Sadržaj
PP1. FALSIFIKOVANI LJEKOVI ................................................................................................ 3
PP1. COUNTERFEIT DRUGS .................................................................................................................. 4
PP2.
PP2.
INTERAKCIJE LJEKOVA................................................................................................. 5
DRUG INTERACTIONS .................................................................................................................. 6
PP3.
PP3.
NEŢELJENA DEJSTVA LJEKOVA.................................................................................. 7
ADVERSE EFFECTS OF DRUGS ...................................................................................................... 8
PP4.
PP4.
NANOČESTICE I NJIHOVA PRIMENA U LEKOVIMA ................................................... 9
NANOPARTICLES AS DRUGS/ DRUG DELIVERY SYSTEMS ........................................................... 11
PP5.
ULOGA BOLNIČKOG FARMACEUTA KAO NOSIOCA FARMACEUTSKE ZAŠTITE:
STANJE I PERSPEKTIVE ............................................................................................................ 13
PP5. THE ROLE OF HOSPITAL PHARMACIST AS PHARMACEUTICAL HEALTHCARE SYSTEM CAREER:
SITATION AND PERSPECTIVES ............................................................................................................... 14
PP6.
PARTNERSTVO AGENCIJA ZA LEKOVE I MEDICINSKA SREDSTVA I
ZDRAVSTVENIH I OBRAZOVNIH INSTITUCIJA- PRIMER SARADNJE CALIMS-a I
VOJNOMEDICINSKE AKADEMIJE U BEOGRADU .................................................................... 15
PP6. PARTNERSHIPS OF AGENCIES FOR MEDICINES AND MEDICAL DEVICES AND HEALTH AND
SCIENTIFIC INSTITUTIONS-EXAMPLE OF COLLABORATION BETWEEN CALIMS AND MILITARY MEDICAL
ACADEMY IN BELGRADE ....................................................................................................................... 16
PP7.
REGULATORNI ZAHTJEVI I DOKUMENTACIJA O ISPITIVANJU STABILNOSTI
LIJEKOVA U EU ........................................................................................................................... 17
PP7. REGULATORY REQUIREMENTS AND DOCUMENTATION
ON STABILITY TESTING OF DRUG PRODUCTS IN THE EU ....................................................................... 18
PP8.
PP8.
REGULATIVA U OBLASTI LEKOVA .......................................................................... 19
REGULATION IN THE MEDICINAL PRODUCTS ............................................................................ 20
PP9.
STRATEŠKI ASPEKTI GENERIČKE FARMACEUTSKE INDUSTRIJE U
CENTRALNO-ISTOČNO EVROPSKOM REGIONU ................................................................... 21
PP9. STRATEGIC ASPECTS OF GENERIC PHARMACEUTICAL INDUSTRY
IN CENTRAL EAST EUROPEAN REGION .................................................................................................. 22
PP10. FARMACEUTSKA KOMORA MAKEDONIJE – ZASTUPANJE, POSREDOVANJE I
LOBIRANJE KOD VLASTI U ZDRAVSTVENOM ZAKONODAVSTVU ...................................... 23
PP10.
PHARMACEUTICAL CHAMBER OF MACEDONIA - ADVOCASY IN HEALTH LEGISLATION ........ 24
PP11. GENSKA TERAPIJA – PRIMJENA U FARMACIJI I MEDICINI ................................... 25
PP11. GENE THERAPY – APPLICATION IN PHARMACY AND MEDICINE ............................................. 26
PP12. SAVREMENI PRISTUP FITOTERAPIJI ........................................................................ 27
PP12.
MODERN APPROACH TO PHYTOTHERAPY ............................................................................. 28
PP13. FLORA CRNE GORE U SLUŢBI FARMACIJE ............................................................. 29
PP13.
FLORA OF MONTENEGRO AS THE SERVICE OF PHARMACY ................................................... 30
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PP14. PELOID U DERMOKOZMETIČKIM PREPARATIMA U TRETMANU AKNI ................. 31
PP14.
THE MINERAL MUD IN DERMOCOSMETICS PREPARATIONS IN ............................................. 32
PP15. LJEKOVITE BILJKE I BILJNI PREPARATI U MANASTIRIMA ..................................... 33
PP15.
MEDICINAL PLANTS AND HERBAL PREPARATIONS IN THE MONASTIRIES ............................. 34
2
PP1.
FALSIFIKOVANI LJEKOVI
Goločorbin-Kon Svetlana
Farmaceutski fakultet, Univerzitet Crne Gore
Medicinski fakultet, Zavod za farmaciju, Univerzitet u Novom Sadu
Falsifikovani ljekovi su sve prisutniji na globalnom trţištu ljekova i predstavljaju veliku pretnju za
zdravlje ljudi. Svetska Zdravstvena organizacija ih definiše kao ljekove koji liče na originalne, a
sadrţaj i poreklo su namerno i laţno predstavljeni radi sticanja profita. Sve vrste ljekova se
falsifikuju, i originalni i generički. Falsifikovani ljekovi mogu sadrţavati originalnu, aktivnu
supstancu ili neku drugu u dovoljnoj količine, u nedovoljnoj količini, u većoj količini ili biti bez
aktivnog principa ili u falsifikovanom pakovanju. Od momenta kad su se prvi put pojavili, danas
se falsifikovani ljekovi proivode veoma sofisticirano, te ih je teško otkriti. Zastupljenost
falsifikovanih ljekova na globalnom trţištu je u prosjeku 10%, u razvijenim zemljama 1%, a u
zemljama u razvoju čak 50%. Znanje o falsifikovanim ljekovima treba da se koristi za edukaciju
studenata farmacije, medicine, zdravstvenih profesionalaca i pacijenata. Farmaceuti i doktori
treba budno da prate i da prijavljuju sumnjive proizvode i da pojavu neţeljenih reakcija i
izostanak terapijskog efekta razmatraju kao mogući efekat falsifikovanog leka. Pacijenti treba da
prijave svom farmaceutu ili doktoru ako sumnjaju da nešto nije u redu sa ljekom koji koriste,
pogotovo ako su imali neţeljene reakcije ili je bio smanjen terapijski efekat ljeka.
Prodaja ljekova preko interneta je sve zastupljenija, zbog čega je Svetska Zdravstvena
Organizacija sprovela istraţivanje i utvrdila da je više od 50% ljekova koji se prodaju preko
interneta falsifikovano.
Radi bezbjednosti pacijenata neophodno je da se ljekovi nabavljaju samo u licenciranim
apotekama.
Ključne riječi: falsifikovani ljekovi, neţeljene reakcije, licencirana apoteka
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PP1.
COUNTERFEIT DRUGS
Goločorbin-Kon Svetlana
Faculty of Pharmacy, Univesity of Montenegro
Medical faculty, Department of Pharmacy, University Novi Sad
Counterfeit drugs are presented at the global market and become growing threat to human
health. WHO defines counterfeit drugs as drugs that are deliberately and fraudulently
mislabelled with respect to identity and/or source. All kinds of drugs have been counterfeited,
branded and generic. Counterfeit drugs may include products with the correct ingredients or
with the wrong ingredients, without active ingredients, with insufficient or too much active
ingredient, or with fake packaging.
Since counterfeit drugs first time have appeared, they have been more sophisticated and more
difficult for detection. The estimate is that up to 1% of drugs available in the developed World
are likely to be counterfeited. This figure rises to 10% globaly, although in some developing
countries it is 50%. The knowledge of counterfeit drugs should be used for the education of the
pharmacy and medicine students, health professionals and patients. Pharmacists and doctors
should stay vigilant and report suspicious products, and consider conterfeits as a possible
cause of adverse reactions or therapeutic failure. Patients should report to their pharmacists
and doctors if they suspect any irregularity with their medication, if they experience side effects
or a decrease in beneficial effect. World Health Organization estimate is that 50% of drugs
available via the internet are counterfeited. The cruicial step in the prevention of counterfeit
drugs is the supply from reliable sources, licenced pharmacies.
Key words: counterfeit drugs, adverse reactions, licensed pharmacy
4
PP2. INTERAKCIJE LJEKOVA
Mikov Momir
Farmaceutski fakultet, Univerzitet Crne Gore
Medicinski fakultet, Univerzitet Novi Sad
Interakcija ljekova je farmakološka ili klinička reakcija koja nastaje kao posljedica primjene
kombinacije lekova, a koja je drugačija od očekivanih reakcija na ljekove koje se javljaju posle
pojedinačne primene svakog ljeka.
Posljedice interakcije ljekova mogu biti: pojačan efekt ili slabiji efekt, brţe ili sporije nastupanje
efekta; štetni efekti: toksičnost ili smanjena efikasnost, novi efekti ili pojačane neţeljene
reakcije; korisni efekti: sinergizam, poboljšana biološka raspoloţivost, pogodniji za primjenu,
smanjena tokisčnost, smanjeni troškovi.
Nakon utvrĎivanja da je promena kod pacijenta rezultat interakcije ljekova, uvjek postoji dilema
je šta učiniti? Prekinuti uzimanje leka ili hrane? Promeniti lek? Promeniti dozu?
Zbog toga je menadţment interakcije ljekova je veoma vaţan u radu savremenog farmaceuta
koji treba: znati gde da naĎete potrebnu informaciju o interakciji, znati koji ljekovi mogu da imaju
toksične metabolite, posumnjajti uvek na interakciju kada je: terapijski efekt slabiji od
očekivanog ili kada se javilo toksično dejstvo, birati ljekove za koje je malo verovatno da će
stupiti u interakciju, provjeriti da li je interakcija klinički značajna, razmotriti kao mogućnost
praćenja koncentracija ljekova koji stupaju u interakciju.
Još kompleksnije pitanje interakcija postaje kada se ima u vidu interakcija ljek-hrana-biljni
proizvod. Danas govorimo o funkcionalnoj hrani i nutraceuticals - sastojci koji promovišu
zdravlje koji su dodati ili inţinjeringom ugraĎeni u hranu.
Znanje o interakcijama ljekova ne prati razvoj novih tehnologija i zbog toga edukacija u oblasti
interakcija ljekova predstavlja izazov.
