Industry News May 2005

Distek, Inc. Unveils the New VIP 4400 In-Situ Dissolution Vessel Washer at Pittcon

North Brunswick, NJ – February 28, 2005 – Distek, Inc has released the VIP 4400 in-situ vessel washer for the rapid draining and washing of dissolution vessels. The system is capable of processing up to 4 dissolution baths or 28 1 liter vessels before the waste tank requires emptying. The patent pending “Cyclone”wash nozzle assembly provides 360 degrees of direct wash and the spring loaded, self adjusting drain minimizes residual wash water.

Gerry Brinker, President and founder of Distek, Inc. says “The addition of an in-situ dissolution vessel washer to our product line is another example of how Distek products make the dissolution laboratory and the dissolution chemist more efficient.”

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


Distek, Inc. Release Mini-Intrinsic, Paddle Over Disk Apparatus

North Brunswick,NJ/Carrboro,NC – February 2, 2005 – Distek, Inc has released a Mini-Intrinsic Apparatus with a 2mm Die Cavity. The Mini-Intrinsic kit is ideal when limited raw material is available, material costs are prohibitive, and/or dissolution media volumes of less than 200mls are required. Use of the intrinsic kit requires a dissolution bath outfitted with a small volume accessory.

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


Salicylic Acid Calibration Media

Fort Collins, CO, April 21, 2005 – CHATA Biosystems now offers pre-mixed calibration media for Salicylic Acid. This dissolution media is a 0.05M phosphate buffer pH 7.40 ± 0.05 (tested at room temperature) manufactured for use in salicylic acid Dissolution <711> and Drug Release <724> found in the USP. This solution, ideal for IQ and PQ calibrations, comes packaged in CHATA's innovative, impermeable 100L CHEM+NECT™ bag technology placed inside a 30 gallon fiber barrel. The product eradicates frequent media preparation and inaccuracies in solution preparation.

The 100L barrel may be connected directly to an automated dissolution system, or can be dispensed into a carboy with an available pump accessory from CHATA.

For 5 years CHATA has manufactured a wide range of prepackaged solutions, specializing in off-the-shelf and custom manufactured solutions for the pharmaceutical industry.

For more information, please contact:

Customer Service
CHATA Biosystems
877-246-2428
customerservice@chatasolutions.com
www.chatasolutions.com


Novel Developments in Apparatus 4 – Flow Through Dissolution and Fiber Optics, Workshop and Seminar

SOTAX USA- Horsham, PA: On June 29 and 30th 2004, the SOTAX Corporation in conjuntion with Delphian Fiber Optics hosted the first Seminar and Workshops series in the USA on recent and innovative developments in the use of Apparatus 4 – Flow through dissolution for the rate of drug release testing. Apparatus 4 has gained recent acceptance into the dissolution world for its versatility in the testing of novel dosage forms where traditional dissolution apparatus and methods have failed. Dosage forms including poorly soluble and extended release tablets, drug eluting stents, microspheres, suspension and injectable formulations, implants, soft-gel capsules, and powders all have provided exciting results and a solution to the troubles associated with traditional dissolution methods.

Highlights of the seminar included Steve Mayock (Cardinal Health), who addressed method development issues associated with Apparatus 4; new developments in the work of Dr. Diane Burgess (University of Connecticut, School of Pharmacy) with Apparatus 4 and fiber optics to detect the release of drug from microsphere formulations; Lancaster Laboratories and their work on the validation and calibration requirements of flow through dissolution; Dr. Saeed Qureshi (Health Canada) and his work on poorly soluble products, Jack Hu (Amgen) and his successes with a unique flow cell for gel caps containing oils; the discussion of the usefulness of Apparatus 4 for IVIVC studies and biological modeling; and Dr. Tahseen Mirza (Novartis) and Ellen Pacewicz (Johnson and Johnson), who shared their experiences with the use and advantages of the Delphian Fiber Optic Dissolution system.

Highlights of the workshop included Dr Eric Beyssac (University of Auvergne,Clermont-Ferrand, France, School of Biopharmaceutics) and his case studies with low solubility products, multi-particulate dosage forms, pH sensitive release products, successes with the dissolution of powders, API's, implants, emulsions and suspensions, and new work on microcapsules and nanocapsules.

If you are interested in receiving information on upcoming USP 4 Workshops, please send us an email at sotaxusa@sotax.com

SOTAX is a global leader in pharmaceutical testing technology and a pioneer in flow through dissolution. With locations throughout the world, our US facilities include conference rooms for special technology seminars, an application laboratory and the headquarters for our Service Department. Choose from our fully automated or semi-automated dissolution systems for Apparatus 1, 2 and 4 (Flow through dissolution) controlled by our fully CFR Part 11 compliant dissolution software,WinSOTAX. New products include automated hardness Testers, disintegration, friability, and powder flow testers. Call 1-888-302-9925 for a free catalogue.


Hellma GmbH in Müllheim (Germany) with Dual Leadership

Lutz Mayer was appointed as Managing Director of Hellma GmbH & Co. KG at the beginning of this year. Together with Lothar Mayer, he is now guiding the fortunes of this medium-sized company in the south of Germany.

After having completed his degree in physical technology and some years working in different optical companies, he joined the family-owned enterprise Hellma in 2000. After a period to allow thorough adjustment to the new job, he assumed the position of Technical Manager two years ago. “Lutz Mayer was in charge of important projects from the beginning and he has importantly contributed to the fact that we were able to enlarge Hellma's market position”, Lothar Mayer points out, going on to add,“The clarification of the succession in management at an early stage was very important to me.”

Hellma GmbH & Co. KG has been producing high precision cells and flat optics made of glass and quartz for over eight decades. At the beginning of the nineties another rapidly growing sector was added to the product range and has been continually expanded ever since: the range of fibre-optical systems.

Picture shows Lutz Mayer on the left hand side, Lothar Mayer on the right hand side.