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Projects / Programmes source: ARIS

Pharmaceutical technology: design, preparation and evaluation of drug delivery systems

Periods
Research activity

Code Science Field Subfield
1.09.00  Natural sciences and mathematics  Pharmacy   

Code Science Field
B740  Biomedical sciences  Pharmacological sciences, pharmacognosy, pharmacy, toxicology 
Keywords
drugs (biologically active substances), excipients, drug delivery systems, pre-formulation studies, formulation studies, interactions, transport, modelling and simulation, clinical effects, pharmacogenetics, pharmacoeconomics, pharmacoepidemiology
Evaluation (rules)
source: COBISS
Researchers (47)
no. Code Name and surname Research area Role Period No. of publicationsNo. of publications
1.  15490  PhD Pegi Ahlin Grabnar  Pharmacy  Researcher  2004 - 2008  207 
2.  15104  PhD Saša Baumgartner  Pharmacy  Researcher  2004 - 2008  306 
3.  25492  PhD Katja Berginc  Pharmacy  Junior researcher  2005 - 2008  77 
4.  11124  PhD Marija Bogataj  Pharmacy  Researcher  2004 - 2008  372 
5.  15623  PhD Matejka Burjak  Pharmacy  Researcher  2004  51 
6.  22658  PhD Mateja Cegnar  Pharmacy  Researcher  2004 - 2008  91 
7.  17432  Margareta Cof    Technical associate  2004 - 2008 
8.  26494  PhD Andrej Dolenc  Pharmacy  Junior researcher  2006 - 2008  12 
9.  21455  PhD Rok Dreu  Pharmacy  Researcher  2004 - 2008  292 
10.  12084  PhD Darja Frankič  Pharmacy  Researcher  2005 - 2006  197 
11.  18700  Valerija Garb    Technical associate  2004 - 2008 
12.  11789  PhD Mirjana Gašperlin  Pharmacy  Researcher  2004 - 2008  598 
13.  28446  PhD Ilija German Ilić  Pharmacy  Junior researcher  2007 - 2008  141 
14.  16107  PhD Iztok Grabnar  Pharmacy  Researcher  2004 - 2008  435 
15.  25600  PhD Miha Homar  Pharmacy  Junior researcher  2005 - 2007  71 
16.  17433  Tatjana Hrovatič    Technical associate  2004 - 2008 
17.  20371  PhD Polona Jurkovič  Pharmacy  Researcher  2004  34 
18.  12942  PhD Janez Kerč  Pharmacy  Researcher  2004 - 2008  240 
19.  20370  PhD Mojca Kerec Kos  Pharmacy  Researcher  2004 - 2008  238 
20.  18699  Mojca Keržan    Technical associate  2004 - 2008 
21.  01466  PhD Vojko Kmetec  Pharmacy  Researcher  2004 - 2008  193 
22.  24402  PhD Petra Kocbek  Pharmacy  Researcher  2005 - 2008  291 
23.  17434  Mihaela Kolarev    Technical associate  2004 - 2008 
24.  20374  PhD Mitja Kos  Pharmacy  Researcher  2004 - 2008  481 
25.  11122  PhD Albin Kristl  Pharmacy  Researcher  2004 - 2008  350 
26.  09032  PhD Julijana Kristl  Pharmacy  Researcher  2004 - 2008  932 
27.  20369  PhD Igor Legen  Pharmacy  Researcher  2004  89 
28.  17430  Nevenka Lilik    Technical associate  2004 - 2008 
29.  24399  PhD Igor Locatelli  Pharmacy  Junior researcher  2005 - 2007  273 
30.  21457  PhD Tatjana Mateović Rojnik  Pharmacy  Junior researcher  2004 - 2005  23 
31.  06086  PhD Aleš Mrhar  Pharmacy  Head  2004 - 2008  1,161 
32.  26510  PhD Nataša Nagelj Kovačič  Pharmacy  Junior researcher  2006 - 2008  16 
33.  25489  PhD Marko Obradović  Pharmacy  Junior researcher  2005 - 2008  30 
34.  17012  PhD Robert Pišek  Pharmacy  Researcher  2004  64 
35.  14935  PhD Odon Planinšek  Pharmacy  Researcher  2004 - 2008  437 
36.  22656  PhD Filip Podlogar  Pharmacy  Junior researcher  2004 - 2005  19 
37.  25488  Branka Rozman  Pharmacy  Junior researcher  2005 - 2008  22 
38.  23833  PhD Polona Smrdel  Pharmacy  Junior researcher  2004 - 2007  18 
39.  09031  PhD Stanko Srčič  Pharmacy  Researcher  2004 - 2008  675 
40.  28860  PhD Karmen Teskač Plajnšek  Pharmacy  Junior researcher  2008  50 
41.  19063  PhD Andrijana Tivadar  Pharmacy  Researcher  2004  72 
42.  23420  PhD Jurij Trontelj  Pharmacy  Researcher  2004 - 2008  254 
43.  18155  PhD Tomaž Vovk  Pharmacy  Researcher  2004 - 2008  227 
44.  08333  PhD Franc Vrečer  Pharmacy  Researcher  2004 - 2008  397 
45.  23590  PhD Jernej Zadnik  Pharmacy  Junior researcher  2004 - 2006  38 
46.  26226  PhD Alenka Zvonar Pobirk  Pharmacy  Junior researcher  2007 - 2008  209 
47.  22659  PhD Simon Žakelj  Pharmacy  Researcher  2004 - 2008  162 
Organisations (1)
no. Code Research organisation City Registration number No. of publicationsNo. of publications
1.  0787  University of Ljubljana, Faculty of Pharmacy  Ljubljana  1626973  17,530 
Abstract
