Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof

A multiparticulate controlled release oral solid formulation comprising:

• (a) a plurality of controlled release particles comprising:
• i) a core comprising levodopa, optionally carbidopa, and at least one pharmaceutically acceptable excipient, ii) a layer or coating applied to the core comprising a muco-adhesive polymer;
• iii) and an enteric coating surrounding the core and the muco-adhesive layer or coating;
• (b) an immediate release component comprising levodopa, optionally carbidopa;
• and
• wherein the controlled release particles pass through a 12 mesh screen and are retained on a 25 mesh screen and comprise a controlled release material and the controlled release material is:
• A) mixed with the levodopa and at least one pharmaceutically acceptable excipient to form a controlled release matrix core;
• B) applied as a coating or layer onto the core comprising the levodopa and at least one pharmaceutically acceptable excipient;
• C) incorporated into the muco-adhesive coating or layer;
• or D) a combination of (A), (B) and/or (C);
• and
• wherein the solid oral formulation does not comprise an organic acid in the core other than levodopa and carbidopa and the solid oral dosage formulation releases at least 90% of the levodopa in approximately 5 to 7 hours when tested in a United States Pharmacopeia (USP) Type I dissolution apparatus at 37° C. with a rotational speed of 75 rpms and 900 mL of simulated gastric fluid with a pH of 1.0 for 2 hours followed by simulated intestinal fluid with a pH of 7.0.