Sheffield Pharmaceuticals, Inc., which combines state-of-the-art pulmonary drug delivery technologies with existing and emerging therapeutic agents, announced the issuance of the fourth U.S. patent for the Company's Tempo Inhaler, the next generation metered dose inhaler (MDI) that is designed to improve pulmonary drug delivery to targeted areas of the lung.
The newly issued U.S. patent, No. 6,367,471, is directed to the Tempo Inhaler's internal vortex mechanism. Driven by the patient's inhalation breath, Tempo Inhaler's novel vortexing generators create a circumferential-swirling turbulent flow. The increased path length induced by the vortexing flow increases the residence time in the inhaler, enabling most of the propellant to evaporate resulting in a soft, easily respirable plume. It also minimizes the impact of the medication on the inner surfaces of the chamber, resulting in significantly improved delivery efficiency.
"The internal vortex mechanism, which is unique to the Tempo Inhaler, offers a number of important benefits. First, it allows us to efficiently impart vortexing airflows in the low flow/low pressure drop situation that is typical of compromised patients and children. Second, the technology lends itself to efficient manufacturing in high volume at a low cost and high level of reliability. Finally, it greatly simplifies customization for specific formulations or patient subpopulations," said Richard M. Pavkov, engineering manager, Sheffield Pharmaceuticals.
The breath-activated Tempo Inhaler utilizes a standard MDI canister encased in a compact, disposable actuator. The Tempo Inhaler combines two unique features, an aerosol flow-control chamber (for which two U.S. patents have previously been issued) and a synchronized triggering mechanism (one previously issued U.S. patent). The synchronous trigger automatically delivers a dose of medication to the patient at a pre-programmed point in the inspiratory breath cycle, a feature that enhances delivery consistency, user compliance and ease of use for patients who rely on MDIs to deliver their medications.
Thomas A. Armer, Ph.D., Sheffield's chief scientific officer said, "Sheffield's drug delivery technologies are now protected by 13 issued U.S. patents, and Sheffield has an additional 4 U.S. applications pending, plus several corresponding International and foreign applications. This latest patent further strengthens our intellectual property portfolio around the Tempo Inhaler. The Tempo vortexing mechanism is an integral, unique design feature that enables us to increase the delivery efficiency of MDI formulations by 200 to 300 percent. This enhanced delivery efficiency is achieved at a low cost with reliable manufacturing in a compact, patient-friendly system, making Tempo unique among MDI systems."