First cycle
degree courses
Second cycle
degree courses
Single cycle
degree courses
School of Medicine
PHARMACEUTICAL BIOTECHNOLOGIES
Course unit
DELIVERY AND FORMULATION OF BIOTECHNOLOGICAL DRUGS
MEP5070484, A.A. 2018/19

Information concerning the students who enrolled in A.Y. 2017/18

Information on the course unit
Degree course Second cycle degree in
PHARMACEUTICAL BIOTECHNOLOGIES
ME2193, Degree course structure A.Y. 2015/16, A.Y. 2018/19
N0
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Number of ECTS credits allocated 11.0
Type of assessment Mark
Course unit English denomination DELIVERY AND FORMULATION OF BIOTECHNOLOGICAL DRUGS
Department of reference Department of Pharmaceutical and Pharmacological Sciences
E-Learning website https://elearning.unipd.it/dsf/course/view.php?idnumber=2018-ME2193-000ZZ-2017-MEP5070484-N0
Mandatory attendance
Language of instruction English
Branch PADOVA
Single Course unit The Course unit can be attended under the option Single Course unit attendance
Optional Course unit The Course unit can be chosen as Optional Course unit

Lecturers
Teacher in charge GIANFRANCO PASUT CHIM/09
Other lecturers STEFANO SALMASO CHIM/09

ECTS: details
Type Scientific-Disciplinary Sector Credits allocated
Core courses CHIM/09 Applied Technological Pharmaceutics 11.0

Course unit organization
Period First semester
Year 2nd Year
Teaching method frontal

Type of hours Credits Teaching
hours
Hours of
Individual study
Shifts
Laboratory 2.0 30 20.0 No turn
Lecture 9.0 72 153.0 No turn

Calendar
Start of activities 01/10/2018
End of activities 18/01/2019

Examination board
Examination board not defined

Syllabus
Prerequisites: Students should have the basic concepts and terminology of organic chemistry and biochemistry, and they should know the reactivity of chemical groups. It is relevant to know the basics of human anatomy and physiology of biological barriers (cell membranes, organ barriers etc.).
The student should know 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, the multimedia tools used in class, the publications and scientific texts suggested by the professors. The slides used by the teacher are all in English.
Target skills and knowledge: Part A. At the end of the course the student will acquire the theoretical knowledge and practical skills necessary to evaluate and understand the different approaches of protein formulation. The protein formulation aims to increase the efficacy and safety of biotech drugs. The student learns the specific problems of biotech drugs and how to set up a formula of a protein in solution or as a lyophilised powder. Furthermore, the student acquires knowledge on the characteristics of the protein delivery systems and comparisons with delivery systems for low molecular weight drugs. Students will learn the role of antibodies both as targeting agents and as drug vehicles.
The practical experience in the laboratory is an integral part of the course. The student gets an immediate feed-back by applying the basic concepts of drug delivery, previously introduced in the lectures. In particular, in laboratory experiments, the students learn to prepare liposomes, hydrogels and polymeric conjugates of enzymes.

Part B. The student will be guided to understand the relevance of designing innovative pharmaceutical dosage form according to a scientific knowledge to guarantee quality of the pharmaceutical product. At the end of Part B, the student will become aware that the pre-formulation study with drugs and proteins provide information to set the dissolution, release and absorption rate of the dosage form for the delivery of drugs to the target tissues. The student knows the properties and preparation strategies of the most common dispersed and colloidal systems for the delivery of classical and biotech drugs. The student learns which polymers and excipients may be employed for the preparation of dispersed systems and which features are required for each component. The student knows the last generation of nanotechnological platforms on the market or under investigation for the delivery of drugs, polypeptides, proteins, oligonucleotides, vaccines, and which properties are crucial for their use. Emphasis will be dedicated to all commonly used techniques to physically characterize these systems. The student will learn the most relevant pharmaceutical dosage forms and preparation strategies to administer biotech drugs via unconventional routes (oral, transdermal, transmucosal, pulmonary). The student knows the effect of technological processes on the stability of biotech drugs (protein energetics) and which tools can be employed to preserve stability and activity or enhance the activity if necessary (vaccines). Emphasis will be dedicated to few production processes and their effect on the stability of drugs.
Examination methods: Part A. The examination will be carried out in writing with questions in English, the student has to answer in English. The student is required to deliver, a week before the date fixed for the examination, the report of the laboratory in which the student includes the results and discussion of the data from the practical experience. The examination will focus on the topics covered in class and on the submitted course program. The Professor can decide to perform the exam in oral form, in English, after a justified request by the student.

