MonoSol’s technology, which is about the size of a postage stamp, is designed to rapidly dissolve on the tongue and release its active and, as such, is regarded as suitable for patients who have difficulty swallowing more conventional medications.
The United States Patent and Trademark Office (USPTO) protection applies to the delivery of actives in a uniform and consistent manner, which is a requirement of both the Food and Drug Administration (FDA) and other drug regulators around the world.
The patent, number 7,425,292, also relates to specific techniques used by MonoSol to preserve the stability and potency of sensitive active pharmaceutical ingredients (APIs) during final dosage manufacture.
MonoSol said that the rights, which are due to be formally issued on September 16, are the first of their kind to protect a drug film manufacturing process.
Alexander Mark Schobel, MonoSol’s CEO, commented that: "The granting of this patent further validates MonoSol Rx and our PharmFilm technology as leaders and innovators in the field of thin film drug delivery technology.
Schobel added that it is “a significant border of protection for MonoSol Rx around the manufacture of its pharmaceutical thin films and will present new challenges for competing companies to achieve uniformity of drug content in a safe, efficient, and cost effective manner."
US ondansetron rights
In June, Strativa Pharmaceuticals acquired exclusive US rights to MonoSol’s technology for use in the delivery of ondansetron, which prevents chemotherapy-induced nausea and vomiting and was a market worth $1.6bn last year
Speaking at the time Schobel said that if approved "ondansetron would be one of the first prescription drugs to come to market utilising thin film drug delivery technology."
Schobel also commented that thin film technology offers drugmakers a way of extending the life span of their products in the face of impending patent loss and generic competition.
Owing to the speed at which it dissolves it "may result in reduced side effects and improved safety". At present the technology, which MonoSol describes as a “major advance for the pharmaceutical industry,” has been used only in breath-freshening strips and over-the-counter medicines.