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US 12,691,074 B2Granted
Muco-adhesive, controlled release formulation of levodopa and/or esters of levodopa and uses thereof
AssigneeImpax Laboratories, LLC
InventorsAnn Hsu, Liang Dong, Amy Ding, Suneel Gupta
Life of this patent
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Abstract
The invention provides an oral solid formulation comprising (a) a plurality of controlled release components comprising (i) a core comprising a mixture of levodopa and at least one pharmaceutically acceptable excipient, (ii) a controlled release coating surrounding the core, (iii) a muco-adhesive coating surrounding the controlled release coating and (iv) an enteric coating surrounding the muco-adhesive coating; and (b) one or more immediate release components comprising levodopa.
Claims20
A capsule comprising:
- (i) one or more immediate release components comprising levodopa and carbidopa;
- and
- (ii) one or more controlled release components comprising:
- (a) a core comprising levodopa;
- (b) a rate-controlling polymer coating comprising cellulose acetate surrounding the core;
- (c) a muco-adhesive polymer coating comprising poly(butyl methacrylate-co-(2-dimethylaminoethyl) methacrylate-co-methyl methacrylate) 1:2:1 surrounding the rate-controlling polymer coating;
- and
- (d) an enteric polymer coating comprising a poly(methacrylic acid-co-methyl methacrylate) 1:1 copolymer surrounding the muco-adhesive polymer coating;
- and
- wherein the controlled release components are free of carbidopa.
7 more elements
A capsule consisting essentially of:
- (i) one or more immediate release components consisting essentially of levodopa, carbidopa, croscarmellose sodium, povidone, and magnesium stearate;
- and
- (ii) one or more controlled release components consisting essentially of:
- (a) a core consisting essentially of levodopa, mannitol, microcrystalline cellulose, sodium lauryl sulfate and povidone;
- (b) a rate-controlling polymer coating consisting essentially of cellulose acetate and copovidone surrounding the core;
- (c) a muco-adhesive polymer coating consisting essentially of poly(butyl methacrylate-co-(2-dimethylaminoethyl) methacrylate-co-methylmethacrylate) 1:2:1 and talc surrounding the rate-controlling polymer coating;
- and
- (d) an enteric polymer coating consisting essentially of a poly(methacrylic acid-co-methyl methacrylate) 1:1 copolymer, talc and triethyl citrate surrounding the muco-adhesive polymer coating;
- and
- wherein the controlled release components are free of carbidopa.
7 more elements
A capsule consisting of:
- (i) one or more immediate release components consisting essentially of levodopa, carbidopa, croscarmellose sodium, povidone, and magnesium stearate;
- and
- (ii) one or more controlled release components consisting of:
- (a) a core consisting of levodopa, mannitol, microcrystalline cellulose, sodium lauryl sulfate and povidone;
- (b) a rate-controlling polymer coating consisting of cellulose acetate and copovidone surrounding the core;
- (c) a muco-adhesive polymer coating consisting of poly(butyl methacrylate-co-(2-dimethylaminoethyl) methacrylate-co-methylmethacrylate) 1:2:1 and talc surrounding the rate-controlling polymer coating;
- and
- (d) an enteric polymer coating consisting of a poly(methacrylic acid-co-methyl methacrylate) 1:1 copolymer, talc and triethyl citrate surrounding the muco-adhesive polymer coating.
5 more elements
Dependencies are inferred from the claim text.