IPEC e-newsletter - Excipients Insight October 2017 - 16-10-17


Inside this issue


EMA publishes paper on developing medicines for older population

The European Medicines Agency (EMA) has published a draft reflection paper on the development of medicines for use in older people, which includes a section covering excipients.

The paper “describes aspects that medicines developers may consider when designing medicines for older people, such as selecting appropriate routes of administration and dosage forms, dosing frequency, excipients, container closure systems, devices and technologies, and user instructions in the product information,” says the agency.

The section on excipients reads as follows:

Generally, the suitability of excipients in the older population needs to be considered in relation to:

  • the risk for altered safety profiles in case of impaired human organ and body functions;
  • conditions associated with ageing (e.g. coconut oil may increase cholesterol levels; sugars may increase blood glucose levels and may cause dental caries and further reduce oral health);
  • the likelihood of, and risk associated with, any excipient overload due to multiple medication use (e.g. sorbitol or mannitol overload may result in altered gastric transit times, laxative effect). 

Besides safety considerations, the potential benefits of excipients in preparations for older people also need to be considered, (e.g. colours may improve medication recognition and reduce the risk of unintentional swapping, preservatives may avoid the need for storage in the refrigerator).  

The reflection paper is open for public consultation until 31 January, 2018.




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