Kniga na apstrakti book of abstrcts

Eksperimentalen dizajn na formulacija na tableti za xvakawe 
so cetirizin dihidrohlorid
Sun~ica Jordanoska, Marija Glava{ Dodov, Katerina Gora~inova
Institut za Farmacevtska tehnologija, Farmacevtski fakultet, 
Univerzitet „Sv. Kiril i Metodij“, Vodwanska 17, 1000 Skopje, Makedonija
Celta na trudot be{e formulirawe na peroralna tableta za xvakawe so cetirizin dihidrohlorid
(CD) vklu~uvaj}i korekcija na vkusot na aktivnata supstancija so oblo`uvawe so polimer bez da se naru{i
profilot na disolucija. Podgotven be{e granulat koj ponatamu be{e oblo`en so 5, 10 i 20%-tna polimer-
na film obvivka koja e rezistentna vo neutralna rN a vedna{ se rastvara vo kiselata sredina vo stomakot.
Ispituvano be{e vlijanieto na procentot na polimernoto oblo`uvawe vrz fizi~kite, farma-
cevtsko-tehnolo{kite i biofarmacevtskite karakteristiki na granulatite. Isto taka be{e isptuvano
i vlijanieto na procentot na polimernoto oblo`uvawe i ekscipiensite vrz korekcijata na vkusot,
fizi~kite, farmacevtsko-tehnolo{kite i biofarmacevtskite karakteristiki na tabletite. Vlijanieto
na nepromenlivite faktori be{e analizirano so primena na "screening" eksperimentalen dizajn. 
Kako nezavisni faktori pri analiza na granulatite prika`ani se procentot na obvivkata i golem-
inata na ~esticite. Ispituvano e vlijanieto na ovie faktori vrz proto~nosta i kompresibilnosta na
granulatite preku odmerenite promenlivi:  karoviot indeks i agolot na protekuvawe. Analizirano be{e
i vlijanieto na nezavisnite faktori vrz brzinata na osloboduvaweto na CD od granulatite vo razli~ni
rN (1.2, 4.6 i 6.8). 
Od aspekt na fizi~kite i biofarmacevtskite svojstva na granulatite, proto~nosta i kompresi-
bilnosta zavisat od procentot na oblo`uvawe, goleminata na ~esticite i vzaemnoto vlijanie na obata
faktori. Spored dobienata matemati~ka zavisnost, proto~nosta i kompresibilnosta se podobruva so
zgolemuvaweto na procentot na obvivkata; 
- vo kisela sredina najzna~ajno vlijanie vrz brzinata na disolucija na oblo`enite granulati ima
goleminata na ~esticite. Sprotivno na toa, procentot na oblo`uvaweto, vo kisela sredina, ne vlijae vrz
brzinata na disolucija zaradi brzoto rastvarawe na polimernata obvivka. Vo neutralna rN sredina
(simulira rN sredinata na plunkata) najgolemo vlijanie vrz brzinata na osloboduvawe od oblo`enite
granuli ima goleminata na ~esticite, no i vzaemniot efekt me|u goleminata na ~esticite i procentot na
oblo`uvawe na film obvivkata;
- kako nezavisni faktori pri analiza na tabletite prika`ani se procentot na oblo`uvaweto na
granulatite/granulite i prisustvoto na ekscipiensite/ dezintegransot. Kaj tabletite e ispituvano vli-
janieto na nezavisnite faktori vrz brzinata na dezintegracija, vrz korekcijata na vkusot i vrz brzinata
na osloboduvawe na CD vo razli~ni rN (1.2, 4.6 i 6.8).
