl hydroxybenzoate 9 Ethyl hydroxybenzoate 2 Propyl hydroxybenzoate 0.8 Carmellose sodium 10 Simethicone 2 Citric Acid Monohydrate 3.75 Disodium Hydrogen Phosphate anhydrous 11.25 Sodium Lauryl sulphate 0.10 Simvastatin having d.sub.90 .ltoreq. 20 .mu.m 40. 8. The suspension of claim 7 wherein the suspension additionally contains: Acesulfame K 2.5 mg/5 ml Flavour 15 mg/5 ml.