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 delivery systems for oligonucleotides (siRNA, miRNA, etc). The student has to show that he/she knows the terminology concerning formulation, components, characterization of the nanocarrier used for the delivery, and the outcome of the in vitro/in vivo studies.
The exam is also made up of at least 3 open questions regarding the topics taught during the course.
The exam is conducted in English, either in the oral mode or in the written mode.
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.
Assessment criteria: Part A. The evaluation will take into account the specific knowledge of the student in relation to the question asked and, more broadly, to the general knowledge of the subject matter and the ability to link the different scientific themes covered during the course. The exposition clarity of the student will be an additional criterion together with the demonstration of having deepened further the topics covered during the course.

Part B. The exam aims at assessing the student’s knowledge according to the objectives of the course:
- knowledge of conventional and advanced colloidal carriers
- ability to identify the critical points in the generation of advanced delivery systems for small molecules and biotech drugs.
- knowledge of materials, polymers, excipients, and their use and combination for the preparation of macro and nanometric systems for the delivery of drugs
- knowledge of the properties and advantages of alternative administration routes and the requirements of the delivery systems designed for these administration routes.

The student is expected to show that he/she has learned the critical issues in the preparation of advanced systems for the delivery of drugs. Particular value will be given to the student's ability to integrate and correlate the knowledge provided by lectures to independently and critically understand studies reported in the literature concerning formulation and delivery strategies for biotech drugs.
Course unit contents: 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.
Planned learning activities and teaching methods: Part A. Teaching takes place in English. The teacher promotes participatory didactics of the students through daily interactions in which questions are asked to the students who elaborate and discuss in groups or singularly specific topics and then confront each other. The comparison of similar topics discussed among groups of students helps them develop a critical sense in a more informal environment among course colleagues. Online tests, anonymous and therefore without impact on the assessment, are carried out in class using the students' smartphones in order to review some topics or stimulate the self-assessment of the students.

Part B. The learning activity takes place in 48 hours of lectures in which the teacher discusses the course contents using slides in English that have been prepared based on information from textbooks and, mainly, from recent scientific publications.
Students will learn the importance of an adequate design of a pharmaceutical delivery system to ensure the required quality of the final pharmaceutical product. Part B of the course provides theoretical knowledge that anticipate the formulation of drugs and biotech molecules. The course aims to highlight how, when drug features are known from pre-formulation studies, when the site of administration and the dosage form have been chosen, it is possible to design innovative drug delivery systems with adequate performance relying also in non-conventional administration routes. Students will be guided through the understanding of the main advantages of using colloidal systems for the administration of small molecules and biotech drugs. Students will be exposed to the issues related to colloidal systems, the different characterization techniques, the materials and polymers to prepare them, how to ensure stability and performance of the drug delivery systems and how pharmaceutical components can be chosen.
Through the learning activities, the students will acquire the necessary knowledge to play as active scientists in the field of biotech drug formulation and delivery both in academic and industrial settings.
Group activities will also be organized according to the "flippping-class" teaching strategies to increase the awareness of the students' knowledge, to stimulate the development of information sharing and work group skills, self-assessment and peer critical evaluation.
These teaching activities are provided as innovative teaching tools; also media resources will be used including video presentations to describe case studies, new technologies, group queries (Kahoot).
Additional notes about suggested reading: Part A. The slides of the lessons are given as printed copies by the Professors on the Moodle platform. Insights on the issues addressed can be carried out with the recommended texts or with material available in the library or in the catalogues of scientific journals online.

Part B. The students will study the course using the slides presented during the lectures and provided by the professor.
Information about some of the topics presented in class and to widen others can also be found on the following textbooks.
Textbooks (and optional supplementary readings)
  • G.S. Banker, C.T. Rhodes, Modern Pharmaceutics. --: edizione Marcel Dekker, New York, --. Cerca nel catalogo
  • AT Florence, D Attwood, Le basi chimico-fisiche della tecnologia farmaceutica. --: edizione EdiSES - Napoli, --. Cerca nel catalogo
  • Villiers, Melgardt M. de; Aramwit, Pornanong; Kwon, Glen S., Nanotechnology in Drug Delivery. Series: “Biotechnology: Pharmaceutical Aspects”.. --: --, --. Cerca nel catalogo
  • D.J.A. Crommelin, R.D. Sindelared, Biotecnologie Farmaceutiche. --: Bologna: Zanichelli, --. Cerca nel catalogo
  • P. Colombo e altri, Principi di tecnologie Farmaceutiche. --: --, --. Cerca nel catalogo
  • Xiaoling Li and Bhaskara R, Design of controlled release drug delivery systems. --: --, --. Cerca nel catalogo

Innovative teaching methods: Teaching and learning strategies
  • Problem based learning
  • Questioning
  • Problem solving
  • Peer feedback
  • Auto correcting quizzes or tests for periodic feedback or exams
  • Active quizzes for Concept Verification Tests and class discussions

Sustainable Development Goals (SDGs)
Quality Education