Emmace Consulting i FDA-projekt i samarbete med Florida universitet

Emmace Consulting i FDA-projekt i samarbete med Florida universitet

 

Lundabolaget Emmace Consulting är utvalt som underleverantör till University of Florida efter att universitetet fått finansiering från FDA. Emmace Consulting, internationellt erkänd för sin expertis inom inhalationsstudier, genomför en omfattande serie laboratoriestudier som en del av ett större projekt under andra kvartalet 2019.

 

Resten av pressmeddelandet ses nedan på engelska samt på Emmace Consultings hemsida.

                       - - - - -

Emmace Consulting chosen to work in collaboration with UF
on FDA Project

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 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: 1) Traditional testing of inhalers (DPI, pMDI, and nebulizers) including cascade impaction, laser diffraction, and delivered dose uniformity characterization according to US and EU Pharmacopeias; 2) Experimental determination of expected lung dose from inhalers by using anatomically realistic mouth-throat inlets in combination with patient-like inhalation profiles (best-in-class in-vitro/in-vivo comparisons); 3) Strategic advising in CMC and clinical support and in lung dose modeling; 4) Software for the prediction of particle delivery to the lung – Mimetikos Preludium™

Emmace Consulting can be found at Medicon Village in Lund, Sweden. www.mediconvillage.se The company is an alumnus of SmiLe Incubator, a life science business incubator. www.smileincubator.life

---

---