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US 2025/0152541 A1Published application
Levodopa dosing regimen
AssigneeAmneal Pharmaceuticals, LLC
InventorsRichard D'Souza, Hester Visser, Suneel Gupta
Life of this patent
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Abstract
The invention is a method for treating patients with Parkinson's disease by orally administering a controlled release levodopa formulation and the method provides an improvement of a patient's total post-dose “Off” time, total post dose “On” time and total post dose “Good On” time compared to post-dose of treatment regimens with oral immediate release levodopa tablets.
Claims29
A method for treating a patient diagnosed with Parkinson's disease comprising:
- (i) selecting a patient diagnosed with Parkinson's disease and being treated with oral immediate release levodopa tablets for a total daily levodopa dose of 500 mg or more;
- (ii) determining the amount of levodopa administered to the patient with each administration of the immediate release levodopa tablets of step (i);
- (iii) determining the patient's most frequent dose of immediate release levodopa tablets from step (ii);
- (iv) discontinuing the administration of the immediate release levodopa tablets;
- and
- (v) orally administering one or more multiparticulate controlled release levodopa dosage forms thrice a day to the patient, wherein the amount of levodopa administered with each administration of the multiparticulate controlled release levodopa dosage form is 2.8 times the amount of levodopa the patient was receiving with each administration of the most frequent dose of immediate release levodopa tablets of step (iii),
- wherein the patient after receiving treatment with the multiparticulate controlled release levodopa dosage form exhibits a decrease of at least 5% of the patient's total post dose “Off” time as compared to post dose of the oral immediate release levodopa tablets;
- and
- wherein the multiparticulate controlled release dosage form comprises:
- (a) a controlled release component comprising a plurality of beads that passes through a 12 mesh screen but are retained on a 24 mesh screen wherein the beads are substantially free of carbidopa, free of a catechol-O-methyl transferase inhibitor and comprise:
- (i) a core comprising levodopa, (ii) a controlled release coating surrounding the core, (iii) a coating comprising a muco-adhesive polymer surrounding the controlled release coating, and (iv) a coating comprising an enteric coating polymer surrounding the coating comprising the muco-adhesive polymer;
- and
- (b) an immediate release component comprising levodopa and carbidopa.
10 more elements
A method for treating a patient diagnosed with Parkinson's disease comprising:
- i) selecting a patient diagnosed with Parkinson's disease and being treated with oral immediate release levodopa tablets administered four or five times a day with each dose of oral immediate release levodopa tablets comprising 150 mg of levodopa;
- ii) discontinuing the administration of the immediate release levodopa tablets to the patient of step (i);
- and
- iii) orally administering one or more controlled release levodopa capsules three times a day to the patient,
- wherein the one or more capsules comprise:
- (a) a controlled release component comprising a plurality of beads that pass through a 12 mesh screen but are retained on a 24 mesh screen wherein the beads are substantially free of carbidopa, free of a catechol-O-methyl transferase inhibitor and comprise:
- (i) a core comprising levodopa, (ii) a controlled release coating surrounding the core, (iii) a coating comprising a muco-adhesive polymer surrounding the controlled release coating, and (iv) a coating comprising an enteric coating polymer surrounding the coating comprising the muco-adhesive polymer;
- and
- (b) an immediate release component comprising levodopa and carbidopa, wherein each administration of the one or more capsules comprises a total of 420 mg of levodopa;
- and
- wherein the patient after receiving treatment with the one or more capsules exhibits a decrease of at least 5% of the patient's total post dose “Off” time as compared to post dose of the oral immediate release levodopa tablets.
8 more elements
A method for treating a patient diagnosed with Parkinson's disease comprising:
- i) selecting a patient diagnosed with Parkinson's disease and being treated with oral immediate release levodopa tablets administered three, four or five times a day with each dose of oral immediate release levodopa tablets comprising 200 mg of levodopa;
- ii) discontinuing the administration of the immediate release levodopa tablets to the patient of step (i);
- and
- iii) orally administering one or more controlled release levodopa capsules three times a day to the patient, wherein the one or more capsules comprise:
- (a) a controlled release component comprising a plurality of beads that pass through a 12 mesh screen but are retained on a 24 mesh screen wherein the beads are substantially free of carbidopa, free of a catechol-O-methyl transferase inhibitor and comprise:
- (i) a core comprising levodopa, (ii) a controlled release coating surrounding the core, (iii) a coating comprising a muco-adhesive polymer surrounding the controlled release coating, and (iv) a coating comprising an enteric coating polymer surrounding the coating comprising the muco-adhesive polymer;
- and
- (b) an immediate release component comprising levodopa and carbidopa,
- wherein each administration of the one or more capsules comprises a total of 560 mg of levodopa;
- and
- wherein the patient after receiving treatment with the one or more capsules exhibits an increase of at least 5% of the patient's total post dose “On” time or “Good On” time as compared to post dose of the oral immediate release levodopa tablets.
8 more elements
Dependencies are inferred from the claim text.