DELIVERY AND FORMULATION OF BIOTECHNOLOGICAL DRUGS

Second cycle degree in PHARMACEUTICAL BIOTECHNOLOGIES

Campus: PADOVA

Language: English

Teaching period: First Semester

Lecturer: STEFANO SALMASO

Number of ECTS credits allocated: 11


Syllabus
Prerequisites: Students should have the basic concepts and terminology of organic chemistry, should know the reactivity of chemical groups and the concepts of the preformulation of drugs with special regard to chemical and physical stability, dissolution, absorption of drugs. It is relevant to know the basics of human anatomy and physiology of biological barriers (cell membranes, organ barriers etc.).
The student already knows the concepts of pharmacology and the most relevant terminology of pharmaceutical technology. It is required that the student comprehend spoken and written English to understand the lectures and the publications and scientific texts he refers to. The slides used by the teacher are all in English.
Examination methods: Part A. The written and/or oral examination is carried out with a preliminary discussion of the report submitted by the student (delivered a week before the exam) on the pratical experiences carried out in the experimental session. The examination will take place in general with some open questions on the topics presented in the classes. The evaluation will take into account the clarity of the exposition of the student.
The examination can be conducted in Italian or in English according to the candidate choice.
The exams will be hold within the appropriate official examination sessions. Extraordinary calls for exams can be fixed at the discretion of the professor.
The student who does not pass the exam may return the next call possibly after a period of at least three weeks.

Part B. The exam is oral. The teacher reserves the right to perform the exam in written mode.
The exam includes a scientific presentation of the student on a personal literature search on one of the topic presented during the lectures by the teacher.
The exam is also made up of at least 3 open questions regarding the topics taught during the course.
The exam may be conducted in Italian or English, according to the candidate's choice.
The exam sections are scheduled within the appropriate official examination sessions.
The student who does not pass the exam may recur to the closest exam section after a period of at least two weeks.
Course unit contents: Part A. The course is centered on the development of clasic and advanced approach of 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 include the few basic concepts of pre-formulation and is mostly dedicated to acquire concepts for the design of advances delivery systems for drugs and biologically active macromolecules (proteins, siRNA, vaccines etc).
Special attention is dedicated to dispersed and colloidal systems in drug delivery: required properties to prepare performing carriers and stability issues will be discussed. Suspensions and emulsions in pharmaceutical technology will be thoroughly discussed with attention to technological components and preparation techniques. Use of microemulsions 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 commercial nanoparticles for the delivery of anticancer and biotech drugs. Use of gold nanoparticles and super paramagnetic nanoparticles (SPIONS) for diagnostic and drug delivery purposes.
Updated techniques for the characterization of drug nanocarriers and colloidal systems. Size, morfology and zeta potential assessment.
Oral, transdermal, transmucosal, pulmonary routes as non conventional administration routes of biotech drugs; 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 delivery, clinical examples. 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.