Zachodniopomorski Uniwersytet Technologiczny w Szczecinie

Wydział Technologii i Inżynierii Chemicznej - Chemical Engineering (S2)

Sylabus przedmiotu Drugs Technology and Pharmaceutical Process Development:

Informacje podstawowe

Kierunek studiów Chemical Engineering
Forma studiów studia stacjonarne Poziom drugiego stopnia
Tytuł zawodowy absolwenta magister inżynier
Obszary studiów charakterystyki PRK, kompetencje inżynierskie PRK
Profil ogólnoakademicki
Moduł —
Przedmiot Drugs Technology and Pharmaceutical Process Development
Specjalność Modern and Green Chemical Engineering
Jednostka prowadząca Katedra Technologii Chemicznej Organicznej i Materiałów Polimerowych
Nauczyciel odpowiedzialny Paula Ossowicz-Rupniewska <Paula.Ossowicz@zut.edu.pl>
Inni nauczyciele
ECTS (planowane) 3,0 ECTS (formy) 3,0
Forma zaliczenia zaliczenie Język angielski
Blok obieralny 5 Grupa obieralna 1

Formy dydaktyczne

Forma dydaktycznaKODSemestrGodzinyECTSWagaZaliczenie
laboratoriaL2 30 2,00,60zaliczenie
wykładyW2 15 1,00,40zaliczenie

Wymagania wstępne

KODWymaganie wstępne
W-1Introduction to chemistry, organic and inorganic chemistry

Cele przedmiotu

KODCel modułu/przedmiotu
C-1Define important keywords and concepts
C-2Know and understand processes involved in drug synthesis
C-3Know and understand processes involved in formulation preparation
C-4Determines the influence of the active pharmaceutical compound structure on its properties
C-5Understand the importance of green chemistry in the aspect of the pharmaceutical industry

Treści programowe z podziałem na formy zajęć

KODTreść programowaGodziny
laboratoria
T-L-1Synthesis of selected API10
T-L-2Preparation of pharmaceutical creams and ointments5
T-L-3Preparation of pharmaceutical gels5
T-L-4Preparation of liquid herbal dosage forms10
30
wykłady
T-W-1Process Research and Development in the Pharmaceutical Industry2
T-W-2Active Pharmaceutical Ingredients: Structure and Impact on Synthesis: - definitions - physicochemical considerations - common features - synthetic sequence - reactions5
T-W-3Development of Potential Drug Candidates2
T-W-4The Importance of Green Chemistry in Process Research & Development3
T-W-5Route Design and Selection3
15

Obciążenie pracą studenta - formy aktywności

KODForma aktywnościGodziny
laboratoria
A-L-1participation in laboratory exercises30
A-L-2preparing for labs (readings)10
A-L-3preparing labs reports10
50
wykłady
A-W-1participation in lectures15
A-W-2individual study of literature8
A-W-3consultations2
25

Metody nauczania / narzędzia dydaktyczne

KODMetoda nauczania / narzędzie dydaktyczne
M-1powerpoint and whiteboard lectures
M-2laboratory exercises
M-3in-class discussion

Sposoby oceny

KODSposób oceny
S-1Ocena podsumowująca: final writing test
S-2Ocena podsumowująca: evaluation of written reports
S-3Ocena formująca: continuous assesment

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_2A_C12b_W01
The student has knowledge of the processes of obtaining pharmaceutically active substances and the technology of producing pharmaceutical formulations		ChEn_2A_W01, ChEn_2A_W02——C-2, C-3T-W-1, T-W-2, T-L-1, T-L-2, T-L-3, T-L-4M-1, M-2S-1, S-2, S-3
ChEn_2A_C12b_W02
The student knows the influence of the structure of a compound on its properties of action, knows the stages of drug development and the routes of drug administration		ChEn_2A_W01——C-1, C-2, C-3, C-4T-W-1, T-W-2, T-W-3, T-W-5M-1, M-3S-1
ChEn_2A_C12b_W03
The student knows the importance of green chemistry in pharmaceutical process research & development		ChEn_2A_W04, ChEn_2A_W05——C-5T-W-4M-1, M-3S-1

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_2A_C12b_U01
The student can perform the synthesis and analysis of selected active pharmaceutical ingredients and pharmaceutical formulations following the instruction		ChEn_2A_U01, ChEn_2A_U02, ChEn_2A_U08——C-2, C-3T-L-1, T-L-2, T-L-3, T-L-4M-2S-2, S-3

