Emmace Consulting will participate in yet another project (Grant #75F40119C10154) sponsored by US Food and Drug Administration (FDA). The company will use its methods and models to conduct studies that may challenge current pharmacopeia methods. The project spans two years and will be carried out in collaboration with the University of Florida. Emmace Consulting has internationally recognized expertise in inhalation studies. The company will carry out studies to simulate how the dose of medicine from a range of commercial inhalers reaches the lungs under various conditions and in different patients. One aim is to explore whether a new method of analysis, which is more clinically relevant and potentially more robust than the method described in current pharmacopeia, should replace it. The company will apply its unique methods and models in the studies, including various oral cavity castings and a "mechanical hand" that applies standardized hand pressure when dosing and can be actuated at any point in the inhalation maneuver. Emmace Consulting has recently participated in FDA-funded research projects since 2015, such as grant #U01FD004943, in which the University of Florida is the Principal Investigator (PI). “We are immensely pleased to take part in a second research project. It shows that our expertise is of the highest quality and meets the requirements that the FDA expects. The comprehensive project will account for a substantial portion of our revenue over a two-year period,” says Mårten Svensson, CEO and founder of Emmace Consulting. For more information, please contact: Mårten Svensson, CEO and founder of Emmace Consulting, marten@emmace.se, telephone: +46 (0)709-59 45 53 Emmace Consulting: Emmace Consulting offers excellence in advising and performance testing of pharmaceutical products on a CRO-basis. Our strengths are in the following areas: Traditional testing [...]

Emmace Consulting, a Swedish Company, was awarded a sub-contract by the University of Florida after they were awarded the U01FD004943 Grant by the FDA. Emmace Consulting, internationally recognized for its expertise in inhalation studies, will conduct a comprehensive series of laboratory studies as part of a larger project during the second quarter of 2019. Since 2015, Emmace Consulting has participated on a small scale in an FDA-funded research project (grant # U01FD004943, which has University of Florida, US, as current grantee).  One of the aims of the project is to explore what impact changes in formulation characteristics of metered dose inhalers (MDIs) have on product performance and predicted lung dose in humans. Recently they have been given a significantly larger task within the same project. Emmace Consulting will be carrying out a large series of laboratory studies on metered dose inhalers (sprays) that have been specially produced for the project. The company will analyze the spray pattern and plume geometry of the aerosols. Emmace Consulting will also carry out laboratory analyses using methods that model actual human-like conditions (“in vivo realistic analyses”) in order to estimate the lung dose that is delivered to the patient. The sub-contract also includes investigation of commercial metered-dose inhalers available on the US market using a newly proposed methodology. Results of Emmace Consulting’s work will be published in scientifically peer-reviewed journals. “We are extremely pleased that our expertise is appreciated and hope to have the opportunity to work with them on other projects. The assignment gives us broader recognition as a provider of attractive services for projects by organizations and companies in the field of inhalation drug therapy,” says Mårten Svensson, CEO and founder of Emmace Consulting. For more [...]