First cycle
degree courses
Second cycle
degree courses
Single cycle
degree courses
Faculty of Science
Course unit
SCP3056679, A.A. 2014/15

Information concerning the students who enrolled in A.Y. 2012/13

Information on the course unit
Degree course First cycle degree in
IF1839, Degree course structure A.Y. 2011/12, A.Y. 2014/15
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Number of ECTS credits allocated 7.0
Type of assessment Mark
Course unit English denomination BIOPHARMACEUTICAL TECHNOLOGY
Website of the academic structure
Department of reference Department of Biology
Mandatory attendance
Language of instruction Italian
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

Teacher in charge PAOLO CALICETI CHIM/09

ECTS: details
Type Scientific-Disciplinary Sector Credits allocated
Educational activities in elective or integrative disciplines CHIM/09 Applied Technological Pharmaceutics 7.0

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

Type of hours Credits Teaching
Hours of
Individual study
Lecture 7.0 56 119.0 No turn

Start of activities 01/10/2014
End of activities 24/01/2015
Show course schedule 2019/20 Reg.2011 course timetable

Examination board
Board From To Members of the board
7 TECNOLOGIA BIOFARMACEUTICA 2019-2020 01/10/2019 27/11/2020 CALICETI PAOLO (Presidente)
SALMASO STEFANO (Membro Effettivo)
6 TECNOLOGIA BIOFARMACEUTICA 2018-2019 01/10/2018 30/11/2019 CALICETI PAOLO (Presidente)
SALMASO STEFANO (Membro Effettivo)
5 TECNOLOGIA BIOFARMACEUTICA 2017/2018 01/10/2017 25/11/2018 CALICETI PAOLO (Presidente)
SALMASO STEFANO (Membro Effettivo)
4 TECNOLOGIA BIOFARMACEUTICA 2016-2017 01/10/2016 30/11/2017 CALICETI PAOLO (Presidente)
SALMASO STEFANO (Membro Effettivo)
3 Tecnologia Biofarmaceutica 2015-2016 01/10/2015 30/09/2016 CALICETI PAOLO (Presidente)
PALUMBO MANLIO (Membro Effettivo)
SALMASO LUIGI (Membro Effettivo)
2 TECNOLOGIA BIOFARMACEUTICA 2014-2015 01/10/2014 30/09/2015 CALICETI PAOLO (Presidente)
SALMASO STEFANO (Membro Effettivo)

Prerequisites: In order to profitably attend the course of Biopharmaceutical 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.
Target skills and knowledge: The course of Biopharmaceutical Technology allows for ther acquisition of the following comptences and abilities
-knwoledge of the rational and objectives of the design of a pharmaceutical products with reference 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 refernce to the route o administration;
-critical knowledge of main processes and equipments for pharamceuitcal production;
-knowledge and ability of selction of excipients for oral formulations;
-cability to design and produce of formualtions for biotech drugs;
-knowledge and ability to design non-cvonventional formualtions;
-knowledge of key factors for the designa nd 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 Biopharmaceutical Technology is written with 3 -5 open questions.
Exams are planned as follows:
2 every official session (February-March, June-July, August-September)
1 in spring (April-May)
1 in autumn(November-December)
Assessment criteria: In order to evaluate the skills gained by the students, the aquired knowldges 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 knowldges and abilities.
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

Pharmaceutical classification: biotech drugs, biosimilars and biobetters.

Issues in biotech drug stability.

Pharmacokinetics. Bioavailability and bioequivalence
Mathematical analysis of non compartmental and compartmental models. Calculations of main pharmacokinetic parameters and their meanings: 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 mediate, passive, pinocytosis, ion-pairing. Mechanisms involved in out-take.

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

Main processes in pharmaceutical technology.

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

Sterile formulations. Sterility, mathematical concepts and sterilization. Sterile products. Water. Sterile production, equipment and engineering.
Planned learning activities and teaching methods: The course of Bioharmaceutical Technology includes only frontal teaching. Frontal teaching are also carried out in collaboration with experts of industry of teachers of foreign universities.
Additional notes about suggested reading: The final exam is basedon 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)
  • P. Colombo, Principi di Tecnologie Farmaceutiche. --: CEA, --. Cerca nel catalogo
  • A Martin,, Physical pharmacy: physical chemical principles in the pharmaceutical sciences. --: --, --. Cerca nel catalogo