Industry News May 2007

Dissolution Discussion Group Annual Meeting Dates Announced

It�s back! The Dissolution Discussion Group is pleased to announce its upcoming DDG Annual Meeting on September 13�14,2007.You�ve been posting online for years�now meet your dissolution colleagues face-to-face for two days of live,collaborative dialog in a free and open environment.

Mark your calendars and plan to join us September 13�14 in Research Triangle Park,North Carolina. The Annual Meeting will feature interactive scientific discussions on the latest regulatory issues in quality control,R&D challenges, and more. Sessions will be moderated by industry experts in the field of dissolution.

Primary session topics include:

Secondary and breakout session topics include:

Save the date to join us for a unique forum for dissolution discussion. Additional details to follow!

The Dissolution Discussion Group (DDG) is a free online, independent forum providing you an opportunity to anonymously discuss issues that challenge the industry and affect the day-to-day task of developing,performing,and validating dissolution tests and related chemical analyses� completely free of regulatory burdens.

“Developing Dissolution”

SOTAX Corporation (Horsham,PA,USA),SOTAX (Canada) Ltd. (Brampton,ON,Canada),SOTAX AG(Basel, Switzerland),and SOTAX China (Shanghai,China),the worldwide market leader and pioneer in USP Apparatus 4 Flow-Through Dissolution introduce to you: SOTAX Pharma Services. SPS is a unique Contract Research Organization based solely on one principle,Dissolution.

Dissolution is a characterization test used by the pharmaceutical industry to formulate the release properties of active drug from a dosage form,develop quality control specifications for the manufacturing process,and correlate with in vitro studies.With over 30 years of experience and innovation,SOTAX has manufactured the instruments needed by industry to develop a better understanding of dissolution.We at SOTAX are pioneers in Flow-Through Dissolution testing for novel drug formulations and specialists in automation for USP Apparatus 1 and 2.

SPS Pharma services brings to our product line another essential dissolution tool:system and method feasibility studies,method development and transfer to automation, and our expertise on development of methods and instruments for formulations including APIs,MR/ER tablets, medical devices and stents,microspheres,injectables, implants,and many more.

During development,dissolution time is precious.

Contact us today for a technical discussion: contact@sps-pharma.com

SOTAX announces Apparent Dissolution is now described in the European Pharmacopeia

SOTAX Corporation, (Horsham,PA,USA),SOTAX (Canada) Ltd.,(Brampton,ON,Canada) SOTAX AG(Basel, Switzerland),and SOTAX China, (Shanghai,China) the worldwide market leader and pioneer in USP Apparatus 4 Flow-Through Dissolution would like to inform you that apparent dissolution is now described in chapter 2.9.43 of the European Pharmacopoeia addendum 5.6.

The powder and granule flow cell that has been used to characterize the dissolution rate of pure active ingredients and compare differences between sources of APIs is now recognized as an official test to determine the apparent dissolution and increase the quality control of APIs.

For over 30 years,SOTAX has been developing USP Apparatus 4, flow-through dissolution with experts in academia and industry.The flow-through cell can give information during the whole life cycle of a dosage form, from characterization of APIs to the control of release characteristics of the final formulation. USP Apparatus 4 can be used for various cases in development,such as in the development of poorly soluble APIs,an open-loop configuration can be used,and for low dose or small sample size,a closed-loop,small volume can be set up.

Today,SOTAX brings its flow-through cell expertise and its 4th generation of systems,including the powder cell, to the new apparent dissolution market.

For more information or consultation on your API,please contact us at:

SOTAX Corp
USA
sotaxusa@sotax.com

SOTAX
Canada Ltd
sotaxcanada@sotax.com

SOTAX AG
Switzerland
sotax@sotax.com

SOTAX China
Shanghai
sotaxchina@sotax.com

CALIBRATED AIR SATURATION�TEMPERATURE PROBE

Laboratories that need quality control monitoring of gasfree distilled water (1) used in water baths,ultrasonic applications, or prepared aqueous media for dissolution testing can now add to their semi-automated systems a compact, simple,calibrated sensor that provides a scaled millivolt output proportional to the Total Dissolved Gas Pressure (TDGP) and also features a temperature sensor. Developed by Common Sensing Inc.,the compact probe,which can accept a 6�24 volt DC supply,can be directly connected to any data logging device with 0�1.0 volt input. Since it provides a scaled output of 1.00 mV/mm Hg and 10.0 mV/�C,it can be read accurately by any digital voltmeter or can be provided with its own digital display allowing both a dedicated display of TDGP/TEMP and sensor input for control of automated systems. Custom scaling in other pressure units is also available.The company�s owner first developed probes suitable for measuring TDGP electronically in the late 70s (2),and this direct sensing method has now become a standard method used extensively in aquaculture, environmental,and industrial applications (3).Most available equipment was designed for field use (4) and is either needlessly bulky and expensive for routine laboratory applications or lacks stand-alone probes that are easily read. The basic probe has been redesigned with SOIC technology to provide a compact laboratory TDGP/TEMPERATURE sensor. Recent dissolution studies (5,6) have revealed the importance of this measurement.

