Zachodniopomorski Uniwersytet Technologiczny w Szczecinie

Wydział Technologii i Inżynierii Chemicznej - Chemical Engineering (S1)

Sylabus przedmiotu Introduction to Pharmaceutical Technology and Analysis:

Informacje podstawowe

Kierunek studiów Chemical Engineering
Forma studiów studia stacjonarne Poziom pierwszego stopnia
Tytuł zawodowy absolwenta inżynier
Obszary studiów charakterystyki PRK, kompetencje inżynierskie PRK
Profil ogólnoakademicki
Moduł
Przedmiot Introduction to Pharmaceutical Technology and Analysis
Specjalność przedmiot wspólny
Jednostka prowadząca Katedra Technologii Chemicznej Organicznej i Materiałów Polimerowych
Nauczyciel odpowiedzialny Małgorzata Dzięcioł <Malgorzata.Dzieciol@zut.edu.pl>
Inni nauczyciele
ECTS (planowane) 6,0 ECTS (formy) 6,0
Forma zaliczenia egzamin Język angielski
Blok obieralny 8 Grupa obieralna 2

Formy dydaktyczne

Forma dydaktycznaKODSemestrGodzinyECTSWagaZaliczenie
wykładyW5 30 3,00,50egzamin
laboratoriaL5 45 3,00,50zaliczenie

Wymagania wstępne

KODWymaganie wstępne
W-1Introduction to chemistry

Cele przedmiotu

KODCel modułu/przedmiotu
C-1Define important definitions and key words
C-2Knowledge and skills related to the basic technologies and processes applied for obtaining, purification and characterization of pharmacologically active substances and formulations
C-3Understand the role and application of different analytical methods in quality control of pharmaceuticals
C-4Discuss delivery-related design considerations of a drug formulation

Treści programowe z podziałem na formy zajęć

KODTreść programowaGodziny
laboratoria
T-L-1Selected methods of synthesis of active pharmaceutical ingredients (API)10
T-L-2Identification, assessment of the purity and determination of physicochemical properties of obtained active pharmaceutical ingredients (API). Characteristic reactions of selected API groups5
T-L-3Application of chromatographic and spectroscopic methods in quality control of pharmaceutical products10
T-L-4Isolation and analysis of selected pharmacologically active substances from plants5
T-L-5Microspheres for Drug Delivery: Preparation5
T-L-6Microspheres for Drug Delievery: Characterization5
T-L-7In vitro drug release study5
45
wykłady
T-W-1History of drugs development, sources of drugs2
T-W-2Technological processes for obtaining of selected active pharmaceutical ingredients (API) - theoretical and practical basics8
T-W-3Types of excipients and their functions in drug formulations for different routes of administration4
T-W-4Analytical methods applied in quality control of pharmaceuticals. Identification of active substances. Types of impurities in drugs and their sources. Falsified medicines6
T-W-5Routes of Delivery, Pharmacokinetics & Pharmacodynamics4
T-W-6Controlled Release4
T-W-7Pharmaceutical Process development and GMP2
30

Obciążenie pracą studenta - formy aktywności

KODForma aktywnościGodziny
laboratoria
A-L-1Participation in laboratory classes45
A-L-2Preparing for labs (readings)10
A-L-3Preparing labs reports18
A-L-4Consultations2
75
wykłady
A-W-1Participation in lecture30
A-W-2Exam3
A-W-3Preparing for class (readings)10
A-W-4Independent study10
A-W-5Preparing for the exam20
A-W-6Consultations2
75

Metody nauczania / narzędzia dydaktyczne

KODMetoda nauczania / narzędzie dydaktyczne
M-1Laboratory classes
M-2Powerpoint and whiteboard lectures
M-3In-class discussion

Sposoby oceny

KODSposób oceny
S-1Ocena formująca: Evaluation of working in the laboratory
S-2Ocena podsumowująca: Evaluation of written reports
S-3Ocena podsumowująca: Exam

Zamierzone efekty uczenia się - wiedza

Zamierzone efekty uczenia sięOdniesienie do efektów kształcenia dla kierunku studiówOdniesienie do efektów zdefiniowanych dla obszaru kształceniaOdniesienie do efektów uczenia się prowadzących do uzyskania tytułu zawodowego inżynieraCel przedmiotuTreści programoweMetody nauczaniaSposób oceny
ChEn_1A_C27b_W01
Student will be able to describe the biological activity of selected medicines
ChEn_1A_W13, ChEn_1A_W15C-1, C-3, C-4, C-2T-W-2, T-W-1, T-W-4, T-W-3, T-W-5, T-W-6, T-W-7M-3, M-2, M-1S-2, S-3
ChEn_1A_C27b_W02
Student will be able to characterize fundamentals of pharmaceutical technological processes, including obtaining and purification of selected active pharmaceutical ingredients (API), drug formulation and delivery systems, analytical methods applied in quality control
ChEn_1A_W13, ChEn_1A_W15C-1, C-3, C-4, C-2T-W-2, T-W-1, T-W-4, T-W-3, T-W-5, T-W-6, T-W-7M-3, M-2, M-1S-3

