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School of Medicine
CHEMISTRY AND PHARMACEUTICAL TECHNIQUES
Course unit
PHARMACEUTICAL TECHNOLOGY
FA01110942, A.A. 2019/20

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

Information on the course unit
Degree course 5 years single cycle degree in
CHEMISTRY AND PHARMACEUTICAL TECHNIQUES
FA1733, Degree course structure A.Y. 2009/10, A.Y. 2019/20
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Number of ECTS credits allocated 10.0
Type of assessment Mark
Course unit English denomination PHARMACEUTICAL TECHNOLOGY
Department of reference Department of Pharmaceutical and Pharmacological Sciences
Mandatory attendance
Language of instruction Italian
Branch PADOVA
Single Course unit The Course unit CANNOT be attended under the option Single Course unit attendance
Optional Course unit The Course unit is available ONLY for students enrolled in CHEMISTRY AND PHARMACEUTICAL TECHNIQUES

Lecturers
Teacher in charge PAOLO CALICETI CHIM/09
Other lecturers STEFANO SALMASO CHIM/09

ECTS: details
Type Scientific-Disciplinary Sector Credits allocated
Core courses CHIM/09 Applied Technological Pharmaceutics 10.0

Course unit organization
Period First semester
Year 3rd Year
Teaching method frontal

Type of hours Credits Teaching
hours
Hours of
Individual study
Shifts
Laboratory 2.0 30 20.0 No turn
Lecture 8.0 64 136.0 No turn

Calendar
Start of activities 30/09/2019
End of activities 18/01/2020
Show course schedule 2019/20 Reg.2009 course timetable

Syllabus
Prerequisites: In order to profitably attend the course of Pharmaceutical Technology, students need to possess knowledge of mathemitics that allow for the elbaoration of simple integrals and derivates, knowledge of inorganic chemistry with particular reference to chemical equilibrium, pH/pKa, solubility, chemical reactions, knowldge of structure and physicochemical properites of organic functions and main organic compounds of pharmaceutical interest, knowledge of simple laws of physics and thermodynamics, basis of biochemistry, knowledge of basis of anatomy and physiology that allow for comprehension of routes of administration and pharmacokinetic/biodistribution profiles of drugs and tehir bioavilability.
Accordingly students should have attended with success the following classes:
Mathematics, Physics, General and Inorganic Chemistry, Organic Chemistry 1 and 2, Physical Chemistry, Biochemistry, Human Anatomy and Animal Biology, Physiology.
Target skills and knowledge: The course of Pharmaceutical Technology allows for acquisition of the following comptences and abilities:
-knwoledge of the rational and objectives of the design of a pharmaceutical products with refernce to in-put and out-put;
-ability of pharamcokinetic analysis addressed to the pharmaceutical development;
-knowledge of main absorption processes and priblems;
-knowledge and ability of analysis and choice of route of administration;
-abilities in the biopharmaceutical analysis with reference to the route o administration;
-knowledge of main methods in pharamceutcial physics with particular attention to solid products;
-critical knowledge of main processes and equipments for pharamceuitcal production;
-knowledge and ability of selction of excipients for oral formulations;
-ability to design and produce of oral formualtions (tablets, capsules and dispersed systems)
-knowledge and ability to design non-conventional formualtions;
-knowledge of key factors for the design and development of parenteral formulations and their prduction;
-knowledges of main factors and properties of disperse systems;
-knowledge of problems and opportunities offered by non conventional route of administration (pulmonary, nasal, transdermal and ocular delivery)and capacity of critical evaluations.
Examination methods: The test of Pharmaceutical Technology icnludes a written test and an oral part
Exams are planned as follows:
2 every official session (February-March, June-July) and 1 exam in the additional session(August-September)

The written part is cheduled at teh end of the course and just before the first sit. This part is focused on specific topics. Students who pass the written exam will move to the oral exam which will be mainly, but not exclusively (this depends on the results of the written part), focused on topics not included into the written part. Students who do not attend teh written exam or do not pass it will pe examined on all parts of the course program
Assessment criteria: In order to evaluate the skills gained by the students, the aquired knowldge of the topics tought in the class will be verified. Particular attention is paid to the ability of the candidates to correlate different aspects of pharamceutical technology and basic scinetific knowledges and abilities.
The technical know-how will be evaluated according to the knowledge of chemical structures of products examined during the course and the mathematical elaborationss.
The ability to understand the objectives of the processes and how the processes must be desigend to achieve them.
Course unit contents: General aspects: from Pharmaceutical Technology to Drug Delivery. Aim of modern drug delivery: reliability, safety, efficacy, specificity. Definitions in drug delivery
In-put and out-put in drug delivery development

Pharmacokinetics. Bioavailability and bioequivalence
Mathematical analysis of non compartmental and compartimental models. Calculations of main pharmacokinetic parameters and their meaning: kinetic constants (Ke, Ka, Kxy), AUC, Vd, MRT, Cl, Co, T1/2, residuals, Wagner-Nelson and Loo-Riegelman.