Common Sensing Inc.
P.O. Box 130
Clark Fork,ID 83811
(208) 266 1541
(208) 266 1428 FAX
(www.comsen.com)
sales@comsen.com

  1. Moore,T.W. Dissolution Testing: a fast efficient procedure for degassing dissolution medium. Dissolution Technol.1996, 3 (2), 3�5.
  2. D�Aoust, B. G.;White, R.; Siebold, H. Direct measurement of total dissolved gas pressure . Undersea Biomed.Res. 1975, 2, 141.
  3. Dissolved Gas Supersaturation. In Standard Methods for the Examination of Water and Wastewater, 17th ed.; Clesceri, L. S., Greenberg, A. E.,Trussell, R. R., Eds.; Am. Public Health Assoc.:Washington, DC, 1989; Section 2810A, pp 2�94.
  4. D�Aoust, B. G.; Clark, M. J. R. Analysis of Supersaturated Air in Natural Waters and Reservoirs. Trans.Amer. Fisheries Soc. 1980, 109 (6), 708�724.
  5. Gao, Z.;Moore,T.W.;Doub,W. H.;Westenberger, B. J.; Buhse, L. F. Methods of Dissolution Testing Effects of Deaeration in Aqueous Media: A Study Using a Total Dissolved Gas Pressure Meter. J. Pharm. Sci.2006, 95, 1606�1613.
  6. Nithyanandan, P.;Deng, G.; Brown,W.;Manning, R.; Wahab, S. Evaluation of the Sensitivity of USP Prednisone Tablets to Dissolved Gas in the Dissolution Medium Using USP Apparatus 2. Dissolution Technol. 2006, 13 (3), 15�18.

Distek, Inc.Announces the Release of a Small Volume Dissolution Kit for use with the Evolution 6300 Bath.

North Brunswick,NJ � April 1,2007 � Distek releases a new version of their small volume conversion kit for performing dissolution in volumes of less than 200 mL.This latest product employs detachable stirring elements for quicker conversion from paddles to baskets and can be installed on the Evolution 6300 running firmware version 2.15.The kit can also be used on any existing 2100 series of dissolution baths.

Distek is a leading manufacturer of pharmaceutical testing instruments that provide solutions for d\issolution, disintegration, friability,and hardness testing.

CONTACT:
Jeff Seely
Distek,Inc.
888-234-7835 phone
732-422-7310 fax
jeff.seely@distekinc.com
www.distekinc.com

Varian, Inc. launches the 400-DS Dissolution Apparatus VII, the first integrated, small-volume compendial apparatus for medical device testing

Cary,North Carolina,USA�Varian,Inc.,launched the 400- DS dissolution apparatus during the 2007 PharmaMedDevice Conference and Exhibition held April 24�26,2007,at the Jacob K. Javits Convention Center in New York City.

The 400-DS is a first-in-class product, the result of Varian�s ongoing commitment to inspiring excellence in the field of dissolution technology. Designed specifically for releaserate testing of medical devices such as drug-eluting stents (DES) and other combinatorial drug delivery devices,the 400-DS meets all compendial requirements of USP Apparatus 7. It provides a high level of automation,throughput, and convenience using PC-driven software that offers compliance with 21 CFR Part 11 guidelines.

Using media volumes ranging from 3 to 10 mL in 13 dissolution cells,the 400-DS brings an unprecedented level of efficiency to the release-rate testing of medical devices. Varian�s patent-pending magnetic reciprocation drive works with a variety of custom device holders,accommodating the most demanding drug-release applications. Bathless heating jackets surround the small-volume dissolution cells, and the evaporation covers ensure less than 0.2% volume loss,even when using aqueous�organic media,thus providing unmatched performance for extended dissolution testing runs.

We are confident that customers will appreciate the convenience and automation provided by our integrated fluidics module,which comprises a bank of syringe pumps, media replacement valves,and an integrated autosampler, all built into this small footprint dissolution apparatus.The 400-DS occupies approximately 35% less area on a lab bench compared to a traditional stand-alone Apparatus 7, not including the accessories such as fraction collectors and pumps.

The integrated autosampler of the 400-DS is capable of sampling at volumes of 1�4 mL into a 13�12 array of HPLC sample vials, for a total of up to 36 timepoints from each of the 13 dissolution cells. Filled vial racks from the autosampler can be removed for HPLC,UV,or other analyses during an extended dissolution run and replaced by empty ones.

The 400-DS Workstation Software runs on a single Windows-based PC and can independently control up to four 400-DS systems,providing flexibility,throughput, automation,and 21 CFR Part 11 compliance to laboratories conducting routine release-rate tests in a QC environment.

The 400-DS is a testament to Varian innovation in R&D and engineering,driven to better serve the needs of our customers in the pharmaceutical,medical device, and life science sectors.

For further details about the Varian 400-DS Dissolution Apparatus VII,please contact our Dissolution Hotline at 1- 888-826-5351,or email us at dissolution.hotline@varianinc.com

For more information on the complete line of industryleading dissolution systems offered by Varian, please visit www.varianinc.com