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AN EXTENDED RELEASE TABLET FORMULATION
专利权人:
发明人:
THOMAS FRIEDL,WOLFRAM EISENREICH
申请号:
IN862/DELNP/2007
公开号:
IN271081B
申请日:
2007.02.01
申请国别(地区):
IN
年份:
2016
代理人:
摘要:
An extended release tablet formulation comprising pramipexole or a pharmaceutically acceptable salt thereof in a matrix comprising at least two water swelling polymers other than pregelatinized starch, and • wherein the contained amount of pramipexole or pharmaceutically acceptable salt, expressed as pramipexole dihydrochloride monohydrate equivalent, being about 0.1 to about 10 mg per tablet and • wherein at least one of the at least two polymers is an anionic polymer, selected from the group of optionally crosslinked acrylic acid polymers, methacrylic acid polymers, alginates and carboxyrnethylcellulose and • wherein at least one of the at least two polymers is a substantially neutral polymer other than pregelatinized starch, and being selected from the group of hydroxypropylcellulose and hydroxypropylmethylcellulose and • wherein at least one of the at least two polymers is a substantially neutral polymer other than pregelatinized starch, and being selected from the group of hydroxypropylcellulose and hydroxypropylmethylcellulose and • wherein the matrix comprises about: (a) pramipexole or a salt thereof 0.05 to 5 wt.-% (b) anionic water swelling polymer(s) 0.25 to 25 wt.-% (c) neutral water swelling polymer(s) 10 to 75 wt.-% (d) further excipients ad 100 wt.-% and wherein furthter excipients are selected from the group of sucrose, lactose, lactose monohydrate, trehalose, maltose, mannitol, sorbitol, corn starch, potato starch, rice starch, wheat starch, microcrystalline cellulose, dibasic calcium phosphate dihydrate, anhydrous dibasic calcium phosphate, colloidal silicon dioxide, magnesium trisilicate, powdered cellulose, talc, tribasic calcium phosphate, magnesium stearate, calcium stearate, canola oil, glyceryl palmitostearate, hydrogenated vegetable oil, magnesium oxide, mineral oil, poloxamer, polyethylene glycol, polyvinyl alcohol, sodium benzoate, sodium lauryl sulfate, sodium stearyl fumarate, stearic acid, hydrogenated vegetable oil, zinc stearate, polyv
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