Od aspekt na fizi~kite i biofarmacevtskite svojstva na tabletite, vremeto na dezintegracija
zavisi od koli~estvoto na dezintegransot. Brzinata na disolucija zavisi od prisustvoto na dezintegransot
i procentot na obvivkata i toa vo site tri ispituvani rN sredini. So procesot na oblo`uvawe se usporu-
va ili izbegnuva kontaktot na CD za vreme na pretstojot vo usnata praznina. Poradi nerastvorlivosta na
obvivkata Eudragit E 100 vo neutralna rN sredina, {to odgovara na rN sredinata na usnata praznina se
spre~uva kontaktot i se onevozmo`uva rastvarawe na CD vo salivarnite te~nosti so {to se spre~uva
dopirot so receptorite za vkus. Sepak zna~ajna uloga imaat i ekscipiensite koi na tabletite im davaat
u{te poprijaten vkus. So zgolemuvawe na procentot na oblo`uvawe, odli~nata rastvorlivost na CD ne
se kompromitira, a pritoa vkusot e koregiran. Korekcija na vkusot be{e postignata vo potpolnost so
tabletna kompozicija so 20% granulat. Dobieni se formulacii kade {to odli~no e maskiran vkusot, a
disolucijata vo 30-tata minuta iznesuva nad 90% vo site tri mediumi. 
Macedonian pharmaceutical bulletin 53 (1,2) 57-58 (2007)
PP - 10
58
^ETVRTI KONGRES NA FARMACIJATA NA MAKEDONIJA SO ME\UNARODNO U^ESTVO
FOURTH CONGRESS OF PHARMACY OF MACEDONIA WITH INTERNATIONAL PARTICIPATION

Filtration in sterile production
Elena Tomovska, M. Simonoska Crcarevska, N. Geskovski, Katerina Goracinova
Institute of Pharmaceutical technology, Faculty of Pharmacy, Vodnjanska 17, 1000, Skopje, Macedonia
Purpose of the Thesis. To demonstrate the stage of sterile filtration as a segment of the validation of the
proves of production of Gentamycine inj. 20mg/2ml through researches on three consecutive pilot series.
Experimental part. The validation of the process of sterile production of Gentamycine inj. 20mg/2ml includes
the stages of the overall process of production. The stage of sterile filtration is the crucial segment of the validation
of the process of production of Gentamycine inj. in aseptic working conditions. The prepared solution of Gentamycine
20mg/2ml is filtered through a pre-filtration filter (membrane filter NYLON 66 POSIDYNE, type SLK7002NLZP
0.45 
µm) and through the filter for sterile filtration (in continuity with the pre-filtration through a membrane filter
for sterile filtration NYLON 66 POSIDYNE, type SLK7002NFZP 0.2
µm). The critical parameters the values of
which will be monitored in the course of the validation procedure are the following:
-  Prepared solution of Gentamycine inj: solution bio-burden, physical and chemical analyses of the solu-
tion, pH value, total organic carbon (TOC), conductivity, bacterial endotoxines.
-  A rinsed portion of a pre-filter SLK7002NLZP 0,45 
µm IK1324 before filtration: pH value, total organic
carbot (TOC), conductivity, bacterial endotoxines.
-  A rinsed portion of a filter for sterile filtration SLK7002NFZP 0.2 mm IK0334 after filtration: pH value,
total organic carbon (TOC), conductivity, bacterial endotoxines.
-  Integrity of a filter for sterile filtration SLK7002NFZP 0.2
µm IK0334 before sterilization and filtration: a
flow through the filter, ml per minute.
-  Integrity of a filter for sterile filtration SLK7002NFZP 0.2
µm IK0334 after sterilization and before filtra-
tion: a flow through filter, ml per minute.
-  Pre-filtration of a solution: bio-burden of a solution, physical and chemical analyses of a solution, bacte-
rial endotoxines.
-  Sterile filtration of a solution: bacterial endotoxines in a final container, sterility of a solution, final con-
tainer, physical and chemical analyses of a solution.
-  Rinsed portion of a pre-filter SLK7002NLZP 0,45
µm IK1324 after filtration: value, total organic carbon
(TOC), conductivity, bacterial endotoxines, residues in the rinsed portion.
-  Rinsed portion from a filter for sterile filtration SLK7002NFZP 0.2 
µmIK0334 after filtration: value, total
organic carbon (TOC), conductivity, bacterial endotoxines, residues in a rinsed portion.
-  Rinsed portion from a filter for sterile filtration SLK7002NFZP 0.2
µm IK0334 after filtration: value, total
organic carbon (TOC), conductivity, bacterial endotoxines, residues in the rinsed portion.
