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US 12,109,185 B2Granted
Levodopa dosing regimen
AssigneeAmneal Pharmaceuticals, LLC
InventorsRichard D'Souza, Hester Visser, Suneel Gupta
Life of this patent
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Abstract
The invention provides oral dosing regimens of controlled release levodopa compositions for use in treating patients with Parkinson's disease, primary parkinsonism/idiopathic parkinsonism, post-encephalitic parkinsonism, parkinsonism that may follow carbon monoxide intoxication, or parkinsonism that may follow manganese intoxication and the dosing regimens provide an improvement of a patient's total post-dose “On” time or “Good On” time compared to post-dose of treatment regimens with oral immediate release levodopa tablets.
Claims32
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, five or more times a day for a total daily levodopa dose of greater than 500 mg;
- ii) determining the amount of levodopa administered to the patient with each administration of the one or more immediate release levodopa tablets of step (i);
- iii) discontinuing the administration of the immediate release levodopa tablets;
- and
- iv) orally administering one or more multiparticulate controlled release levodopa dosage form 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 one or more immediate release levodopa tablets of step (i),
- wherein the patient after receiving treatment with the multiparticulate controlled release dosage form exhibits an increase of at least 10% of the patient's total post-dose “On” time or “Good On” time compared to post-dose of the oral immediate release levodopa tablets,
- wherein the multiparticulate controlled release dosage form comprises:
- (a) a plurality of controlled release components comprising a core comprising levodopa wherein the core is coated with a layer comprising a muco-adhesive polymer and externally coated with a layer comprising an enteric coating polymer;
- and
- (b) an immediate release component comprising levodopa and carbidopa.
7 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, five or more times a day for a total daily levodopa dose of greater than 500 mg;
- ii) determining the amount of levodopa administered to the patient with each administration of the one or more immediate release levodopa tablets of step (i);
- iii) discontinuing the administration of the immediate release levodopa tablets;
- and
- iv) orally administering one or more multiparticulate controlled release levodopa dosage form 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 one or more immediate release levodopa tablets of step (i),
- wherein the patient after receiving treatment with the multiparticulate controlled release levodopa dosage form exhibits a decrease of at least 10% of the patient's total post dose “Off” time as compared to post dose of the oral immediate release levodopa tablets,
- wherein the multiparticulate controlled release dosage form comprises:
- (a) a plurality of controlled release components comprising a core comprising levodopa wherein the core is coated with a layer comprising a muco-adhesive polymer and externally coated with a layer comprising an enteric coating polymer;
- and
- (b) an immediate release component comprising levodopa and carbidopa.
7 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, five or more times a day for a total daily levodopa dose of 500 mg or less;
- ii) determining the amount of levodopa administered to the patient with each administration of the one or more immediate release levodopa tablets of step (i);
- iii) discontinuing the administration of the immediate release levodopa tablets;
- and
- iv) orally administering one or more multiparticulate controlled release levodopa dosage form twice 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 one or more immediate release levodopa tablets of step (i),
- wherein the patient after receiving treatment with the multiparticulate controlled release dosage form exhibits an increase of at least 10% of the patient's total post-dose “On” time or “Good On” time compared to post-dose of the oral immediate release levodopa tablets,
- wherein the multiparticulate controlled release dosage form comprises:
- (a) a plurality of controlled release components comprising a core comprising levodopa wherein the core is coated with a layer comprising a muco-adhesive polymer and externally coated with a layer comprising an enteric coating polymer;
- and
- (b) an immediate release component comprising levodopa and carbidopa.
7 more elements
Dependencies are inferred from the claim text.