Zamierzone efekty uczenia się - umiejętności

Zamierzone efekty uczenia sięOdniesienie do efektów kształcenia dla kierunku studiówOdniesienie do efektów zdefiniowanych dla obszaru kształceniaOdniesienie do efektów uczenia się prowadzących do uzyskania tytułu zawodowego inżynieraCel przedmiotuTreści programoweMetody nauczaniaSposób oceny
ChEn_1A_C27b_U01
Student will be able to obtain selected pharmacologically active substances, prepare drug formulations and perform the analyses of pharmaceutical products following the instruction
ChEn_1A_U03, ChEn_1A_U05, ChEn_1A_U08, ChEn_1A_U16, ChEn_1A_U01C-3, C-4, C-2T-L-5, T-L-6, T-L-7, T-L-1, T-L-2, T-L-4, T-L-3M-1S-1, S-2
ChEn_1A_C27b_U02
Student will be able to elaborate the experimental data and interpret the obtained results using data from literature
ChEn_1A_U03, ChEn_1A_U05, ChEn_1A_U08, ChEn_1A_U16, ChEn_1A_U01C-3, C-4, C-2T-L-5, T-L-6, T-L-7, T-L-1, T-L-2, T-L-4, T-L-3M-1S-2

Zamierzone efekty uczenia się - inne kompetencje społeczne i personalne

Zamierzone efekty uczenia sięOdniesienie do efektów kształcenia dla kierunku studiówOdniesienie do efektów zdefiniowanych dla obszaru kształceniaOdniesienie do efektów uczenia się prowadzących do uzyskania tytułu zawodowego inżynieraCel przedmiotuTreści programoweMetody nauczaniaSposób oceny
ChEn_1A_C27b_K01
Student will be aware of the importance of quality control in pharmaceutical industry
ChEn_1A_K05, ChEn_1A_K01C-3, C-4, C-2T-W-2, T-W-1, T-W-4, T-W-3, T-W-5, T-W-6, T-W-7, T-L-5, T-L-6, T-L-7, T-L-1, T-L-2, T-L-4, T-L-3M-3, M-2, M-1S-1, S-2

Kryterium oceny - wiedza

Efekt uczenia sięOcenaKryterium oceny
ChEn_1A_C27b_W01
Student will be able to describe the biological activity of selected medicines
2,0
3,0Student is able to describe the basics of biological activity of selected medicines
3,5
4,0
4,5
5,0
ChEn_1A_C27b_W02
Student will be able to characterize fundamentals of pharmaceutical technological processes, including obtaining and purification of selected active pharmaceutical ingredients (API), drug formulation and delivery systems, analytical methods applied in quality control
2,0
3,0Student is able to describe the basics of selected technological processes and analytical methods applied in pharmaceutical industry
3,5
4,0
4,5
5,0

Kryterium oceny - umiejętności

Efekt uczenia sięOcenaKryterium oceny
ChEn_1A_C27b_U01
Student will be able to obtain selected pharmacologically active substances, prepare drug formulations and perform the analyses of pharmaceutical products following the instruction
2,0
3,0Student is able to perform the synthesis, formulation and analysis of selected medicines following the instruction with help of the teacher
3,5
4,0
4,5
5,0
ChEn_1A_C27b_U02
Student will be able to elaborate the experimental data and interpret the obtained results using data from literature
2,0
3,0Student is able to prepare a report from laboratory classes with basic required data
3,5
4,0
4,5
5,0

Kryterium oceny - inne kompetencje społeczne i personalne

Efekt uczenia sięOcenaKryterium oceny
ChEn_1A_C27b_K01
Student will be aware of the importance of quality control in pharmaceutical industry
2,0
3,0Student is aware of importance of pharmaceuticals quality control
3,5
4,0
4,5
5,0

