Resultado final
The 1st Summer School will be organised and hosted by Trinity College Dublin in cooperation with APC. The programme will consist of lectures on the state of the art and recent advances in preformulation studies, as well as practical workshops and hands-on demonstrations of various API and dosage form characterisation techniques, e.g. thermal analysis or X-ray diffraction. The Summer School will be based on the expertise both from the ORBIS partners (especially TCD as the member of Synthesis and Solid State Pharmaceutical Centre) and invited external experts in preformulation studies from academia and industry. Apart from upskilling ORBIS ESRs in the area of preformulation studies, the Summer School will offer an excellent academia-industry networking opportunity by gathering the members of all Consortium Partners, as well as an opportunity to demonstrate the capabilities of TCD and APC.
Mid-term meeting.This meeting will take place in Warsaw. The purpose of this meeting is to assess the fulfillment of all aspects (scientific, research, training, management, etc) of the project described in the Grant Agreement- Annex no.1. The structure of the work plan will be reviewed. Particular attention will be paid to the training activities and secondments aspects including activities across different sectors of the ORBIS consortium.
ORBIS final meeting.ORBIS final meeting will take place in PoznanThe purpose of this meeting is to summarizing of the fulfilment and results of scientific research training dissemination and management aspects of the whole ORBIS project as well as assessment of the possibility of the cooperation within another common scientific project
Workshop on dosage forms and drug delivery systems.The workshop will be hosted in Helsinki directly after 2nd Summer School, while ZNT as an industrial partner will be responsible for the programme organisation. The event will be directed specifically to the ORBIS members and will consist of meetings, presentations and discussions on the scientific outcomes of the activities described in WP2. The case studies demonstrated by the participants will focus especially on topics such as: - design and development of polymeric micro- and nanoparticles, minitablets and self-microemulsifying systems, - application of novel spectroscopic and imaging approaches for structural characterisation of solid formulations, - implementation of Quality by Design principles to manufacturing process, - design of topical and transdermal delivery system, including ionic liquids or microemulsion-based solid systems. The workshop is intended to create a favorable environment for knowledge sharing between all ORBIS members and an opportunity to discuss the outcomes of secondments as well as further research collaboration between industrial and academic participants. Moreover, the event will also foster the soft skills development for the involved ESRs, who will have an excellent opportunity for the public presentation of their scientific results and secondments experience in the form of posters and/or short oral presentations.
4th School on biopharmaceutical evaluation of dosage forms and drug delivery.The Summer School will be organised and hosted by ZNT The programme will consist of lectures and workshops on the state of the art and recent progress in the biopharmaceutical evaluation methods of oral topical and transdermal drug delivery systems Relying on the expertise of ORBIS members especially ZNT and PHY as well as invited external highprofile experts the School will focus on topics such as development and validation of bioanalytical methods biorelevant in vitro dissolutionex vivo permeation testing of dosage forms or biopharmaceutical modelling and in vitroin vivo correlations Apart from upskilling ORBIS ESRs in the area of biopharmaceutical evaluation of dosage forms the Summer School will offer an excellent academiaindustry networking opportunity by gathering the members of all Consortium Partners
3rd School on topical and transdermal drug delivery systems.The Summer School will be organised and hosted by PUMS The programme will consist of lectures on the state of the art and recent progress in the development of topical and transdermal delivery systems eg hydrogels microemulsions ionic liquids transdermal or buccal patches as well as practical workshops on the formulation and characterisation techniques eg rheology in vitro releasepermeation of the abovementioned drug delivery systems Apart from upskilling ORBIS ESRs in the area of topical and transdermal drug delivery studies the Summer School will offer an excellent academiaindustry networking opportunity by gathering the members of all Consortium Partners as well as showcase PUMS capabilities
Kick-off meeting.Kick of meeting will take place in Poznan at coordinator place. It provides high level information about the project and help: to set expectations across the entire team, to crack the ice that can inhibit team communication to ensure that every consortium partner understand the ORBIS vision, objectives, benefits, deliverables and milestones, thereby helping the all team be successful.
