Extended release tablet formulation containing pramipexole or a pharmaceutically acceptable salt thereof

• US 8,377,977 B2
• Filed: 07/22/2009
• Issued: 02/19/2013
• Est. Priority Date: 08/13/2004
• Status: Active Grant

• Current Assignee: Boehringer Ingelheim International GmbH (C.H. Boehringer Sohn AG & Co. KG)
• Original Assignee: Boehringer Ingelheim International GmbH (C.H. Boehringer Sohn AG & Co. KG)
• Inventors: Friedl, Thomas, Eisenreich, Wolfram
• Primary Examiner(s): Duffy, Patricia A
• Assistant Examiner(s): Gotfredson, Garen
• Application Number:
  US12/507,256
• Publication Number:
  US 20090281153A1
• Time in Patent Office: 1,308 Days
• Field of Search: None
• US Class Current: 514/367
• CPC Class Codes: A61K 31/428 condensed with carbocyclic rings
• CPC Class Codes: A61K 9/14 Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles microspheres A61K9/16; microcapsules A61K9/50; nanocapsules, nanoparticles of the matrix type A61K9/51
• CPC Class Codes: A61K 9/2027 obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
• CPC Class Codes: A61K 9/2031 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
• CPC Class Codes: A61K 9/2054 Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
• CPC Class Codes: A61K 9/2059 Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
• CPC Class Codes: A61K 9/2846 Poly(meth)acrylates
• CPC Class Codes: A61K 9/2866 Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
• CPC Class Codes: A61K 9/2886 having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer of the type active core-drug layer-inactive layer A61K9/209
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/14 for treating abnormal movements, e.g. chorea, dyskinesia
• CPC Class Codes: A61P 25/16 Anti-Parkinson drugs
• CPC Class Codes: A61P 25/28 for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

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.

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.