Study of CPPs for dissolution prediction of TCB tablets

LUCAS PEDRO MUZI; MARINA ANTONIO; RUBEN MARIANO MAGGIO

Rosario

Congreso; 7ma Reunión Internacional de Ciencias Farmacéuticas (RICiFa 2023); 2023

Universidad Nacional de Rosario

Triclabendazole (TCB) is an anthelmintic drug used for the treatment of fascioliasis, aneglected tropical disease. TCB presents crystalline polymorphism, the existence of two or morecrystalline structures for the same chemical formula. Polymorphism is a problem for thepharmaceutical industry due to the different physicochemical properties of each solid form.Additionally, TCB belongs to class II or IV in the Biopharmaceutical Classification System because it presents poor water solubility and variable permeability, compromising its bioavailability and, in consequence, its efficacy. In a Quality by Design (QbD) paradigm, an integral comprehension of the product and the associated process is essential to ensure the quality of the drug product. In the case of TCB, the most important Critical Quality Attribute (CQA) is the dissolution of the ActivePharmaceutical Ingredient (API), which could compromise its therapeutical efficacy. As a result, itbecomes necessary to identify and study the Critical Process Parameters (CPPs) that impact this CQA.The scope of this work was to identify the responsible CPPs for dissolution behaviour and develop a statistical model able to predict the dissolution profiles of TCB tablets from their CPPs.