036

Title:

EFFECT OF SOLVENT ON THE CRITICAL QUALITY ATTRIBUTES IN ORAL FILM MANUFACTURING VIA SOLUTION CASTING

Discipline: Chemical Engineering

Presenter:

Eylul Cetindag

Abstract:

Oral films are now emerging dosage form for drug delivery considering their advantages over other solid dosage forms such as patience compliance and continuous manufacturing. There are three main film manufacturing methods, namely, hot melt extrusion (HME), solution casting and slurry casting. HME and solution casting are mostly used techniques since they allow higher dissolution rate due to amorphous form of the drug. However, by the nature of amorphous state, it is not stable and needs formulation optimization for each drug. Different from the studies in the literature, rather than polymer type, here, we have investigated the effect of solvent on the critical quality attributes of oral films using solution casting. The feasibility of solution casting with a binary solvent system was experimentally examined using HPMC E15 as a film former, glycerin as a plasticizer, fenofibrate as a BCS class II model drug and different organic solvents namely ethanol, methanol, acetone and dichloromethane. We systematically explored content uniformity, mechanical properties, and dissolution rate of films. To the best of our knowledge, this is the first report presenting the films prepared with different organic solvents led different properties while improving the dissolution rate compared to the as-received crystalline drug. It is demonstrated that this behavior is related with the crystallinity of the drug in the film. Solution cast films had good uniformity, despite the re-crystallization of drug. However, solution casting has considerable manufacturing problems starting from polymer solution preparation to drying indicating the need for process optimization for each drug.

Author(s):

Eylul Cetindag, John G. Pentangelo, Thierry Arrieta Cespedes, , Rajesh N. Dave

Funding Acknowledgements:

Financial support from the National Science Foundation through grant EEC-0540855 as well as National Institutes of Health through grant U01FD005521 is gratefully acknowledged.