Ključne reči: interakcija, sinergizam
5
PP2. DRUG INTERACTIONS
Mikov Momir
Faculty of Pharmacy, University of Montenegro
Medical faculty, University Novi Sad
Drug interactions are the pharmacological or clinical response to the administration of a drug
combination different from that anticipated from the known effects of the two agents when given
alone. The result of drug interactions could be: Increased or reduced effect, slower or more
rapid effect; harmful: toxicity and/or reduced efficacy, new or increased side effects and
beneficial: synergistic combinations, pharmacokinetic boosting, increased convenience, reduced
toxicity, cost reduction
Major dilemma when drug interactions have been observed is what the action should be:
Discontinue drug treatment and/or specific food? Switch to another drug? Change dose?
Drug Interactions management is very important for modern pharmacist who should: Know
where to locate information on interactions; Be familiar with toxic metabolites; Be suspicious
when: Therapeutic response is less than expected, toxic effects are present; Choose drugs that
are less likely to interact; Consider TDM in certain situations during therapy with drugs that are
more likely to interact; Check is the interaction clinically significant?
The question of interactions becomes more complex with food or herb or drug Interaction
question. Today we speak about functional foods, nutraceuticals putative health-promoting
ingredients either added or engineered into foods
Key words: interaction, synergism
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PP3. NEŽELJENA DEJSTVA LJEKOVA
Duborija-Kovačević Nataša
Medicinski fakultet Univerziteta Crne Gore, Katedra za farmakologiju i kliničku farmakologiju,
Podgorica, Crna Gora
Farmaceutski fakultet Univerziteta Crne Gore, Katedra za Farmakologiju, Podgorica, Crna Gora
Svjetska zdravstvena organizacija definiše neţeljena dejstva ljekova (NDLJ) kao bilo koje
djelovanje nekog lijeka koje je štetno, nenamjeravano i koje se dešava pri dozama koje se
primjenjuju u prevenciji, dijagnostici ili liječenju. Svijest o značaju NDLJ postoji još od nastanka
prvih ljekova. William Withering je 1785. opisujući pozitivna djelovanja digitalisa, istovremeno
opisao i povraćanje, smetnje vida, bradikardiju, konvulzije, pa čak i smrtni ishod koji ovaj lijek
moţe izazvati.
Klinički je značajna klasifikacija NDLJ na ona koja zavise od doze (tip A, eng. augmented,
pojačano terapijsko dejstvo lijeka) i na ona koja ne zavise od doze, već primarno od osobina
organizma bolesnika (tip B, eng. bizarre, idiosinkrazija i alergijske reakcije). RjeĎa su NDLJ tip
C (eng. chronic, povezana sa dugotrajnom upotrebom lijeka), tip D (eng. delayed, nastaju
odloţeno) i tip E (eng. end of use, nastaju nakon nagle obustave hronične primjene lijeka).
Osnovne metode kojima se prikupljaju podaci o NDLJ su eksperimentalne, koje
podrazumijevaju formalna terapijska ispitivanja ljekova u toku prve tri faze kliničkog ispitivanja, i
opservacione studije, kojima se lijek prati epidemiološki tokom njegove uobičajene upotrebe u
fazi tzv. postmarketinskog pracenja (Faza 4).
Na poseban značaj NDLJ upućuju i literaturni podaci da je oko 5% hospitalizacija uzrokovano
NDLJ, a da će se kod 10-20% hospitalizovanih bolesnika tokom boravka u bolnici javiti neko
NDLJ, što će najvjerovatnije uzrokovati produţetak hospitalizacije i povećanje troškova liječenja.
Brojni su faktori koji doprinose nastanku NDLJ i, najšire gledano, mogu biti vezani za pacijenta
(starost, pol, genetska konstitucija, postojeće bolesti i sl.), lijek (farmaceutske farmakokinetske i
farmakodinamske osobine) i propisivača (vrsta lijeka, doza, način i duţina primjene,
istovremena primjena sa drugim ljekovima i sl.).
Poznavanjem NDLJ, sa mogućnošću predviĎanja njihove učestalosti i teţine, praćenjem i
prepoznavanjem faktora predispozicije, kao i prijavljivanjem NDLJ sa kojima se srijeću u
svakodnevnom radu, farmaceuti daju značajan doprinost bezbjednoj primjeni ljekova. U tom
smislu njihova uloga u smanjivanju uticaja NDLJ na efikasnu i bezbjednu farmakoterapiju će biti
sve vaţnija.
Ključne riječi: neţeljena dejstva ljekova, klasifikacija, značaj, predisponirajući faktori
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PP3. ADVERSE EFFECTS OF DRUGS
Duborija-Kovačević Nataša
Faculty of Medicine of the University of Montenegro, Department of Pharmacology and Clinical
Pharmacology, Podgorica, Montenegro
Faculty of Pharmacy, University of Montenegro, Department of Pharmacology, Podgorica,
Montenegro
World Health Organization defines adverse effects of drugs (AED) as any action of a drug that is
harmful, unintended and that occurs at doses that are used in the prevention, diagnosis or
treatment. Awareness of the importance of AED existed since the creation of the first drug.
William Withering, describing the positive effects of digitalis in 1785th, also described and
vomiting, visual disturbances, bradycardia, convulsions and even death, which may cause
digitalis.
Clinically significant classification divides AED into those that depend on the dose (type A, eng.
augmented, enhanced therapeutic effect of a medicine) and those that do not depend on the
dose, but primarily from the characteristics of the organism of patients (type B, eng. bizarre,
idiosyncrasy and allergic reactions). Rarer are AED type C (eng. chronic, associated with
prolonged use of medication), type D (eng. delayed, resulting delayed) and type E (eng. end of
use, arising after the abrupt cessation of chronic drug administration).
The basic methods to obtain data on the AED are experimental, which include a formal
therapeutic drug investigation during the first three phases of clinical trials, and observational
studies, which monitors drug epidemiologically during its usual usage in the so-called post
marketing surveillance phase (Phase 4).
On the particular importance of AED indicates and literature data that about 5% of
hospitalizations are caused by AED, and that AED occur in 10-20% of hospitalized patients
during their stay in hospital, which will likely result in an extension of hospital stay and increased
costs of treatment.
There are many factors that contribute to the AED and, in broadest terms, may be related to the
patient (age, sex, genetic constitution, a disease, etc.), drug (pharmaceutical, pharmacokinetic
and pharmacodynamic properties) and prescriber (a type of drug, dosage and length of use,
concomitant use with other drugs, etc.).
The knowledge about AED, with the possibility of predicting their frequency and severity,
monitoring and identifying predisposing factors, as well as reporting of AED with that meet in
their daily work, pharmacists make a significant contribution to safe use of medicines. In this
respect, their role in reducing the influence of AED to effective and safe pharmacotherapy will
be increasingly significant.
Key words: adverse effects of drugs, classification, importance, predisposing factors
8
PP4. NANOČESTICE I NJIHOVA PRIMENA U LEKOVIMA
Vuleta Gordana, Kovačević Andjelka, Savić Sneţana
Katedra za farmaceutsku tehnologiju i kozmetologiju, Farmaceutski fakultet, Univerzitet u
Beogradu, Beograd, Srbija
U najširem smislu, nanočestice su koloidni sistemi veličine od 1 do 1000 nm tj. 1 μm.
Najnovije definicije koje daje National Nanotechnology Initiative definišu nanotehnologiju kao
disciplinu koja se bavi ispitivanjem struktura čija je veličina u opsegu od 1 do 100 nm.
U istraţivanjima koloidnih nosača lekova, obuhvaćene su matriksne nanočestice (lipidne i
polimerne nanočestice) kao i liposomi i nanoemulzije. Savremena istraţivanja baziraju se i na
lek-nanokristalima, česticama sastavljenim od lekovitih supstanci slabo rastvornih u vodi (grupa
II i IV po Biofarmaceutskom Sistemu Klasifikacije lekova, BSK). U fizičko-hemijskom smislu, lek
nanokristali su disperzije čiste lekovite supstance u vodenom ili nevodenom medijumu, dok
lipidne nanočestice predstavljaju vodene disperzije čvrstog lipida unutar koga je inkorporirana
lekovita supstanca. Oba tipa nanočestica su uobičajeno stabilizovana surfaktantima ili
polimernim sternim stabilizatorima.
Najznačajniji ciljevi razvoja lek-nanokristala i lipidnih nanočestica jesu:
• poboljšanje biološke raspoloţivosti lekovitih supstanci koje su slabo rastvorne u vodi, odnosno
u biološkim tečnostima,
• povećanje dermalne raspoloţivosti lekovitih supstanci koje imaju ograničenu penetraciju u/kroz
koţu,
• smanjenje neţeljenih efekata konvencionalnih farmaceutskih oblika posle i.v. primene i
postizanje ciljnog delovanja za odreĎene lekovite supstance.
Lek-nanokristali su do sada primenjeni u razvoju farmaceutskih oblika za peroralnu primenu u
obliku tableta ili kapsula. Do sada su lekovite supstance iz više farmakoloških grupa
upotrebljene u obliku nanokristala u farmaceutskim preparatima za peroralnu primenu:
imunosupresivi (sirolimus, Rapamune®, Wyeth Pharmaceuticals), antiemetici (aprepitant,
Emend®, Merck&Co), opioidni analgetici (morfin-sulfat, Avinza®, King Pharmaceuticals),
miorelaksansi (tizanidin-hidrohlorid, Zanaflex Capsules®, Acorda). U obliku peroralne
suspenzije na trţištu je Megace® ES (Par Pharmaceutical Companies Inc. Spring Valley, NY,
SAD) u kome je lekovita supstanca megestrolacetat (koristi se u terapiji anoreksije) u obliku leknanokristala.
Parenteralna primena lek-nanokristala omogućava postizanje ciljnog delovanja, ali i produţenog
oslobaĎanja lekovitih supstanci zbog mogućnosti preuzimanja i akumulacije lek-nanočestica u
makrofagama mononuklearnog fagocitnog sistema u jetri. Nakon akumulacije lek-nanočestica u
jetri, ona moţe posluţiti kao "depo" za usporeno oslobaĎenje leka u krvotok (primer
itrakonazol).
