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. 2017/18

Information concerning the students who enrolled in A.Y. 2016/17

Information on the course unit
Degree course Second cycle degree in
PHARMACEUTICAL BIOTECHNOLOGIES
ME2193, Degree course structure A.Y. 2015/16, A.Y. 2017/18
N0
bring this page
with you
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
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 STEFANO SALMASO CHIM/09
Other lecturers GIANFRANCO PASUT CHIM/09

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

Mode of delivery (when and how)
Period First semester
Year 2nd Year
Teaching method frontal

Organisation of didactics
Type of hours Credits Hours of
teaching
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 02/10/2017
End of activities 19/01/2018

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.
Target skills and knowledge: Part A. At the end of the teaching course the student will acquire the theoretical knowledge and practical skills required to assess and understand the different approaches of protein formulation. Protein formulation has the aim to increase the effectiveness and safety of biotech drugs. The student learns how to set a formulation of a protein in aqueous solution for injection or as a lyophilisate. In addition, the student acquires advanced knowledge of the most used drug delivery systems for therapeutic proteins. In this section, students are introduced also to the delivery systems for classic low molecular weight drugs with special emphasis to the targeting opportunities with antibodies. 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 to the pharmaceutical product. At the end of Part B the student will become aware that the pre-formulative 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 to 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 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.
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 molecule 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 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 understand studies reported in the literature concerning formulation and delivery strategies for biotech drugs.
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.
Planned learning activities and teaching methods: Part A. The course will be divided into lectures in which the teacher will present the topics with the help of slides. Students will be encouraged to participate in the lessons by teacher's questions in order to stimulate their attention. In the pratical experiences, students will explore the experimental evidence related to the topics covered in the course. Students will be encouraged to participate workshops held by experts and organized directly by the teacher or by colleagues of the department.

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 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 “flipping classes” teaching strategies to increase students’ knowledge awareness, to stimulate the development of sharing information and team playing abilities.
Additional notes about suggested reading: Part A. The slides of the lessons are given as printed copies by the Professor.

Part B. The students will study the course using the slides presented during the lectures and provided by the professor.
Information about the topics presented can also be (in part) found on the following textbooks.
• G.S. Banker, C.T. Rhodes, Modern Pharmaceutics. New York: Marcel Dekker, --.
• P. Colombo e altri, Principi di tecnologie Farmaceutiche. --: Ambrosiana, --.
• AT Florence, D Attwood, Le basi chimico-fisiche della tecnologia farmaceutica. Napoli: EdiSES, --.
• D.J.A. Crommelin, R.D. Sindelared., Biotecnologie Farmaceutiche. Bologna: Zanichelli, 2000.
• Xiaoling Li and Bhaskara R. Jasti, Design of controlled release drug delivery systems. New York: Ed. McGraw-Hill, 2006.
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