Fiber optic dissolution is the quicker, more reliable alternative for large or difficult data sets.
Traditional dissolution testing is conducted by manually removing samples from dissolution vessels and bringing the samples to a UV spectrometer or HPLC for testing. With fiber optics, real-time drug release level is determined in-situ or in the vessels without sample removal. The labor-intensive manual sampling procedure is eliminated and the testing procedure is simplified.
It is more economical because consumables for sampling, such as pipettes, syringes, sippers, tubing, and filters, are not needed. In addition, fiber optics can generate more frequent data points and produce a more detailed dissolution profile, which may be beneficial for showing a method’s discriminating ability.
With over 15 years on the market, Pion’s Rainbow fiber optic technology is the benchmark of reliability. Ten out of ten of the top pharmaceutical companies use Rainbow fiber optic technology for their in-situ UV monitoring needs. It has programmable data collection of the entire UV Spectra as fast as every 2 seconds from any type of dissolution vessel, vial or chamber. Rainbow fiber optic technology is a flexible and reliable tool for determining the rate of release of a drug substance over time.
Benefits of Fiber Optics
Fiber optic dissolution has been proven to be the less expensive and time consuming method of dissolution testing for large and complicated data sets. It's benefits include:
Traditional dissolution testing is labor-intensive and time consuming. With fiber optics, more samples can be tested in less time, saving both time and money and eliminating the need of using a subset.
Fiber optic technology gives you the ability to collect data for a product or solution that you could not have collected otherwise. Because fiber optic dissolution testing has a faster turn-around, you can analyze all samples instead of using a subset and get a clearer picture of the full data. Fiber optics can also generate more frequent data points and produce a more detailed dissolution profile.
Fiber optics provides more data and a clearer picture of the dissolution profile faster, allowing you to make better informed decisions on which direction to go with your product or solution.
Fiber Optic Applications
Fiber optic in-situ UV monitoring can be used for anything that traditional UV monitoring solutions can be used for. Applications include:
- Small volume dissolution – tablets and powder
- Excipient screening
- Nanoparticle dissolution
- Salt screening
- Intrisic dissolution
- Media pH change
- Stability monitoring
- Supersaturation studies
- Solubility – Aqueous and Non-Aqueous
- Biorelevant dissolution media
- Rank order intrinsic dissolution
- Detect polymorphic changes
- Follow stability profiles
- Track supersaturation effects
- Determine equilibrium solubility
- USP and EU dissolution
- Dynamic media change
- And more
If you have any questions about other fiber optic applications, Contact Us.
- Up to 8 channels with dedicated PDA for each channel
- Programmable data collection of the entire UV Spectra (200-720 nm) as fast as every two seconds
- Linear range up to 2.0+ A.U.
- Simultaneous real-time data collection and analysis in a user-friendly graphical software
- Durable stainless steel dip probes with variable path lengths
The Rainbow Dynamic Dissolution Monitor (RDDM®) is a powerful analytical instrument that accurately and efficiently measures percent dissolved data in real time.
The µDISS Profiler™ is specially designed to monitor small volume concentrations. Powered by AuPRO™ software, the most comprehensive data analysis software available in the industry, the µDISS Profiler™ evaluates the various effects on solubility, intrinsic disc dissolution rate, dissolution profiles, super-saturation, precipitation profiles, and more.
The Latest in Pion’s Comprehensive Monitoring Software
AuPRO™ 5.1 brings Pion’s fiber optic users advanced tools for the analysis of kinetic solubility and dissolution. Addressing the needs of today’s drug development scientists, AuPRO™ 5.1 provides exciting new ways to analyze data:
- Implementation of ZIM (Zero Intercept Method) for Dual Component Analyses—An application of second derivative spectroscopy to account for the presence of two different absorbing components within the same matrix
- Two Component Concentration Monitoring—Enabling multiple standard curves to be utilized for the analysis of dual component systems
- Spectral Shape Analysis—Detection of Spectral Changes Between Standard and Sample Spectra due to pH, degradation, or other chemical in situ phenomena
- Media Change Manager with Volume Tracking vs. Time—Allows for a single data file to have multiple media addition steps while accurately calculating concentration and % dissolved
- Reference and Blank Channel Designation—Accounts for changes in molar absorption related to peak shifting, media change, or any other chemical change in a drug substance
Pion is proud to collaborate with Hanson Research to offer fiber optic dissolution monitoring for dissolution labs around the world. Hanson Vision® G2 dissolution testers are designed with over 60 years of dissolution expertise and know-how. The modular design is plug-and-play ready making these systems upgradeable or automated without the need for separate firmware. They come standard with a full color touchscreen and intuitive menus, giving users the confidence of precision control for speeds 25-250 rpm and temperature 25-55 °C. Powerful programming, backed by a robust security system for 25 users, features the ability to create up to 100 unique protocols that can be conveniently transferred by flash drive to other Vision G2 testers, resulting in higher throughput and sample analysis. For more information about these instruments, please visit hansonresearch.com/dissolution-testing.
Hanson Research is a global technology company that specializes in analytical test instruments for the pharmaceutical industry. Founded by the innovator of modern dissolution test technology, Hanson Research helps ensure the world’s pharmaceuticals are pure, safe, and effective by manufacturing equipment that sets the global standard for quality, innovation, and long-term value. Hanson instruments are used by scientists in over 75 countries worldwide and are supported by the industry’s top customer service team. For more information, please visit hansonresearch.com.