A Green Solution for the Dissolution Laboratory That Also Saves Money

Patrick Mahn
Validation Services and Analytical Support Manager
Distek, Inc., 121 North Center Drive, North Brunswick, NJ 08902
732.422.7585, fax 732.422.7310

In today's business climate, where maximizing shareholder equity and conserving capital is a top priority, going "green" can be difficult, especially if the project increases the overall cost of doing business. Unfortunately, when business conditions are difficult, many environmentally friendly initiatives and other peripheral programs not deemed critical to the performance of the business are some of the first to be put on hold or abandoned altogether. Fortunately, several solutions from analytical instrument suppliers offer cost and time savings that are environmentally friendly as well. A bathless dissolution system is one such solution for the dissolution lab.

One method of saving money and reducing a company's carbon footprint is to decrease the amount of electricity that a lab consumes in its day-to-day operations. When an instrument with equal or superior performance capabilities requires less electricity than other instruments that perform the same function, serious consideration should be given to using the more energy-efficient instrument. With USP Apparatus 1 and 2 dissolution testing, a "traditional" water-bath system is used to heat the vessels and the medium contained within them. A bathless dissolution unit consumes less than half of the electricity while offering similar or superior performance to that of a water-bath system. A substantial amount of money may be saved on electricity in a dissolution lab by simply changing the type of dissolution tester.

The Distek Evolution 6100 Bathless Dissolution Test System (EVO 6100) is the second generation of the patented bathless system first offered by Distek in 1996. In this study, the EVO 6100 was tested against four common brands of bath-based dissolution systems. In energy consumption tests, water-bath systems typically consume at least twice that of the EVO 6100. In the studies conducted for this article, two typical operating scenarios were considered, the time and power consumed during a 24-h dissolution run and the power consumed by the equipment between runs.

When a bath-based dissolution tester is not being used to execute a run, the thermocirculator is typically left running to maintain the temperature of the water bath; this consumes energy. Even if the bath is turned off between tests, it uses comparatively large amounts of electricity to re-heat several gallons of water to 37 °C, whereas the EVO 6100 has no such requirement, making it more energy efficient.

Below are the results from two power-consumption studies involving typical operating scenarios. The studies were conducted using an Energy Consumption Monitor/ Logger, Model ECM-1220 by Brutech. The baths were manufactured by various suppliers including Distek, Inc.; Varian, Inc.; and Hanson Research.

SCENARIO #1

Performing a Dissolution Run

In this scenario, four common brands of bath-based dissolution systems were heated with their vessels in place but without medium. The thermocirculator temperature was set to 37 °C, and when the bath temperature reached its set point, 900 mL of room-temperature medium was added to the vessels. The time required for the various bath-based systems to reach the set point temperature ranged from 30 to 55 min. The temperature of the medium in the vessels was allowed to heat up with the paddles stirring at 100 rpm. Once all of the vessel temperatures were 37 ± 0.2 °C, a 24-h dissolution run was executed. The vessels were covered and maintained at a temperature of 37 °C for the duration of the test.

The EVO 6100 was also programmed to run a 24-h test at 37 °C with paddles stirring at 100 rpm. Because there is no water bath to heat up, the vessels were filled with 900 mL of room-temperature medium, covered, and the method program was initiated. For the EVO 6100, there was approximately 10�12 min of preheat and equilibration time. At equilibration, the 24-h program was started.

Table I shows the power consumed by four typical baths and the Distek EVO 6100.

SCENARIO #2

Between Dissolution Runs

When bath-based systems are not performing a dissolution run, they are typically left on with the thermocirculator heating and water circulating in the bath. They can also be turned off when not in use, but would have to be reheated when turned on again. The amount of energy required to reheat the water in the bath is shown in the first row of Table I. Table II shows the amount of power used to maintain the bath temperature for a 24-h period with empty vessels secured into the vessel plate and without any vessels in place.

Some of the variances in power consumption of the different brands of dissolution baths are due to the size of the bath and the volume of water it holds. The higher the volume of water, the greater amount of energy that is required. Another factor that can affect energy consumption is the water circulation within the bath. A higher flow rate generally results in a more consistent temperature throughout the bath, but may consume more power for pumping the water. Lastly, the temperature in the lab itself will make a difference in the efficiency of a bath-based system. When water-bath systems are in a cooler environment, they require more power to maintain the proper temperature.