Kryterium oceny - wiedza

Efekt uczenia sięOcenaKryterium oceny
ChEn_2A_C12b_W01
The student has knowledge of the processes of obtaining pharmaceutically active substances and the technology of producing pharmaceutical formulations		2,0
3,0Student is able to describe the basic synthesis methods of selected active pharmaceutical ingredients and pharmaceutical formulation
3,5
4,0
4,5
5,0
ChEn_2A_C12b_W02
The student knows the influence of the structure of a compound on its properties of action, knows the stages of drug development and the routes of drug administration		2,0
3,0The student knows the influence of selected functional groups on the properties of a compound, can list the stages of drug development and the route of drug administration
3,5
4,0
4,5
5,0
ChEn_2A_C12b_W03
The student knows the importance of green chemistry in pharmaceutical process research & development		2,0
3,0The student knows the principles of green chemistry and chooses more ecological and economic processes for the synthesis of selected drugs
3,5
4,0
4,5
5,0

Kryterium oceny - umiejętności

Efekt uczenia sięOcenaKryterium oceny
ChEn_2A_C12b_U01
The student can perform the synthesis and analysis of selected active pharmaceutical ingredients and pharmaceutical formulations following the instruction		2,0
3,0The student can perform the synthesis and analysis of selected active pharmaceutical ingredients and pharmaceutical formulations following the instruction with the help of the teacher
3,5
4,0
4,5
5,0

Literatura podstawowa

  1. A. John Blacker and Michael T. Williams, Pharmaceutical Process Development Current Chemical and Engineering Challenges, RSC Publishing, Cambridge, UK, 2011
  2. Gary Prager, Practical Pharmaceutical Engineering, Wiley, Hoboken, USA, 2019
  3. Anthony J. Hickey, David Ganderton, Pharmaceutical Process Engineering, Informa healthcare, New York, USA, 2010, 2nd ed.

Literatura dodatkowa

  1. Shayne Cox Gad PH.D., D.A.B.T., Pharmaceutical Manufacturing Handbook: Production and Processes, John Wiley & Sons, Inc., 2008

Treści programowe - laboratoria

KODTreść programowaGodziny
T-L-1Synthesis of selected API10
T-L-2Preparation of pharmaceutical creams and ointments5
T-L-3Preparation of pharmaceutical gels5
T-L-4Preparation of liquid herbal dosage forms10
30

Treści programowe - wykłady

KODTreść programowaGodziny
T-W-1Process Research and Development in the Pharmaceutical Industry2
T-W-2Active Pharmaceutical Ingredients: Structure and Impact on Synthesis: - definitions - physicochemical considerations - common features - synthetic sequence - reactions5
T-W-3Development of Potential Drug Candidates2
T-W-4The Importance of Green Chemistry in Process Research & Development3
T-W-5Route Design and Selection3
15

Formy aktywności - laboratoria

KODForma aktywnościGodziny
A-L-1participation in laboratory exercises30
A-L-2preparing for labs (readings)10
A-L-3preparing labs reports10
50
(*) 1 punkt ECTS, odpowiada około 30 godzinom aktywności studenta

