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3M™ Integrated Dose by Dose Counter Receives FDA Approval


3M™ Integrated Dose by Dose Counter Receives FDA Approval

New product also utilizes Fluorinated Ethylene Propylene coating

 

ST. PAUL, MN – July 28, 2010 – The FDA has granted approval to a new inhalation product utilizing the 3M™ Integrated Dose by Dose Counter. The product, which also incorporates 3M’s Fluorinated Ethylene Propylene (FEP) coating, received FDA approval after a one-cycle review of the New Drug Application.

The Integrated Dose by Dose Counter helps prevent patients from running out of medication in their metered-dose inhalers by providing an accurate count of how much medication remains. The device is displacement driven and utilizes a novel split-count design that matches dose counter actuation as closely as possible to valve travel to prevent under-counting and to minimize the potential for over-counting due to misuse. The counter utilized global patient research during development, resulting in a device that is easy for patients to use, requiring no additional training, and that retains a familiar look and feel. The 3M Integrated Dose by Dose Counter is compatible with most valves and customizable to meet partners’ requirements.

An additional component of the newly approved product, the FEP coated canister, helps reduce drug deposition to improve chemical and physical stability. Whether formulated as a suspension or solution, the active pharmaceutical ingredients (API) in pressurized metered-dose inhalers can interact with the container closure system. The FEP coating, however, helps prevent deposition of the API on canister walls and reduces canister-formulation interactions. 

“The approval of this new product following a one-cycle review is a testament to the quality of our dose counter and FEP coating, as well as a demonstration of our expertise in regulatory documentation,” said Robert Odenthal, Vice President of Respiratory Business. “3M is pleased to help bring this product to market successfully.”
For more information, visit www.3M.com/dds.

  

 

About 3M Drug Delivery Systems 

3M Drug Delivery Systems partners with pharmaceutical and biotech companies to develop pharmaceuticals using 3M’s inhalation or transdermal drug delivery technology. 3M offers a full range of feasibility, development and manufacturing capabilities combined with regulatory guidance to help bring products to market.  In-house resources, including toxicology, regulatory expertise, quality assurance, operations, and marketed product support, are available for each step of the development and commercialization process. This depth of resources is one reason why more than 50 percent of all metered-dose inhalers worldwide and 80 percent of all transdermal systems in the United States utilize 3M drug delivery technology.  For more information, please visit www.3M.com/dds or call 1-800-643-8086. 

 

About 3M Health Care

3M Health Care, one of 3M’s six major business segments, provides world-class innovative products and services to help health care professionals improve the practice, delivery and outcome of patient care in medical, oral care, drug delivery and health information markets.

3M is a trademark of 3M Company

 

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