IPEC e-newsletter - Excipients Insight March 2018 - 28-03-18


Inside this issue


APV/IPEC Europe Excipient Conference 2018

A reminder to mark your calendars for the APV/IPEC Europe Excipient Conference 2018, which this year will be held in Cologne, Germany, on 18-19 September.

The annual update on regulatory and technological developments affecting pharmaceutical excipients will this year include three parallel workshops to provide practical, hands-on insight and discussion on regulatory topics, with a view to IPEC Guidelines providing tools to achieve compliance. These workshops will focus on implementation of GMP in an excipient manufacturing site, supplier qualification and auditing, as well as analytical data and certificates of analysis provided by suppliers of excipients.

Beyond that the regulatory session will highlight compendial topics of EDQM and USP. Challenges relating to the control of particulate contamination in excipients and requirements for excipients in parenteral applications will be presented and discussed by industry experts from pharma industry.

The technical and scientific part of the conference will deal with the importance of excipient on drug bioavailability. Low bioavailability is most common with oral dosage forms of poorly water-soluble, slowly absorbed drugs. Lipid based drug delivery system will be presented and can be an approach to overcome low bioavailability.

The way of drug release from modified-release (MR) dosage forms is intentionally different from that of a immediate-release drug formulation to produce a desired therapeutic purpose or improved patient compliance. Here a method to predict the modified release performance of drugs will be discussed.

Molecules used as active drug substances can be categorised into two classes – small and large molecules. Small, chemically synthesised molecules are the conventional active substances and still constitute over 90 percent of the drugs available on the market today. Contrary to small molecules, large molecules are complex and often consist of heterogeneous mixtures and they are becoming increasingly important. The role of excipients in small/large molecule drug formulation will be highlighted.

New scientific findings in the molecular processes of life are advancing knowledge of health and disease. The objective of individualized medicine is to make such knowledge useful for individually tailored prevention, diagnosis and treatment. As new drugs are elaborated that have differential effects within populations, there is also a need to consider new manufacturing methods. The requirements of excipients for individualised medicines and continuous manufacturing processes will be emphasised.

Last but not least networking and exchange of information is a key feature of the event and table-top exhibitions aligned to the conference will encourage communication between suppliers and users.

For more information, contact apv@apv-mainz.de




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