Sep 12 2008
MonoSol Rx, a drug delivery company specializing in quick dissolving thin film pharmaceutical products, today announced that it has been granted U.S. patent No. 7,425,292 from the United States Patent and Trademark Office (USPTO).
The patent, which is expected to issue on September 16, 2008, relates to the Company's proprietary processes for manufacturing a broad range of prescription and over-the-counter products with controlled uniformity of drug content. MonoSol Rx's technology is a major advance for the pharmaceutical industry with its ability to meet the regulatory approval standards for thin film pharmaceutical products. The patent provides broad protection for the Company's drug-containing film manufacturing process and represents the first film patent of its kind to protect the manufacturing process and its ability to insure consistent dosing of medication in each strip. This uniformity is critical to the safety of the patient and is an FDA and global regulatory drug requirement. The patented process also includes steps to preserve the stability of drugs and other active ingredients, by a procedure which permits inclusion of the most sensitive actives in a way which protects them from interacting or losing their potency when the dosage form is manufactured.
"The granting of this patent further validates MonoSol Rx and our PharmFilm(R) technology as leaders and innovators in the field of thin film drug delivery technology. We strive to constantly improve our technology to provide greater benefit to our current and prospective partners and to expand the applicability of thin film to a broader array of drug delivery opportunities and challenges. This patent represents 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," said A. Mark Schobel, President and Chief Executive Officer of MonoSol Rx.