Pharmaceutical Technology 4

Data

Official data in SubjectManager for the following academic year: 2022-2023

Course director

  • Dr. Szilárd PÁL

    assistant professor,
    Institute of Pharmaceutical Technology and Biopharmacy

Number of hours/semester

lectures: 28 hours

practices: 56 hours

seminars: 0 hours

total of: 84 hours

Subject data

  • Code of subject: OPG-GT4-T
  • 6 kredit
  • Pharmacy
  • Pharm. theoretical module and practical skills modul
  • spring
Prerequisites:

OPG-GT3-T completed , OPG-GK3-T completed , OPG-GH2-T parallel

Exam course:

no

Course headcount limitations

min. 1 – max. 80

Topic

In this semester solid dosage forms, theoretical introduction of granulation, tabletting and tablet coating is discussed. Quality control of prepared dosage forms are also carried out such as disintegration, dissolution, tablet hardness test, etc. Aspects and work in industrial pharmacy is also presented during this semester.

Lectures

  • 1. Drug Delivery Systems 1 - Dr. Pál Szilárd
  • 2. Drug Delivery Systems 1 - Dr. Pál Szilárd
  • 3. Drug Delivery Systems 2 - Dr. Pál Szilárd
  • 4. Drug Delivery Systems 2 - Dr. Pál Szilárd
  • 5. Drug Delivery Systems 3 - Dr. Pál Szilárd
  • 6. Drug Delivery Systems 3 - Dr. Pál Szilárd
  • 7. Drug Delivery Systems 4 - Dr. Kása Péter
  • 8. Drug Delivery Systems 4 - Dr. Kása Péter
  • 9. Written test - Dr. Pál Szilárd
  • 10. Written test - Dr. Pál Szilárd
  • 11. Multiparticulate systems 1 (microcapsules, micropellets) - Dr. Pál Szilárd
  • 12. Multiparticulate systems 1 (microcapsules, micropellets) - Dr. Pál Szilárd
  • 13. Multiparticulate systems 2 (molecular dispersion, liposomes, dendrimers, kohleats, kvantum dots, nanotubes) - Dr. Pál Szilárd
  • 14. Multiparticulate systems 2 (molecular dispersion, liposomes, dendrimers, kohleats, kvantum dots, nanotubes) - Dr. Pál Szilárd
  • 15. Development of pharmaceutical dosage forms 1 - Dr. Kása Péter
  • 16. Development of pharmaceutical dosage forms 1 - Dr. Kása Péter
  • 17. Development of pharmaceutical dosage forms 2 - Dr. Pál Szilárd
  • 18. Development of pharmaceutical dosage forms 2 - Dr. Pál Szilárd
  • 19. Written test - Dr. Pál Szilárd
  • 20. Written test - Dr. Pál Szilárd
  • 21. Stability of preparations - Dr. Pál Szilárd
  • 22. Stability of preparations - Dr. Pál Szilárd
  • 23. Wrapping of pharmaceutical preparations - Dr. Pál Szilárd
  • 24. Wrapping of pharmaceutical preparations - Dr. Pál Szilárd
  • 25. Quality Assurance, GMP - Ámanné Dr. Takácsi-Nagy Anna Erzsébet
  • 26. Quality Assurance, GMP - Ámanné Dr. Takácsi-Nagy Anna Erzsébet
  • 27. Official approval, validation, reproducibility, process control - Dr. Pál Szilárd
  • 28. Written test - Dr. Pál Szilárd