Drug absorption. Mechanisms of drug absorptions and their mathematical analysis: active, carrier mediated, passive, pinocytosis, ion-pairing. Mechanisms involved in out-take.

Oral absorption. Anatomical and physiological considerations
pH, pKa, virtual pH.

Drug Availability. Rate limiting step. Dissolution and solubility, thermodynamic considerations, Noyes Withney, micronization and nanoization, pharmaceutical processes, bagnability, hydrophobic and hydrophilic excipients, eutectic and solid solutions, Oswald-Freundlich, solid state, polymorphism, cyclodextrins, micelles, conjugates, pH/pKa, ionic state and salts, complexes. Diffusion, I and II Fick law, Higuchi, semiempirical analysis. Swellable systems. Degradable systems

Physicochemical preformualtion: micrometerics.
Physical and mechanical properties of solid pharmaceutical ingredients. Particle size, definitions, diameters and statistical analysis, representation, analytical methods (light scattering, microscopy, sedimentation, electric methods, sieving). Particle morphology (frattal analysis, circularity). Porosity, Walshburn analysis. Surface analysis, Langmuir and BET. Density, definitions and analysis with cylinder or liquid and gas picnometers. Mechanical properties, elastic plastic and viscoelastic parameters

Main processes in pharmaceutical technology. Design and maangement of processes: flow-chart and lay-out. Milling, theory and instruments. Mixing, theory and instruments. Desiccation and lyophilization, theory and instruments. Granulation, theory, aim and instruments and processes.

Solid oral dosage formulations. Classification.
Tablets. General description. Excipients; classification, chemistry and application. Non-conventional tables, enteric tablets, coating, sugar coating, sublingual and buccal tablets, effervescent tablets, slow release.Tablet production
Capsules.Description, classification and use. Chemistry and role of excipients. Production

Disperse systems. General information. Classifications. DLVO and Z potential. Suspensions, pharmaceutical use, composition and production. Emuslions, pharmaceutical use, composition and production. Stability, mathematical analysis. HLB and surfactants, classification and chemistry

Respiratory routes. Nasal and pulmonary delivery. Anatomic and physiologic considerations. Formualtion strategies and products for nasal, bronchial and pulmonary delivery.

Sterile formulations. Sterility, mathematical concepts and sterilization. Sterile products. Water. Sterile production, equipment and engineering. Lyophilizations. Packaging
Planned learning activities and teaching methods: The course of Pharmaceutical Technology includes 64 hours of frontal teaching. Frontal teaching is also carried out in collaboration with experts of industry of teachers of foreign universities.
The course is given in active teaching mode.
AStudents will atke a medinal product package and leaflet that will be used for considerations during the course.
At the beginning of teh corurse students are casually assigned to a number in order to form working couples or groups. Students must sit in the same place during teh course according to the number in order to work in couple or group.
At the beginning of each lecture students casually chosen wil resume in 3 min the content of the previous lecture.
Exercise are given to students to work in couple/group in class or at home and tehn teh resulots are discussed in class.
All topic is introduced with questions to students on main aspects of the topic.
At the end of each topic tstudents participate to an evaluation of knowledge by using athe on-line program Kahoot with about 10 questions.
At the end of the course the class is dived into groups which will work as flipped class reporting the main aspects of all topics terated during the course.
Practical teaching includes 30 hours. Practical exercitations are carried out in student laboratories and IT room. The IT training is focused on bioavailability and pharmacokinetic simulations. The exercitations are performed as individual, couple or group activities. The bench teaching allows for the verification of knowledges gained during the face-to-face teaching. Mai aspects include the physcal pharamcy , design, preparation and characterization of solid sorms.
Practical activities include also visit to pharmaceutical industries and the participation to the annual AFI meeting.
Additional notes about suggested reading: The final exam is mainly based on topics tought in the class. Therefore, the student notes represent the main text to prepare the exam.
The slides used by the teacher during the lessons are give to the students.
Textbooks (and optional supplementary readings)
  • A.N. Martin, Physical Pharmacy: Physical Chemical Principles in the Pharmaceutical Sciences. --: --, --. Cerca nel catalogo
  • M. Amorosa, Principi di Tecnica Framaceutica. --: Tinnarelli, --. Cerca nel catalogo
  • P. Colombo, Principi di Tecnologie Farmaceiutiche. --: CEA, --. Cerca nel catalogo

Innovative teaching methods: Teaching and learning strategies
  • Lecturing
  • Problem based learning
  • Case study
  • Interactive lecturing
  • Working in group
  • Action learning
  • Problem solving
  • Flipped classroom
  • Work-integrated learning
  • Auto correcting quizzes or tests for periodic feedback or exams
  • Loading of files and pages (web pages, Moodle, ...)

Innovative teaching methods: Software or applications used
  • Moodle (files, quizzes, workshops, ...)

Sustainable Development Goals (SDGs)
Good Health and Well-Being Quality Education Gender Equality Industry, Innovation and Infrastructure Reduced Inequalities Responsible Consumption and Production