Inventors:
Ehab Hamed - Maple Grove MN, US
Lisa Hillman - Brooklyn Park MN, US
Rajendra Khankari - Maple Grove MN, US
Derek Moe - Maple Grove MN, US
Thanh-Tam Nguyen - Limeil-Brevannes, FR
Assignee:
CIMA LABS INC. - Eden Prairie MN
Cephalon France - Maisons-Alfort Cedex
International Classification:
A61K 9/26, A61K 31/135, A61K 31/165, A61K 31/426, A61K 31/445, A61K 9/16
US Classification:
424469000, 424490000, 514315000, 514370000, 514618000, 514646000
Abstract:
The present invention provides an orally dissolvable/disintegrable, lyophilized, dosage form adapted for direct oral dosing, including an active pharmaceutical ingredient (“API”) containing particle which is coated with a lyophilizing solvent protective coating, which protects the form and/or attributes of the particle and/or API, and a matrix. There is also provided a method of making an orally dissolvable/disintegrable lyophilized dosage form in accordance with the present invention, and a method of treating a patient with a dosage form in accordance with the present invention.