Authors: Linas Mockus, Jose Lainez, Gintaras Reklaitis, Carl Wassgren, Kristine Alston, Ann Catlin

Nowadays, scientific collaborations are considerably growing and all forms of cyber-infrastructure are often used to tackle a single complex problem. To sustain and exploit this movement, the establishment of long-term community-wide hubs has been envisaged. Here, a Hub deployed to support knowledge sharing and scientific collaboration for pharmaceutical science and engineering, the pharmaHUB.org, is presented.

As an example of global scientific collaboration a database of excipient properties which is implemented on pharmaHUB will be discussed. Excipients are the non-pharmacologically active portion of the dosage form and are used in virtually all drug products. An excipient may fulfill various functional purposes depending on its use in a formulation and manufacturing process. The chemical and physical properties of excipients are critical to manufacturing, stability, and performance of drug products. However, not all the critical properties have been identified and specified in the compendial standards.

Generally, excipients are derived from natural products, synthetically modified natural products, or completely synthetic, and they are available from a multitude of sources. As a result, their properties may vary from lot-to-lot, vendor-to-vendor, and occasionally even within a lot. It is variations like these that are often at the root of production problems and failures that emerge unpredictably during the life cycle of a drug product.

The objective of database is to provide manufacturers and regulators better information concerning excipient property variation. A variety of property measurements, such as particle size distribution, powder flowability, and compact elastic modulus, will be collected from several independent laboratories for a range of excipients and lots. The web interface used to view the data is flexible and can be used to search for particular excipients, properties, or property ranges, compare selected excipients, and plot histograms and scatter plots of the data.

Dr. Mockus is currently Sr. Research Scientist at Purdue University where he is actively supporting QbD projects. From 2004 to 2008 he was with Allergan as Sr. Project Engineer and from 1997 he was with Pfizer as Sr. Development Engineer. He earned his Ph.D. in Chemical Engineering from Purdue University as well as equivalent degree in Computer Science from Moscow Institute of Physics and Technology.

Carl Wassgren, Kristine Alston

Researchers should cite this work as follows:

• Linas Mockus; Jose M Lainez; Rex Reklaitis; Ann Christine Catlin (2011), "Research collaboration and knowledge sharing in the pharmaceutical domain," https://help.hubzero.org/resources/431.

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1. Hubbub 2011