Practices

  • 1. General instructions, rules and regulations on practices, solutions, nasal drops, ear drops
  • 2. General instructions, rules and regulations on practices, solutions, nasal drops, ear drops
  • 3. General instructions, rules and regulations on practices, solutions, nasal drops, ear drops
  • 4. General instructions, rules and regulations on practices, solutions, nasal drops, ear drops
  • 5. Emulsions, suspensions
  • 6. Emulsions, suspensions
  • 7. Emulsions, suspensions
  • 8. Emulsions, suspensions
  • 9. Eye oinments, eyes drops, tea mixtures, decoctum, infusum
  • 10. Eye oinments, eyes drops, tea mixtures, decoctum, infusum
  • 11. Eye oinments, eyes drops, tea mixtures, decoctum, infusum
  • 12. Eye oinments, eyes drops, tea mixtures, decoctum, infusum
  • 13. Ointments/creams/pastes/gels
  • 14. Ointments/creams/pastes/gels
  • 15. Ointments/creams/pastes/gels
  • 16. Ointments/creams/pastes/gels
  • 17. Vaginal, rectal suppositories
  • 18. Vaginal, rectal suppositories
  • 19. Vaginal, rectal suppositories
  • 20. Vaginal, rectal suppositories
  • 21. Powders, pills, hard gelatin capsules
  • 22. Powders, pills, hard gelatin capsules
  • 23. Powders, pills, hard gelatin capsules
  • 24. Powders, pills, hard gelatin capsules
  • 25. Personal assessment 1.
  • 26. Personal assessment 1.
  • 27. Personal assessment 1.
  • 28. Personal assessment 1.
  • 29. Personal assessment 2.
  • 30. Personal assessment 2.
  • 31. Personal assessment 2.
  • 32. Personal assessment 2.
  • 33. Personal assessment 3.
  • 34. Personal assessment 3.
  • 35. Personal assessment 3.
  • 36. Personal assessment 3.
  • 37. Personal assessment 4.
  • 38. Personal assessment 4.
  • 39. Personal assessment 4.
  • 40. Personal assessment 4.
  • 41. Personal assessment 5.
  • 42. Personal assessment 5.
  • 43. Personal assessment 5.
  • 44. Personal assessment 5.
  • 45. Personal assessment 6.
  • 46. Personal assessment 6.
  • 47. Personal assessment 6.
  • 48. Personal assessment 6.
  • 49. Personal assessment 7.
  • 50. Personal assessment 7.
  • 51. Personal assessment 7.
  • 52. Personal assessment 7.
  • 53. End-semester assessment of practice
  • 54. End-semester assessment of practice
  • 55. End-semester assessment of practice
  • 56. End-semester assessment of practice

Seminars

Reading material

Obligatory literature

Literature developed by the Department

Notes

Recommended literature

European Pharmacopoeia
Formulae Normales VII. (FoNo VII.)
James Swarbrick: Encyclopedia of Pharmaceutical Technology, Informa Healthcare, New York, London
Gilbert S. Banker, Christopher T. Rhodes: Modern Pharmaceutics, Marcel Dekker Inc., New York- Basel
Chris Langley, Dawn Belcher: Pharmaceutical Compounding and Dispensing, Pharmaceutical Press
www.gytk.pte.hu
www.sciencedirect.com
Attila Dévay: The Theory and Practice of Pharmaceutical Technology, electronic book, PTE-Pécs
Attila Dévay: Investigation of Pharmaceutical Preparations, electronic book, PTE-Pécs

Conditions for acceptance of the semester

1. Accepted preparations made on practices.
2. Accepted work reports.
3. Accepted practical and theoretical assessments.
4. At the beginning of all practice classes students write short tests of different types (dose checking, synonim names and latin expressions, calculations). Semester only can be accepted if students reach at least 50% from each short test type.
Evaluation of the practices is according to the semester work (practice work, assessments, work reports) by practice grade.
5. During the 2nd part of the semester students have to make 2 preparations for grade on each practice. After taking into account average of all grades students have to reach grade 2,50 for the acceptance of the semester.

Mid-term exams

Students have to write three assessments during the semester and they have to reach 60 % after average calculation. After two assessments if students reach average 60 % taking into account both tests, writing the third assesment it not compulsory. The third assessments (which is considered as the 1st retake) has to above 60,1 %. If the student fails on the 3rd assessment, there is still chance for the 2nd retake, where student has to reach 60,1% for the acceptance of the semester. In case of confirmed absence from the assessment, re-take chance is sossible for the student. Missing the re-take results 0 % assessment.

Making up for missed classes

Students must fulfil requirements determined by the Code of Studies and Examinations.
All missed or failed preparations manufactured on the practice should be made up on supplementary practices!

Exam topics/questions

After the semester the exam is a complex exam from all Pharmaceutical Technology 1-2-3-4 courses evaluated by a five-grade system. Knowledge acquired is tested based on subject matter defined by a list of topics provided by the institute.The end-semester exam will be evaluated by a five-grade system.
Knowledge acquired is tested based on subject matter defined by a list of topics provided by the institute.
At the end of semester, students take oral exam. Chance "B"and "C"are also oral exams, which is preceded by the "Minimum Test" (MT). To write the MT, students have at most 30 minutes, and will be evaluated percent rating. Those students, who achieve less than 60% in MT, unsatisfactory grade will be assessed and cannot pass them to the oral part of the exam.
Oral part includes two topics. In the case of any part done with insufficient knowledge, will result in assessment of the exam to unsatisfactory grade.

In addition to the exam topics, part of the exam is answering questions that aim at assessing the general knowledge of the student.

Examiners

  • Dr. Dévay Attila
  • Dr. Pál Szilárd

Instructor / tutor of practices and seminars

  • Dr. Farkas Gyula
  • Dr. Kása Péter
  • Dr. Mayer Klára
  • Dr. Pál Szilárd