Open Workshop on biopharmaceutical evaluation of dosage forms and drug delivery systems.The workshop will be hosted in Prague directly after 4th Summer School while PHY as an industrial partner will be responsible for the programme organisation The event will be directed specifically to the ORBIS members and will consist of meetings presentations and discussions on the scientific outcomes of the activities described in WP3 The case studies demonstrated by the participants will focus especially on topics such asbiorelevant dissolution testing of oral dosage forms and in vitro release of topical and transdermal delivery systemsdevelopment and validation of bioanalytical methodspharmacokinetic studies PKPD modelling and in vitroin vivo correlationThe workshop is intended to create a favourable environment for knowledge sharing between all ORBIS members and an opportunity to discuss the outcomes of secondments as well as a further research collaboration between industrial and academic participants Moreover the event will also foster the soft skills development for the involved ESRs who will have an excellent opportunity for the public presentation of their scientific results and secondments experience in the form of posters andor short oral presentations
2nd School on oral dosage and drug delivery systems.The Summer School will be organised and hosted by UoH. The programme will consist of lectures on the state of the art and recent progress in the development of oral dosage forms and advanced delivery systems, such as nano- and microparticles, minitablets, self microemulsifying drug delivery systems (SMEDDS) or mesoporous materials. Apart from the lectures, some of which are planned to be given by external high-profile experts in the field of oral drug delivery, School participants will be involved in practical exercises on different formulation techniques (e.g. fluid bed granulation, spray drying, minitablets) and advanced techniques for in-depth characterisation of dosage forms (e.g. various modifications of Raman spectroscopy) owing to UoH capabilities. Apart from upskilling ORBIS ESRs in the area of oral drug delivery studies, the Summer School will offer an excellent academia-industry networking opportunity by gathering the members of all Consortium Partners.
Open Workshop on process development of drug substances.The workshop will be hosted in Dublin directly after 1st Summer School, while FMK as an industrial partner will be responsible for the programme organisation. The event will be directed specifically to the ORBIS members and will consist of meetings, presentations and discussions on the scientific outcomes of the activities described in WP1. The case studies demonstrated by the participants will focus especially on topics such as continuous scalable synthesis of APIs, development of key synthetic transformations or process validation and transfer. The workshop is intended to create a favorable environment for knowledge sharing between all ORBIS members and an opportunity to discuss the outcomes of secondments as well as further research collaboration between industrial and academic participants. Moreover, the event will also foster the soft skills development for the involved ESRs, who will have an excellent opportunity for the public presentation of their scientific results and secondments experience in the form of posters and/or short oral presentations.
ORBIS final conference.The conference will be hosted in Poznan and PUMS will be responsible for the programme organisation The event will be directed to the general public including industry professionals academics as well as students and ESRs The conference will include presentations and discussions on the multidisciplinary scientific outcomes of the ORBIS project The areas of biopharmaceutic sciences will be represented by synthetic and analytical chemistry pharmaceutical technology pharmaceutical analysis bioanalysis and pharmacokinetics quality assurance and control statistics and simulations The consortium policies developed by an academic and industrial partners of the consortium including knowledge sharing policy will be also presentedThe conference is intended to create a friendly environment for spreading the knowledge gained during the ORBIS project with the outside communities Both industrial professionals and ESRs will get an excellent opportunity to present their results to the general public in the form of posters short oral presentations or lectures The conference will also include networking events to facilitate facetoface discussions as well as to strengthen existing and boost the formation of novel collaborations
