ORGANIZACIONI ODBOR NAUNI/ZNANSTVENI ODBOR

Organizing CommiƩee ScienƟĮc CommiƩee

Predsjednik/President Predsjednik/President
Zahida Binakaj, mr.ph. prof. dr. Lejla Begiđ

Dopredsjednici/Vice Presidents Dopredsjednici/Vice Presidents

Rada Amidžiđ, mr.ph.spec. prof. dr. Jasminka Nikoliđ
FaƟma Insaniđ-Jusufoviđ, mr.ph. prof. dr. Davorka Završnik
prof. dr. Monika Tomiđ
lanovi/Members
Tarik aƟđ, mr.ph.sci. Sekretar/Secretary
Miljana Vuloviđ, mr.ph. doc. dr. Zahida Ademoviđ - Sekretar
urĜica Kopanja, mr.ph.
Ivo Nuiđ, mr.ph. lanovi/Members
Sead Osmanēeviđ, mr.ph. prof. dr. Zlata Mujagiđ
Bilsena Šahman, mr.ph. prof. dr. Danica Agbaba
prof. dr. Sote Vladimirov
doc. dr. Selma Škrbo
doc. dr. Ivica Briziđ
doc. dr. Ivanka Mikuli
doc. dr. Alija Uzunoviđ
doc. dr. Saša Pilipoviđ
doc. dr. Jasmina eĜibegoviđ
Enisa Salihefendiđ, Prim.mr.ph.spec.

POASNI LANOVI NAUNOG/

ZNANSTVENOG ODBORA:
Honorary ScienƟĮc CommiƩee

prof. dr. emeritus Sabira Hadžoviđ

prof. dr. Stanko Srēiđ

ORGANIZATORI/ORGANIZERS
 PHARMACIA
Journal of the Pharmaceutical Society
of Federation of Bosnia and Herzegovina

PUBLISHER
Pharmaceutial Society of
Federation of Bosnia and Herzegovina
Čekaluša 34
71 000 Sarajevo
Bosnia and Herzegovina
www.farmadrustvo.ba

For publisher:
Fatima Insanić-Jusufović
President (2014-2018)
Pharmaceutical Society
of Federation of Bosnia and
Herzegovina

Editor in Chief
Zahida Ademović

Managing and Technical Editor

Tarik Čatić

Editorial Board
Lejla Begić (BH),
Dušanka Krajnović (Serbia),
Marijana Zovko-Koncic (Croatia)
Emina Obarčanin (Germany),
Begler Begović (BH),
Zoran Sterjev (FYR Macedonia),
Esra Tatar (Turkey)

EDITORIAL OFFICE
Address: Čekaluša 34,
71 000 Sarajevo
Bosnia and Herzegovina
Tel: +387 33 269 270
pharmacia@farmadrustvo.ba

Design
a. PERFECTA, Sarajevo

Circulation
1.500 copies

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Annual subscription rates: FREE

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For requests from industry and
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Pharmacia is indexed in
Pharmacia is an international journal of the Pharmaceutical Society of
Bosnia and Herzegovina publishing scientific articles of general interest
to pharmacy. Two issues are published annually, some of them are Special
issues (Festschrift issues and issues devoted to a particular subject or
selected from a conference). Contributions should be written in English.
Pharmacia publishes Original Scientific Articles, Notes, Preliminary
Communications, Reviews and Conference Articles. The Journal also
publishes Letters to the Editor, Essays , Book Reviews, Obituaries and some
Pharmaceutical Society news.

All contributions are peer reviewed according to the criteria of originality

and quality of their scientific content and only articles with favourable
reports are accepted for publication. It is assumed that submitted
Chemical Abstracts articles are in agreement with Ethical Guidelines, especially with respect
to plagiarism, fictitious data, multiple reporting of research, reference
ISSN 0480-2551 (Print)
ISSN 2303-7245 (Online) omissions and incorrect authorship.

52 Pharmacia 2015; Vol. 18; (1) supl. 1: 52

 and extent of drug delivery into and through the skin. Expert Opin Drug Deliv. 2009; 6(4):355-369. Navidi W., Hutchinson
A., N’Dri-Stempfer B., Bunge A. Determining bioequivalence of topical dermatological drug products by tape-stripping. J.
Pharmacokinet. Pharmacodyn. 2008; 35(3):337-348.

ZNAČAJ ODABIRA PRIMARNOG PAKOV

PAKOVNOG
VNOG MATERIJALA ZA
8-P-7 NOVI PROIZVOD – SPREJ ZA NOS
E. Perviz1, I. Jakupović1
1
Sektor Razvoj, Bosnalijek d.d. Sarajevo, Jukićeva 53, 71000 Sarajevo, Bosna i Hercegovina,
emira.d@bosnalijek.ba, irvana.c@bosnalijek.ba