Zbog niza povoljnih efekata koji mogu doprineti povećanoj dermalnoj raspoloţivosti, lipidne
nanočestice se intenzivno istraţuju kao novi nosači za lekovite supstance koje imaju ograničenu
penetraciju u/kroz koţu. Mala veličina lipidnih nanočestica i adhezivne osobine povećavaju
akumulaciju u niţim delovima respiratornog trakta što otvara mogućnost razvoja farmaceutskih
oblika za pulmonarnu primenu.
Usled rizika od pojave toksičnih efekata, razvoj formulacija nanočestica nametnuo je i razvoj
metoda za praćenje i procenu njihove bezbednosti. Nedavno je predloţen Nanotoksikološki
Sistem Klasifikacije (NSK) prema kome su definisane četiri kategorije nanočestica (I, II, III, IV).
Kao kriterijumi za procenu bezbednosti nanočestica uzeti su veličina, biodegradabilnost
nanočestica i intracelularno preuzimanje. Danas su istraţivanja u ovoj oblasti usmerena ka
9
razvoju lipidnih nanočestica i lek-nanokristala, klase I prema NSK (biodegradabilne nanočestice
sa prosečnim dijametrom iznad 100 nm).
Pored lipidnih nanočestica i lek-nanokristala, poslednjih godina intenzivno se istraţuju i
polimerne nanočestice (nanočestice izraĎene od polimera). Polimerne nanočestice mogu
posluţiti kao rezervoar lipofilnih lekovitih supstanci koje isporučuju lek u stratum corneum, što
moţe biti način za kontrolu permeacije leka u/kroz koţu. Biodegradabilne polimerne
nanočestice se takoĎe ispituju kao potencijalni nosači za proteine, peptide i DNA u genskoj
terapiji.
Ključne reči: lipidne nanočestice, lek-nanokristali, polimerne nanočestice
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PP4. NANOPARTICLES AS DRUGS/ DRUG DELIVERY SYSTEMS
Vuleta Gordana, Kovačević Andjelka, Savic Snezana
Department of Pharmaceutical Technology and Cosmetology, Faculty of Pharmacy, University
of Belgrade, Belgrade, Serbia
In general, nanoparticles are colloidal systems with a size in the range from 1 to 1000 nm i.e. 1
μm. Latest definitions provided by the National Nanotechnology Initiative define nanotechnology
as a discipline which investigates structures with size in the range 1 to 100 nm. Investigations of
colloidal drug delivery systems include matrix nanoparticles (lipid and polymeric nanoparticles)
as well as liposomes and nanoemulsions. Modern research are based also on drug
nanocrystals which are particles made from poorly soluble drugs (Biopharmaceutical
Classification System (BCS) class II and IV drugs). Drug nanocrystals are pure drug particles
dispersed in aqueous or non-aqueous medium, while lipid nanoparticles are aqueous
dispersions of a solid lipid with an incorporated drug (physico-chemical term). Both type of
nanoparticles are typically stabilized by surfactants or polymeric steric stabilizers.
The most important objectives for the development of drug nanocrystals and lipid nanoparticles
are the following:
• to improve too low bioavailability of actives that are poorly soluble in water or biological fluids
• to increase low dermal bioavailability of actives with an limited penetration into/through the skin
• to reduce undesired side effects after intravenous application when using traditional
formulations and to target certain drug to specific site.
Drug nanocrystals have been applied in the formulation development of pharmaceutical dosage
forms for oral application such as tablets or capsules. Drugs in the form of nanocrystals belong
to the following pharmacological groups: immunosuppressants (sirolimus, Rapamune®, Wyeth
Pharmaceuticals), antiemetics (aprepitant, Emend®, Merck&Co), opioid analgesics (morphine
sulphate, Avinza®, King Pharmaceuticals), muscle relaxants (tizanidine hydrohloride, Zanaflex
Capsules®, Acorda). One marketed product is in the form of oral suspension (Megace® ES, Par
Pharmaceutical Companies Inc. Spring Valley, NY, USA). The product contain megestrol
acetate (antianorexic) as an active ingredient as drug nanocrystals.
Parenteral application of drug nanocrystals enable drug targeting to a specific site and
prolonged release due to the possibility of the uptake of the nanocrystals by the macrophages of
the mononuclear phagocytic system in the liver. After accumulation of the drug in the liver, the
liver can acts as depot slowly releasing the drug into the blood (e.g. itraconazole).
Due to a number of positive effects that may contribute an enhanced dermal bioavailability, lipid
nanoparticles have been investigated intensively as novel drug delivery systems for the drugs
with reduced penetration into/through the skin. The small size of lipid nanoparticles and
adhesive properties increase the accumulation of the particles in the lower part of the
respiratory tract, giving the possibility for the formulation of dosage forms for pulmonary
application.
Due to the risk of toxic effects formulation development of nanoparticles is imposed
development methods for monitoring and evaluation of safety of nanoparticles. Recently,
Nanotoxicological Classification System (NCS) is proposed. Based on NCS the particles are
divided in a four classes (I, II, III, IV). The criteria for the evaluation of safety of the particles are
size, biodegradability and intracellular uptake. Actual research in the field of nanoparticles have
focused on the formulation of lipid nanoparticles and drug nanocrystals, class I according to the
NCS (i.e. biodegradable nanoparticles with an average diameter above 100 nm).
11
In addition to lipid nanoparticles and drug nanocrystals, polymeric nanoparticles (nanoparticles
made from polymers) have attracted considerable attention during the last years. Polymeric
nanoparticles can be used as reservoirs of lipophilic drugs to deliver them in the stratum
corneum being an important strategy to control their permeation into the skin. Biodegradable
polymeric nanoparticles have been also investigated as carriers of proteins, peptides and DNA
in gene therapy.
Keywords: drug nanocrystals, lipid nanoparticles, polymeric nanoparticles
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PP5. ULOGA BOLNIČKOG FARMACEUTA KAO NOSIOCA
FARMACEUTSKE ZAŠTITE: STANJE I PERSPEKTIVE
Antunović Mirjana
Vojnomedicinska akademija, Institut za farmaciju, Beograd, Republika Srbija
Uvod :Tradicionalna uloga većine bolničkih farmaceuta danas, odnosi se na snabdevanje
lekovima, izradu i kontrolu kvaliteta lekovitih preparata koji se primenjuju u bolnici. Ali, u
savremenim bolničkim apotekama sve prisutniji je koncept rada orijentisan prema pacijentu.
Neophodno je podrţati ovakav koncept, na svim nivoima zdravstvenog sistema. Sekcija
bolničkih farmaceuta Srbije, donela je dokument o mogućem delokrugu rada. Republička
komisija za farmaciju radi na povećanju broja bolničkih farmaceuta, prema njihovoj savremenoj
delatnosti.
Metode:Prvo, bilo je neophodno da sami članovi sekcije predloţe moguće delatnosti bolničkog
farmaceuta, sa praktičnim primerima, da se taj dokument objavi i ponudi Ministrstvu zdravlja na
dalju nadleţnost.
Rezultati:Predloţene su neke aktivnosti. Glavna uloga u “profesionalnoj proveri” svih recepata
garantuje da su izdati lekovi odgovarajući i bezbedni za pacijenta. U odeljenju za
farmakoinformatiku, farmaceuti koriste širok spektar referentnih izvora, da bi obezbedili “up to
date” informacije o svim aspektima upotrebe lekova, namenjene zdravstvenim radnicima i
pacijentima. Farmaceuti su, takoĎe, uključeni u izradu i kontrolu kvaliteta lekova, kada neki
lekovi kao komercijalni nisu dostupni. Na primer, priprema smeša za totalnu parenteralnu
ishranu ili izrada prezervacionih rastvora za transplantaciju organa. Specijalizovane uloge u
oblasti radioterapije, centralizovane pripreme citotoksičnih lekova, racionalne primene
antibiotika, kliničkih studija, edukacije i nabavke lekova, takoĎe su navedene.
Zaključak: U narednom periodu neophodno je promovisati svaku delatnost bolničkog
farmaceuta, kao člana bolničkog tima, koja će omogućiti da pacijent dobije najbolju moguću
terapiju.
Ključne reči: bolnički farmaceut, farmaceutska zdravstvena zaštita, bolnički tim
13
PP5. THE ROLE OF HOSPITAL PHARMACIST AS
PHARMACEUTICAL HEALTHCARE SYSTEM CAREER: SITATION
AND PERSPECTIVES
Antunović Mirjana
Military Medical Academy, Belgrade, Republic of Serbia
Background: Today, the majority of hospital pharmacists engaged in the traditional
pharmaceutical activities of dispensing medicines and manufacturing and quality control of
pharmaceuticals used in a hospital. But, the modern hospital pharmacy has been moving to a
very substantial direct “patient orientation” concept. It is necessary to support this concept, at all
levels of the health system. The Serbian Section of Hospital Pharmacists, has published a
paper to demonstrate what it is possible to delegate to hospital pharmacists. It also aims to
increase the numbers of hospital pharmacists. The Republic Commission of Pharmacy is
working on increasing the number of hospital pharmacists, according to their contemporary
activities.
Method: First, it was essential that members of the section alone suggest the possible roles of
hospital pharmacists, with some practical examples, than to publish this document and provide
to the Ministry of Health for further action.
Results: There were proposed a number of activities. Main role is to “professionally check” all
prescriptions to ensure that the dispensed medicines are appropriate and safe for the individual
patient. In the medicines information department, pharmacists use a range of reference
sources, to provide “up to date” information to healthcare professionals and patients about all
aspects of medicines usage. Pharmacists are also involved in the preparation of medicines and
quality control, when ready-made preparations are not available. For example, intravenous
feeding solutions need to be made under sterile conditions for individual patients, or production
of transplantation organ preservation solution. Specialised roles in other areas such as
radiotherapy, centralised preparation of cytotoxic drugs, clinical trials, education and
procurement also exist.
Conclusion: In the future, it is necessary to promote every activity of hospital pharmacist, as a
hospital teamwork member, which will allow the patient to obtain the best possible treatment.
