DELIVERY AND FORMULATION OF BIOTECHNOLOGICAL DRUGS

formulations of biotech drugs. In particular, the issues related to the stability of proteins and the steps that can be implemented to reduce the degradation processes of these entities will be presented together with the methods used for the characterization of the most frequent degradations. Basics will be provided for the definition of the main polymers used in this field and greater emphasis will be devoted to the study of advanced drug delivery systems for proteins, which are proposed as current or future therapeutic applications. The practical part of the course will provide the student with the knowledge necessary to set up some of the most commonly used drug delivery systems.

Part B. The course content includes the few basic concepts of pre-formulation and is mostly dedicated to acquire concepts for the design of advanced delivery systems for drugs and biologically active macromolecules (proteins, siRNA, vaccines etc).
Special attention is dedicated to dispersed and colloidal systems exploited in drug delivery applications: required properties to prepare performing carriers and stability issues will be thoroughly discussed. Suspensions and emulsions in pharmaceutical technology will be discussed with attention to technological components and preparation techniques. Use of micro- and nano-emulsions for oral administration of drugs and peptides. Preparation and advantages of polymer and lipid based micro- and nano-particles for the administration of biotech drugs. Examples of commercially available nanoparticles for the delivery of drugs and biotech molecules. Use of methal based nanoparticles for diagnostic and drug delivery purposes.
Up-to-date techniques for the characterization of drug nanocarriers and colloidal systems. Size, morphology and zeta potential assessment.
Oral, transdermal, transmucosal, pulmonary routes as non conventional administration routes of biotech drugs will be presented as alternatives to improve their efficacy; the requirements to formulate a drug for the administration through those routes will be discussed. Strategies to improve the stability and immunological performances of vaccines (commercial examples). Use of biodegradable polymers in drug delivery and biotechnology. Cyclodextrins as natural carriers for targeted delivery of drugs and si-RNA, clinical examples of this family of excipient. Carbon nanotubes as innovative carrier for intracellular delivery of biotech drugs. Basic concepts of the good laboratory and manufacturing practice.
Industrial processes: examples. Sterilization and lyophilization.