Projects / Programmes
Farmacevtska tehnologija: od dostavnih sistemov učinkovin do terapijskih izidov zdravil pri otrocih in starostnikih (Slovene)
January 1, 2009
- December 31, 2013
| Code |
Science |
Field |
Subfield |
| 1.09.00 |
Natural sciences and mathematics |
Pharmacy |
|
| Code |
Science |
Field |
| 3.01 |
Medical and Health Sciences |
Basic medicine |
Researchers (49)
Organisations (1)
Significance for science
This research program can be viewed as a part of contemporary scientific trends in the field of development and evaluation of new safe and effective medicines with the purpose to decrease interindividual variability and increase effectiveness of therapy. Different approaches were studied using chosen model drugs, thus enabling their implementation on the classical low molecular as well as on the new protein drugs. The development of validated numeric model of two-phase particles flow inside the coating process equipment is necessary to understand the results of coating process and also gives an insight into those parts of process chamber which can not be easily reached by experimental techniques. The numerical model of particles flow is additionally important as it represents a useful tool for planning and development of innovative coating process equipment. Development and optimization of technological procedures lead to the production of new delivery systems which enable us to control drug release and increase bioavailability of selected drugs. In this context solid peroral dosage forms on the basis of S(M)EDS were developed. This delivery system possesses all advantages of microemulsions together with increased stability and higher incorporation efficiency of model drugs. With the optimization of technological processes the applicability of these systems, which are limited to liquid systems and soft gelatin capsules till now, increases significantly. With the development of delivery systems like nanoparticles the efficacy of the therapy might be increased significantly and drugs’ adverse effects decreased. The results of our research work give us important information about interactions between different macromolecules (polymers and proteins) and show us how to apply the rules valid in natural biological systems (molecular interactions, spontaneous conformation, biological recognition, cell processes) for the preparation of new drug delivery systems. The possibilities how to circumvent the limitations and take the advantages of protein drugs when incorporating them in delivery systems were explored. The contemporary scientific trends are followed also in the field of studying LADME processes to identify those critical physico-chemical and biological parameters that influence the safety and efficacy of medicines. The experimental models of diversified degree of complexity which were developed in accordance with the goal of our researches are of key importance. Our aims were followed considering all processes to which the drug is exposed after different modes of application. With the development of in vitro tests, which enable us to describe the processes of drug release and absorption in in vivo conditions after fasted or fed administration, a significant contribution to further development of BCS system was given and by experimental approaches for description and prediction of presystemic metabolism one of its main deficiencies was clarified. Physiological parameters were introduced in the dissolution models to give common applicative approach additional scientific dimension and the results of permeability studies enable us a new insight in the mechanisms of mucosal transport of all studied types of drugs. Pharmacokinetic-pharmacodynamic models combined with the methods of population pharmacokinetics help us to identify the reasons for variability in pharmacokinetics, pharmacodynamics and consequently in clinical outcomes. By the use of this technique, the introduction of appropriate procedures before the start of therapy, like avoidance of drug interactions, assessment of genetic polymorphism of transport and metabolic systems, consideration of demographic and clinical-biochemical factors, were proposed. These studies represent most interesting scientific trends in the process of drug dosing optimization, especially if they are combined, as in our case, with monitoring economic and humanistic outcomes.
Significance for the country
The results of the proposed research program are important for the Slovenian pharmaceutical industry as well as for the Slovenian health care system, which have to follow the modern regulatory requests (EMA, FDA) for introducing the new technologies and application routes which will assure safe, effective and qualitative drug products and their rational use. Peptides and protein drugs are connected with high specificity, potency and effectiveness in small doses which will have a great impact on the human therapy in the near future. However, their use in the clinical praxis is more or less limited because of the unacceptable biopharmaceutical properties. These properties are a consequence of large molecular weight, hidrophylicity, complex and labile structure and reduce the use of already approved drugs to the parenteral route. This therapy is dealing with frequent dosing, additionally systemic adverse/toxic effect, lower patient compliance and higher costs. All these shortcomings are the driving forces for the pharmaceutical research regarding the development of new drug delivery systems, especially nanosystems. Slovenian pharmaceutical industry is able, due to its high technological level, to implement knowledge developed in this program into the pharmaceutical products with a very high added value. Proposed research program includes also some new technology strategies which mean challenge for the Slovenian process technology industry as well. The optimized technology processes together with the quality of the input ingredients, drugs and excipients, represent imperative for the quality of the drug products. Inside of the program also the aspects of the rationality in the energy and the materials use are considered and implemented. Proposed research program will also assure the knowledge which is important for sustainability of Slovenian health care systems in the fields of drug usage and utilization. Pharmacoepidemiological and pharmacoeconomic studies are included in wider context of health economics and are therefore of national importance.
Most important scientific results
Annual report
2009,
2010,
2011,
2012,
final report,
complete report on dLib.si
Most important socioeconomically and culturally relevant results
Annual report
2009,
2010,
2011,
2012,
final report,
complete report on dLib.si
