Modified Release Formulations of (6R)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazole-diamine and Methods of Using the Same
First Claim
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1. A single dose modified release composition comprising at least about 50 milligrams of (6R)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazole-diamine;
- less than about 4.5 milligrams of (6S)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazole-diamine and a pharmaceutically acceptable carrier.
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Abstract
Modified release pharmaceutical compositions (controlled release, sustained release, and/or extended release) of the R-(+) enantiomer of pramipexole (RPPX) and methods of using such compositions for the treatment of neurodegenerative diseases, or those related to mitochondrial dysfunction or increased oxidative stress are disclosed.
144 Citations
102 Claims
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1. A single dose modified release composition comprising at least about 50 milligrams of (6R)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazole-diamine;
- less than about 4.5 milligrams of (6S)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazole-diamine and a pharmaceutically acceptable carrier.
- View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26)
- 27. A modified release pharmaceutical composition comprising from about 50 milligrams to about 5,000 milligrams of (6R)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazole-diamine, said composition having therapeutic neuroprotective effects and a no adverse effect level attributable to either the (6R)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazole-diamine or any (6S)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazole-diamine.
- 48. A method of treating an acute disease in a patient in need thereof, comprising administering to said patient a daily dose amount of about 50 milligrams to about 5,000 milligrams of (6R)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazole-diamine in a modified release pharmaceutical composition.
- 59. A method of treating a chronic disorder in a patient in need thereof comprising administering a daily dose of about 50 milligrams to about 5000 milligrams of (6R)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazole-diamine in a modified release pharmaceutical composition.
- 72. A modified release tablet comprising from about 50 milligrams to about 500 milligrams of (6R)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazole-diamine and a pharmaceutically acceptable carrier.
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76. The tablet of 72, wherein said pharmaceutically acceptable carrier comprises microcrystalline cellulose, mannitol, croscarmellose sodium, magnesium stearate, or combination thereof.
- 77. A modified release tablet comprising from about 100 milligrams to about 500 milligrams of (6R)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazole-diamine and a pharmaceutically acceptable carrier.
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81. The tablet of 77, wherein said pharmaceutically acceptable carrier comprises microcrystalline cellulose, mannitol, croscarmellose sodium, magnesium stearate, or combination thereof.
- 82. A modified release tablet comprising from about 150 milligrams to about 500 milligrams of (6R)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazole-diamine and a pharmaceutically acceptable carrier.
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86. The tablet of 82, wherein said pharmaceutically acceptable carrier comprises microcrystalline cellulose, mannitol, croscarmellose sodium, magnesium stearate, or combination thereof.
- 87. A modified release tablet comprising greater than about 168 milligrams and less than about 2000 milligrams of (6R)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazole-diamine and a pharmaceutically acceptable carrier.
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91. The tablet of 87, wherein said pharmaceutically acceptable carrier comprises microcrystalline cellulose, mannitol, croscarmellose sodium, magnesium stearate, or combination thereof.
- 92. A method of treating a neurodegenerative disease in a patient in need thereof comprising administering to said patient a starting dose of about 50 milligrams to about 5,000 milligrams of (6R)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazole-diamine in a modified release pharmaceutical composition.
Specification