Konzervansi u topikalnim lijekovima za oko

professional thesis

• Author: Andrea Papst Lopac
• Mentor: Ivan Pepić (mentor)
• Committee member: Ivan Pepić (predsjednik povjerenstva)
• Committee member: Maja Šegvić Klarić (član povjerenstva)
• Committee member: Marijana Erceg (član povjerenstva)
• Granter: University of Zagreb; Faculty of Pharmacy and Biochemistry; (Department of pharmaceutical technology); Zagreb
• Defense date and country: 2016, Croatia
• Scientific / art field, discipline and subdiscipline: BIOMEDICINE AND HEALTHCARE; Pharmacy; Pharmacy

Abstract

Cilj istraživanja: Cilj ovog rada je pregledno opisati standardne i suvremene konzervanse, prikazati farmakopejsko ispitivanje antimikrobne učinkovitosti konzervansa te raspraviti pretkliničke i kliničke aspekte sigurnosti njihove primjene u topikalnim oftalmičkim pripravcima.
Materijali i metode: Literatura je pretraživana prema temi i predmetu istraživanja, autorima i časopisu. Ciljana pretraga provedena je na bazama MEDLINE/PubMed, Science Direct, Google pretraživaču, na stranicama Agencije za lijekove i medicinske proizvode, putem znanstvenih članaka te dostupnim dokumentima proizvođača i pretraživanjem patenata. Literaturni pregled obuhvaća razdoblje do rujna 2016. godine i oslanja se na javnodostupne baze.
Rezultati: Topikalni oftalmički lijekovi su sterilni farmaceutski oblici koji se najčešće pakiraju u višedozne spremnike i sadrže prikladan konzervans u odgovarajućoj koncentraciji radi sprječavanja sekundarne mikrobiološke kontaminacije lijeka. Dugotrajna upotreba topikalnih oftalmičkih lijekova može izazvati toksične ili alergijske oftalmičke nuspojave, odnosno jatrogene bolesti oka, a može ih uzrokovati bilo koja pomoćna (primjerice, konzervans) ili djelatna tvar sadržana u oftalmičkom lijeku. Benzalkonijev klorid (BAK) je konzervans koji se najčešće koristi u topikalnim oftalmičkim lijekovima. Mogući štetni učinci BAK ovise o vremenu i dozi primjene. S ciljem prevladavanja nedostataka BAK razvijaju se suvremeni konzervansi ili načini pakiranja topikalnih oftalmičkih lijekova.
Zaključak: S obzirom da primjena kapi za oko bez dodatka konzervansa ima znatno manje izražene nuspojave u odnosu na primjenu konzerviranih kapi za oko, kod pacijenata koji boluju od kroničnih bolesti oka i/ili imaju oštećenu površinu oka uputno je primjenjivati kapi za oko bez dodatka konzervansa.

Abstract (english)

Objectives: The aim of this work is to describe standard and modern preservatives, pharmacopeic testing of antimicrobial effectiveness of preservatives and discuss preclinical and clinical safety aspects of their use in topical ophthalmic preparations.
Materials and methods: Targeted literature search was done on MEDLINE / PubMed, Science Direct, Google search engine, website and database of Croatian Agency for Medicinal Products and Medical Devices, articles in the research journals, available documents of manufacturers and patents. The database searching of the scientific literature includes period up to October 2016.
Results: A topical ophthalmic medicinal products are sterile pharmaceutical forms which are most often packaged in multidose containers containing a preservative, in a suitable concentration for the prevention of secondary microbial contamination of the drug. Long-term use of topical ophthalmic medicinal products can cause toxic ophthalmic side effects or allergy, but also iatrogenic diseases of the eye, and they may be caused by any excipient (e.g., preservative) or the active substance contained in an ophthalmic medicinal product.Benzalkonium chloride (BAK) is a preservative commonly used in topical ophthalmic medicinal products. Possible adverse effects of BAK depend on the duration and dose of application. With the aim of overcoming the disadvantages of BAK, modern preservatives or inovative packaging of topical ophthalmic medicinal products are being developed.
Conclusion: Since the application of eye drops without preservatives has significantly less pronounced side-effects as compared to administration of the preserved eye drops, in patients with chronic diseases of the eye and / or with a damaged ocular surface it is advisable to apply eye drops without preservatives.

• Keywords: konzervansi; topikalni oftalmički pripravci; benzalkonijev klorid; oftalmički lijekovi
• Keywords (english): preservatives; topical ophthalmic preparations; benzalkonium chloride; ophthalmic drugs
• Language: croatian
• URN:NBN: urn:nbn:hr:163:978921
• Study programme: Title: Drug development; Study programme type: university; Study level: postgraduate specialist; Academic / professional title: sveučilišni magistar/sveučilišna magistra razvoja lijekova (sveučilišni magistar/sveučilišna magistra razvoja lijekova)
• Type of resource: Text
• File origin: Born digital
• Access conditions: Open access
• Created on: 2017-01-12 12:28:06