Key words: hospital pharmacist, pharmaceutical healthcare system, hospital teamwork.
14
PP6. PARTNERSTVO AGENCIJA ZA LEKOVE I MEDICINSKA
SREDSTVA I ZDRAVSTVENIH I OBRAZOVNIH INSTITUCIJAPRIMER SARADNJE CALIMS-a I VOJNOMEDICINSKE AKADEMIJE U
BEOGRADU
Dobrić Silva
Vojnomedicinska akademija, Institut za naučne informacije, Beograd, Srbija
Cilj svake agencije za lekove i medicinska sredstva jeste uspostavljanje najviših standarda u
oblasti lekova i medicinskih sredstava kako bi se obezbedila kvalitetna zdravstvena zaštita
širokih slojeva stanovništva. To, izmeĎu ostalog, podrazumeva i obezbeĎenje potrebnih uslova
za rad i razvoj, ali i nadzor nad radom, svih sudionika u zdravstvenoj zaštiti, počevši od
farmaceutske industrije, preko distributera lekova i medicinskih sredstava, sve do zdravstvenih
institucija koje neposredno pruţaju zdravstvenu uslugu pacijentima, kao krajnjim korisnicima
zdravstvene zaštite. U skladu sa tim agencije za lekove i medicinska sredstva vrše poslove u
oblasti njihove registracije, farmakovigilance, kliničkih ispitivanja i kontrole kvaliteta, a zaduţeni
su i za nezavisno informisanja stručne i šire javnosti o odnosu rizika i koristi od primene lekova i
medicinskih sredstava.
Da bi se ostvarili svi postavljeni ciljevi u ovako širokoj lepezi javnozdravstvene delatnosti, kao
logična, nameće se saradnja agencija za lekove i medicinskih sredstava sa stručnim i
akademskim institucijama u oblasti zdravstva. U skladu sa tim, 22. januara 2011. godine
potpisan je Protokol o naučno-tehničkoj saradnji izmeĎu Agencije za lijekove i medicinska
sredstva Crne Gore (CALIMS) i Vojnomedicinske akademije (VMA), Beogradu.
VMA je institucija tercijarnog nivoa zdravstvene zaštite u kojoj se, osim stručne, sprovode i
naučno-istraţivačka i obrazovna delatnost i to, gotovo, u svim oblastima od interesa za rad
jedne agencije za lekove i medicinska sredstva. Centar za kliničku farmakologiju, Centar za
kontrolu trovanja, klinike i instututi VMA, posebno Institut za farmaciju, kao i novoosnovani
Medicinski fakultet VMA, sada u sastavu Univerziteta odbrane, mesta su gde se svakodnevno
sprovode aktivnosti u kojima stručnjaci CALIMS-a mogu pronaći elemente za poboljšanje svoje
delatnosti, ali i pruţiti korisne informacije kojima će unaprediti rad pojedinih sluţbi unutar VMA.
Kao posebno značajna područja zajedničkih aktivnosti treba istaći nadzor nad sprovoĎenjem
kliničkih ispitivanja lekova i medicinskih sredstava, uključujući i studije bioekvivalencije,
sprovoĎenje farmakoepidemioloških i farmakoekonomskih istraţivanja, kao i redovno
informisanje o novostima u oblasti lekova. Poslovi Instituta za farmacija VMA iz domena
proizvodnje odreĎenih grupa lekova za sopstvene potrebe, i kontrole polaznih lekovitih
supstancija i gotovih medicinskih proizvoda, predstavljaju posebno vaţan segmant saradnje,
ako se uzme u obzir da se od CALIMS-a očekuje značajna podrška razvoju kompletne
farmaceutske delatnosti u Crnoj Gori.
Saradnja CALIMS-a i VMA moţe posluţiti kao dobar primer partnerstva, pogotovo za zemlje sa
nedovoljno razvijenim resursima u oblasti farmaceutske delatnosti.
Ključne reči: agencija za lekove i medicinska sredstva, zdravstvene institucije, zdravstvena
zaštita, farmaceutska delatnost, zakonska regulativa lekova.
15
PP6. PARTNERSHIPS OF AGENCIES FOR MEDICINES AND
MEDICAL DEVICES AND HEALTH AND SCIENTIFIC
INSTITUTIONS-EXAMPLE OF COLLABORATION BETWEEN
CALIMS AND MILITARY MEDICAL ACADEMY IN BELGRADE
Dobric Silva
Military Medical Academy, Institute for Scientific Information, Belgrade, Serbia
The goal of every agency for medicines and medical devices is to establish the highest
standards in the field of medicines and medical devices in order to provide a high quality of
health care for the population. This, among others, includes providing necessary conditions for
operation and development, as well as for the supervision of that operation, over all participants
in health care, starting from pharmaceutical industry, through distributors of medicines and
medical devices, to health institutions which directly provide health care to patients as its end
users. In accordance with that, agencies for medicines and medical devices perform activities in
the fields of registration of medicines and medical devices, pharmacovigilance, clinical trials and
drug quality control, and they are also responsible for providing objective information for
professional community and general public on the risk and benefit assessment of the use of
medicines and medical devices.
Collaboration between agencies for medicines and medical devices and expert and scientific
institutions is a logical manner to achieve all the goals in such a wide range of public health
activities. Consequently, Protocol on Scientific-Technical Cooperation between Agency for
Medicines and Medical Devices of Montenegro (CALIMS) and Military Medical Academy (MMA),
Belgrade, Serbia is signed on 22 January, 2011.
MMA is a tertiary health care institution in which, beside professional activities, scientific
research and education activities are carried out in almost every field that is important to the
work of an agency for medicines and medical devices. Activities by which CALIMS experts may
improve work of the Agency are on daily basis carried out in the Centre for Clinical
Pharmacology, Poison Control Centre, clinics and institutes of MMA, especially in the Institute of
Pharmacy, and also in newly established Medical School of MMA (now part of the University of
Defense). Within these activities, CALIMS experts may also give useful informations which may
advance certain services in MMA. Particularly important areas of joint activities are monitoring of
clinical trials of medicines and medical devices, including bioequivalence studies, conducting
pharmacoepidemiological and pharmacoeconomic research, as well as regular informing about
news in the field of medicines. If it is taken into account that CALIMS is expected to significantly
support complete pharmaceutical sector in Montenegro, affairs of MMA Institute of Pharmacy in
the field of production of certain medicines for its own use, as well as control of the initial
medical substances and finished medical products, are particularly important segment of
collaboration.
Collaboration between CALIMS and MMA may serve as a good example of partnership,
especially for countries with underdeveloped resource in the field of pharmacy practice.
Key words: agency for medicines and medicine devices, health care institutions, health care
service, pharmaceutical practice, drug legislation.
16
PP7. REGULATORNI ZAHTJEVI I DOKUMENTACIJA O ISPITIVANJU
STABILNOSTI LIJEKOVA U EU
Tabak-Slošić Maja
Agencija za lijekove i medicinske proizvode, Zagreb, Republika Hrvatska
Stabilnost gotovih lijekova je jedno od najvaţnijih svojstava njegove kakvoće i obavezni je dio
dokumentacije koja se prilaţe prilikom odobravanja lijeka i kasnije prilikom prihvaćanja izmjena
u dokumentaciji o lijeku. Pojam stabilnosti je stoga često spominjan u regulativi. Ispitivanje
stabilnosti lijekova regulirano je u Europi farmakopejskim zahtjevima, smjernicama i različitim
propisima. No pregledom dokumentacije o lijeku, dopuna/odgovora proizvoĎača na primjedbe
regulatornih agencija kao i pregledom EU smjernica i ostale stručne literature, postaje jasno da
su mnoga područja ostala nepokrivena regulativom, a time i nedovoljno definirana. Stoga se
stručna mišljenja često donose ovisno od slučaja do slučaja. Današnji izgled dokumentacije o
lijeku uvelike se razlikuje od onoga koji je još donedavno bio prihvatljiv, a vidljive su i razlike u
tumačenju propisa meĎu nositeljima odobrenja. Zahtjevi su sve veći, strogo fokusirani na
kakvoću, sigurnost primjene i djelotvornost lijeka. Podaci koji su donedavno predstavljali samo
dodatne podatke, danas su obavezni dio dokumentacije o razvoju lijeka. Priopćenje će
sadrţavati primjere koji su sastavni dio ispitivanja stabilnosti a predstavljaju neizostavan dio
dokumentacije za odobravanje lijeka kao npr.: „stress test” i „in bulk” ispitivanje stabilnosti,
ispitivanje stabilnosti lijeka tijekom primjene odnosno nakon prvog otvaranja spremnika,
karakterizacija onečišćenja, usporedni profili onečišćenja s referentnim lijekom i sl. Kao
posljedica ispitivanja stabilnosti definira se rok valjanosti i uvjeti čuvanja lijeka te način primjene
nekih farmaceutskih oblika lijekova. Ovi podaci se navode u saţetku opisa svojstava lijeka, uputi
o lijeku i označavanju kako bi bili dostupni zdravstvenom osoblju i pacijentima. Bit će izneseni
primjeri dobre i loše prakse u navoĎenju podataka. ProizvoĎači lijekova u ţelji da ubrzaju
postupak odobravanja, odnosno izbjegnu primjedbe regulatornih agencija, s krajnjim ciljem što
brţeg izlaska lijeka na trţište, ulaţu veliki trud i novac u ispitivanje stabilnosti. Na taj način
uglavnom postiţu cilj da podaci o stabilnosti budu potpuni u vrijeme podnošenja zahtjeva za
odobravanje lijeka.
Ključne riječi: ispitivanje stabilnosti lijekova, zakonska regulativa ispitivanja stabilnosti lijekova u
EU, stress test, rok valjanosti, uvjeti čuvanja
17
PP7. REGULATORY REQUIREMENTS AND DOCUMENTATION ON
STABILITY TESTING OF DRUG PRODUCTS IN THE EU
Tabak-Slošić Maja
Agency for Medicinal Products and Medical Devices of Croatia, Zagreb, Croatia
Stability of drug products is one of the most important characteristics of its quality. Stability
results are obligatory part of the documentation to be submitted during the approval of the drug,
and later during accepting variations to the documentation of the drug.
