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Call for PhD Studentships – University of Porto

Title: Quality-by-design (QbD) based process development of cocrystals for modified-release drug delivery

Scientific supervision: The PhD program will be supervised by Dr. João Almeida Lopes (Faculty of Pharmacy, University. of Lisbon, Lisbon, Portugal) and by Dr. Mafalda Sarraguça (REQUIMTE, Faculty of Pharmacy, University of Porto, Porto, Portugal)

Description: The pharmaceutical factories of the future will rely mostly on these technologies since drugs like biopharmaceuticals will increase their share, thus opening the way to stratified medicines and personalized medicine. This paradigm shift will require a new generation of pharmacists with competences in process design, monitoring and control that can cope with an increasing demand of new products to be manufactured in small batch sizes, eventually using manufacturing concepts relatively new such as continuous manufacturing. Pharmaceutical cocrystals are interesting to the pharmaceutical industry since they offer a number of opportunities to modify the chemical and/or physical properties of an API without changing its structure, and are a potential alternative in the selection of optimal solid forms in drug development. The ability to control cocrystallization on-line represents a highly useful process which aligns well with the current regulatory drive towards continuous monitoring and real-time quality-control. A sound cocrystallization process is the key to ensure that the final product is consistent delivered with the intend characteristics. This objective can be accomplished by applying the concepts of quality-by-design (QbD) to the cocrystallization process. By using PAT tools such as near infrared spectroscopy (NIR) and Raman spectroscopy the process can be monitored on-line and in real-time with the objective of controlling the cocrystallization process through timely measurements of the critical quality performance attributes such as solvent content and seeding time and in this way ensuring the cocrystals quality. This project is intended to accelerate the development of new pharmaceutical forms based on co-crystals for modified release drug delivery. Manufacturing and testing of designed co-crystals require a significant amount of time and analytical resources that can be circumvented by the adoption of PAT tools. These tools will integrate the design, manufacturing and characterization of the cocrystals acting as an unified methodology for design, production and testing. PAT tools such as vibrational spectroscopic tools (NIR and Raman spectroscopy) and concepts of QbD will be developed and applied and in this way gain in-depth process understanding, to mitigate risk of delivering cocrystals with poor quality.

Application requirements: Master or BSc in Chemistry, Chemical Engineering , Pharmaceutical sciences or related areas with a minimal classification of 15. The selected candidate will apply for a PhD grant in Portugal (FCT/MCTES).
Dead-line application: Applicants should send a motivation letter and Curriculum Vitae to the email address jjlopes@ff.ulisboa.pt or to mafalda.cruz@ff.up.pt until 4 of May.

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