Projects / Programmes
Pharmaceutical technology: from drug delivery systems to therapeutic outcomes of medicines in children end elderly
January 1, 2018
- December 31, 2027
| Code |
Science |
Field |
Subfield |
| 1.09.00 |
Natural sciences and mathematics |
Pharmacy |
|
| 3.08.00 |
Medical sciences |
Public health (occupational safety) |
|
| Code |
Science |
Field |
| B740 |
Biomedical sciences |
Pharmacological sciences, pharmacognosy, pharmacy, toxicology |
| Code |
Science |
Field |
| 3.01 |
Medical and Health Sciences |
Basic medicine |
| 3.03 |
Medical and Health Sciences |
Health sciences |
Pharmaceutical technology, Biopharmacy, Pharmacokinetics, Bioanalysis, Social Pharmacy, Pharmacotherapy, Subpopulations, Elderly, Children, Polypharmacotherapy, Medication Adherence, Biologicals.
Data for the last 5 years (citations for the last 10 years) on
April 19, 2024;
A3 for period
2018-2022
| Database |
Linked records |
Citations |
Pure citations |
Average pure citations |
| WoS |
1,049 |
21,074 |
19,050 |
18.16 |
| Scopus |
1,264 |
24,296 |
22,077 |
17.47 |
Researchers (56)
Organisations (1)
Abstract
The main focus of the Programme Group “Pharmaceutical technology: from drug delivery systems to therapeutic outcomes of medicines in children and elderly” is the delivery of the active pharmaceutical ingredients (API) to the targeted site in the body and the optimization of drug therapy in different groups of patients. The Group's research programme is designed and substantiated with three pillars, originating in the knowledge of three participating departments and will be horizontally and vertically integrated. The programme content is of increasingly complexness, spanning from the development of drug delivery systems, including all aspects of their physico-chemical, technological, biological, biopharmaceutic and pharmacokinetic characterisation, to the evaluation of therapeutic outcomes after using the designed new and modified drug delivery systems, mostly in children and elderly.
Multiunit and flexible dosage forms, such as granules, pellets and mini tablets will be produced. Oral films will be prepared by casting technology, electrospinning and 2D-printing. Orodispersible tablets will be prepared by lyopillisation or direct compression. Bioadhesive polymers, which can improve drug bioavailability, will be also systematically investigated. Lipid based drug delivery systems as well as other technological approaches to solve the problem of variable (low) drug bioavailability and large presystemic metabolism will be researched. Advanced delivery systems for application of macromolecules in their biological active form will be developed as well.
Release of API from formulations in vitro under physiological and pathophysiological conditions and those of special patient subpopulations will be studied. The solubility as well as supersaturation of different active substances will be investigated. Permeability, distribution and metabolism of API in different in vitro and in vivo models will be examined. In silico testing, e.g. mathematical modelling and computer simulation will be used as a support to reduce the extent of experimental work.
To support multiple and diverse fields of research within our Programme Group, such as evaluation of delivery systems, studies of biopharmaceutic and pharmacokinetic processes, the therapeutic drug monitoring and screening and analysis of environmental samples, our analytical expertise will provide a state-of-the-art methodology offering a reliable identification and confident quantification of (multiple) APIs and their metabolites in various complex samples.
Finnaly, clinical, humanistic and economic outcomes of pharmacotherapy will be evaluated to improve patients’ adherence, to study medication burden with concomitant alcohol use and the frailty syndrome among the elderly and to develop new approaches in medicines’ evaluation systems for healthcare decision-making, especially for new and innovative medicines.
Significance for science
The Programme group “Pharmaceutical technology: from drug delivery systems to therapeutic outcomes of medicines in children and elderly” at the Faculty of Pharmacy, University of Ljubljana includes members of three chairs: The Chair of Biopharmaceutics and Pharmacokinetics, The Chair of Pharmaceutical Technology and The Chair of Social Pharmacy and experts from Slovenian pharmaceutical industry. Wide and interdisciplinary expertise of research group enables diverse approaches to the challenges in the development of generic and biosimilar drug delivery systems, thus enabling basic and applicative scientific work on the highest level on the fields of pharmaceutical technology, biopharmacy, experimental and clinical pharmacokinetics, and social and clinical pharmacy.