U VOD I CILJ: Cilj ovog rada je da se prikaže značaj odabira primarnog pakovnog materijala (PPM) odnosno sredstva
za doziranje u procesu razvoja novog proizvoda. PPM se smatra dijelom lijeka i podliježe svim propisima i ispitiva-
njima kao i ostali materijali koji se upotrebljavaju kao sastojci za proizvodnju lijeka. Određeni aspekti razvoja nazalnih
sprejeva su jedinstveni. Efikasnost proizvoda u obliku spreja za nos ovisi o mogućnosti sredstva za doziranje da osigura
reproducibilan sprej i uniformnost isporučene doze. Upravo zbog toga, osim formulacije, bitnu ulogu u razvoju proizvoda
sprej za nos ima odabir sredstva za doziranje kojeg čine pumpica i aplikator. Jedino pravilan odabir formulacije i sredstva
za doziranje osigurava definirana svojstva finalnog proizvoda. METODE: Uzimajući u obzir navedeno, smjernica EMEA/
CHMP/QWP/49313/2005 – Guideline on the pharmaceutical quality of inhalation and nasal products definiše specifične
testove koje je neophodno provesti u toku razvoja: utvrđivanje volumena / mase pojedinačne doze pumpice; dosljed-
nost aplikacije minimalne doze kroz cijelu upotrebu proizvoda; minimalno punjenje; distribucija veličine kapljica; potreban
broj pritisaka na pumpicu za postizanje prve pune doze i prve pune doze nakon dužeg nekorištenja pumpice. RESULTS:
Odabir sredstva za doziranje predstavlja izazov, jer je potrebno osigurati: reproducibilnost tačno definisanog volumena
doziranja (efikasnost doziranja); odgovarajuću veličinu i distribuciju kapljica (ravnomjerno oblaganje nosne sluznice a da
pritom ne prelazi iz nosne šupljine u ždrijelo niti da izlazi izvan nosne šupljine); odgovarajući aplikator za predviđenu na-
mjenu proizvoda (funkcionalnost). ZAKLJUČCI: Na tržištu je prisutan veliki broj sredstava za doziranje te je stoga potreb-
no posebnu pažnju posvetiti segmentu odabira / definisanja tipa pumpice (volumena doziranja) i adekvatnog aplikatora
(funkcionalnost primjene). REFERENCE: Trows S., Wuchner K., Spycher R., Steckel H. Analytical Challenges and Regulatory
Requirements for Nasal Drus Products in Europe and the U.S.. Pharmaceutics. 2014. Vol 6, pp: 195-219. 2: Marx D. Birkhoff
M. Multi-Dose Container for Nasal and Ophthalmic Drugs: A Preservative Free Future?. Drug Development - A Case Study
Based Insight into Modern Strategies, Dr. Rundfeldt C. (Ed.). 2011, pp: 509-525. 3: European Medicines Agency. Guideline
on the Pharmaceutical Quality of Inhalation and Nasal Products; European Medicines Agency: London, UK, 2006; pp:1–27.

PLS MODELING OF BURST RELEASE AND DRUG DISSOLUTION RATE

8-P-8 FOR SN-38 LOADED PAA13-PCL35-PA
PAA13-PCL35-PAA13AA13 MICELLES
S. Dimchevska1, B. Djurdjic1, N. Geskovski
ski1, G. Georgiev2, P. Petrov2, K. Gorac
Geskovs acinova1
Goracinova
1
Institute of Pharmaceutical Technology, Faculty of Pharmacy, University Sv. Cyril and Methodius,
Skopje, Macedonia, Majka Tereza 47, 1000 Skopje, Macedonia, betibd@t-com.me, betibd@t-com.me
2
Institute of Polymers, Bulgarian Academy of Sciences, Sofia, Bulgaria, Akad. G. Bonchev Street 103A,
1113 Sofia, Bulgaria,

I NTRODUCTION AND OBJECTIVE: The purpose of the present study was to utilize PLS (partial least square) metho-
dology in order to study the influence of the relationship of different process and formulation factors on drug release
rate of kinetically stable core-shell polymeric micelles that were prepared and characterized as previously described [1].
METHODS: The training set for PLS study was defined using D-optimal design technique. The influence of process factors
like temperature of organic and water phase, type of organic solvent, and formulation properties (particle size, encapsula-
tion efficiency and drug content) upon dissolution rate was evaluated. The Y matrix was composed of percentages of the
drug dissolved after 1, 2, 3, 7 and 12 hours. RESULTS: The R2 and Q2 coefficients from PLS analysis pointed that the model
is highly predictive. PLS analysis revealed two distinct groups of nanoparticles with significant difference between the
burst release and drug dissolution rate. High burst release and increased dissolution rate was noticed for larger particles
prepared by fast solidification and crystallization process of the poly(ε-caprolactone) core. CONCLUSIONS: PLS modeling
is a very useful approach for in depth quantitative explanation of the influence of processing and formulation parameters
upon the burst release and the drug dissolution rate. REFERENCES: 1.Beti Djurdjic, Simona Dimchevska, Nikola Geskovski,
Marija Petrusevska, Valerya Gancheva, Georgi Georgiev, Petar Petrov and Katerina Goracinova. Synthesis and self-assembly
of amphiphilic poly(acrlicacid)-poly(ε-caprolactone)-poly(acrylicacid) block copolymer as novel carrier for 7-ethyl-10-hy-
droxy camptothecin, J of Biomat App 2015 Jan 10; 29(6):867-81.

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