Results of the pilot scale study demonstrate impressive efficiency of Zerion Pharmas Dispersome formulation

As reported, Zerion Pharma A/S, a Danish company, has recently shared its positive results from the first human clinical study of a Dispersome® formulation of Ivacaftor. Ivacaftor belongs to a class of medications called cystic fibrosis transmembrane conductance regulator (CFTR) potentiators that function to decrease the build-up of thick mucus in the lungs by improving protein function. 

The clinical trial to study its oral bioavailability was undertaken by ZERION’s Spanish partner, Insud Pharma, the leading generic and branded drug worldwide. A pilot scale study was planned to assess the pharmacokinetic parameters of the two different Ivacaftor Dispersome ® formulations compared to the approved product Kalydeco® 150 mg film-coated tablets (Ivacaftor). Ivacaftor is formulated as a polymeric amorphous solid dispersion in Kalydeco®.

It was a crossover study with a total count of 18 healthy volunteers as subjects. One of the formulations of Ivacaftor Dispersome® demonstrated enhanced bioavailability compared to the reference product. Meanwhile, the pharmacokinetic parameters for the second formulation were equivalent to Kalydeco®. 

Both the formulations of Ivacaftor Dispersome® had a high drug loading capacity of Ivacaftor and were designed to improve the solubility of the least soluble compound.  

The Ivacaftor Dispersome® product is the first to be investigated in a human clinical trial since its partnership with Insud Pharma in August 2022.