The assurance of quality of the performance was monitored and it was proved, through monitoring the nec-
essary physical and chemical parameters, and the micro-biological quality, the content of active substance and preser-
vatives, the pH value, the absorbance, the mechanical impurities, the total organic carbon, the microbiological puri-
ty and the concentration of bacterial endotoxines in the solution before filtration, sterility and the concentration of
bacterial endotoxines of the solution after the sterile filtration, as inevitable control parameters through which we
can understand the integrity of the filter and the security of performance of the sterile filtration. The monitoring of
the content of the active component and preservatives after filtration, as a parameter, offers some information about
whether the filters perform the absorption, how much of the material wad adsorbed, as well as about the possibility
to solve the problem if adsorption takes place. The bio-burden of the solution, as a parameter, is of a considerable
significance. The bio-burden control is very important not only from the aspect of the burdening of the filter, but
also from the aspect of control of the bacterial endotoxines. The validation of the process of sterile production in
aseptic working conditions, confirms the capacity of the process to yield a product of an adequate quantitative, qual-
itative and micro-biological quality. 
Macedonian pharmaceutical bulletin 53 (1,2) 59-60 (2007)
PP - 11
59
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FOURTH CONGRESS OF PHARMACY OF MACEDONIA WITH INTERNATIONAL PARTICIPATION

Filtracija vo sterilno proizvodstvo
E. Tomovska, M. Simonoska Crcarevska, N. Ge{kovski, K. Gora~inova
Institut za Farmacevtska tehnologija, Farmacevtski fakultet, Univerzitet Sv. Kiril i Metodij,
Vodwanska 17, Skopje 1000, Makedonija
Cel na trudot.   Da se prika`e fazata na sterilna filtracija kako segment od validacijata na pro-
cesot na proizvodstvo na Gentamicin inj 20mg/2ml preku ispituvawa na tri konsekutivni pilot serii. 
Eksperimentalen del.   Validacijata na procesot na sterilno proizvodstvo na Gentamicin inj. 20mg/2ml
gi opfa}a fazite na vkupniot proces na proizvodstvo.Fazata na sterilnata filtracija e krucijalen seg-
ment od validacijata na procesot na proizvodstvo na Gentamicin inj. 20mg/2ml vo asepti~ni uslovi na rabo-
ta. Podgotveniot rastvor na Gentamicin se filtrira niz filter za predfiltracija (membranski filter
NYLON 66 POSIDYNE, tip SLK7002NLZP 0.45 µm) i filter zasterilna filtracija (vo kontinuitet so pred-
filtracijata niz membranski filter NYLON 66 POSIDYNE, tip SLK7002NFZP 0.2µm). Kriti~nite para-
metri ~ii vrednosti }e bidat sledeni vo tek na postapkata na validacija se:
- Podgotoven rastvor na Gentamicin inj. 20mg/2ml: bioburden na rastvor, fizi~ko/hemiski ispitu-
vawa na rastvor, rN vrednost, vkupen organski jaglenorod (TOC),konduktivnost, bakteriski endotoksini
- Ispirok od predfilter SLK7002NLZP 0.45 µm IK1324 pred filtracija: rN vrednost, TOC, konduk-
tivnost, bakteriski endotoksini
- Ispirok od filter za sterilna filtracija SLK7002NFZP 0.2µm IK0334 po filtracija: rN vred-
nost, TOC, Konduktivnost, Bakteriski endotoksini
- Integritet na filter za sterilna filtracija  SLK7002NFZP 0.2µm IK0334 pred sterilizacija i
filtracija: protok niz filter ml vo minuta
- Integritet na filter za sterilna filtracija  SLK7002NFZP 0.2µm IK0334 po sterilizacija pred
filtracija:  protok niz filter ml vo minuta
- Predfiltracija na rastvor:bioburden na rastvor, fizi~ko/hemiski ispituvawa na rastvor, bak-
teriski endotoksini
- Sterilna filtracija na rastvor: Bakteriski endotoksini vo finalen kontejner, sterilnost na
rastvor finalen kontejner, fizi~ko/hemiski ispituvawa na rastvor
- Ispirok od predfilter SLK7002NLZP 0.45 µm IK1324 po filtracija: vrednost, TOC, konduktivnost,
bakteriski endotoksini, rezidui vo ispirok
- Ispirok od filter za sterilna filtracija SLK7002NFZP 0.2µm IK0334 po filtracija: vrednost,
TOC, konduktivnost, bakteriski endotoksini, rezidui vo ispirok.
