Project description
An innovative in vitro assay for screening lipid-based drugs
Although oral drug administration is the preferred method of choice for both patients and healthcare providers, most drug candidates exhibit low solubility in a water-based environment such as the gut. To increase drug solubility, researchers have developed lipid-based formulations (LBFs), which, however, are difficult to characterise in vivo and incur high drug development costs. The EU-funded DINAMIC project is working on an efficient, rapid and cost-effective in vitro assay that mimics the gut microenvironment and can be used to screen LBFs. The assay setup provides an integrated, more physiologically relevant description of LBF performance and drug bioavailability in less than an hour. DINAMIC will develop an assay prototype and undertake activities towards its commercialisation.
Objective
Oral administration of drugs is the method of choice for patients and healthcare providers alike because it is both convenient and inexpensive. About 70-90% of the drug candidates have low solubility in the water-based environment of the gut, and therefore a number of strategies have been developed to increase drug solubility, one of these being Lipid-Based Formulations (LBFs). Currently, less than 4% of commercial drug products are LBFs due, in large part, to the difficulty of characterisation of in vivo performance, resulting in slower and more costly drug development and fewer oral drug formulations on the market. Clearly, there is a pressing need for a rapid, inexpensive, accurate, and integrated method to screen and evaluate the performance of LBFs in a physiologically relevant environment. We have developed a novel in vitro assay that can rapidly and accurately evaluate in vivo drug exposure. Dr. Bergström was previously awarded an ERC Starting Grant in 2014 to investigate the dynamics of drug, dosage form, and the complex environment of the gastrointestinal tract; DINAMIC is a direct result of this work. Whereas the current state-of-the-art methods involve analysis of LBF digestion and permeation in separate assays, DINAMIC is an integrated digestion-permeation setup that provides a more physiologically relevant, and thereby more accurate, description of LBF performance and drug bioavailability in less than an hour. The technical and commercial feasibility of DINAMIC will be assessed in this ERC PoC project, including development of a prototype that meets the needs of the target customers, as well as the commercial proof-of-concept.
Programme(s)
Funding Scheme
ERC-POC-LS - ERC Proof of Concept Lump Sum PilotHost institution
751 05 Uppsala
Sweden