Quartz crystal microbalance technique for analysis of cooling crystallization.

A quartz crystal microbalance (QCM) technique is developed for the in situ analysis of the cooling crystallization processes of crystal nucleation and growth. In contrast to conventional techniques based on property changes in the solid or solution phase, the proposed QCM technique simultaneously exploits property changes in both the solid and solution phases, such as the solid mass and liquid viscosity, to analyze the crystallization processes. When initially cooling the solution, an increase in the solution viscosity is reflected in the QCM responses for the resonant frequency and resonant resistance.

Polymorphic and kinetic investigation of adefovir dipivoxil during phase transformation.

To search polymorphs of adefovir dipivoxil (AD), the polymorphic transformation approach in solution was developed. Also, the kinetics of polymorphic transformation was investigated to effectively control polymorphs. The AD crystals were obtained by crystallization at -10°C, and then the polymorphic transformation was induced by raising temperature.

In-line monitoring and interpretation of an indomethacin anti-solvent crystallization process by near-infrared spectroscopy (NIRS).

PAT (process analytical technology) has been emphasized as one of key elements for the full implementation of QbD (quality-by-design) in the pharmaceutical area. NIRS (near-infrared spectroscopy) has been studied intensively as an in-line/on-line monitoring tool in chemical and biomedical industries. A precise and reliable monitoring of the particle characteristics during crystallization along with a suitable control strategy should be highly encouraged for the conformance to new quality system of pharmaceutical products.

Polymorph transformation in paracetamol monitored by in-line NIR spectroscopy during a cooling crystallization process.

The reliable in-line monitoring of pharmaceutical processes has been regarded as a key tool toward the full implementation of process analytical technology. In this study, near-infrared (NIR) spectroscopy was examined for use as an in-line monitoring method of the paracetamol cooling crystallization process. The drug powder was dissolved in ethanol-based cosolvent at 60°C and was cooled by 1°C/min for crystallization.

Preparation and characterization of salmon calcitonin-sodium triphosphate ionic complex for oral delivery.

Even though salmon calcitonin (sCT) has been known as a potent hypocalcemic agent, only injection or nasal spray products are available on the market. In order to develop oral delivery system of the agent, a novel sCT-sodium tripolyphosphate (STPP) ionic complex was fabricated and also characterized. For the optimization of the ionic complexation, the effect of incubation time and molar ratio between sCT and STPP was evaluated.

Dynamic calibration for the in-line NIR monitoring of film thickness of pharmaceutical tablets processed in a fluid-bed coater.

NIR spectroscopy has been extensively employed for the in-line monitoring of pharmaceutical processes as one of the key PAT implementation tools. Nevertheless, pharmaceutical processes such as fluid-bed coating have not fully made the most of the NIR in-line monitoring primarily due to a difficulty in handling random in-line spectra. In this study, novel approaches to develop a reasonable dynamic calibration model were proposed; averaging and clustering.