Prevention of dose dumping in up to 40% alcohol
Delivery technologies that enable alcohol-infused dose dumping prevention can help to enhance the safety and efficacy of drug products including opioids and amphetamines that utilize modified release formulations. The use of alcohol with sustained release formulations, such as those designed for once-per-day administration, may result in high plasma concentrations that can cause severe patient side effects. Delayed release formulations combined with the use of alcohol may also result in the loss of enteric protection and an increased risk of gastric irritation, which can impact levels of drug product efficacy and patient compliance. To address growing concerns amongst patients, prescribers and regulatory agencies regarding dose dumping prevention, Evonik has created an effective oral drug delivery technology solution called EUDRATEC® ADD.
EUDRATEC® ADD for the prevention of dose dumping
EUDRATEC® ADD is a double coating formulation technology for dose dumping prevention that has been developed for use with monolithic and multiparticulate formulations. EUDRATEC® ADD can make modified release formulations resistant to hydro-alcoholic media for over two hours with alcohol concentrations of up to 40%. The patent-protected technology meets both U.S. and European guidelines for dose dumping prevention, and has the potential to reduce the risk of unexpected API release even in instances of excessive alcohol intake.
Flexible dose dumping prevention options for delayed or sustained release formulations
EUDRATEC® ADD utilizes an inner layer of sodium alginate, a hydrocolloid isolated from marine algae that is practically insoluble in ethanol for the prevention of dose dumping, and an outer coating of EUDRAGIT®. For sustained release formulations, EUDRAGIT® NM 30 D is utilized to enable the release of the API over extended periods such as 24 hours. For delayed release formulations, EUDRAGIT® L 30 D-55 or other related coatings such as EUDRAGIT® FS 30 D-55 can be utilized to provide effective enteric protection. For either sustained or delayed release formulations, a simple three step process may be utilized with no additional equipment required to achieve dose dumping prevention.