Liquid oral simvastatin compositions
AssigneeRosemont Pharmaceuticals Ltd
InventorPhillip Driver
Life of this patent
Estimating the term…
Abstract
Aqueous suspensions for oral administration are disclosed that include simvastatin having a d90 of simvastatin particles of less than about 100 μm 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.
Claims20
An aqueous suspension which is suitable for oral administration comprising:
- simvastatin particles having a d90 of less than about 100 μm 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.
An aqueous suspension which is suitable for oral administration comprising:
- simvastatin particles having a d90 of less than about 30 μm 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.
Dependencies are inferred from the claim text.