Head of the unit:

prof. Aleksander Mendyk, Ph.D.
 

Chair and Department of Pharmaceutical Technology and Biopharmaceutics

Faculty of Pharmacy – Medical College

Jagiellonian University

Medyczna 9 St.

30-688 Kraków

tel. 12 620-56-00

tpl@uj.edu.pl

The Chair and Department of Pharmaceutical Technology and Biopharmacy is a research and educational unit at the Faculty of Pharmacy, Jagiellonian University Medical College, undertaking a broad spectrum of comprehensive research, pedagogical, and administrative efforts.

The research topics of the scientific works are focused on the development and evaluation of modern forms in the field of pharmaceutical technology, considering biopharmaceutical aspects. In light of new research directions, experimental studies are conducted concerning, among other things, the development of new drug forms or their modifications to ensure proper quality and safety of use in patients. The fundamental research directions include:

1. technological aspects of improving the pharmaceutical availability of very difficult and practically insoluble medicinal substances,

2. optimization of modern drug forms in configurations such as multi-compartment systems, tablets, and films that disintegrate in the oral cavity (ODT, ODF), tablets with a liquid fraction,

3. optimization of modified-release drug forms based on a knowledge base from fundamental sciences,

4. designing drug forms with an emphasis on personalized therapy,

5. evaluation of the physicochemical properties of excipients to optimize the technology of manufacturing oral drug forms using modern analytical methods,

6. application of additive manufacturing tools (3D printing) as a platform for innovative technological solutions,

7. designing testing methods to ensure the quality of modern drug forms,

8. decision support systems for optimizing manufacturing strategies of medicinal products based on computational intelligence tools,

9. innovative solutions in drug form design utilizing Quality by Design principles and Process Analytical Technology.

The laboratory and equipment facilities of the Department allow for conducting research across a broad scope, including technological and analytical work aimed at evaluating the quality of drug forms. Among the most important pieces of equipment in the Department, there is production apparatus that is used for preparing various drug forms on a laboratory scale.

From the perspective of conducting research projects, significant devices included in the unit’s equipment are impact and rotary tablet presses: Korsch EK0, Korsch PH 103, Erweka TRB 10, which allow for the production of ODT tablets and tablets with pellets. Additionally, there is an extrusion and spheronization set: Alexanderwerk GA 60 extruder, Caleva 120 spheronizer, Fukae Powtec FS-GS high-speed granulator, fluid bed equipment for granulation, drying, and coating: Bosch-Solidlab and 4M8-F Pro-C-epT, Buchi B-191 spray dryer, Elcometer 4340 device for creating polymer films with precisely defined thickness, Fritsch Pulverisette 7 Classic Line and Premium Line planetary mills, and two Z-Morph 3D printers.

The Department also has a wide range of research devices used to evaluate drug forms, including: sets for studying the release of medicinal substances (USP Apparatus 1 and 2): Hanson SR8 water bath and Dissoette II fraction collector, and Hanson Research Elite 8 Vision G2; a set for studying the release of medicinal substances by flow-through method (USP Apparatus 4) Erweka DFZ 60 with HKP 60 pump, PharmaTest PTF-E friabilator, VanKel VK 200 hardness tester, Electrolab ED-2 SAPO disintegration test apparatus, spectrophotometers: UV-VIS JASCO V-530 and Shimadzu UV-1800 UV-VIS, high-performance liquid chromatography (HPLC) set Agilent 1260 Infinity, particle size measuring device by laser diffraction Malvern 3000, Shimadzu EZ-SX texture analyzer, Haake VT 550 rheometer, optical microscopes: Hund Wetzlar H600 and MST-ZOOM PZO,

The academic and teaching staff is composed of three independent scientific employees, including 1 full professor and 2 associate professors, 5 adjuncts, 2 senior lecturers, 5 assistants, and 2 doctoral students. They possess significant knowledge and experience, as evidenced by their scientific publications (63 publications in the period 2013-2016, 4 books), awarded grants for research projects (international IPROCOM project, Polish-Singaporean, PHAR-QA, 1 POIG1.1 project, 2 National Science Centre (NCN) research projects: SONATA 4, SYMFONIA 3, DIALOG, 1 statutory project, and 4 targeted projects), and active participation in both international and national scientific conferences (63 presentations from 2013-2016). The scope of their activities also includes preparing pharmacopeial monographs for the Polish Pharmacopeia, providing opinions for monographs in the International Pharmacopeia, and participating in expert groups convened by national and international or foreign institutions (WHO, EAFP).