Stability is therefore often mentioned topic in the regulations.
Many areas of stability testing remained uncovered, although stability testing of drugs is
regulated and defined by European and ICH guidelines and various regulations. Therefore, the
expert opinions are often made based on a case by case basis. Today's requirements for
registration dossier differ greatly from recently acceptable ones.
The demands are increasing, strictly focused on quality, safety and efficacy. Supportive data
become mandatory. Stress test results, in bulk and in-use stability testing, characterisation of
impurity and comparative impurity profiles are integral part of the documentation for the
approval of the drug.
There should be a direct linkage between the label statement, PIL and SmPC information (shelf
life and storage conditions) and results from stability studies, presented at the time of the
submission. The presentation will give a thorough understanding of regulatory expectations for
stability testing programs. The examples of good and bad practice regarding declaration of the
storage conditions will be presented.
Pharmaceutical industry, in order to get approval without deficiency letter, invests a lot of effort
in testing stability, so the stability data documentation matches the date of the submission.
Key words: stability testing, guidelines on stability testing, stress test, shelf life, storage
conditions, label statement
18
PP8. REGULATIVA U OBLASTI LEKOVA
Jovanović Slobodanka1, Petrović Slobodan D.2
1
Ekonomski institut, Beograd, Srbija
Tehnološko-metalurški fakultet Univerziteta u Beogradu, Srbija
2
Farmaceutska industrija se sastoji od dva sektora: inovativnog i generičkog sektora. Inovativne
farmaceutske kompanije (proizvoĎači originalnih lekova) imaju kao primarni cilj patentnom
zaštitom što duţe sprečavanje generičkih kompanija od uvoĎenja proizvoda na trţište i zbog
toga uvode „‟total produkt strategiju‟‟ ili „‟maksimizaciju ţivotnog ciklusa‟‟. Osnovna namera je da
se dobije što više patenata tokom razvojnog i marketinškog ciklusa i patenti prošire na nove
primene registrovanih proizvoda, ili da se doda vreme ekskluzivnosti na osnovu regulative koja
povezuje patentnu zaštitu i registraciju lekova. Za ovu svrhu, pored osnovne patentne zaštite
za novi molekul, uvedeni su drugi aspekti patentne zaštite: patenti za kompoziciju, zaštita
(bio)sintetskog dobijanja, formulacija, metod lečenja (uključujući novu primenu poznatog
jedinjenja), različito doziranje, terapije u kombinaciji sa drugim lekovima, pro-lekovi, metaboliti,
različite kristalne ili hidratne structure, gen-markeri koji pokazuju odgovor na terapiju. Patentna
zaštita od 20 godina se moţe produţiti do 5 godina Sertifikatom dodatne zaštite (SPC) a
proizvoĎači originalnih lekova mogu da koriste, dodatno patentnoj zaštiti, ekskluzivnost
podataka za registraciju novog leka, „‟data exclusivity‟‟. Generička farmaceutska industrija
obezbeĎuje trţištu lek koji je porediv ili suštinski sličan originalnom leku u pogledu kvaliteta,
sigurnosti, efikasnosti i bio-ekvivalencije. Svetski trend u oblasti razvoja generičkih lekova se
danas bazira na novim materijalima i primeni novih tehnologija, koje obezbeĎuju dobijanje
takozvanih specijaliteta, biogenerika ili supergenerika. Srbija i Crna Gora su harmonizovale
zakone o patentima i regulativu u oblasti lekova sa meĎunarodnom legislativom u skladu sa
WIPO/TRIPS/KEP odredbama i EU regulativom.
Ključne reči: lekovi, patentna zaštita, regulativa
19
PP8. REGULATION IN THE MEDICINAL PRODUCTS
Jovanović Slobodanka 1, Petrović Slobodan D. 2
1
Economics Institute, Belgrade, Serbia
Faculty of Technology and Metallurgy, Belgrade University, Serbia
2
Pharmaceutical industry consists of two sectors: the innovative sector and the generic sector.
Innovator pharmaceutical companies (pharmaceutical originators) have a primary goal to
prevent by patent protection the generic companies as far as possible to launch their products
on the market and because of that practice „‟total product strategies‟‟ or „‟lifecycle maximization‟‟.
The basic intention is obtaining as many patents as possible during the development and
marketing cycle and to extend them for new uses of established products, or to add on to the
time- lag between patent grant and public health approval. For this purpose, beside the basic
patent for a new molecule as an active ingredient, other patent protection aspects have been
employed: patents for composition, (bio)-synthetic production, formulation, method of treatment
(including new use of known compounds), different dosing, and therapies in combination with
other medicinal products, pro-drugs, substances resulting from metabolism in body, different
crystalline or hydrated structures, gene-markers showing response to drug therapy. The 20-year
patent protection can be increased by up to 5 more through a Supplementary Protection
Certificate (SPC) and the originator pharmaceutical companies also can use, in addition to
patent protection, a separate period of regulatory data exclusivity during which the regulatory
authorities are not allowed to refer to the data on file for a generic medicine. Generic
pharmaceutical industry provides to the market a medicinal product considered to be
comparable i.e. essentially similar to the original medicinal product in term of quality, safety,
efficacy and bio-equivalency. The worldwide trend of generic medicinal products development is
now based on new materials and new technologies implementation, which enables the
development of so-called specialties, bio-generic medicinal products and super-generics.
Serbia and Montenegro harmonized the Patent Laws and the regulations of the medicinal
products with the international legislation in accordance with the WIPO/TRIPS/EPC
recommendations and EU regulations.
Keywords: medicinal products, patent protection, regulation
20
PP9. STRATEŠKI ASPEKTI GENERIČKE FARMACEUTSKE
INDUSTRIJE U CENTRALNO-ISTOČNO EVROPSKOM REGIONU
Bertoncelj Andrej
Univerzitet Primorska, Fakultet za menadţment - Koper, Slovenija
Uvod i cilj rada: Cilj ovog rada je istraţivanje strateških aspekta generičke farmaceutske
industrije u kontekstu centralno-istočnog evropskog (CEE) regiona. I pored velikog istraţivačkog
interesa, naše je znanje o ovoj temi još nepotpuno.
Metode: Evaluacijska anketa o odabranim strateškim aspektima generičkih farmaceutskih
poduzeća u centralno-istočno evropskom regionu.
Rezultati: Istraţivanja strateških aspekta generičke farmaceutske industrije u centralno-istočno
evropskom regionu sugerišu da su, lokalna farmaceutska preduzeća zanemarila bitne strateške
faktore kao tehnološki inovacijski kapacitet, trţišnu orijentaciju i performansu, ulogu strateškog
menadţmenta i podcijenila proces globalizacije. To je dovelo do pogoršanja performanse,
gubitka konkurentnosti kao i smanjene dominacije u trţišnoj poziciji u regionu, a stoga i u
konsolidaciji industrije kroz prekogranična preuzimanja i spajanja.
Diskusija: U okolini rastuće konkurencije, neophodno je obratiti veću paţnju gradnji onih
kompetentnosti koje će omogućiti CEE zemljama da sačuvaju odrţiv razvoj industrija temeljen
na znanju, uključivši farmaceutsku industriju. Tehnološka inovacija u farmaceutskoj grani moţe
se postignuti kroz donošenje novih tehnologija (kupovina, licence i zajedničko ulaganje),
formiranje razvojno-istraţivačkih saveza, uvećanje ulaganja u razvoj i istraţivanje, bolje
istraţivačko obrazovanje, saradnju sa bazičnima razvojno-istraţivačkima institucijama
(univerziteti), licenciranje potencijalnih proizvoda u različitim razvojnim fazama od drugih
farmaceutskih poduzeća ili specijalista, kupovina ekskluzivnih prava za potencijalne proizvode
u različitim razvojnim fazama od drugih izvora (druga farmaceutska preduzeća ili specijalisti) ili
kupovinu čitavih farmaceutskih preduzeća.
Zaključak: Veća paţnja ulaganjima u intelektualni kapital i promicanju tehnološke inovativnosti
prije fokusiranja na pitanja ekonomske produktivnosti, trebalo bi uključivati razvoj istraţivačkih
centara za aplikaciju inţinerskog i tehničkog znanja u budućnosti. Napredak u tehnologiji je
danas nova norma u globalnoj utakmici.
Ključne riječi: centralno-istočno evropski region (CEE),
globalizacija.
21
tehnološki inovacijski kapacitet,
PP9. STRATEGIC ASPECTS OF GENERIC PHARMACEUTICAL
INDUSTRY IN CENTRAL EAST EUROPEAN REGION
Bertoncelj Andrej
University of Primorska, Faculty of Management, Koper, Slovenia
Introduction and purpose: The aim of this paper is to investigate strategic aspects of generic
pharmaceutical industry in the Central East European (CEE) region‟s context. Despite
significant research interest in this topic our knowledge is still incomplete.
Methodology/approach: The evaluation survey of some strategic aspects of generic
pharmaceutical companies in the CEE region.
Findings: Research of the strategic aspects of the generic pharmaceutical industry in CEE
region suggests that local pharmaceutical companies neglected important strategic issues such
as technological innovation capability, market orientation and performance, role of strategic
management and underestimated the process of globalization. This resulted in deteriorated
performance, lost competitiveness and reduced dominance as market leaders in the region and
consequently in industry consolidation through cross-border mergers and acquisitions.
Discussion: In increasingly competitive business environment in CEE countries, a new focus on
competence building to preserve sustainable development of their knowledge-based industry,
including the pharmaceutical industry, is required. Technological innovation in the
pharmaceutical industry can be achieved by bringing in new technologies (by acquisitions,
licensing and joint ventures), forming R&D alliances, increasing investments into R&D,
improving technological backgrounds, cooperating with basic R&D institutions (universities,
smaller private R&D companies), licensing potential products in the different stages of
development from other pharmaceutical companies or specialists, acquiring the exclusive rights
for potential products in the different stages of development from various sources (other
pharmaceutical companies, R&D companies or institutions, specialists) and acquiring an entire
pharmaceutical company or institution.
