Uniform TitleIn-vitro testing of the influence of ethanol on the release rate of oral extended-release solid dosage forms
NameCook, Rebecca Ann (author), Michniak-Kohn, Bozena (chair), Minko, Tamara (internal member), Sinko, Patrick (internal member), Cook, Rebecca Ann, Rutgers University, Graduate School-New Brunswick,
DescriptionThere are many factors that can affect the rate of drug release from an extended-release formulation, such pH of the gastrointestinal tract and dietary intake . However, there is on going concern that alcohol could also greatly affect the release rate of extended-release products. It has recently come to the FDA's attention that some extended-release oral dosage forms are comprised of drugs and/or excipients that exhibit higher solubility in ethanolic solutions than compared to water. Because of this, it can be expected that more rapid drug dissolution may occur when a patient simultaneously consumes alcohol with an extended-release product that is highly soluble in ethanol. This could potentially cause a large dose of the drug to be released at once instead of the slow steady release that was intended, posing a potential health risk to the patient .
Currently, there is a strong need to look at the potential of alcohol altering the drug release profile of controlled-release products. A large concern of the FDA is if there are alcohol sensitive extended-release products currently on the market. The goal of this research was to study the affect ethanol has on the release profile of four different types of extended-release formulations. Dissolution testing was conducted on the different dosage forms without ethanol to serve as the control and with various levels of ethanol to determine if the ethanol had an effect on drug release. Dissolution testing was used for the testing because of its ability to provide insight into an oral drug product's characterization and its in vivo performance . High performance liquid chromatography was used as the means of analysis to determine such release rates.
The affect of ethanol on the drug release profiles of Palladone® XL Capsules, Detrol® LA Capsules, Cystrin® CR Tablets and Concerta® Tablets has been studied. The drug release profiles for all the formulations were altered by the presence of ethanol in the dissolution media, especially for the Palladone® XL Capsule formulation. The extended-release function of these melt-extrusion pellets was diminished with the smallest amount of ethanol present.
Note[bibliography] Includes bibliographical references (p. 89-93).
CollectionGraduate School - New Brunswick Electronic Theses and Dissertations
Organization NameRutgers, The State University of New Jersey
RightsThe author owns the copyright to this work.