478483 Characterization of Adipic Acid/PVP Mixtures Formed By Novel Evaporation and Extrusion Techniques: Comparative Study

Monday, November 14, 2016
Grand Ballroom B (Hilton San Francisco Union Square)
Katherine Warfel, Bucknell University, Lewisburg, PA, Katsuyuki Wakabayashi, Department of Chemical Engineering, Bucknell University, Lewisburg, PA and Ryan C. Snyder, Chemical Engineering, Bucknell University, Lewisburg, PA

Organic molecular particles play an important role in the pharmaceutical industry because they are a primary component in solid oral dosage forms, one of the most common forms of drug delivery. The production of these particles must be carefully controlled in order to create products that meet standards and have the desired performance. As research and development advances drug performance, the complexity of pharmaceutical molecules is increasing, leading to formulations that are more difficult to dissolve in the human body. These experiments study the importance of particle properties, including size, morphology (shape) and internal structure (arrangement of the molecules in the solid state). Internal structure and the crystalline/amorphous character of model formulations is the primary focus in these experiments due to the significant impact on solubility. In order to face this impending challenge, the pharmaceutical industry must explore new processing techniques to create soluble formulations using insoluble active ingredients. Multiple methods exist to induce a crystalline-amorphous transition, however because the need to increase drug solubility and therefore bioavailability is so great, novel methods are also being pursued.

Two of the most common methods used in the pharmaceutical industry to create amorphous materials from an active ingredient and a polymer excipient are spray drying and hot melt extrusion. These experiments will also test novel evaporation technology: vibrating orifice aerosol generation (VOAG), as well as novel extrusion technology: solid-state shear pulverization (SSSP). In this work, the goal is to compare the resulting properties of a sample small molecule/polymer mixture, Adipic Acid/Polyvinylpyrrolidone (PVP), formed via some of these processing technologies. Information on novel processing techniques can provide direct comparison to existing technologies and provide insight in material processing and characterization for increased solubility. Different formulations are tested across methods and the resulting materials are characterized using x-ray diffraction (XRD), differential scanning calorimetry (DSC), and scanning electron microscopy (SEM).

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