Conclusion: More attention on investing in intellectual capital and promoting technological
innovation, rather than focusing only on economic productivity issues, should involve building
research hubs for the application of engineering and technical knowledge in the future. The
advance of technology is now a new rule of the global game.
Keywords: Central East European region, technological innovation capability, globalization.
22
PP10. FARMACEUTSKA KOMORA MAKEDONIJE – ZASTUPANJE,
POSREDOVANJE I LOBIRANJE KOD VLASTI U ZDRAVSTVENOM
ZAKONODAVSTVU
Petruševska-Tozi Lidija, Patčeva Jasminka, Zdravkovska Nataša, Kovačeva Maja
Farmaceutska komora Makedonije
Farmaceutska komora Makedonije (FKM) je profesionalno udruţenje svih diplomiranih
farmaceuta u Makedoniji, čiji je cilj zaštita interesa farmaceuta, promovisanje njihovih
profesionalnih i ličnih znanja i jačanje njihove uloge u procesima unapreĎenja zdravstvenog
sistema. FKM štiti interese farmacije kao profesije i obezbeĎuje najbolje uslove za kontinuirano
obrazovanje i profesionalni razvoj kvalifikovanih farmaceuta.
U zadnjih nekoliko godina FKM je priznata kao veoma vaţna zainteresovana strana u velikom
broju različitih procesa koji se odnose na regulisanje obezbeĎivanja kvaliteta farmaceutske
djelatnosti. Na ovaj način, veliki značaj dobija misija za zastupanje, posredovanje i lobiranje kod
vlasti kao strategija za vršenje uticaja nad osobama koje donose politike i drugim regulatorima u
kreiranju zakona, pravilnika, preporuka, uputstva i odluka koje utiču na farmaceutsku profesiju.
TakoĎe, uloga za poboljšanje profesionalnog razvoja članova FKM je postala izuzetno vaţna.
Razlog uspostave ovog kredibiliteta je u jačanju vlastitih kapaciteta, a osobito u obezbeĎivanju
informacija u pravo vreme za relevantna pitanja, što je postalo moguće posle reorganizacije
uprave udruţenja putem procesa decentralizacije.
Angaţman u pripremi zakonodavstva sa Ministarstvom zdravlja i pregovori za Ugovore sa
Javnim apotekama sa Fondom za zdravstveno osiguranje su glavni izazovi sa kojima je komora
bila suočena u zadnjim godinama.
Ispunjavanje obaveza za organizaciju drţavnog ispita i izdavanje licenca za profesionalni rad
farmaceuta, koje su prenete Komori sa strane Ministarstva zdravlja, su uspešno izvršene i
dobijene su pozitivne povratne informacije. Proces relicenciranja je u toku.
Kontinuisani profesionalni razvoj naših članova i aktivnosti za njegovo proširenje i unapreĎenje
ponovo ostaju, kao i prije, jedno od najvaţnijih pitanja u našem radu.
Ključne reči: profesionalno udruţenje, zastupanje, posredovanje i lobiranje kod vlasti, nacionalni
organi, kontinuisani profesionalni razvoj
23
PP10. PHARMACEUTICAL CHAMBER OF MACEDONIA - ADVOCASY
IN HEALTH LEGISLATION
Petrushevska-Tozi Lidija, Patceva Jasminka, Zdravkovska Natasha, Kovaceva Maja
Pharmaceutical Chamber of Macedonia
The Pharmaceutical Chamber of Macedonia (PCM) is a professional association of all
graduated pharmacists in Macedonia, with the aim to protect the interests of the pharmacists, to
promote their professional and personal competences and to strength their role in the processes
of the improvement of the health-care system. PCM protects the interests of the pharmacy as a
profession and provides the best conditions for continuous education and professional
development of the qualified pharmacists.
In the last few years the PCM has been recognized as a very important stakeholder in many
different processes concerning the regulation of provision the quality pharmaceutical care. In
this way, the mission to advocate as a strategy to influence policy makers and other regulators
when making laws, rule books, recommendation, guidelines and decisions that affect pharmacy
profession become very important. Also, the role for improvement of the professional
development of PCM members has become extremely important.
The reason for establishing this credibility was strengthening the own capacities especially the
provision of the information in the right time for the relevant issue which was possible after
reorganizing the management of the association by the process of decentralization.
The involvement in preparing legislation with the Ministry of Health, and negotiations for the
Contracts with Community Pharmacies with the Health Insurance Found were the main
challenges that the Chamber faced in the last years.
Fulfilling the responsibility for organizing the state exam and issuing license for professional
work of the pharmacists, that was transferred to the Chamber by the MoH, was successfully
carried out, and positive feedback was received. The process of relicensing is in progress.
The continuous professional development of our members, and the activities for expanding and
improving it, still remains, as it was previously, one of the most important issues for future work.
Key words: professional association, advocacy, national authorities, continuous professional
development
24
PP11.
GENSKA TERAPIJA – PRIMJENA U FARMACIJI I MEDICINI
Jevrić –Čaušević Adlija
Farmaceutski fakultet Sarajevo, Univerzitet u Sarajevu
Potencijal genske terapije počeo je da se prepoznaje početkom devedesetih godina prošlog
stoljeća.Velika otkrića u domenu molekularne biologije navela su ljekare i naučnike na
razmišljanje da se patogeni proces moţe zaustaviti na mjestu svoga nastanka, primjenom
transfera gena sa potencijalnim terapeutskim efektima. Danas se ovaj način terapije u medicini,
bez obzira na brojne probleme vezane za njenu aplikaciju (nesavršen sistem isporuke gena,
insercija ubačenih gena na pogrešnu lokaciju) moţe smatrati vrlo obećavajućom metodom u
terapiji monogenskih i poligenskih obolenja i podrazumijeva manipulaciju genima odnosno
modifikaciju ili manipulaciju ekspresijom produkata gena.(u radu će biti dat pregled aplikativnih
protokola)
Genskom terapijom se vrši korekcija nedostajućih ili aberentnih genetskih funkcija te se tako
interferira sa procesom razvoja obolenja. Pri tome se funkcionalno moţe raditi o adiciji novog
gena u ciljane ćelije sa ciljem poništavanja funkcije mutiranog gena, o zamjeni mutirane
sekvence sa ispravnom genskom sekvencom, ili pak o promjeni genetske regulacije. Genetski
materijal moţe unijeti direktno u ciljane ćelije posredstvom vektora(terapija in vivo) ili pak u
izolovane ciljane ćelije(terapija ex vivo) koje se nakon toga vrate u organizam bolesnika.
Dodana DNK, bez obzira na tip terapije mora biti permanentno integrirana u hromozome
pacijenata te imati adekvatnu ekspresiju u ciljanim ćelijama ukjučujući i spolne gdje dolazi do
produkcije funkcionalnih proteinskih produkata koji onda dovode ćelije u normalno stanje.
Molekula prenosilac terapeutskog gena pacijentu je najčešće vektor(najčešće je to genetski
izmijenjen virus), mada se koristi i nevirusna isporuka DNK. U novije vrijeme se prilikom
ubacivanja gena počinje koristiti i RNK komponenta genske terapije(RNK interferenca).
Enorman aplikativni potencijal transfera gena je u farmaceutskom sektoru vidljiv u domenu
discipline genoceutika.U ovom slučaju, on se zasniva na ubacivanju gena od interesa u ćelije u
kojim dolazi do sinteze ţeljenog farmaceutski aktivnog proteina. U ovom radu bit će
prezentirani brojni izazovi vezani za ovu oblast.
Ključne riječi: Genska terapija, DNK, medicina, genoceutika
25
PP11. GENE THERAPY
– APPLICATION IN PHARMACY AND MEDICINE
Jevric -Causevic Adlija
Faculty of Pharmacy,University of Sarajevo
Potential of gene therapy began to be recognized in early 20th century. Principles lying behind
big discoveries in molecular biology have led MDs and scientists to think that pathogenic
process can be stopped at the site of its initiation through effective transfer of relevant genes
resulting at the end with potential therapeutic effects. Nowdays, this type of therapy, even when
numerous poblems with its application are considered (problems with gene delivery, genes
inserted to wrong location), can be thought of as very promising method in therapy of numerous
monogenic and poligenic diseases and implies gene manipulation or modification or
manipulation with gene expression products, sometimes change in genetic regulation.(in this
work, numerous applicative protocols will be presented). Different approaches are used in order
to achieve this goal., new genes can be added to target cells in order to stop function of mutated
gene, or mutated sequence can be removed and new gene with correct sequence inserted. A
carrier molecule called a vector can be used to directly deliver the therapeutic gene to the
patient's target cells (therapy in vivo) or genetic material is transferred at first to isolated target
cells and later on to patient (therapy ex vivo). Functional protein product obtained from
therapeutic gene restores the target cell to a normal state.Viruses are used mostly in the
process of gene delivery, however various non viral delivery systems are recognized. Recently,
new technique called RNA interference has been described with a great potential of overcoming
problems with viral and nonviral delivery systems.
Enormous application potential of gene transfer has been recognized by pharmaceutical
industry within discipline called genoceutics. It relies on insertion of the genes of interest into
cells where synthesis of pharmaceutically active functional protein occurs. In this work,
numerous issues related to this field will be presented.
Key words: Gene therapy,DNA,medicine, genoceutics
26
PP12. SAVREMENI PRISTUP FITOTERAPIJI
Tadić Vanja1, Bojović Dragica 2
1
Institut za proučavanje lekovitog bilja “Dr Josif Pančić“, Beograd, Srbija
Galenika Crna Gora, Podgorica, Crna Gora
2
Uvod i cilj rada. Prema definiciji fitoterapija predstavlja metodu liječenja, ublaţavanja i
sprečavanja bolesti i tegoba upotrebom biljnih droga - cijelih ljekovitih biljaka ili njihovih dijelova
(cvjetova, listova, korijena, itd.), upotrebom biljnih izolata (etarskih ulja, ekstrakata) kao i gotovih
pripravaka (čajeva, tinktura, masti, kapsula). Cilj ove prezentacije je sagledavanje mjesta
fitoterapije u savremenoj farmakoterapji. Prikazano je i proučavanje vodeno-etanolnog ekstrakta
nadzemnog dijela biljke Sideritis scardica Griseb. Lamiaceae (šarplaninski čaj), kako bi
tradicionalna upotreba ove biljke kao gastroprotektiva bila potvrĎena i dokumentovana i
farmakološkim ispitivanjiima.
