Biopharmacy

Data

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

Topic

Aim of this course is to introduce biopharmaceutical aspects of medicines taking into account dosage forms and routes of administration. Basic pharmacokinetic aspects (kinetics of active agents, compartmental analysis, routes of administration), some in vitro and in silico biopharmaceutical practices (using special biopharmaceutical softwares) are presented, bioequivalence studies of medicines are discussed. Students learn to design and develop pharmaceutical dosage forms according to biopharmaceutical requirements. Single and repeated dosing calculations are discussed according to pharmaceutical and physiological aspects.

Lectures

• 1. Subject and general approach of biopharmacy - Pál Szilárd
• 2. Subject and general approach of biopharmacy - Pál Szilárd
• 3. Drug delivery systems and the input options - Pál Szilárd
• 4. Drug delivery systems and the input options - Pál Szilárd
• 5. Biopharmaceutical classification of substances and pharmaceutical preparations - Pál Szilárd
• 6. Biopharmaceutical classification of substances and pharmaceutical preparations - Pál Szilárd
• 7. Biopharmaceutical basics of drug qualification I (drug liberation studies) - Pál Szilárd
• 8. Biopharmaceutical basics of drug qualification I (drug liberation studies) - Pál Szilárd
• 9. Biopharmaceutical basics of drug qualification II (dissolution and absorption models) - Pál Szilárd
• 10. Written test - Pál Szilárd
• 11. Biopharmaceutical basics of drug qualification II. (IVIVC, original and generic preparations) - Pál Szilárd
• 12. Biopharmaceutical basics of drug qualification II. (IVIVC, original and generic preparations) - Pál Szilárd
• 13. LADME system and its control options I - Pál Szilárd
• 14. LADME system and its control options I - Pál Szilárd
• 15. LADME system and its control options II - Pál Szilárd
• 16. LADME system and its control options II - Pál Szilárd
• 17. Written test - Pál Szilárd
• 18. Written test - Pál Szilárd
• 19. Biopharmaceutical basics of medicinal therapy I (dermal and transdermal therapy) - Kása Péter
• 20. Biopharmaceutical basics of medicinal therapy I (dermal and transdermal therapy) - Kása Péter
• 21. Biopharmaceutical basics of medicinal therapy II (eye, nasal and ear preparations) - Pál Szilárd
• 22. Biopharmaceutical basics of medicinal therapy II (eye, nasal and ear preparations) - Pál Szilárd
• 23. Biopharmaceutical basics of medicinal therapy III (hormonal disorders) - Pál Szilárd
• 24. Biopharmaceutical basics of medicinal therapy III (hormonal disorders) - Pál Szilárd
• 25. Biopharmaceutical basics of medicinal therapy IV (chronotherapy, cardiovascular diseases, asthma) - Pál Szilárd
• 26. Biopharmaceutical basics of medicinal therapy IV (chronotherapy, cardiovascular diseases, asthma) - Pál Szilárd
• 27. Biopharmaceutical basics of medicinal therapy V (specific medicinal therapy) - Kása Péter
• 28. Written test - Pál Szilárd

Practices

Seminars

Reading material

Obligatory literature

Literature developed by the Department

Notes

Recommended literature

Leon Shargel, A. B.C: .Applied Biopharmaceutics and Pharmacokinetics, Yu, Stamford

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

www.gytk.pte.hu

www.sciencedirect.com

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 60,1 % after average calculation. After two assessments if students reach average 60,1 % 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 possible 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.

Exam topics/questions

Students will receive the topic lists in the Institute and/or on the website.

At the end of semesters, students take oral exam.Exams is preceded by the "Minimum Test" (MT). To write the MT, students have at most 30 minutes, and will be evaluated by percentage. Those students, who achieve less than 60% in MT, will get unsatisfactory grade and cannot continue with the oral part of the exam.

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

Examiners

• Pál Szilárd

Instructor / tutor of practices and seminars

• Kása Péter
• Pál Szilárd