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
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Abstract
The invention provides an oral solid formulation comprising (a) a controlled release component comprising a core comprising levodopa, wherein the core is coated with a muco-adhesive coating and the muco-adhesive coating is externally coated with an enteric coating; and (b) an immediate release component comprising levodopa. The invention further provides a method for making and using the oral solid formulation.
Claims23
A multiparticulate controlled release formulation comprising:
- i) an immediate release component comprising levodopa, esters or salts thereof and a decarboxylase inhibitor, and
- ii) a controlled release component comprising a core comprising levodopa, esters or salts thereof,
- wherein the formulation is free of a pH adjusting carboxylic acid.
A multiparticulate controlled release formulation comprising:
- i) an immediate release component comprising levodopa, esters or salts thereof and a decarboxylase inhibitor, and
- ii) a controlled release component comprising a core comprising levodopa, esters or salts thereof,
- wherein the formulation is free of a pH adjusting carboxylic acid, and
- wherein the formulation on oral administration to a human subject under fasting conditions provides 50% of a maximum levodopa plasma concentration (50% Cmax) within one hour of the administration of the formulation and the 50% Cmax plasma concentration of levodopa is maintained for at least about 3 hours.
A multiparticulate controlled release formulation comprising:
- i) an immediate release component comprising granules comprising levodopa, esters or salts thereof and a decarboxylase inhibitor, and
- ii) a controlled release component comprising spheronized bead cores comprising levodopa, esters or salts thereof,
- wherein the formulation is free of a pH adjusting carboxylic acid.
A method for treating Parkinson's disease or Primary Parkinsonism in a subject in need of such treatment comprising oral administration of a multiparticulate controlled release formulation comprising:
- i) an immediate release component comprising levodopa, esters or salts thereof and a decarboxylase inhibitor, and
- ii) a controlled release component comprising a core comprising levodopa, esters or salts thereof, and
- wherein the formulation is free of a pH adjusting carboxylic acid.
Dependencies are inferred from the claim text.