Report will be delivered on translation of the discovery synthesis of API(s) into technology development and on investigation of the solid state physicochemical characteristics of API(s). The Deliverable will contain observations, results and discussion of results against the state of the art obtained within the duration of ORBIS on the improvement of unfavorable characteristics of API(s) and describe: - synthesis of drug substances including scale-up and continuous model development - validation of analytical methods - process development of key synthetic transformations - intrinsic and derived solid state physicochemical properties of selected API(s) - preparation of crystalline and/or amorphous forms of selected API(s) - correlation between physicochemical properties of API(s) and formulability, manufacturability and biopharmaceutical performance
Pharmacokinetics driven development of dosage forms specifications and estimation of pharmacokinetics based on in vitro data.The Deliverable will be prepared as a public report It will be delivered on role of pharmacokinetics in the development of novel drug delivery forms and in vitro models for predictions of pharmacokinetic parameters of various drugs The report will summarize observations and results obtained within the duration of ORBIS including discussion of their significance against the state of the art It will focus on multidisciplinary research results from WP3 but may include also observations from other WPs if applicable Some speculations on the future perspective of the biopharmacy will also be included The following specific topics will be the backbone of the report pharmacokinetics as a rationale for development of new patientfriendly drug formulations predictive in vitro models for selected medicines development optimisation and validation of bioanalytical pharmacokinetic and pharmacogenetic methodsimprovements and trends in combining in vitro and in vivo data
New insights into oral dosage forms and delivery systems progress in controlled release oral drug delivery systems, development of novel topical and transdermal drug delivery.Report will be delivered on development of novel drug delivery systems for oral and topical administration of various active compoundsThe Deliverable will contain description of the design preparation characteristization and general observations concerning new concepts for polymeric nano and microparticles minitablets selfmicroemulsifying systems SMEDDS or mesoporous materials in terms of oral drug delivery preparation of topical liquids semisolids and adhesives for skin delivery of active agents optimisation of novel technologies useful to achieve high and accurate drug loading improvement and development of in vitro drug dissolution and release testing
The ORBIS website will be designed as a main platform for communication of ORBIS participants with multiple audiences. The aims, key contributors and the current progress of the action will be presented on an interactive and dynamic website, driven by participating organisations and WP6 leaders and powered by a professional web-site administrator. The website content will be addressed to both peer scientists and the general public. News for media, placed periodically in a dedicated section, will be provided by ORBIS researchers and translated into a popular style by website WP6 dedicated editor. The website will gather data on ORBIS members and activities as well as will feature a constantly updated collection of publications, lectures and training materials created by ORBIS participants. The information presented on the portal will be also oriented for potential users of ORBIS achievements and for the wider research and innovation community, including national and international technology transfer centres as well as SMEs, to amplify the potential impact of this action. To increase global project visibility on the Internet, the dissemination of results on ORBIS website will be supported by social media channels. Regular updates will be posted for professionals on ResearchGate and for general public on Twitter and Facebook. Both ORBIS website and social media chanells will be launched at the very beginning of the project and will be operated by PUMS. All ORBIS participants will be involved in creation of website content and updates.