Obezbeduvaweto na kvalitetot na izvedbata go pratevme i doka`avme preku pratewe na potreb-
nite fizi~ko hemiski parametri i mikrobiolo{kiot kvalitet, sodr`ina na aktivnata supstanca i konzer-
vansite, rN vrednost, absorbanca, mehani~ko one~istuvawe, TOC, mikrobiolo{ka ~istota i koncentraci-
ja na bakteriski endotoksini vo rastvorot pred filtracija, sterilnost i koncentracija na bakteriskite
endotoksini na rastvorot po sterilnata filtracija, kako neophodni kontrolni parametri preku koi mo`e
da go sogledame integritetot na filterot i bezbednosta na izvedbata na sterilnata filtracija. Sledeweto
na parametarot sodr`ina na aktivnata komponenta i konzevansite po filtracijata dava informacija za
toa dali filtrite vr{at adsorpcija, kolku od materijalot se adsorbiral i za mo`nosta za re{avawe na prob-
lemot dokolku ima adsorpcija. Bioburdenot na rastvorot kako parametar e od golemo zna~ewe. Kontrolata
na bioburdenot e od zna~ewe ne samo od aspekt na opteretuvawe na filterot tuku i od aspekt na kontrola na
bakteriskite endotoksini. Validacijata na procesot na sterilno proizvodstvo vo asepti~ni uslovi na
rabota, ja potvrduva sposobnosta na procesot da se proizvede proizvod so soodveten kvantitativen, kvali-
tativen i mikrobiolo{ki kvalitet. 
Macedonian pharmaceutical bulletin 53 (1,2) 59-60 (2007)
PP - 11
60
^ETVRTI KONGRES NA FARMACIJATA NA MAKEDONIJA SO ME\UNARODNO U^ESTVO
FOURTH CONGRESS OF PHARMACY OF MACEDONIA WITH INTERNATIONAL PARTICIPATION

The influence of the diluents on the release rate of diclofenac sodium
from hydrophylic matrix system
Hristina Litovin
1
, Stojne Tanevska
1
, Gorica Pavlovska
1
1
Jaka 80 Farmacevtska kozmeticka i dietetska industrija, Radovis
Direkcija: Ankarska 33, 1000 Skopje, Republika Makedonija
Hydrophylic matrix tablets are among the most popular orally administered types of controlled release sys-
tems. Cellulose eters are commonly employed as water soluble, swellable matrix polymers. Hydroxyethylcellulose
(HEC) is appropriate for near zero-order release attainable with sparingly and slightly soluble drugs.
In this study we investigated the influence of the most commonly used diluents: lactose anhydrous, lactose
monohydrate and microcrystalline cellulose on the release rate of Diclofenac sodium incorporated in hydroxyethyl-
cellulose (HEC) as matrix former.  
The formulation with lactose anhydrous has the highest release rate as a result of its highest solubility in
water and the formation of the small ducts into the matrix which enables quick penetration of the dissolution medi-
um with polymer swelling, forming of the gel layer and diffusion of Diclofenac sodium.
The results proved that the release rate follows the zero order kinetics. That means that release rate is inde-
pendent the remaining drug concentration into the matrix system. The release exponent scaled through the Korsmeyer
- Peppas equation can explain the release mechanism of the drug. The value for the exponent n, (n = 0.8399), for the
formulation with lactose monohydrate indicates release mechanism where dominant factor is the disentangling of the
polymer chains and synchronization in the movement of the swelling and erosion front. This is the main postulate for
the permanent development of the gel layer, important for the diffusion of the drug into the surrounding medium.
Macedonian pharmaceutical bulletin 53 (1,2) 61-62 (2007)
PP - 12
61
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Vlijanie na polnitelite na brzinata na osloboduvawe 
na diklofenak natrium od hidrofilen matriks sistem
Hristina Litovin
1
, Stojne Tanevska
1
, Gorica Pavlovska
1
1
Jaka 80 Farmacevtska kozmeti~ka i dietetska industrija, Radovi{
Direkcija: Ankarska 33, 1000 Skopje, Republika Makedonija
Hidrofilnite matriks tableti se najupotrebuvani peroralni sistemi so kontrolirano oslobo-
duvawe na lekovitata supstanca. Kako hidrofilni, babre~ki matriks polimeri, voobi~aeno se primenu-
vaat celuloznite etri. Hidroksietil celuloza (HEC) e pogodna za postignuvawe na kinetika na oslobo-
duvawe od nulti red za mnogu te{ko rastvorlivi vo voda lekoviti supstancii.  