Literatura podstawowa

  1. Lednicer D., The Organic Chemistry of Drug Synthesis, Wiley, New York, 1995
  2. Kleemann A., Engel J., Pharmaceutical Substances. Syntheses, Patents, Applications, Thieme, Stuttgard, 2001, 4th Ed.
  3. Gad S.C., Pharmaceutical Manufacturing Handbook. Production and Processes, John Wiley & Sons, Inc., New Jersey, 2008

Literatura dodatkowa

  1. Crist et al., Common pitfalls in nanotechnology: lessons learned from NCI’s Nanotechnology Characterization Laboratory, Integrative Biology, 2013, 5, 66, 10.1039/c2ib20117h
  2. Kim et al, Nanomedicine, NEJM, 2010, 363, 25, 2434, 10.1056/NEJMra0912273
  3. Furniss B.S., Hannaford A.J., Smith, P.W.G., Tatchell A.R., Vogel’s Textbook of Practical Organic chemistry, The School of Chemistry, Thames Polytechnic, London, 1989, 5th Ed.
  4. Joseph DiPiro, Introduction to Pharmacokinetics and Pharmacodynamics, ASHP, 2010, in: Concepts in Clinical Pharmacokinetics

Treści programowe - laboratoria

KODTreść programowaGodziny
T-L-1Selected methods of synthesis of active pharmaceutical ingredients (API)10
T-L-2Identification, assessment of the purity and determination of physicochemical properties of obtained active pharmaceutical ingredients (API). Characteristic reactions of selected API groups5
T-L-3Application of chromatographic and spectroscopic methods in quality control of pharmaceutical products10
T-L-4Isolation and analysis of selected pharmacologically active substances from plants5
T-L-5Microspheres for Drug Delivery: Preparation5
T-L-6Microspheres for Drug Delievery: Characterization5
T-L-7In vitro drug release study5
45

Treści programowe - wykłady

KODTreść programowaGodziny
T-W-1History of drugs development, sources of drugs2
T-W-2Technological processes for obtaining of selected active pharmaceutical ingredients (API) - theoretical and practical basics8
T-W-3Types of excipients and their functions in drug formulations for different routes of administration4
T-W-4Analytical methods applied in quality control of pharmaceuticals. Identification of active substances. Types of impurities in drugs and their sources. Falsified medicines6
T-W-5Routes of Delivery, Pharmacokinetics & Pharmacodynamics4
T-W-6Controlled Release4
T-W-7Pharmaceutical Process development and GMP2
30

Formy aktywności - laboratoria

KODForma aktywnościGodziny
A-L-1Participation in laboratory classes45
A-L-2Preparing for labs (readings)10
A-L-3Preparing labs reports18
A-L-4Consultations2
75
(*) 1 punkt ECTS, odpowiada około 30 godzinom aktywności studenta