In the scope of the pharmaceutical technology field we will focus on patient friendly delivery systems which represent a basis of personalized pharmacotherapy and improve patient adherence during therapy. Study of drug delivery systems from the view of formulation and its production process will enable the development of multiunit and flexible dosage forms. New approaches to the production of delivery systems based on the electrospinning and electrospraying, 2D-printing and lyophilisation will be developed, thus enabling the preparation of new (nano)delivery systems and flexible formulations. Lipid based drug delivery systems, dry emulsions, self-(micro) emulsifying dosage forms and (trans)dermal delivery systems based on the colloidal associative structures of surface active substances will be studied. The results of our work will contribute to the scientific development also on the fields of nanotheranostics and nanofibres with biomolecules for tissue regeneration. The technology of layer-by-layer process of delivery systems or live cell nanoencapsulation will also be developed. The results will enable better knowledge of the structures of developed systems and the mechanisms of the processes during their preparation and after administration.
The researches of the new drug delivery systems will be accompanied by studies of biopharmaceutical and pharmacokinetic processes to which the drug incorporated in these delivery systems is exposed after administration, evaluation of these processes and parallel development of advanced analytical methodology for determination of drugs and their metabolites in technological and biological samples. Mechanisms of drug release and the influences on this process will be evaluated in simulated in vivo conditions, and the different processes of supersaturation as possible mechanism of drug release will be studied also from the point of delivery system. Insight into the mechanisms of membrane transport and basic classification of permeability and distribution will be obtained using models with different levels of complexity like cell lines and ex vivo animal tissues; metabolism and distribution will also be evaluated in in vivo animal models. Primarily, the permeability through the intestinal mucosae and the distribution between the blood and the brain will be researched. The development of complex models based on different cell lines will enable concurrent evaluation of transport and metabolism where the in vitro preservation of intracellular architecture and intercellular communications will be highly relevant. The study of the described processes will be supported by the development of advanced analytical methodology. Mathematical modelling will enable additional insight into the mechanisms of different processes, also in the cases where there is limited possibility of experimentation on real systems and large variability of the results. We will develop methods for modelling the impact of concomitant variables, including the genetic factors for the purpose of evaluation of interindividual differences observed in the action of drugs, and the pharmacokinetic-pharmacodynamic models for the small molecules and for biopharmaceuticals
Significance for the country
Programme group 'Pharmaceutical technology: from drug delivery systems to therapeutic outcomes of medicines in children end elderly' represents national research center for drug development from production, through laboratory in vitro and in vivo testing to evaluation of therapeutic and pharmacoeconomic outcomes. The group develops technologic, biopharmaceutic, pharmacokinetic and pharmacosocial experises, which are complementary combined and in this manner enables successful and competetiv ability of national pharmaceutical industry. Consequently it significantly contributes and will contribute to development of better drugs and health outcomes improvement with emphasis on patients life quality.
Republic of Slovenia similarly as other EU countries faces pronounced changes in population age picture moving towards more mature structure with lower percentage of workers. This influences healthcare expenditure which has reached 8,7% (2013) of Slovenian GDP and about 500 million EUR is spent for drugs every year. According to the demographic changes in Europe, the European Medicines Agency adopted Guidelines for the development of drugs for pediatric use (EMA/480235/2010) and Geriatrics medicines strategy (EMA/CHMP/137793/2011).
In the frame of the proposed programme challenges appearing by the development of new drugs and different therapeutics regimens for treatment of children and eldery popuation will be solved using scientific aproaches in three pilars which are interconnected horizontally and vertically and follow the approach of growing complexity, which means from the development of delivery systems, their physico-chemical, technologic, biologic, biopharmaceutic and pharmacokinetic evaluation to therapeutic outcomes.
Knowledge which is needed in the area of development, production and use of drugs is
of strategic importance also for the batchelors of pharmacy, masters of science and
doctors of pharmacy who are educated at the Faculty of Pharmacy in Ljubljana. Most
of them find an employment in Slovenian pharmaceutical industry and are
mostly experts in pharmaceutical technology and biopharmacy. Young specialists from
both fields are important factors of companies' success and regions development
where drugs are produced. Similar is true also for pharmacists employed in Slovenian health care system (community pharmacists, clynical pharmacists and pharmacoinformators) who are capable of supporting optimal patient treatment in relation to expenditure for drugs. Results of proposed programme will lead to decreased use of drugs in the population with consequently positive impact on drug efectivness and safety with lower costs of patient treatment.
We thus believe that the results of proposed programme will be important for Slovenian pharmaceutical industry and for Slovenian health care system.
Most important scientific results
Interim report
Most important socioeconomically and culturally relevant results
Interim report
