Modified Release Formulation
First Claim
1. An extended release formulation comprising pramipexole or a pharmaceutically acceptable salt thereof having a reduced side effect profile when administered to a patient in terms of at least one condition selected from sleepiness and/or hallucinations and/or dizziness and/or headache and/or dyskinesia and/or obstipation and/or periphere oedema and/or nausea when compared to an immediate release formulation comprising pramipexole or a pharmaceutically acceptable salt thereof when the immediate release formulation is administered to the patient as often as needed to provide the same average blood plasma concentration of pramipexole in said patient as is achieved during the release period of the extended release formulation when the extended release formulation is administered once in the same period.
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Accused Products
Abstract
The invention is directed to the use of an extended release tablet formulation for pramipexole.
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Citations
40 Claims
- 1. An extended release formulation comprising pramipexole or a pharmaceutically acceptable salt thereof having a reduced side effect profile when administered to a patient in terms of at least one condition selected from sleepiness and/or hallucinations and/or dizziness and/or headache and/or dyskinesia and/or obstipation and/or periphere oedema and/or nausea when compared to an immediate release formulation comprising pramipexole or a pharmaceutically acceptable salt thereof when the immediate release formulation is administered to the patient as often as needed to provide the same average blood plasma concentration of pramipexole in said patient as is achieved during the release period of the extended release formulation when the extended release formulation is administered once in the same period.
- 2. A method for treating a disease in a patient that is responsive to dopaminergic treatment, comprising administering to a patient having said disease an extended release formulation comprising pramipexole or pramipexoledichloride monohydrate or another pharmaceutically acceptable salt of pramipexole and said formulation having an at least partially pH-dependant release profile.
- 26. A method for treating a disease in a patient that is responsive to dopaminergic treatment, comprising administering to a patient having said disease an extended release formulation comprising pramipexole or pramipexoledichloride monohydrate or another pharmaceutically acceptable salt of pramipexole and said formulation having an at least partially pH-independent in vitro release profile.
Specification