Formy aktywności - wykłady

KODForma aktywnościGodziny
A-W-1Participation in lecture30
A-W-2Exam3
A-W-3Preparing for class (readings)10
A-W-4Independent study10
A-W-5Preparing for the exam20
A-W-6Consultations2
75
(*) 1 punkt ECTS, odpowiada około 30 godzinom aktywności studenta
PoleKODZnaczenie kodu
Zamierzone efekty uczenia sięChEn_1A_C27b_W01Student will be able to describe the biological activity of selected medicines
Odniesienie do efektów kształcenia dla kierunku studiówChEn_1A_W13Has knowledge of the current state and the latest developmental trends in chemical engineering and technology as well as the related areas in Poland and abroad.
ChEn_1A_W15Knows basic methods, techniques, tools and materials used for solving simple engineering tasks within the scope of chemical engineering and technology.
Cel przedmiotuC-1Define important definitions and key words
C-3Understand the role and application of different analytical methods in quality control of pharmaceuticals
C-4Discuss delivery-related design considerations of a drug formulation
C-2Knowledge and skills related to the basic technologies and processes applied for obtaining, purification and characterization of pharmacologically active substances and formulations
Treści programoweT-W-2Technological processes for obtaining of selected active pharmaceutical ingredients (API) - theoretical and practical basics
T-W-1History of drugs development, sources of drugs
T-W-4Analytical methods applied in quality control of pharmaceuticals. Identification of active substances. Types of impurities in drugs and their sources. Falsified medicines
T-W-3Types of excipients and their functions in drug formulations for different routes of administration
T-W-5Routes of Delivery, Pharmacokinetics & Pharmacodynamics
T-W-6Controlled Release
T-W-7Pharmaceutical Process development and GMP
Metody nauczaniaM-3In-class discussion
M-2Powerpoint and whiteboard lectures
M-1Laboratory classes
Sposób ocenyS-2Ocena podsumowująca: Evaluation of written reports
S-3Ocena podsumowująca: Exam
Kryteria ocenyOcenaKryterium oceny
2,0
3,0Student is able to describe the basics of biological activity of selected medicines
3,5
4,0
4,5
5,0
PoleKODZnaczenie kodu
Zamierzone efekty uczenia sięChEn_1A_C27b_W02Student will be able to characterize fundamentals of pharmaceutical technological processes, including obtaining and purification of selected active pharmaceutical ingredients (API), drug formulation and delivery systems, analytical methods applied in quality control
Odniesienie do efektów kształcenia dla kierunku studiówChEn_1A_W13Has knowledge of the current state and the latest developmental trends in chemical engineering and technology as well as the related areas in Poland and abroad.
ChEn_1A_W15Knows basic methods, techniques, tools and materials used for solving simple engineering tasks within the scope of chemical engineering and technology.
Cel przedmiotuC-1Define important definitions and key words
C-3Understand the role and application of different analytical methods in quality control of pharmaceuticals
C-4Discuss delivery-related design considerations of a drug formulation
C-2Knowledge and skills related to the basic technologies and processes applied for obtaining, purification and characterization of pharmacologically active substances and formulations
Treści programoweT-W-2Technological processes for obtaining of selected active pharmaceutical ingredients (API) - theoretical and practical basics
T-W-1History of drugs development, sources of drugs
T-W-4Analytical methods applied in quality control of pharmaceuticals. Identification of active substances. Types of impurities in drugs and their sources. Falsified medicines
T-W-3Types of excipients and their functions in drug formulations for different routes of administration
T-W-5Routes of Delivery, Pharmacokinetics & Pharmacodynamics
T-W-6Controlled Release
T-W-7Pharmaceutical Process development and GMP
Metody nauczaniaM-3In-class discussion
M-2Powerpoint and whiteboard lectures
M-1Laboratory classes
Sposób ocenyS-3Ocena podsumowująca: Exam
Kryteria ocenyOcenaKryterium oceny
2,0
3,0Student is able to describe the basics of selected technological processes and analytical methods applied in pharmaceutical industry
3,5
4,0
4,5
5,0
PoleKODZnaczenie kodu
Zamierzone efekty uczenia sięChEn_1A_C27b_U01Student will be able to obtain selected pharmacologically active substances, prepare drug formulations and perform the analyses of pharmaceutical products following the instruction
Odniesienie do efektów kształcenia dla kierunku studiówChEn_1A_U03Is able to prepare, in English or another foreign language, a well-documented study of problems within the scope of chemical and process engineering; is able to develop documentation concerning the accomplishment of an engineering task.
ChEn_1A_U05Has the ability to learn, e.g. to raise professional competences.
ChEn_1A_U08Is able to plan and conduct process experiments, including measurements and computer simulations, as well as to interpret the obtained results and draw conclusions.
ChEn_1A_U16Is able to assess the usefulness of routine methods and tools used for solving a simple engineering task of practical nature characteristic for chemical engineering and technology as well as select and use a proper performance method and tools.
ChEn_1A_U01Is able to obtain information from literature, data bases and other sources related to chemical engineering and technology as well as related areas; is able to integrate the obtained information, interpret it, draw proper conclusions and formulate opinions with their justification.
Cel przedmiotuC-3Understand the role and application of different analytical methods in quality control of pharmaceuticals
C-4Discuss delivery-related design considerations of a drug formulation
C-2Knowledge and skills related to the basic technologies and processes applied for obtaining, purification and characterization of pharmacologically active substances and formulations
