European Patent Office approves DissolvIt, bringing ‘IVIVC-as-a-standard closer’
The patent for DissolvIt, ISAB’s in vitro simulation technology, has been approved by the EPO (European Patent Office).
“Establishing in vitro data early on can save companies developing inhaled drugs literally millions of Euros,” says ISAB CEO Fredrik Sjövall. “It prevents late stage clinical failure and for patients means access to much-needed inhaled drugs faster. Combined with things like the UK recently approving new inhaler technology on the basis of in vitro data alone, this EPO approval shows that the age of IVIVC as a medical and regulatory standard is getting ever closer.”
Actively perfused with receptor liquid, DissolvIt delivers exceptionally detailed pharmacokinetic (PK) data, including curve profiles with Cmax and Tmax. ISAB CSO Per Gerde says: “The Drug Candidate behaviour in air/blood interface (e.g. a mucous membrane of the respiratory system) can be carefully analysed visually/optically, gravimetrically and chemically by analysing the resulting perfusate. It is also conceivable to estimate the time of appearance of Drug Candidates in the circulatory system…”
ISAB is currently carrying out a four-year research project with Hovione on DissolvIt, further exploring its IVIVC capabilities. Following recent research with Kings College London (KCL), Dr Ben Forbes, Reader in Pharmaceutics at the Institute of Pharmaceutical Science at KCL, said “ISAB’s in vitro dissolution capabilities are excellent, in fact, leading.”