Inventors:
Howard L. Levine - Oceanside NY, US
William J. Bologna - Paris, FR
Philippe J. Cartier - Paris, FR
Dominique De Ziegler - Geneva, CH
Assignee:
Columbia Laboratories, Inc. - Livingston NJ
International Classification:
A61K 31/33, A61K 31/553, A61K 31/554
Abstract:
A bioadhesive controlled, extended release progressive hydration composition wherein the active ingredient may be protected from water or the surrounding environment, thereby protecting it from metabolism or from other degradation caused by moisture, enzymes, or pH effects, and making it bioavailable only at a controlled rate. The active ingredient may be protected from moisture during the manufacturing process, as necessary or desired, and more importantly may be protected from moisture and the immediate septic environment until well after the patient has applied the composition, and then only at a slow and controlled rate. It is by this process of progressive hydration that the active ingredient remains protected for many hours after administration. It is also by the process of progressive hydration that controlled and sustained release is achieved because only that part of the active ingredient that is the hydrated (aqueous) fraction of the composition is available for absorption (bioavailable).