Recipharm Analytical Solution

Swedish speciality pharmaceutical company, Lobsor Pharmaceutical AB, recently gained approval for its advanced Parkinson’s disease (PD) treatment, Lecigon® intestinal gel. A combination drug product containing three active pharmaceutical ingredients (APIs) in a viscous gel, the treatment is continually administered directly to the small intestine via a small portable pump enabling a dosage within the narrowing therapeutic window in advanced PD.

Recipharm’s experience of developing complex drug products, including analytical chemical control methods, scale-up of manufacturing processes and tech transfer to commercial manufacturing, led Lobsor to select the company to perform all formulation development work. This included establishing the necessary analytical methods and providing module 3 of the Marketing Authorisation Application (MAA). The complexity of the product meant that developing a suitable analysis method was highly challenging due to the combination of an unstable/reactive API and the liquid (gel) formulation.