Vo ovaa studija ispitano e vlijanieto na naj~esto upotrebuvanite polniteli: anhidri~na laktoza,
laktoza monohidrat i mikrokristalna celuloza na brzinata na osloboduvawe na diklofenak natrium
inkorporiran vo hidroksietil celulozen (HEC) matriks. 
Formulacijata so anhidri~na laktoza poka`uva najgolema brzina na osloboduvawe, {to se dol`i
na nejzinata rastvorlivost vo voda i sozdavawe na t.n. kanal~iwa vo matriks sistemot preku koi se ovoz-
mo`uva pobrza penetracija na disolucioniot medium, so posledovatelno babrewe na polimerot i difuz-
ija na diklofenak natriumot. 
Podatocite dobieni od kinetikite na osloboduvawe potvrduvaat postignuvawe na kinetika od
nulti red, odnosno brzinata na osloboduvawe e nezavisna od koncentracijata na preostanata lekovita sup-
stanca vo matriks sistemot. Eksponentot na osloboduvawe presmetan preku Korsmeyer-Peppas ravenkata
dava uvid vo mehanizmot na osloboduvawe na lekovitata supstanca. Vrednosta na eksponentot n, (n = 0.8399),
kaj formulacijata so laktoza monohidrat e indikator za mehanizmot na osloboduvawe kade dominanten
faktor e relaksacija na polimernite lanci i sinhronizacija vo dvi`eweto na babre~kiot i erozioniot
front kako preduslov za sozdavawe na konstanten geloviden sloj od koj difundira lekovitata supstanca
vo okolniot medium.
Macedonian pharmaceutical bulletin 53 (1,2) 61-62 (2007)
PP - 12
62
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FOURTH CONGRESS OF PHARMACY OF MACEDONIA WITH INTERNATIONAL PARTICIPATION

Accelerated stability testing and shelf-life prediction
M. Pasic
1,2
, Gabriele Betz
1
, Seherzada Hadzidedic
2
, Silvia Kocova El-Arini
2,3
, Hans Leuenberger
1
1
Institute of Pharmaceutical Technology, University of Basel, Klingelbergstr. 50, 4056 Basel, Switzerland
2
Bosnalijek d.d. Development Department, Jukiceva 53, 71000 Sarajevo, Bosnia and Herzegovina
3
National Research Centre, Tahrir Street, Cairo, Egypt
Lansoprazole is a poorly water soluble drug and belongs to Class II according to the BCS. It is applied in
the therapy of gastric and duodenal ulcer, as a gastric proton pump inhibitor (PPI). Lansoprazole degrades rapidly
in acidic aqueous solutions and it is usually applied as an enteric coated dosage form. The degradation of the proton
pump inhibitor manifests itself in a loss of drug content and increasing amounts of degradation products. Different
methods of stabilization of lansoprazole have been described and most frequent approaches were usage of alkaline
and non-alkaline compounds, as pH adjusters, and usage of subcoting as a protection between the drug and enteric
coating polymer. 
The aim of the study was to evaluate the effect of different formulation parameters on chemical stability of
lansoprazole at different storage conditions (30°C, 40°C and 55°C and relative humidity (RH) of 79%). Exposure
of pellets to higher temperatures was not applicable due to nature of enteric polymer used and its property to stick
to the walls of bottles. Experimental data from stability tests were used to estimate degradation parameters and to
predict shelf-lives at room temperature using Arrhenius plots.
Pellets were prepared using lansoprazole which was purchased from Cipla (India), sugar spheres NF (Suglets
®
)
were obtained from NP Pharm, cellulosum microcrystallinum pellets were purchased from NP Pharma, hydrox-
ypropyl methylcellulose was purchased from Hercules (Klucel LF
®
), magnesium carbonate (heavy) was purchased
from Fluka, disodiumhydrogen phosphate from Merck, 30% aqueous dispersion Eudragit
®
L 30 D-55 was obtained
from Röhm (Germany). All further materials and solvents were of analytical grade. 
