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Posted: September 11, 2008

U.S. Patent Granted for Pharmaceutical Thin Film Manufacturing Process

(Nanowerk News) 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® 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.
About MonoSol Rx
MonoSol Rx is a specialty pharmaceutical company leveraging its proprietary PharmFilm® technology to deliver drugs in quick dissolving films. PharmFilm® is designed to benefit patients by improving the convenience, efficacy, and compliance of currently marketed drugs. The Company is a leader in thin film drug delivery and has a strong intellectual property position, a portfolio of commercialized OTC drug products, and a pipeline of prescription formulations utilizing its PharmFilm® technology. With a vertically integrated development and production infrastructure, MonoSol Rx has the capacity to manufacture OTC drug products for near-term revenues that enable the funding of prescription product development programs that will generate long-term value.
The Company's commercialization strategy for all PharmFilm® products is to partner with the innovator or other specialty pharma or leading consumer products companies who have the core competency to sell-in and manage the sales and marketing of the products. For the Company's existing and future partners, PharmFilm® formulations represent revenue-life cycle extensions for products with patent lives that have expired or are approaching expiration. PharmFilm® is also a tool to help sales and marketing partners differentiate in competitive markets while offering unique advantages over drugs dosed by traditional tablets, capsules and ODTs.
About PharmFilm®
PharmFilm® is a proprietary drug delivery technology that utilizes a novel process and encapsulation compositions to develop easy to use, taste-masked, quick dissolving thin-film drug formulations. PharmFilm® delivers a convenient efficacious dose of drug that in some instances can deliver improved therapeutics. PharmFilm's drug delivery advantages significantly benefits patients and their prescribing physicians, and helps improve compliance in pediatric, elderly and other patients who have difficulty swallowing traditional dosage forms.
Source: MonoSol Rx (press release)
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