Making Pharmaceuticals Safer by Addressing Alcohol Induced Dose Dumping

- July 12, 2016 -

Consuming medications with alcohol or while alcohol is still present in the body can create unwanted effects and initiate release of a drug too quickly, leading to serious over dosage and severe threats to a patient’s health. Whether accidental or intentional, the premature or escalated release of a drug in the body – called “dose dumping” – is a serious issue facing pharmaceutical manufacturers formulating modified release drugs.

Modifying release slows down the release of the drug so that the medicine does not have to be taken too often and therefore improves compliance. The other benefit from modifying release is that the drug release is controlled, thus reducing the chance of peak effects and increasing the likelihood of therapeutic effectiveness for longer periods of time. While modified release drugs greatly benefit a large percentage of the population, alcohol-induced dose dumping is a continuous concern to formulators when formulating new medications and revising existing critical medications.

Adding to the issue, the Federal Drug Administration (FDA) and the European Medicines Agency (EMA) currently have two different sets of guidelines about formulating modified release drugs to battle alcohol-induced dose dumping. The two different sets of guidelines can be a big problem for global pharmaceutical manufacturers formulating with global customers in mind.

In a recent whitepaper, Amina Faham, Pharma technical service and development leader for North America and EMEA, advocates for the need for consistency across global agencies on this topic. Faham´s position paper, \"Regulatory Considerations for Alcohol-Induced Dose Dumping of Oral Modified-Release Formulations,” received the endorsement of the International Pharmaceutical Excipients Council (IPEC) and Generic Pharmaceutical Association (GPhA).

Marc van Gerwen, global business director, Dow Pharma & Food Solutions, said: “Amina’s outstanding thought leadership and experience in pharmaceutical formulations helps customers to formulate new and safer products and positions Dow as a leading choice for drug delivery formulations. For Dow, the updated guidance will help clarify how our ETHOCEL product can be used to create safer drugs.”