Extemporaneous preparation in the event of shortage of Tamiflu®/Oseltamivir oral suspension

Wed, 10/07/2009

The US Food and Drug Administration (FDA) has approved that, in the event of a shortage of Tamiflu®1/Oseltamivir oral suspension for children, pharmacists should revert to emergency compounding, using Ora-Sweet SF® or Humco Cherry Syrup®, for this method of administering the drug. This information has been issued in response to the worldwide health threat from the new variant of the influenza A virus (H1N1), better known as swine flu.

Fagron, the European market leader in pharmaceutical compounding, includes Ora® and Humco Cherry Syrup® in its product range. Ora® and Humco Cherry Syrup® are syrup bases which have been used for decades by pharmacists and hospital dispensaries in the preparation of oral suspensions. Extensive stability studies, involving more than 80 different APIs (including Tamiflu®/Oseltamivir)2, have been carried out and it has been shown that an extremely stable and pleasant-tasting medication for oral administration can be made with Ora® and Humco Cherry Syrup®.

Medication is often not available in small doses for children or in oral suspensions for seriously ill patients. A compounded preparation is the ideal solution in such cases, for both public pharmacies and hospital dispensaries. Using Ora® or Humco Cherry Syrup®, pharmacists can prepare pleasant-tasting compounded oral suspensions, to the obvious benefit of patient compliance in the therapy.

The World Health Organisation (WHO) raised the level of influenza pandemic alert to phase 6 on 11 June 2009. Many people in the European Union have already contracted the virus. The current pandemic caused by the new influenza A virus is expected to peak in Europe in late 2009/early 2010.

Pharmacists in Europe are advised to obtain a reasonable stock of Ora® and Humco Cherry Syrup® in advance to ensure that patient needs can be met.

1 Tamiflu is a registered trade name owned by Roche.
2 Preparation and stability of extemporaneous oral liquid formulations of Oseltamivir using commercially available capsules. Journal of the American Pharmacists Association 2007;47:747-755.