Metodologija: Koncipiranje sveobuhvatnih farmakoloških i kliničkih studija u cilju afirmisanja
realnih terapijskih svojstava velikog broja ljekovitih biljnih droga, kao i potvrde hiljadugodišnjeg
empirijskog iskustva u njihovoj upotrbi primjenom naučnih metoda.
Rezultati i diskusija: Polazeći od sloţenog hemijskog sastava i naučno potvrĎene realne
terapijske vrijednosti aktivnih sastojaka biljnih droga, konstatovan je veoma širok opseg
indikacionih područja gdje se moţe preporučiti fitoterapija. Najširu primjenu fitopreparati nalaze
u liječenju oboljenja digestivnog trakta, respiratornih organa, urogenitalnog trakta, centralnog
nervnog sistema, i kardiovaskularnog sistema. Biljni lijekovi koji se primjenjuju u racionalnoj
fitoterapiji izraĎeni su od standardizovanih biljnih ekstrakata, imaju definisan i standardni
farmaceutski kvalitet, ispoljavaju dozno-zavistan terapijski efekat, a njihova efikasnost i
bezbjednost je naučno potvrĎena. Biljni lijekovi se upotrebljavaju preventivno, za terapiju u
početnim fazama oboljenja, za ublaţavanje tegoba kod blaţih poremećaja zdravlja, i kao
dopunska terapija lijekovima kod teţih poremećaja zdravlja. Pogodni su za primjenu kod
hroničnih tegoba, blagotvorni su za regulisanje poremećenih fizioloških funkcija, a samo mali
broj biljnih droga i biljnih lijekova primjenjuje se i ima efekta kod akutnih stanja . U prikazanom
pojedinačnom slučaju, in vivo ispitivanja anti-inflamatornog potencijala i gastroprotektivne
aktivnosti ukazuju na značajnu anti-inflamatornu aktivnost i značajan gastroprotektivni efekat
vodeno-etanolnog ekstrakta šarplaninskog čaja (smanjenje inflamacije za 50%, odnosno
smanjenje intenziteta gastričnih lezija), koji su poredivi ili bolji u odnosu na referentne sintetske
lijekove, indometacin i ranitidin.
Zaključak: Primjenom savremenih farmakoloških i kliničkih ispitivanje utvrĎena je naučna
osnova za racionalnu fitoterapiju u okviru savremene farmakoterapije. Savremena naučna
istraţivanja potvrĎuju ili opovrgavaju tradicionalnu upotrebu odreĎene vrste ljekovitog bilja.
Ključne riječi: Racionalna fitoterapija; biljni lijekovi; farmakološka i klinička ispitivanja;
šarplaninski čaj
Zahvalnica: Izrada ovog rada je bila omogućena zahvaljujući finansijskoj pomoći Ministrastva za
nauku i tehnološki razvoj Srbije, projekat br. 45017.
27
PP12. MODERN APPROACH TO PHYTOTHERAPY
Tadić Vanja1 , Bojović Dragica2
1
Institute for Medicinal Plant Research “Dr. Josif Pančić“,Belgrade, Serbia
Galenika Crna Gora, Podgorica, Montenegro
2
Introduction and scope of study: Phytotherapy represents one of the branch of herbal medicine,
which describes the potentials and limitations of herbal drugs in the treatment of human
diseases. According to the definition, phytotherapy is a method of treatment and prevention of
disease using herbal drugs - whole herbs or their parts (flowers, leaves, roots, etc.), the plant
isolates (essential oils, extracts) and finished preparations (teas, tinctures, ointments, capsules).
In this work, the results of Sideritis scardica Griseb. Lamiaceae (mountain tea) water-ethanol
extract investigation has been shown, as well, in order to evaluate the traditional use of this
plant as effective gastroprotective and anti-inflammatory herbal remedy.
Methods: One of the most important issues facing integrative medicine today is the need to
access information about clinical research on herbal products. Comprehensive scientific studies
confirmed the traditional application, and pharmacological and clinical trials affirmed traditional
therapeutic properties of a large number of herbal drugs.
Results and discussion: An enormous increase in the knowledge of herbal drug constituents,
their effects, and side effects has occurred in recent years. Taking into account the complex
chemical composition and scientifically proven real therapeutic values of the active ingredients
of herbal drugs, the range of indications where they can be recommended, is large. Herbal
remedies are widely used in the treatment of gastrointestinal, respiratory and urogenital tract
diseases, , as well as diseases of central nervous and cardiovascular system. Rational
phytotherapy presents the application of herbal drugs made from standardized herbal extracts
(with standardized quality and quantity composition), having a specific and standard
pharmaceutical quality, exhibiting dose-dependent therapeutic effect, with efficacy and safety
scientifically confirmed. The most important facts regarding applications of phytopreparations
are that their therapeutic effects occur after some time of application. Also, they are supposed to
exhibit effect in chronical and subacute states and diseases. Rarely they are used for acute
states. The reffered investigation of anti-inflammatory and gastroprotective activities of S.
scardica extracts, aimed to prove the above-stated folkloric utilizations.
Conclusion: As a complementary part of pharmacotherapy, phytotherapy has an important
position in modern medicine. Modern scientific studies confirm or deny the traditional use of
certain herbal drugs.
Keywords: Rational phytotherapy, herbal remedies, pharmacological and clinical trials; mountain
tea
Acknowledgement: The authors acknowledge their gratitude to the Ministry for Science and
Technological Development Project No 45017 for financial support.
28
PP13. FLORA CRNE GORE U SLUŽBI FARMACIJE
Vincek Daniel, Marjanović-Vincek Zora
Botanička bašta planinske flore Crne Gore, Kolašin
Crna Gora svojim geografskim poloţajem, klimatom, razuĎenim reljefom (od čega je 50% iznad
500 metara nadmorske visine) , te sastavom zemljišta, a što je sve omogučilo ţivotni prostor za
3.200 autohtonih biljnih vrsta od kojih je bar 500 identifikovano i uvedeno u oficijelnu ili su
korištene u tradicionalnoj medicini..
Danas Crna Gora raspolaţe institucijama za edukaciju kadrova specijaliziranih za ljekovito bilje.
To su Prirodno matematički fakultet, Farmaceutski fakultet, Biotehnički fakultet, Prirodnjački
muzej. Ovim institucijama predstoji opremanje laboratorijama, modernim i funkcionalnim
Centralnim herbarom flore Crne Gore, a prije svega podizanjem reprezentativne zgrade
Prirodnjačkog muzeja koji bi afirmisao Ekološku Crnu Goru.
Za sada u Crnoj Gori postoje i funkcionišu, već desetine godina, manje botaničke bašte u
Kolašinu i Plavu .Te bašte bi trebalo podrţati i proširiti kroz planove razvoja Sjevera Crne Gore.
Crnoj Gori je nuţno potrebno, oformljenje botaničkih bašti ljekovitog bilja kontinenetalne i
mediteranske Crne Gore. Ove specijalizirane bašte trebale bi da budu u sastavu Biotehničkog
fakulteta, Bijelo polje, i Farmaceutskog fakulteta u Podgorici.
Posebno treba istači ulogu Biološkog, Hemiskog i Farmaceutskog fakulteta, Beograd, koji su
mnogo učinili kako na istraţivanju terena tako i na stvaranju kadrova Crne Gore i njihovom
naučnom napredovanju.
Plan razvoja ljekovitog bilja kao grane privrede treba da proĎe kroz osmišljene faze edukacije
kadrova, metoda i način prikupljanja, izradu normativa, te registraciju i certifikaciju centara
prikupljanja kao i pojedinaca angaţovanih oko ljekovitog bilja.
Šansa i usmjerenost ljekobilja je kako u klasičnoj tako i u homeopatiji.Uz organsku poljoprivredu
ljekobilje će predstavljati i značajan izvozni artikal.
Temelji za gornju aktivnost su već udareni kroz višegodišnji rad na istraţivanju ljekovitog bilja,
na cijeloj teritoriji Crne gore, od strane Instituta Dr. Josif Pančić, Beograd. Ovaj projekat koji je
doveden skoro do kraja trebalo bi isfinansirati kao priručnik i atlas za eksploataciju i primjenu
ljekovitog bilja.
Ključne riječi : Ljekobilje, Crna Gora, Farmakopeja, Institucije
.
29
PP13. FLORA OF MONTENEGRO AS THE SERVICE OF PHARMACY
Vincek Daniel, Marjanović- Vincek Zora
Botanical Garden Mountain flora of Montenegro, Kolašin
By its geographycal position, by its climat, of the developed relief ( 50% of its surface is over
500 met overseas high ! ), considering its soil composition, all this facts were created the
favorable life condition for 3.200 autochthonal plant species, between at least 500 were
identified and introduced in the officional as well are in the use in the traditional medicine.
Today Crna Gora has at disposition some institutions dedicated to the education of medical
plants experts.There are existing Faculties of nature, pharmacy, Biotechnical faculty, Museum
of the nature.All these institutions are waiting to be completed by laboratories, by the modern
and operative central herbarium of montenegrian flora and to be able on such way to confirm
the ecological state of Montenegro.
Actually in Montenegro are exsisting and in function for many years twoo smal botanical
gardens in Plav and Kolašin. These gardens merited to be supported and enlarged trough the
development plans for the north part of Montenegro.
For Montenegro is urgently necessary to perform some botanical gardens of mediecal plants
belonged to the continental and mediterranean parts of Montenegro. Theese specifical gardens
should be connected to the biotechnical faculty of Bijelo polje and to the faculty of pharmacy,
Podgorica.
It is a special favour to point out the importance of Biological, Chemical and Pharmaceutical
faculties of Belgrade who did involved so much in the exploring of terrains as in the preparation
of the montenegrian staff and their scientifical progres.