CONCLUSION

It is clear that operation of a water-bath-based dissolution system requires, on average, twice the power of a bathless dissolution system. Now that the industry and the global community are cognizant of the need to conserve resources and work "green," the Distek EVO 6100 bathless dissolution unit is an obvious choice for the planet and the bottom line.

Hanson Presents the ADD™ Dissolution Vessel Cover for Automatic Dosage Delivery

Los Angeles, CA, April 9, 2009?Hanson Research Corp., a world leader dissolution test technology, now offers the Add™ (Auto-Dosage Delivery Cover, ideal for suspensions, solid dosage forms, and sinkers. "The Hanson ADD Cover is a newly designed dissolution vessel cover," explains Hanson CEO, Roy Hanson, "providing ease of use, sample probe ports, evaporation control, and an innovative dosage delivery device�al built into one cover." The ADD Cover, which is manufactured from rugged PVC material, incorporates a convenient hinge for easy placement and removal. The unique ADD delivery mechanism can be triggered by finger-touch (ideal for manual sampling and staggered start times) or automatically on the Vision� Elite 8™ with Auto-Mag™.

The Hanson ADD™ Cover is available for either the Hanson SR8-Plus™ or Vision dissolution testers. For more information, please visit hansonresearch.com

Hanson among First Worldwide to Earn ISO 9001:2008 Certification

Los Angeles, CA, February 2, 2009?Hanson Research Corp. proudly announces their ISO recertification through January 2012 by the National Standards Authority of Ireland (NSAI). Hanson's recertification was held to the new ISO 9001:2008 standard, which was officially published November 15, 2008.

"Hanson essentially made the transition to ISO 9001:2008 at the same time the new standard was published," explains Dave Walker, Hanson's Quality Manager & ISO Management Representative. "This certification shows our continued commitment to quality and the latest developments in ISO in order to better serve our customers."

For more information on Hanson's quality program, please visit hansonresearch.com

About Hanson

Hanson Research is a world leader in dissolution test technology for the pharmaceutical industry. Founded in California in 1951, we design, manufacture, install, and service equipment for pharmaceutical research and quality control. We offer a complete line of tablet dissolution, topical, and transdermal test systems and premiered our Vision® dissolution testers in March 2008. We support customers throughout the United States and over 75 countries worldwide.

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pION INC launches the Mini-BathTM™, an eight-place temperature-controllable sample holder with computer programmable stirring, for use with the μDISS Profiler™

pION INC announces the launch of its 8-position Mini-Bath as an integral part of the best-selling fiber-opt detection system, the 8-channel μDISS Profiler. This desig is a continuation of improvements brought about by suggestions from our users of the 6-channel Mini-Bath. The two extra channels offer additional possibilities in experimental design, such as inclusion of a permanent standard or more pH-points in case of dissolution/pH profiling, or more points for profiling of stirring or media effects.

The Mini-Bath allows dissolution experiments to be performed in solution volumes as low as 1�25 mL in simulated or even human intestinal fluids at a time in the drug-development process when only small amounts of API are available. Accessories are available for both powder and rotating-disk intrinsic-dissolution experiments, which both have been shown to perfectly correlate with data from large volume (250�900 mL) experiments used in later development stage dissolution tests.

The computer-controlled stirring of the Mini-Bath provides fully independent stirring control for all eight sample positions. Stirring can be initiated manually, automatically, or with any combination of the two schemes. This allows complete flexibility in the design of experiments, so that even dissolution tests of different APIs can be conducted within the same run.

In addition, the redesigned probe holder features a longer slot for easier and more accurate probe alignment.

"Some of the best product ideas and improvements come from dedicated customers who use our equipment," said Alex Avdeef, CSO and co-founder of pION. "We take the time to consider their suggestions, refine and implement them. We're happy to provide this improved version of the Mini-Bath, which demonstrates our commitment to our customers and our technologies to make even more reliable absorption-related measurements possible. We take pride in our unique technical position as the industry respected experts in the 'A' of ADME."

pION has been granted U.S. and foreign patents on the dynamic in situ data acquisition and presentation along with a patent for hollow-shaft measurement.

About pION INC

pION INC offers ADME-related analytical tools to the pharmaceutical and biotechnology laboratories: instruments, supplies, reagents, software, and contract services. Excipient screening is based on the patented solubility/permeability μSOL/PAMPA Evolution� manual and robotic platforms. Patented in situ fiber-optic UV/vis-based dissolution monitoring systems: the μDISS Profiler� for preformulation/delivery research and the Rainbow Dynamic Dissolution Monitor� detection system for time-savings in R&D/QC solid dosage forms testing.

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