Process development and manufacturing

The active ingredient

The active pharmaceutical ingredient in LIB-01 is a completely new pharmacological substance, a small molecule of the so-called phragmalin type belonging to the limonoid class. The substance is an analog molecule developed based on traditional medicinal use.

In the development of the pharmaceutical ingredient, seeds are currently used, which are harvested sustainably in accordance with the implementation of the Nagoya Protocol (“Nagoya Protocol on Access and Benefit Sharing”; https://www.cbd.int/abs/). Substances are extracted from the seeds that, in themselves, do not have a pharmacological effect, i.e., they are inactive. These substances are then transformed through a manufacturing process involving several synthesis steps into the active pharmaceutical ingredient included in LIB-01.

In parallel, development is underway to find other biotechnological methods to obtain raw materials for the pharmaceutical substance. The company, in collaboration with institutions such as Uppsala University and the W. Szafer Institute of Botany, has developed proof of concept at the laboratory scale, where plant cells from the seeds are cultured to produce the substances. Further development and scaling of the manufacturing method are now ongoing, which is based on established technology for large-scale commercial production of various pharmaceutical substances derived from nature.

Formulation development

The formulation of a pharmaceutical substance determines how a product can be administered to the body. Dicot Pharma has developed an oral drug formulation that is currently being used in clinical studies. Data shows that the formulation contributes to good bioavailability of the active substance, which is otherwise poorly soluble. Development of a tablet for future commercial use is ongoing. The starting point is to use the already developed formulation and further adapt it to create a tablet. The tablet's properties and manufacturability will be the focus.

Dicot Pharma uses international and established contract manufacturers in the production of LIB-01.