Details for Patent: 8,377,977
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Title: | Extended release tablet formulation containing pramipexole or a pharmaceutically acceptable salt thereof |
Abstract: | An extended release tablet formulation comprising pramipexole or a pharmaceutically acceptable salt thereof in a matrix comprising at least one water swelling polymer other than pregelatinized starch. |
Inventor(s): | Friedl; Thomas (Ochsenhausen, DE), Eisenreich; Wolfram (Ulm, DE) |
Assignee: | Boehringer Ingelheim International GmbH (Ingelheim am Rhein, DE) |
Filing Date: | Jul 22, 2009 |
Application Number: | 12/507,256 |
Claims: | 1. An extended release tablet formulation, wherein the tablet consists of pramipexole-dihydrochloride monohydrate, carbomer 941 as a water swelling polymer, lactose monohydrate, microcrystalline cellulose, colloidal silicon dioxide, and magnesium stearate, such that the pramipexole-dihydrochloride monohydrate is in a matrix of the water swelling polymer. 2. The extended release tablet formulation according to claim 1, wherein the tablet consists of 0.75 mg pramipexole-dihydrochloride monohydrate, 87.5 mg carbomer 941, 225.4 mg lactose monohydrate, 33.2 mg microcrystalline cellulose, 1.4 mg colloidal silicon dioxide, and 1.75 mg magnesium stearate. 3. The extended release tablet formulation according to claim 1, wherein the tablet consists of 0.75 mg pramipexole-dihydrochloride monohydrate, 70.0 mg carbomer 941, 242.9 mg lactose monohydrate, 33.2 mg microcrystalline cellulose, 1.4 mg colloidal silicon dioxide, and 1.75 mg magnesium stearate. 4. An extended release tablet formulation, wherein the tablet consists of pramipexole-dihydrochloride monohydrate, carbomer 941 as a water swelling polymer, lactose monohydrate, calcium phosphate dibasic hydrate, colloidal silicon dioxide, and magnesium stearate, such that the pramipexole-dihydrochloride monohydrate is in a matrix of the water swelling polymer. 5. The extended release tablet formulation according to claim 4, wherein the tablet consists of 0.75 mg pramipexole-dihydrochloride monohydrate, 70.0 mg carbomer 941, 140.0 mg lactose monohydrate, 136.1 mg calcium phosphate dibasic hydrate, 1.4 mg colloidal silicon dioxide, and 1.75 mg magnesium stearate. 6. The extended release tablet formulation according to claim 4, wherein the tablet consists of 0.75 mg pramipexole-dihydrochloride monohydrate, 52.5 mg carbomer 941, 140.0 mg lactose monohydrate, 153.6 mg calcium phosphate dibasic hydrate, 1.4 mg colloidal silicon dioxide, and 1.75 mg magnesium stearate. |