Formy aktywności - wykłady

KODForma aktywnościGodziny
A-W-1participation in lectures15
A-W-2individual study of literature8
A-W-3consultations2
25
(*) 1 punkt ECTS, odpowiada około 30 godzinom aktywności studenta
PoleKODZnaczenie kodu
Zamierzone efekty uczenia sięChEn_2A_C12b_W01The student has knowledge of the processes of obtaining pharmaceutically active substances and the technology of producing pharmaceutical formulations
Odniesienie do efektów kształcenia dla kierunku studiówChEn_2A_W01Graduate has in-depth knowledge in the field of chemical processes, including appropriate selection of materials, raw materials, methods, techniques, equipment and devices for the implementation of chemical and biochemical processes and characterization of the raw materials and products obtained.
ChEn_2A_W02Graduate has extended and deep knowledge necessary for planning, designing and scaling-up of technological industrial processes as well as planning experiments and elaborating the results of experimental research.
Cel przedmiotuC-2Know and understand processes involved in drug synthesis
C-3Know and understand processes involved in formulation preparation
Treści programoweT-W-1Process Research and Development in the Pharmaceutical Industry
T-W-2Active Pharmaceutical Ingredients: Structure and Impact on Synthesis: - definitions - physicochemical considerations - common features - synthetic sequence - reactions
T-L-1Synthesis of selected API
T-L-2Preparation of pharmaceutical creams and ointments
T-L-3Preparation of pharmaceutical gels
T-L-4Preparation of liquid herbal dosage forms
Metody nauczaniaM-1powerpoint and whiteboard lectures
M-2laboratory exercises
Sposób ocenyS-1Ocena podsumowująca: final writing test
S-2Ocena podsumowująca: evaluation of written reports
S-3Ocena formująca: continuous assesment
Kryteria ocenyOcenaKryterium oceny
2,0
3,0Student is able to describe the basic synthesis methods of selected active pharmaceutical ingredients and pharmaceutical formulation
3,5
4,0
4,5
5,0
PoleKODZnaczenie kodu
Zamierzone efekty uczenia sięChEn_2A_C12b_W02The student knows the influence of the structure of a compound on its properties of action, knows the stages of drug development and the routes of drug administration
Odniesienie do efektów kształcenia dla kierunku studiówChEn_2A_W01Graduate has in-depth knowledge in the field of chemical processes, including appropriate selection of materials, raw materials, methods, techniques, equipment and devices for the implementation of chemical and biochemical processes and characterization of the raw materials and products obtained.
Cel przedmiotuC-1Define important keywords and concepts
C-2Know and understand processes involved in drug synthesis
C-3Know and understand processes involved in formulation preparation
C-4Determines the influence of the active pharmaceutical compound structure on its properties
Treści programoweT-W-1Process Research and Development in the Pharmaceutical Industry
T-W-2Active Pharmaceutical Ingredients: Structure and Impact on Synthesis: - definitions - physicochemical considerations - common features - synthetic sequence - reactions
T-W-3Development of Potential Drug Candidates
T-W-5Route Design and Selection
Metody nauczaniaM-1powerpoint and whiteboard lectures
M-3in-class discussion
Sposób ocenyS-1Ocena podsumowująca: final writing test
Kryteria ocenyOcenaKryterium oceny
2,0
3,0The student knows the influence of selected functional groups on the properties of a compound, can list the stages of drug development and the route of drug administration
3,5
4,0
4,5
5,0
PoleKODZnaczenie kodu
Zamierzone efekty uczenia sięChEn_2A_C12b_W03The student knows the importance of green chemistry in pharmaceutical process research & development
Odniesienie do efektów kształcenia dla kierunku studiówChEn_2A_W04Graduate has broadened and deep knowledge about the modern and green chemical and material technologies, including advanced materials and nanomaterials technologies as well as current trends in the development of chemical industrial processes.
ChEn_2A_W05Graduate has expanded knowledge in the field of environmental protection and sustainable chemical engineering, including environmental risks and dilemmas related to the implementation of industrial chemical processes as well as knows the rules of occupational health and safety.
Cel przedmiotuC-5Understand the importance of green chemistry in the aspect of the pharmaceutical industry
Treści programoweT-W-4The Importance of Green Chemistry in Process Research & Development
Metody nauczaniaM-1powerpoint and whiteboard lectures
M-3in-class discussion
Sposób ocenyS-1Ocena podsumowująca: final writing test
Kryteria ocenyOcenaKryterium oceny
2,0
3,0The student knows the principles of green chemistry and chooses more ecological and economic processes for the synthesis of selected drugs
3,5
4,0
4,5
5,0
PoleKODZnaczenie kodu
Zamierzone efekty uczenia sięChEn_2A_C12b_U01The student can perform the synthesis and analysis of selected active pharmaceutical ingredients and pharmaceutical formulations following the instruction
Odniesienie do efektów kształcenia dla kierunku studiówChEn_2A_U01Graduate is able to utilize the in-depth knowledge in the field of chemical processes, including appropriate selection of materials, raw materials, methods, techniques, equipment and devices for the implementation of chemical and biochemical processes and characterization of the raw materials and products obtained.
ChEn_2A_U02Graduate is able to use the extended and deep knowledge necessary for planning, designing and scaling-up of technological industrial processes as well as planning experiments and elaborating the results of experimental research.
ChEn_2A_U08Graduate is able to apply the principles of occupational health and safety in the laboratory.
Cel przedmiotuC-2Know and understand processes involved in drug synthesis
C-3Know and understand processes involved in formulation preparation
Treści programoweT-L-1Synthesis of selected API
T-L-2Preparation of pharmaceutical creams and ointments
T-L-3Preparation of pharmaceutical gels
T-L-4Preparation of liquid herbal dosage forms
Metody nauczaniaM-2laboratory exercises
Sposób ocenyS-2Ocena podsumowująca: evaluation of written reports
S-3Ocena formująca: continuous assesment
Kryteria ocenyOcenaKryterium oceny
2,0
3,0The student can perform the synthesis and analysis of selected active pharmaceutical ingredients and pharmaceutical formulations following the instruction with the help of the teacher
3,5
4,0
4,5
5,0