Projects / Programmes
Pharmaceutical technology: from drug delivery systems to therapeutic outcomes of medicines in children end elderly
January 1, 2014
- December 31, 2017
| 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 |
Researchers (49)
Organisations (1)
Abstract
Many scientific challenges exist with regards to development of original, generic and supergeneric drugs, which should be designed to treat patients of various populations. They will be solved using approaches which are designed to generate new knowledge for comprehensive therapy of children and eldery. In the field of development of novel dosage forms a concept of Quality by design will be followed. We will start with ingredients of these systems and modification of drugs and exscipients properties and production of coprocessed materials. Using scientific approaches correlations between relevant physicochemical properties of drug components at the level of particle and at the bulk level will be studied. Novel delivery systems such as mini and (oro)dispersible tablets, mixtures for oral suspensions for easier swallowing, non-invasive delivery systems based on liquid crystals and/or (micro)emulsions for dermal application and many others will be developed. Different nanosized delivery systems will be also developed. From the scientific point of view these are most challenging systems due to their nanometer size, they reach the cellular level and act directly on cells and their subcellular structures, thus can realize drug delivery challenges, which cannot be resolved using the classical approaches. We will develop models for evaluation of LADME processes and PK/PD within existing drugs. Different physiological conditions for various populations will be simulated in experimental models to evaluate biorelevant drug release, complex processes of drugs transport and their metabolism. Simillary PK/PD modelling will be applied to all stages of drug development as well as to personalized pharmacotherapy. We will develop models for dosage regimen design in children and elderly, investigate the influence of genetic polymorphisms of drug-metabolising enzymes, drug transporters, and drug targets; and predict PK/PD of novel drug delivery systems. Important research segment will be bioanalytical methods for quantitative determination of drugs and metabolites in biological liquids which are of key importance for the evaluation and interpretation of PK and PK/PD studies. Approaches for the sampling of biomaterial will be developed for this purpose, especially in the sense of reducing the invasiveness for the patients; the sample collection as dry spot is the most acceptable for the newborn and small children and also for elderly. On the field of prevention and resolution of drug related problems analysis of prescription, dispensing and use of medicines will be done as these can be influenced by several factors that lead to ineffective treatment, adverse effects and irrational use of medicines. Due to the nature of biological processes drug related problems are particularly challenging in elderly and children. Health technology assessment and patient access to medicines in relation to health policy measures given by new or upgrading existing treatment strategies will be evaluated.
Significance for science
Recent advances in the field of medical, biological, chemical, physical, and engineering sciences have brought tremendous alterations in contemporary pharmaceutics and revolutionary changed the research and development of new medicinal products. Together with new possibilities in early diagnosis of diseases and demographic changes in population aging Europe, these have set new guidelines in individualized pharmacotherapy and development of novel therapeutics for specific subpopulations of patients. Development in the field of theranostics and pharmacogenomics facilitates personalization of pharmacotherapy and patient adjusted drug dosage regimens based on genotype and various biochemical and clinical factors. Differentiation in physiological characteristics of children and elderly from younger adults requires adjustments in pharmacotherapy to achieve the optimal therapeutic effects. The aim of the proposed research is development of novel methods for design and preparation of drug particles and their incorporation in advanced drug delivery systems. With novel drug delivery systems based on lipids, liquid crystals, (micro)emulsions, mini and (oro)dispersible tablets, and medicated wafers with controlled drug release (chronotherapeutics, floating systems) we will aim to improve bioavailability and patient adherence to pharmacotherapy (easier swallowing, taste masking, flexible dosing). Drug delivery challenges, which cannot be resolved using the classical methodolgy, will be approached by nanotechologies (nanosuspensions, polymeric and solid lipid nanoparticles, nanofibers). We will study the interactions of nanosystems with subcellular structures and mechanisms of their intra and intercellular transport. Experimental models for evaluation of drug release from various dosage forms, drug absorption and metabolism will be developed to optimize the development of generic and innovative medicines. Advanced population pharmacokinetic-pharmacodynamic modeling analysis will be applied for individualization of pharmacotherapy and evaluation of variability in drug effects. For this purpose bioanalytical methods and alternative less invasive methods of sampling of biomaterial will be developed. Additionally, the incidence of drug related problems in children and elderly which may lead to lead to ineffective treatment, adverse effects, and irrational use of medicines will be evaluated. Since uptake of new and upgrades in existing treatment strategies are not necessarily rational from the health care system perspective comparative effectiveness, cost-effectiveness, and budget impact will be assessed. The research program includes basic research as well as translational research with the aim to convert new evidence to pharmaceutical industry and clinical practice. Finally, we believe that this program will have, similarly as the previous one, high impact on development of pharmaceutical sciences, as well as on recognition of Slovenian science in the global scene.
Significance for the country
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). Health represents also one of the key social challenges in the scope of research and innovations in EU framework program Horizon 2020. Age-appropriate drug formulations are a challenge in drug development. A critical review of available drugs shows that a number of marketed products cannot be easily used for pediatric or geriatric patients who differ in many aspects from the “adult standard patient”. 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 separated work packages which are designed to generate new knowledge in steps. In this way many problem solutions will be developed in the frame of proposed researh field.
Results of proposed programme will be important for Slovenian pharmaceutical industry and for Slovenian health care system. Pharmaceutical generic drug industry that represents an important segment of Slovenian economy together with other industries that support it (for example drug production and packaging equipment industries) must follow global developent trends in order to remain competitive. Similar stands for a segment of Slovenian health system which deals with drug therapy and which when used in an optimal way leads into best therapeutic outcomes.
Knowledge that is needed in the field 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 (for example Lek from Ljubljana, Krka from Dolenjska, Marifarm from Štajerska and Galex from Prekmurje). Similar is true also for pharmacists employed in Slovenian health care system (community pharmacists, clynical pharmacists and pharmacoinformators) that are capable of supporting optimal patient treatment also in correlation to costs used for disease treatment with drugs. Identification, prevention and resolving actual and potential drug related problems incidence for elderly is a domain of community pharmacists. Similary are community pharmacists involved also in pharmacotherapy for children and parents’ perceptions towards medicines, including vaccines. Results of proposed programme will lead to decrease of drug usege in the population which will have positive impact on drug efectivness and safety with decreased costs of patient treatment.
Most important scientific results
Annual report
2014,
2015,
2016,
final report
Most important socioeconomically and culturally relevant results
Annual report
2014,
2015,
2016,
final report
