Pharma Test and Fraunhofer IME Announce the Dispersion Releaser – a New Solid Testing Apparatus for Nano- and Microformulations

Pharma Test and Fraunhofer IME Announce the Dispersion Releaser – a New Solid Testing Apparatus for Nano- and Microformulations

Frankfurt a.M. / Hainburg, Germany – Oct 2018 – The Fraunhofer Institute for Molecular Biology and Applied Ecology IME together with the Goethe University Frankfurt/Main and Pharma Test has developed the new Dispersion Releaser apparatus (PT-DR) for a standard dissolution tester to provide a solid system for the release testing of nanomedicines, microformulations and semi-solid dosage forms.

Nanomedicine is on the Rise

Nanomedicines have emerged on a worldwide scale. A huge benefit of the application of nanotechnology in medicines is their mode of operation: The dissolution of the active pharmaceutical ingredient (API) is much quicker. Thereby the amount of API can be less compared to conventional drug formulations and thus be more efficient. Nanocarrier technology even controls the target site where the drug substance is released which is leading to remarkable efficacies in cancer therapy.

A Growing Need for Reliable Standard Procedures

Since a rising number of pharmaceuticals and medical devices take advantage of nanotechnologies, there is a growing need for procedures assuring their quality and safety. Until today there is no international regulation for the release rate test (dissolution test) of nanomedicines. Authorities are currently working on new monographs for standardized nanomedicine quality control tests. The standard dissolution apparatuses such as USP 1 (Basket) and USP 2 (Paddle) are not suitable since the nanomedicines usually dissolve too fast. Other techniques, such as the “dialysis membrane bag” method and the USP 4 method, have been shown to be problematic because so called “membrane clogging” occurs frequently. The transport of the API through the membrane is affected and therefore the dissolution rate of the drug is shown to be inaccurate.

“In our trials we could already prove that by using the Dispersion Releaser you’ll get much more reproducible results compared to the currently used methods. We have seen remarkable outcomes with liposomes, micro and nanoparticles and will now explore more applications of this disruptive technology in formulation development and quality control.”

Dr. Matthias G. Wacker, Fraunhofer IME / Goethe University Frankfurt/Main

Developing the Dispersion Releaser PT-DR

For this reason the Fraunhofer IME together with the Goethe University Frankfurt/Main under the leadership of Dr. Matthias G. Wacker developed the Dispersion Releaser technology. With Pharma Test, a global leader in the field of testing equipment for the pharmaceutical, food and cosmetics industry, they found an ideal associate to improve and distribute this new development for the international market. The Dispersion Releaser (DR) technology is a dialysis-based device to test the dissolution rate of dispersed dosage forms using a standard USP apparatus 2 tablet dissolution bath. Wacker was recently appointed an associate professor at the National University of Singapore where in an international collaboration more applications of this new technology will be explored.

Dispersion Releaser with all of its components (left) and separated into its removable parts (right)

An Ideally Designed Apparatus for the Release Testing of Nanomedicines

The Dispersion Releaser is composed of a sample holder cell serving as the donor compartment. A dialysis membrane is attached around this housing. This donor chamber is agitated by a paddle stirrer that is connected to the USP apparatus 2. The propulsion is transmitted to a magnetic stirring device in the acceptor compartment agitating the medium at the same rate. This specific design allows controlling the shear forces applied to the nano-formulation while achieving a more rapid membrane transport compared to other setups. The Dispersion Releaser can also be used to check the release rate of semisolid and other dosage forms in a much more reproducible way compared to other dissolution apparatuses.

The Dispersion Releaser introduced at ACHEMA 2018 in Frankfurt/Main by Pharma Test

Dispersion Releaser in different vessel configurations inside a PTWS dissolution testing instrument
Dispersion Releaser in a dissolution tester with its donor compartment filled with a colored suspension and separated by a membrane from the acceptor compartment

Dispersion Releaser in different vessel configurations inside a PTWS dissolution testing instrument

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Compatibility and Availability

The Dispersion Releaser PT-DR is compatible with all Pharma Test PTWS dissolution testers but also with most common dissolution testers on the market. The PT-DR is available for test trials and sale through the Pharma Test distribution network. For more information contact Pharma Test.

About Fraunhofer IME

The Fraunhofer Institute for Molecular Biology and Applied Ecology IME conducts research in the field of applied life sciences from a molecular level to entire ecosystems. Our interdisciplinary organization and laboratories with most recent equipment allow a wide spectrum of research and development services in the divisions ʺMolecular Biotechnologyʺ, ʺApplied Ecology and Bioresourcesʺ and ʺTranslational Medicineʺ. Translational Medicine and Pharmacology covers a wide spectrum of research and development services in the area of formulation development, preclinical and clinical research. It has close affiliations with the Institute for Clinical Pharmacology of Goethe University Hospital in Frankfurt/Main . Applications of the Dispersion Releaser technology are explored in an international collaboration between Fraunhofer IME and the Department of Pharmacy of the National University of Singapore.

About Pharma Test

Since almost 40 years Pharma Test has been a worldwide household name for the development and production of high-value test devices and systems for the quality control in the pharmaceutical, food and cosmetics industry as well as for universities and public authorities. We offer a complete product range from manual instruments for physical testing to fully automated online dissolution testing systems to analyze the active chemical composition of a dosage form as well as its release rate. With our “Made in Germany”-label “The German Gründlichkeit” you can expect well thought-out, long-lasting, user-oriented products and solutions.

Contacts

Fraunhofer Institute for Molecular Biology and Applied Ecology IME / Goethe University
Department Pharmaceutical Technology and Nanosciences: Dr. Matthias G. Wacker matthias.wacker@nanomedicines.de
Max-von-Laue-Str. 9, 60438 Frankfurt/Main, GERMANY
T: +49 69 798-29691
www.ime.fraunhofer.de
www.nanomedicines.de

Head of Product Management:
Dr. Dirk Beilke d.beilke@pharma-test.de,
sales@pharma-test.de

Press Contact:
Ms. Oanh Hoang o.hoang@pharma-test.de,
marketing@pharma-test.de

T: +49 6182 9532-600 (central)

Publications:

PT-DR

PT-DR

Dispersion Releaser – Release Apparatus for Nano- and Microformulations

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