Effects of Pharmaceutical Excipients On Particle Crystallization

Effects of Pharmaceutical Excipients on Particle Crystallization

Anna K. Maassel

Advisor: Ryan C. Snyder

Department of Chemical Engineering

The need for new and more efficient active pharmaceutical ingredients is a modern dilemma researchers and pharmaceutical companies are working to improve. Once a new active pharmaceutical ingredient (API) is created, it is often difficult for the body to absorb it because many new APIs have a low solubility in the digestive system. One way to increase a drug's solubility is to produce the drug in its amorphous form instead of its naturally forming and more stable crystalline form. Producing an amorphous form of a drug is more difficult than producing its crystalline form, and often requires extra processing steps such as grinding, melting, and freeze-drying. It would be beneficial to be able to produce an amorphous drug without these extra processing steps. This research investigates the effects of known drug additives on crystallization of an organic molecule, succinic acid. A Vibrating Orifice Aerosol Generator (VOAG) is used to produce a monodispersed sample of particles dried from solutions of succinic acid and an additive. Scanning electron microscopy is used to analyze particle size, morphology, and surface characteristics. X-Ray diffraction is used to analyze the internal structure of the particles. In this work, we show that while the additive mannitol did not have an effect on the crystallization of succinic acid, it was observed that succinic acid did have an effect on the crystallization of mannitol. SEM images of particles containg PVP (another additive) and succinic acid suggest that PVP has more potential to effect succinic acid's crystallization as compared to mannitol. It would be beneficial to continue this research, and to also test more additives.