Publicaciones
Autores:
Michał Kaza; Alexander Sokolovskyi; Piotr J. Rudzki
Publicado en:
Pharmaceutical Research, Edición 37, Article number: 140 (2020), 2020, ISSN 1573-904X
Editor:
Springer Nature
DOI:
10.1007/s11095-020-02871-3
Autores:
Skotnicki Marcin, Jadach Barbara, Skotnicka Agnieszka, Milanowski Bartłomiej, Tajber Lidia, Pyda Marek, Kujawski Jacek
Publicado en:
Pharmaceutics, Edición 13, 2021, Página(s) 118, ISSN 1999-4923
Editor:
Multidisciplinary Digital Publishing Institute (MDPI)
DOI:
10.3390/pharmaceutics13010118
Autores:
Kaza Michał, Karaźniewicz-Łada Marta, Kosicka Katarzyna, Siemiątkowska Anna, Rudzki Piotr J.
Publicado en:
Journal of Pharmaceutical and Biomedical Analysis, Edición 165, 2019, Página(s) 381-385, ISSN 0731-7085
Editor:
Elsevier BV
DOI:
10.1016/j.jpba.2018.12.030
Autores:
Sidoryk Katarzyna, Michalak Olga, Kubiszewski Marek, Leś Andrzej, Cybulski Marcin, Stolarczyk Elżbieta U., Doubsky Jan
Publicado en:
Molecules, Edición 25, 2020, Página(s) 3470, ISSN 1420-3049
Editor:
Multidisciplinary Digital Publishing Institute (MDPI)
DOI:
10.3390/molecules25153470
Autores:
Dorota Haznar‑Garbacz, Dagmara Hoc, Grzegorz Garbacz, Marek Lachman, Daria Słomińska, Michał Romański
Publicado en:
AAPS PharmSciTech, Edición 23, 2023, Página(s) 203, ISSN 1530-9932
Editor:
American Association of Pharmaceutical Scientists
DOI:
10.1208/s12249-022-02310-z
Autores:
Karazniewicz-Łada, Marta; Kosicka-Noworzyn, Katarzyna; Rao, Prakruti; Modi, Nisha; Xie, Yingda L.; Heysell, Scott K.; Kagan, Leonid
Publicado en:
Journal of Pharmaceutical and Biomedical Analysis, Edición 235, 2023, Página(s) 115650, ISSN 0731-7085
Editor:
Elsevier BV
DOI:
10.1016/j.jpba.2023.115650
Autores:
Malaviya Rama, Peters Eric, Casillas Robert P., Laskin Jeffrey D., Laskin Debra L., Abramova Elena V., Rancourt Raymond C., Sunil Vasanthi R., Napierala Marta, Weinstock Daniel, Croutch Claire R., Roseman Julie, Tuttle Rick
Publicado en:
Toxicological Sciences, Edición 178, 2020, Página(s) 358–374, ISSN 1096-0929
Editor:
Oxford Academic
DOI:
10.1093/toxsci/kfaa150
Autores:
Zielińska Monika, Garbacz Grzegorz, Sczodrok Jarosław, Voelkel Adam
Publicado en:
Pharmaceutics, Edición 14, 2022, Página(s) 717, ISSN 1999-4923
Editor:
Multidisciplinary Digital Publishing Institute (MDPI)
DOI:
10.3390/pharmaceutics14040717
Autores:
Juszczyk Ewelina, Garbacz Grzegorz, Sczodrok Jaroslaw, Danielak Dorota, Kisło Kamil, Żero Paweł, Tratkiewicz Ewa, Wieczorek Maciej, Paszkowska Jadwiga, Banach Grzegorz, Wiater Marcela, Hoc Dagmara
Publicado en:
Pharmaceutics, Edición 13, 2021, Página(s) 804, ISSN 1999-4923
Editor:
Multidisciplinary Digital Publishing Institute (MDPI)
DOI:
10.3390/pharmaceutics13060804
Autores:
Jakubowska Emilia, Davin Sharon, Dumicic Aleksandra, Garbacz Grzegorz, Juppo Anne, Michniak-Kohn Bożena, Rudzki Piotr J., Smułek Wojciech, Strachan Clare, Syarkevych Oleg, Tajber Lidia, Lulek Janina
Publicado en:
Journal of Medical Science, Edición 89, 2020, Página(s) 419, ISSN 2353-9798
Editor:
Poznan University of Medical Sciences, Poland
DOI:
10.20883/medical.419
Autores:
Zhang Julia, Osmałek Tomasz, Michniak-Kohn Bożena
Publicado en:
International Journal of Nanomedicine, Edición 15, 2020, Página(s) 9319—9335, ISSN 1178-2013
Editor:
Dove Medical Press
DOI:
10.2147/ijn.s274954
Autores:
Aleksandra Dańczak-Pazdrowska, Justyna Gornowicz-Porowska, Adriana Polańska, Violetta Krajka-Kuźniak, Maciej Stawny, Aleksandra Gostyńska, Błażej Rubiś, Sarah Nourredine, Sarah Ashiqueali, Augusto Schneider, Tamara Tchkonia, Saranya P. Wyles, James L. Kirkland, Michal M. Masternak
Publicado en:
Aging Cell, Edición 22, 2023, Página(s) e13845, ISSN 1474-9726
Editor:
John Wiley & Sons Ltd and The Anatomical Society
DOI:
10.1111/acel.13845
Autores:
Ashley Dan, Haresh Vaswani, Alice Šimonová, Aleksandra Grząbka-Zasadzińska, Jingzhe Li, Koyel Sen, Shubhajit Paul, Yin-Chao Tseng, Rohit Ramachandran
Publicado en:
International Journal of Pharmaceutics: X, Edición 6, 2023, Página(s) 100188, ISSN 2590-1567
Editor:
Elsevier
DOI:
10.1016/j.ijpx.2023.100188
Autores:
Paczkowska-Walendowska Magdalena, Dvorák Jakub, Rosiak Natalia, Tykarska Ewa, Szymańska Emilia, Winnicka Katarzyna, Ruchała Marek A., Cielecka-Piontek Judyta
Publicado en:
Pharmaceutics, Edición 13, 2021, Página(s) 417, ISSN 1999-4923
Editor:
Multidisciplinary Digital Publishing Institute (MDPI)
DOI:
10.3390/pharmaceutics13030417
Autores:
Grynkiewicz Grzegorz, Maruszak Wioleta
Publicado en:
Cancer Studies and Therapeutic, Edición 4, 2019, Página(s) 1-3, ISSN 2771-7933
Editor:
Research Open
DOI:
10.5281/zenodo.3579114
Autores:
Skupin-Mrugalska Paulina, Minko Tamara
Publicado en:
Pharmaceutics, Edición 12, 2020, Página(s) 939, ISSN 1999-4923
Editor:
Multidisciplinary Digital Publishing Institute (MDPI)
DOI:
10.3390/pharmaceutics12100939
Autores:
Piotr J. Rudzki, Przemysław Biecek, Michał Kaza
Publicado en:
The AAPS Journal, Edición 21/2, 2019, ISSN 1550-7416
Editor:
Springer New York
DOI:
10.1208/s12248-019-0293-2
Autores:
Danielak Dorota, Banach Grzegorz, Walaszczyk Juliusz, Romański Michał, Bawiec Marek, Paszkowska Jadwiga, Zielińska Monika, Sczodrok Jarosław, Wiater Marcela, Hoc Dagmara, Kołodziej Bartosz, Garbacz Grzegorz
Publicado en:
Journal of Pharmaceutical and Biomedical Analysis, Edición 189, 2020, Página(s) 113415, ISSN 0731-7085
Editor:
Elsevier BV
DOI:
10.1016/j.jpba.2020.113415
Autores:
Aleksandra Bartkowiak; Jacek Lewandowicz; Monika Rojewska; Klaudia Krüger; Janina Lulek; Krystyna Prochaska
Publicado en:
Journal of Molecular Liquids, Edición 361, 2022, Página(s) 119623, ISSN 0167-7322
Editor:
Elsevier BV
DOI:
10.1016/j.molliq.2022.119623
Autores:
Danielak Dorota, Milanowski Bartłomiej, Wentowski Krzysztof, Nogowska Maria, Kątny Michał, Rogowski Piotr, Konwicki Łukasz, Puk Ewa, Pieczuro Jarosław, Bawiec Marek, Garbacz Grzegorz, Lulek Janina
Publicado en:
AAPS PharmSciTech, Edición 21, 2020, Página(s) 161, ISSN 1530-9932
Editor:
American Association of Pharmaceutical Scientists
DOI:
10.1208/s12249-020-01662-8
Autores:
Dorota Danielak, Tereza Krejčí, Josef Beránek
Publicado en:
European Journal of Pharmaceutical Sciences, Edición 176, 2022, Página(s) 106254, ISSN 0928-0987
Editor:
Elsevier BV
DOI:
10.1016/j.ejps.2022.106254
Autores:
Hincker Alexander, Karlsson Páll, Bakos Kristopher, Kosicka Katarzyna, Kagan Leonid, Haroutounian Simon, Frey Karen, Rao Lesley, Wagner-Johnston Nina, Ben Abdallah Arbi, Tan Benjamin R., Amin Manik, Wildes Tanya M., Shah Rajiv
Publicado en:
Pain, Edición 160, 2019, Página(s) 1835-1846, ISSN 0304-3959
Editor:
Elsevier BV
DOI:
10.1097/j.pain.0000000000001577
Autores:
Ricardo Machado Cruz; Tereza Boleslavská; Josef Beranek; Eszter Tieger; Brendan Twamley; Maria Jose Santos-Martinez; Ondřej Dammer; Lidia Tajber
Publicado en:
Pharmaceutics, Edición 28, 2020, ISSN 1999-4923
Editor:
Multidisciplinary Digital Publishing Institute (MDPI)
DOI:
10.3390/pharmaceutics12080741
Autores:
Osmałek Tomasz, Wrotyńska-Barczyńska Joanna, Michniak-Kohn Bozena, Froelich Anna, Jadach Barbara, Tatarek Adam, Gadziński Piotr, Falana Aleksandra, Gralińska Kinga, Ekert Michał, Puri Vinam, Wrotyńska-Barczyńska Joanna, Michniak-Kohn Bozena
Publicado en:
Pharmaceutics, Edición 13, 2021, Página(s) 884, ISSN 1999-4923
Editor:
Multidisciplinary Digital Publishing Institute (MDPI)
DOI:
10.3390/pharmaceutics13060884
Autores:
Grynkiewicz Grzegorz, Rudzki Piotr J., Jachowicz Renata, Kopeć Krzysztof, Krause Anna, Kuźmierkiewicz Wojciech, Lulek Janina, Maciejewska Beata, Moszczyński-Petkowski Rafał, Rachoń Janusz
Publicado en:
Nauka, Edición 3, 2021, Página(s) 47–66, ISSN 1231-8515
Editor:
Polish Academy of Sciences
DOI:
10.24425/nauka.2021.136326
Autores:
Zhang Julia, Froelich Anna, Michniak-Kohn Bożena
Publicado en:
Pharmaceutics, Edición 12, 2020, Página(s) 282, ISSN 1999-4923
Editor:
Multidisciplinary Digital Publishing Institute (MDPI)
DOI:
10.3390/pharmaceutics12030282
Autores:
Froelich Anna, Osmałek Tomasz, Jadach Barbara, Puri Vinam, Michniak-Kohn Bozena
Publicado en:
Pharmaceutics, Edición 13, 2021, Página(s) 201, ISSN 1999-4923
Editor:
Multidisciplinary Digital Publishing Institute (MDPI)
DOI:
10.3390/pharmaceutics13020201
Autores:
Rudzki, P.J.; Milanowski, B.; Tajber, L.; Garbacz, G.; Jakubowska, E.; Rychter, M.; Kutner, A.; Lulek, J.
Publicado en:
Farmacja Polska, Edición 74 (7), 2018, Página(s) 413-416, ISSN 0014-8261
Editor:
Polish Pharmaceutical Society
DOI:
10.5281/zenodo.3579024
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