HIGUCHI INC. Product Lineup

The dissolution tester 708-DS features one-touch centering with the TruAlign vessel, and its design minimizes the risk of misalignment after installation, reducing the risk of failure during mechanical calibration. It supports Japanese language, has a two-piece paddle, and significantly improves basic operability with an expanded space between the drive unit and the vessel plate. It accommodates a wide range of dosage forms for dissolution testing, including tablets, capsules, rotating cylinders, and the paddle-over-disk method.

The 280-DS MQS measures the parameters of mechanical calibration of dissolution testers with high precision. Measurement is done hands-free thanks to sensor technology, taking only about 30 minutes per unit. It complies with 21 CFR Part 11. ★ Mechanical calibration has been included as reference information in the 17th edition revision. "To aim for reduced variability in test results through mechanical calibration, it is recommended to apply this reference information." (From the 17th Japanese Pharmacopoeia revision "Standard Methods for Mechanical Calibration of Dissolution Testers")

■Efficiency Automation enables easy and quick sampling. It eliminates the labor involved in dissolution testing and prevents variations in sampling volume and position that would be difficult to manage manually. All functions, including the pump, filter (optional), and sampler, are integrated into a device just 39 cm wide. One filter plate used for sample filtration contains the equivalent of eight 0.45 μm filters. ■Flexibility In addition to the standard pump function, you can select filter functions according to your needs. Sampling can accommodate test tubes, HPLC vials, and well plates. ■Accuracy The rotary piston syringe pump ensures precise sampling of the specified amount at designated sampling points. Uniformity The color touch panel of the 850-DS allows for input of the dissolution test program. ■Test Results Test data can be printed using the built-in printer.

The Cary 60 spectrophotometer, when combined with a pump in an online UV system, along with the sampling station 850-DS, allows for filter filtration and simultaneous sampling into test tubes or HPLC vials after filtration. **Evaluation Method for Drugs in Dissolution Testing Using Fiber Optics** Using fiber optics enables direct quantification of drugs within the vessel without the need for sampling. For example, when using fiber optics in dissolution testing for the evaluation of crystallization suppression of solid dispersions aimed at improving solubility, detailed dissolution profiles can be obtained through measurements at short intervals, as no sampling is required.

OD-mate was developed for the automatic measurement of disintegration time of orally disintegrating tablets. The testing device is a compact and cost-effective solution. The development of this product was made possible with the cooperation of Kyoto Pharmaceutical Industry Co., Ltd. Additionally, using the small taste recognition device SA501C from Intelligent Sensor Technology Co., Ltd., it is possible to measure the bitterness intensity of solutions measured for disintegration time with OD-mate.

The manual sampling of the dissolution tester typically uses a cannula. The cannula is submerged into the vessel, and the sampling zone is confirmed visually. However, visual work is cumbersome for confirmation, and it is not easy to sample accurately and reproducibly. By using the Agilent manual sampling bracket, the hassle of visual confirmation for the operator is reduced, allowing for manual sampling that enhances the accuracy and reproducibility of the sampling zone.

The Nano Dis system is a new option that uses conventional dissolution testing equipment. Currently, many new drug candidates are poorly soluble compounds, and improving the solubility of these compounds is important. One attractive solution for improving solubility is nanoparticle formulation. To facilitate the selection of compounds in nanoparticle development, an efficient dissolution testing method is necessary. In the current dissolution testing systems, insufficient filtration of nanoparticles from the test solution leads to variability in test results, resulting in unreliable outcomes. The Agilent NanoDis system addresses these issues and provides researchers with accurate dissolution profiles of active pharmaceutical ingredients through an automated system. This functionality allows researchers to optimize nanoparticle formulations more quickly and bring them to market faster. The automated process yields consistent and reliable dissolution test results for nanoparticle formulations.

Automation of the Agilent Dissolution Tester 708-DS and Sampling Station 850-DS using a robotic arm. Cleaning of vessels, paddles, sampling cannulas, and DDM, injection of test solution into vessels, and sample set into DDM. Supports automation for up to 8 batches. The robotic arm completes its tasks in almost one minute without affecting the dissolution test. Cleaning solution and test solution are stored in internal tanks. Waste liquid is discharged externally from a dedicated port.