|Tipo di tesi||Tesi di laurea magistrale|
|Titolo||Nuove Forme Solide di Pitavastatina Calcio: Progettazione, Sintesi e Caratterizzazione|
|Titolo in inglese||New Solid Forms of Pitavastatin Calcium: Design, Synthesis and Characterization|
|Struttura||Dipartimento di Scienze della Vita|
|Corso di studi||CHIMICA E TECNOLOGIA FARMACEUTICHE (D.M. 270/04)|
|Data inizio appello||2020-10-29|
|Disponibilità||Accessibile via web (tutti i file della tesi sono accessibili)|
In questa tesi vengono studiate nuove forme solide della pitavastatina calcio.
In this thesis, new solid forms of pitavastatin calcium are investigated. Pitavastatin calcium is a new synthetic statin used in the treatment of hypercholesterolemia. The oral bioavailability of this pharmaceutical active ingredient is limited by its low solubility in water, in fact it belongs to Class II of the Biopharmaceutical Classification System. The objective of this study is the characterization of polymorphism of pitavastatin calcium and the search for co-crystals able to improve its solubility and therefore its bioavailability. For the study of the polymorphism of pitavastatin calcium, two crystallization techniques were mainly used, the crystallization in solution and the slurry technique, in both cases different solvents and different experimental conditions were used. Co-crystallization was carried out by Liquid Assisted Grinding, Neat Grinding and solvent crystallization. The products were analysed using Power X-Ray Diffraction, Infrared Spectroscopy, Differential Scanning Calorimetry, Thermogravimetric Analysis and Polarized Light Thermo Microscopy and Karl Fischer titration was used to quantify the possible presence of water in the samples. Five different polymorphic forms of pitavastatin calcium were isolated and characterized and seven co-crystals candidates were obtained. After verification of their safety and stability, dissolution tests were carried out on two of these products, one of them proved to be about 5 times more soluble the pure API.