Larry Augsburger - Severna Park MD, US Ngoc Do - Bel Air MD, US Min Michael He - Ellicott City MD, US Cheng Der Tony Yu - Baltimore MD, US
Assignee:
University of Maryland, Baltimore - Baltimore MD
International Classification:
A61K 9/14 A61K 9/50
US Classification:
424489, 424490, 424494, 424498
Abstract:
Novel methods for making dosages form comprising a cushioning component. The methods of the present invention provides dosage forms which can be compressed to form compressed dosage forms that are substantially uniform in composition and robust and exhibit reduced friability. The invention also relates to methods for making fast-disintegrating dosage forms.
Ngoc Do - Bel Air MD, US Cheng Der Yu - Baltimore MD, US Larry Augsburger - Severna Park MD, US
International Classification:
A61K009/20 D04H001/00
US Classification:
424/465000, 264/109000
Abstract:
The current invention relies on a process already provided in great detail in U.S. Pat. No. 60/437,507 and an associated CIP filed on May 23, 2003 and hereby incorporated by reference. However, it was noted during additional studies that if the Cushioning Beads™ were milled to a particle size between about 10 mesh and about 50 mesh and to a most preferred size of 30-40 mesh, the Cushioning Beads™ did not loose their ability to protect coated particles during compression, as would be expected because of the fine milling. Moreover, it was also discovered that tablets compressed from the milled Cushioning Beads™ immediately disperse in the mouth. A final advantage of the current invention is the improved hardness and friability. The invention produces a tablet of 2Kp or 20N hardness. A vast improvement because it allows for use of conventional manufacturing and packaging equipment.