Tantargy

Data

Official data in SubjectManager for the following academic year: 2024-2025

Topic

Aim of Pharmaceutical Technology course is to introduce basic technological processes, preformulation and formulation of pharmaceutical dosage forms taking into account physico-chemical, pharmaceutical and biopharmaceutical properties of active agents and pharmaceutical excipients related to the field of biotechnology.

Practices usually begin with seminars where basic introduction of the proper lesson takes place. After seminars students have to prepare medicines according to the rules of pharmaceutical formulation technology in proper dosage forms including calculation of single and daily maximal dose, preparation and labelling.Practices of quality control of medicines are carried out as well.

During the lectures and practices dosage forms with higher importance in the field biotechnologically produced medicines will be elaborated.

Lectures

• 1. Introduction to pharmaceutical technology: basic terms (API, vehicle, solvent, etc.) - Pál Szilárd
• 2. Introduction to pharmaceutical technology: basic terms (API, vehicle, solvent, etc.) - Kása Péter
• 3. Dosage forms, drug delivery systems of different routes of administration, modified drug release - Pál Szilárd
• 4. Dosage forms, drug delivery systems of different routes of administration, modified drug release - Kása Péter
• 5. Importance of LADME system, BCS system and bioavailability in pharmaceutical technology - Pál Szilárd
• 6. Importance of LADME system, BCS system and bioavailability in pharmaceutical technology - Kása Péter
• 7. Preparation of dosage forms for oral administration: liquid, solid - Pál Szilárd
• 8. Preparation of dosage forms for oral administration: liquid, solid - Kása Péter
• 9. Inroduction to aseptic preparation, methods of sterilization, pyrogens - Pál Szilárd
• 10. Inroduction to aseptic preparation, methods of sterilization, pyrogens - Kása Péter
• 11. Preparation of dosage forms of parenteral administration: injections - basics, APIs, solvents, preparation - Pál Szilárd
• 12. Preparation of dosage forms of parenteral administration: injections - basics, APIs, solvents, preparation - Kása Péter
• 13. Preparation of dosage forms of parenteral administration: injections - examinations - Pál Szilárd
• 14. Preparation of dosage forms of parenteral administration: injections - examinations - Kása Péter
• 15. Preparation of dosage forms of parenteral administration: infusions - preparation, types of infusions - Pál Szilárd
• 16. Preparation of dosage forms of parenteral administration: infusions - preparation, types of infusions - Kása Péter
• 17. Basics of nanotechnology - Secenji Aleksandar
• 18. Basics of nanotechnology - Secenji Aleksandar
• 19. Drug design and development - CAD, DOE, ANN - Pál Szilárd
• 20. Drug design and development - CAD, DOE, ANN - Kása Péter
• 21. Interactions and incompatibilities - Pál Szilárd
• 22. Interactions and incompatibilities - Kása Péter
• 23. Stability of drug products/biopharmaceuticals - Pál Szilárd
• 24. Stability of drug products/biopharmaceuticals - Kása Péter
• 25. Original, generic and biosimilar products, their comparison, bioequivalence - Pál Szilárd
• 26. Original, generic and biosimilar products, their comparison, bioequivalence - Kása Péter
• 27. Pharmaceutical industrial plant, clean area, biohazard box, safety - Pál Szilárd
• 28. Pharmaceutical industrial plant, clean area, biohazard box, safety - Kása Péter

Practices

• 1. Introduction to parenteral dosage forms
• 2. Introduction to parenteral dosage forms - isotonic calculations I.
• 3. Introduction to parenteral dosage forms - isotonic calculations II.
• 4. Introduction to parenteral dosage forms - isotonic calculations III.
• 5. Preparation of injections - practice I.
• 6. Preparation of injections - practice II.
• 7. Examination of injections I.
• 8. Examination of injections II.
• 9. Preparation of infusions - practice I.
• 10. Preparation of infusions - practice II.
• 11. Examination of infusions
• 12. Demonstration of interactions and incompatibilities in parenteral dosage forms
• 13. Demonstration of industrial manufacture of medicines
• 14. Practice test

Seminars

Reading material

Obligatory literature

Literature developed by the Department

Notes

Recommended literature

James Swarbrick: Encyclopedia of Pharmaceutical Technology, Informa Healthcare, New York, London

Susanna Wu-Pong, Yon Rojanasakul: Biopharmaceutical Drug Design and Development, Humana Press

Gilbert S. Banker, Christopher T. Rhodes: Modern Pharmaceutics, Marcel Dekker Inc., New York- Basel

European Pharmacopoeia

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

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

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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

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 have to take written exam.

Examiners

• Kása Péter
• Pál Szilárd

Instructor / tutor of practices and seminars

• Kása Péter
• Pál Szilárd