IPEC e-newsletter - Excipients Insight July/August 2018 - 31-08-18

 

Inside this issue

     

Last chance! 7th annual conference on pharmaceutical excipients

There’s still time to register for IPEC Europe and APV’s 7th annual conference on pharmaceutical excipients, which will take place on 18-19 September in Cologne, Germany.

The conference will focus on “hot topics” in the area of excipient regulation and technology.

As part of the programme APV and IPEC Europe will offer three parallel workshops to provide practical, hands-on insight and discussion on regulatory topics, and how IPEC Guidelines are useful 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 pharma industry experts.

The technical and scientific part of the conference will deal with the importance of excipients on drug bioavailability. Low bioavailability is most common with oral dosage forms of poorly water-soluble, slowly absorbed drugs. Lipid based drug delivery systems will be discussed as they can present solutions to overcome low bioavailability.

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

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; 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 our knowledge of health and disease. The objective of individualised medicine is to make such knowledge useful for individually tailored prevention, diagnosis and treatment. As new drugs are developed 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 addressed.

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.

More information on the programme and registration can be found here.

 

 

 

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