New findings in science and medicine tend to encourage the etiological treatment and disease prevention over the symptomatic treatment. Classical active ingredients, which are mostly small molecules, are more and more replaced by peptide and protein related substances, which are in many cases hydrophilic and metabolicaly unstable. As a result, these drugs can in their unchanged form hardly pass through different physical and biological barriers in comparison to classical drugs. Thus, a development of new methodologies is necessary in order to evaluate the kinetics and mechanisms of the processes that alter the fate of a drug after its application. Furthermore, a development of new drug delivery systems is required for drug targeting. The purpose of the research in the field of drug delivery systems, regardless of the drug properties, is the introduction of the principle of controlled drug delivery and targeting. In the biological systems, this principle can be applied in two levels; at the site of drug absorption and at the site of drug action. It is generally accepted that only a minor part of the administered drug reaches the site of action. On the other hand, the majority of the drug is equally distributed throughout the body, bound to the non-specific binding sites. Consequently, adverse effects can occur, and in some cases, serious adverse events can happen. Moreover, a constant drug plasma concentration profile does not necessarily provide optimal drug concentration profile at the site of action. For several diseases it was established that the concentration of a drug at the site of action (organ, tissue, or cell) must oscillate in order to achieve the optimal effect according to various physiological rhythms in the body. Therefore, it is urgent to develop »intelligent« delivery systems, in which optimal site of drug delivery and optimal rate and extent of drug release can be adjusted to the instantaneus body requirements. We focus our research to the development of new drug delivery systems and new pharmaceutical excipients, together with the evaluation of their properties, compatibility, and stability and the preparation and design of these systems. Additionally, an emphasis is made on technological processes, investigation of mechanisms of interactions and drug transport in the body, and development of pharmaceutical technological and chemical analytical methods taking into acount also the measures of protecting the environment. Our research is performed within four interactive sections: • Evaluation of drugs in models of growing complexity: classification into BCS (Biopharmaceutical Classification System); drug transport processes and metabolism in relation to the genotype; kinetics and mechanism of ADME processes (Absorption, Distribution, Metabolism, and Elimination); bioavailability (at the site of action); stability; assays of drug and metabolite (degradation products) levels in heterogeneous (technological and biological) systems; relationship between pharmacokinetics, pharmacodynamics and drug effects. • Integration of drugs into delivery systems: pre-formulation drug research (small and large molecules - hidro/lipophilicity, solubility, permeability, stability, crystallinity, surface energy, primray, secondary, tertiary and quaternary structure), excipients (drug carriers, absorption enhancers, bioadhesives, bioconjugates, lioprotectants, antioxidants, antiadsorbents, antiaggregation agents - physicochemical properties, rheological properties, functional properties, biocompatibility, biodegradability. formulation drug research – the appropriate choice of excipients for a selected drug, considering the purpose of drug formulation; preparation and design of micropheres/microcapsules, microtablets, pellets, nanoparticles and liposomes with controlled time and site drug release and for different types of application. • Evaluation of drug delivery systems in models of growing complexity: development of e
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 increase the effectiveness of therapy. Different approaches have been used and their correlations evaluated using chosen model drugs, thus enabling their implementation on the classical low molecular as well as on the new protein drugs. New techniques of particles design were developed that will enable the preparation of colloidal and larger particles of uniform properties, which will assure the processibility in the delivery systems production and high quality of final products. 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 gave us important information about interactions between different macromolecules (polymers and proteins) and showed 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 will 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 will be given and by experimental approaches for description and prediction of presystemic metabolism one of its main deficiencies will be 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, will be 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 (EMEA, 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 Final report, complete report on dLib.si
Most important socioeconomically and culturally relevant results Final report, complete report on dLib.si
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