Stabilized pharmaceutical composition
The invention relates to stabilized pharmaceutical composition comprising pregabalin and a disaccharide or higher polyol as stabilizer and optionally a conventional pharmaceutically acceptable carrier. The stabilized pharmaceutical composition according to the invention is useful in the treatment of a number of diseases such as epilepsy, Alzheimer's disease or Parkinson's disease.
1. A stabilized solid pharmaceutical composition, in powder form as a capsule filled with powder or as a tablet, suitable for oral administration, consisting of about 10% to about 99% by weight pregabalin and about 0.01% to about 75% by weight isomalt as stabilizer in an amount effective to stabilize the pregabalin against lactam formation, and optionally a pharmaceutically acceptable inert carrier.
2. The stabilized solid pharmaceutical composition for treating pain defined in claim 1 wherein pregabalin and isomalt are present in a weight ratio of 4.4:1 to 1:3.
3. A method of treating or preventing pain which comprises the step of orally administering to a patient in need of said treatment, a therapeutically effective amount of the stabilized solid pharmaceutical composition defined in claim 1 .
4. The stabilized solid pharmaceutical composition defined in claim 1 wherein pregabalin and isomalt are present in a weight ratio of 1:3.