Pellets were prepared using solution/suspension layering technique in bottom spraying fluidised bed Unilab-
5 (Huettlin, Germany) and tested on quantity of lansoprazole, gastric resistance and dissolution, porosity and scan-
ning electron microscopy. During the elevated temperature stability studies quantity of lansoprazole was monitored
in different time intervals, for different temperatures, using official HPLC assay method described in USP, which
allows the separation of lansoprazole from its degradation products, as well as the quantification of the drug.
The results of the study showed that storage at 30°C, 40°C and 55°C and 79% relative humidity resulted in
a gradual decomposition of lansoprazole in all tested lansoprazole pellet formulations. Comparison of rate constants
and predicted shelf-lives of different formulations indicated the most stable one containing pH adjuster and protec-
tive layer. Predicted shelf-life will be compared with the actual data accumulated in time.
Macedonian pharmaceutical bulletin 53 (1,2) 63 (2007)
PP - 13
63
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Effect of roll compaction on disintegration time 
and dissolution rate of Theophilline
E. Hadzovic
1,2
, G. Betz
1
, S. Hadzidedic
2
, S. Kocova El-Arini
2,3
, H. Leuenberger
1
1
Institute of Pharmaceutical Technology, University of Basel, Klingelbergstr. 50, 4056 Basel, Switzerland.
2
Bosnalijek d.d., Development Department, Jukiceva 53, 71000 Sarajevo, Bosnia and Herzegovina
3
National Research Center, Tahrir Street, Cairo, Egypt
Theophylline is used in asthma therapy and classified as Class I drug according to Biopharmaceutics
Classification System. It exists as monohydrate and two polymorphic forms of anhydrate (stable and metastable
form). In contact with water Theophylline anhydrate form is converted to the hydrate form, which dehydrates to the
metastable anhydrate during drying. The metastable anhydrate form of Theophylline has different properties in com-
parison to the stable anhydrate form, such as solubility and dissolution rate. Therefore wet granulation step in for-
mulation development is not the first choice for Theophylline.
The aim of the study is to investigate the effect of roll compaction (dry granulation) on the dissolution rate
and disintegration time of different Theophylline grades. Theophylline monohydrate, Theophylline anhydrate pow-
der and Theophylline anhydrate fine powder (BASF ChemTrade GmbH, Germany) were used in order to check if
there is any difference in compactibilty of different pseudopolymorphs and different particle size of the same poly-
morphs (anhydrate). The binary mixture of 0%, 10%, 30%, 50% and 100% Theophylline anhydrate powder,
Theophylline anhydrate fine powder, Theophylline monohydrate and Cellulose Microcrystalline AVICEL PH 101
(FMC BioPolymer, USA) respectively were prepared by mixing the powders during 15 min in Turbula
®
mixer. Roll
compaction of the mixtures were performed using a Fitzpatrick IR220 Chilsonator and subsequently milling of the
ribbons with a L1A LabScale FitzMill.
Tablets of a total weight of 350 mg and 10 mm diameter were compressed using the constant gap of 3.2 mm
with a Compaction simulator, MCC Presster
®
. 
Influence of roll compaction and milling on the dissolution rate and disintegration time of Theophylline was
analyzed by Dissolution Test Apparatus (Sotax AT 7, Sotax, Switzerland) and Tablet Disintegration Tester (Sotax
DT 2 Automated Detection, Sotax, Switzerland).
The results of this study showed that roll compaction and milling has no influence on the polymorphic forms
and compressibility of Theophylline.
The investigations of dissolution rate and disintegration time are currently running and will be completed in
near future. The conclusions will be drawn after having completed all investigations.
Macedonian pharmaceutical bulletin 53 (1,2) 64 (2007)
PP - 14
64
^ETVRTI KONGRES NA FARMACIJATA NA MAKEDONIJA SO ME\UNARODNO U^ESTVO
FOURTH CONGRESS OF PHARMACY OF MACEDONIA WITH INTERNATIONAL PARTICIPATION