The project of medical plants prosperity is to be recognise as one branch of economy and does
pass one process of gradual education together with the metod and mode of collecting,
performing of normatives, as the registration and the certification of the established colecting
centers having in mind the persons engadged in medical plants.
The probability and decision for medical plants has to be for both i.e.classical as well for the
homeopaty. Together with the organic agriculture the medical plants may be one of important
exports articles.
The basic point for this activity are yet put down by the more yearly work executed by Institut
Josif Pančić, Belgrad in the exploration of medical plants on whole teritory of Montenegro. This
project is quite finished and now is necessary to find financial support for this manual / atlas
dedicated to the exploatation and aplication of medical plants.
Key words : Medical plants, Montenegro, Pharmacopedia, Institutions
30
PP14. PELOID U DERMOKOZMETIČKIM PREPARATIMA U
TRETMANU AKNI
Potpara Zorica 1,2, Janković Slobodan 3
1
Fontis doo, Podgorica, Crna Gora
Farmaceutski fakultet Univerziteta Crne Gore
3
Medicinski Fakultet, Univerzitet u Kragujevcu, Kragujevac, Srbija
2
Uvod i cilj: Jedno od najčešćih koţnih bolesti adolescenata su akne, koje zahvataju 85% te
populacije. Uprkos velikom broju utvrĎenih terapijskih metoda za liječenje akni, čak
12,7 % pacijenata ne moţe se trajno izliječiti. Da bi se prevazišla ograničenja utvrĎenih
terapijskih metoda, sve više se u liječenju akni koriste preparati dobijeni kombinacijom ljekovitog
bilja i minerala. Cilj naše studije je bio ispitivanje efikasnosti lokalne terapije akni preparatima
koji sadrţe kombinaciju peloida sa lokaliteta ulcinjske obale i ljekovitog bilja iz Crne Gore.
Metodologija: Studija je dizajnirana kao retrospektivna kohortna studija, sa dvije kohorte
definisane vrstom korišćenog lokalnog preparata. Jednu kohortu (n=70) su činili pacijenti koji su
koristili Peloderm (preparat za lokalnu primjenu koji sadrţi i peloid i ekstrakte ljekovitih biljaka),
a drugu kohortu (n=70) pacijenti koji su akne tretirali Antiakne kremom (preparat za lokalnu
primjenu koji sadrţi samo ekstrakte ljekovitih biljaka). Pacijenti u obje kohorte su koristili
preparate 18 mjeseci.
Rezultati: U obje studijske grupe, FDA skor teţine akni se postepeno poboljšavao tokom
korišćenja preparata. MeĎutim, krajnji FDA skor ( poslije 18 mjeseci lokalne terapije ) je bio
značajno niţi (T=7.556, df=1, p=0.000) u grupi sa Pelodermom (1.0±0.0) nego u grupi sa
Antiakne preparatom (1.8±0.9).
Zaključak: Iako se peloid koristi za liječenje širokog spektra bolesti, do sada nema objavljenih
studija o njegovom dejstvu na akne. I peloid, i odabrane biljke, pripremljene u obliku lokalnih
preparata u odnosima korišćenim u našoj studiji, su efikasni i bezbjedni u lokalnoj terapiji akni,
pri čemu peloid ima veći terapijski efekat.
Ključne riječi: peloid, akne, lokalna terapija
31
PP14. THE MINERAL MUD IN DERMOCOSMETICS
PREPARATIONS IN TREATMENT OF ACNE
Potpara Zorica 1,2, Janković Slobodan 3
1
Fontis Ltd., Podgorica, Montenegro
Faculty of Pharmacy of the University of Montenegro
3
Medical Faculty, University of Kragujevac, Kragujevac, Serbia
2
Introduction: One of the most frequent skin diseases in adolescence is acne, affecting as much
as 85% of that population. In spite of a variety of established therapeutic approaches to
treatment of acne vulgares, up to 12.7% of patients could not be cured. In order to overcome
limitations of the established therapy, botanicals and natural preparations of mineral origin are
also used in therapy of acne. The aim of our study was to investigate efficacy of topical therapy
of acne with preparation made by combination of peloid and medicinal plants from Montenegro.
Method: The study was designed as retrospective cohort study, with two cohorts defined by the
type of topical preparation used: one cohort (n = 70) comprised of the patients treated with
Peloderm (topical preparation containing both peloid and medicinal plants‟ extracts), and
another cohort (n = 70) of the patients treated by Antiacne (topical preparation with only
medicinal plants‟ extracts). The patients in both cohorts were treated for 18 months.
Results: In both treatment groups, the FDA acne severity score improved gradually throughout
the study visits. However, final FDA score (after 18 months of topical treatment) was
significantly (T = 7.556, df = 1, p = 0.000) lower in the Peloderm group (1.0 ± 0.0) than in the
Anitiacne group (1.8±0.9).
Conclusion: Both peloid and selected medicinal plants from Montenegro, prepared as topical
preparations in ratios observed in this study, are efficient and safe options for local treatment of
acne, the peloid having somewhat greater potency.
Key Words. Peloid, acne vulgares, topical therapy.
32
PP15. LJEKOVITE BILJKE I BILJNI PREPARATI U MANASTIRIMA
Bojović Dragica 1, Tadić Vanja 2, Đuričković Milena 3
1
Galenika Crna Gora
Institut Josip Pančić
3
Institut za javno zdravlje Crne Gore
2
Uvod: Vaţnu ulogu u očuvanju tradicionalnog lijeka imali su manastiri o čemu svjedoče usmena
predanja i riznice pisanih receptura o branju, čuvanju čajeva, o „kuvanju” melema, pravljenju
gorkoh likera, mirišljavih sapuna, začina za hranu.
Cilj rada:Cilj ovog istraţivanja je da se potvrdi ispravnost postupaka, kvalitet sirovina, higijenska
ispravnost pri izradi tradicionalnih biljnih lijekova u manastirima. Posjeta je obavljena u tri
ţenska manastira: jedan u blizini Podgorice, drugi u blizino Cetinja i treći na lokalitetu
crnogorskog primorja.
Metode: Obavljen razgovor sa monahinjam čije je poslušanje: ubiranje, sušenje i čuvanje
ljekovitih biljaka i njihova primjena u izradi čajnih mješavina i ostalih biljnih lijekova. Pregledane
dozvoljene nam recepture i ostale sirovine: maslinovo ulje, smole, voskovi, eterična ulja. Uzeti
uzorci osušenih biljaka, sirovina i gotovih proizvoda. Za procjenu :kvaliteta uraĎena opšta
ispitivanja i sadrţaja eteričnog ulja kod 8 aromatičnih biljaka, opšta ispitivanja 5 uzoraka
maslinovog ulja, 2 uzorka kantarionovog ulja, 3 uzorka meda, 2 uzorka pčelinjeg voska, 3
uzorka ljekovitih sapuna, mikrobiološka aktivnost 2 melema.
Rezultati :Rezultati svih ispitivanja odgovaraju propisima prema kojima seu raĎene analize.
Diskusija: Vrijeme branja, način sušenja i čuvanja ljekovitih biljaka na osnovu dobijenih rezultata
odgovaraju zahtjevima farmakopeja. Sirovine koje se koriste za pripremanje biljnih lijekova:
maslinovo ulje, kantarionovo ulje, med, pčelinji vosak odgovaraju prema propisima pravilnika o
ispravnosti hrane. Uzorci sapuna odgovaraju propisima pravilnika o predmetima opšte upotrebe.
Uzorci melema pokazuju značajnu mikrobiološku aktivnost na referntnim sojevima.
Zaključak:Ljekovite biljke, prirodne sirovine i gotovi proizvodi koji se izraĎuju prema starim
manastirskim recepturama u tri ţenska manastira u Crnoj Gori zadovoljavju zahtjeve vaţećih
propisa u pogledu kvaliteta.
Ključne riječi: Manastirske recepture, biljni preparati, melem, sapun, med
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PP15. MEDICINAL PLANTS AND HERBAL PREPARATIONS IN THE
MONASTIRIES
Bojović Dragica 1, Tadić Vanja 2, Đuričković Milena 3
1
Galenika Crna Gora,
Institut Josip Pančić,
3
Institute of Public Health of Montenegro
2
Introduction: Monasteries played an important role in the preservation of oral medicine tradition,
retaining the traditional prescription for picking, storing teas, the "cooking" the balsams, making
the bitter liquor, aromatic soaps, and spices for food.
The aim of investigation: The aim of this study was to estimate quality of the traditional herbal
preparations in the monasteries, the quality of starting plant materials, and to compare the
results with the pharmaceutical standards, first of all with Pharmacopoeia 6.0 and Ph. Jug. IV
requests. The research was conducted in three women's monasteries: one near Podgorica, the
other in the vicinity of Cetinje and the third at the site of the Montenegrin coast.
Methods: Information was gathered from a nun whose obedience was: harvesting, drying and
storing herbs and their application for tea blends and other herbal remedies by use of oral
interviews and implementing the defined pharmacopoeia‟s methods to control the quality of
dried plants and final herbal preparations. Dry plant material (determination of essential oil in
eight plants), olive oil (five samples were tested), resins, waxes (two samples) and final
products (three samples of honey, three samples of medicinal soap, two samples of St. John‟s
Wort oil, and two ointments - balsams) were examined in order to get the information about the
quality of the plants and natural material used in the final products and the quality of the final
herbal preparation, as well.
Results: The results of all investigated samples met the pharmacopoeia quality control request.
Discussion: Time of harvest, method of drying and storing medicinal plants on the basis of these
results satisfied the requirements of Pharmacopoeia 6.0 and Ph. Jug IV. The raw materials used
for preparing herbal remedies: olive oil, St. John‟s Wort oil, honey, beeswax, certified according
to requirements defined for food safety. Soap samples met the requirements for the items of
common use. Samples of balsams showed significant microbial activity against referential
strains.
Conclusion: Quality of examined medicinal plants, natural raw materials and final herbal
preparations, made according to traditional prescription in the three female monasteries in
Montenegro, were in accordance to defined standard regulations.
Keywords: Monastery prescription, herbal medicine, balsams, soap, honey.
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