Treści programoweT-L-5Microspheres for Drug Delivery: Preparation
T-L-6Microspheres for Drug Delievery: Characterization
T-L-7In vitro drug release study
T-L-1Selected methods of synthesis of active pharmaceutical ingredients (API)
T-L-2Identification, assessment of the purity and determination of physicochemical properties of obtained active pharmaceutical ingredients (API). Characteristic reactions of selected API groups
T-L-4Isolation and analysis of selected pharmacologically active substances from plants
T-L-3Application of chromatographic and spectroscopic methods in quality control of pharmaceutical products
Metody nauczaniaM-1Laboratory classes
Sposób ocenyS-1Ocena formująca: Evaluation of working in the laboratory
S-2Ocena podsumowująca: Evaluation of written reports
Kryteria ocenyOcenaKryterium oceny
2,0
3,0Student is able to perform the synthesis, formulation and analysis of selected medicines following the instruction with help of the teacher
3,5
4,0
4,5
5,0
PoleKODZnaczenie kodu
Zamierzone efekty uczenia sięChEn_1A_C27b_U02Student will be able to elaborate the experimental data and interpret the obtained results using data from literature
Odniesienie do efektów kształcenia dla kierunku studiówChEn_1A_U03Is able to prepare, in English or another foreign language, a well-documented study of problems within the scope of chemical and process engineering; is able to develop documentation concerning the accomplishment of an engineering task.
ChEn_1A_U05Has the ability to learn, e.g. to raise professional competences.
ChEn_1A_U08Is able to plan and conduct process experiments, including measurements and computer simulations, as well as to interpret the obtained results and draw conclusions.
ChEn_1A_U16Is able to assess the usefulness of routine methods and tools used for solving a simple engineering task of practical nature characteristic for chemical engineering and technology as well as select and use a proper performance method and tools.
ChEn_1A_U01Is able to obtain information from literature, data bases and other sources related to chemical engineering and technology as well as related areas; is able to integrate the obtained information, interpret it, draw proper conclusions and formulate opinions with their justification.
Cel przedmiotuC-3Understand the role and application of different analytical methods in quality control of pharmaceuticals
C-4Discuss delivery-related design considerations of a drug formulation
C-2Knowledge and skills related to the basic technologies and processes applied for obtaining, purification and characterization of pharmacologically active substances and formulations
Treści programoweT-L-5Microspheres for Drug Delivery: Preparation
T-L-6Microspheres for Drug Delievery: Characterization
T-L-7In vitro drug release study
T-L-1Selected methods of synthesis of active pharmaceutical ingredients (API)
T-L-2Identification, assessment of the purity and determination of physicochemical properties of obtained active pharmaceutical ingredients (API). Characteristic reactions of selected API groups
T-L-4Isolation and analysis of selected pharmacologically active substances from plants
T-L-3Application of chromatographic and spectroscopic methods in quality control of pharmaceutical products
Metody nauczaniaM-1Laboratory classes
Sposób ocenyS-2Ocena podsumowująca: Evaluation of written reports
Kryteria ocenyOcenaKryterium oceny
2,0
3,0Student is able to prepare a report from laboratory classes with basic required data
3,5
4,0
4,5
5,0
PoleKODZnaczenie kodu
Zamierzone efekty uczenia sięChEn_1A_C27b_K01Student will be aware of the importance of quality control in pharmaceutical industry
Odniesienie do efektów kształcenia dla kierunku studiówChEn_1A_K05Is able to manage his/her own professional development, taking decisions and solving problems, including interpersonal ones connected with job performance.
ChEn_1A_K01Understands the need of learning and raising professional and personal competences, motivating other colleagues.
Cel przedmiotuC-3Understand the role and application of different analytical methods in quality control of pharmaceuticals
C-4Discuss delivery-related design considerations of a drug formulation
C-2Knowledge and skills related to the basic technologies and processes applied for obtaining, purification and characterization of pharmacologically active substances and formulations
Treści programoweT-W-2Technological processes for obtaining of selected active pharmaceutical ingredients (API) - theoretical and practical basics
T-W-1History of drugs development, sources of drugs
T-W-4Analytical methods applied in quality control of pharmaceuticals. Identification of active substances. Types of impurities in drugs and their sources. Falsified medicines
T-W-3Types of excipients and their functions in drug formulations for different routes of administration
T-W-5Routes of Delivery, Pharmacokinetics & Pharmacodynamics
T-W-6Controlled Release
T-W-7Pharmaceutical Process development and GMP
T-L-5Microspheres for Drug Delivery: Preparation
T-L-6Microspheres for Drug Delievery: Characterization
T-L-7In vitro drug release study
T-L-1Selected methods of synthesis of active pharmaceutical ingredients (API)
T-L-2Identification, assessment of the purity and determination of physicochemical properties of obtained active pharmaceutical ingredients (API). Characteristic reactions of selected API groups
T-L-4Isolation and analysis of selected pharmacologically active substances from plants
T-L-3Application of chromatographic and spectroscopic methods in quality control of pharmaceutical products
Metody nauczaniaM-3In-class discussion
M-2Powerpoint and whiteboard lectures
M-1Laboratory classes
Sposób ocenyS-1Ocena formująca: Evaluation of working in the laboratory
S-2Ocena podsumowująca: Evaluation of written reports
Kryteria ocenyOcenaKryterium oceny
2,0
3,0Student is aware of importance of pharmaceuticals quality control
3,5
4,0
4,5
5,0