Vrednotenje in napoved procesne učinkovitosti pilotnega oblagalnika tablet z vidika enakomernosti nanosa količine obloge

Kocjančič, Tjaša (author), Dreu, Rok (mentor)

Zaradi starajočega prebivalstva in soobolevnosti se mora farmacevtska industrija vse bolj prilagajati in razvijati nove farmacevtske izdelke, tudi kombinacijske. Največ peroralnih zdravil je v obliki tablet, med katerimi prevladujejo filmsko obložene tablete. Pri filmskem oblaganju na tabletno jedro nanesemo filmsko oblogo, ki ima lahko vpliv na funkcionalnost končnega izdelka, lahko pa je nanešena zgolj z estetskega vidika. Ne glede na namen filmske obloge, moramo z vidika zagotavljanja kakovosti med oblaganjem zagotoviti enakomeren nanos obloge, saj je že enakomeren videz obloženih tablet eden izmed pomembnih atributov kakovosti filmsko obloženih tablet. V primeru, da je v oblogo tablete vključena učinkovina, pa moramo tudi za učinkovino v oblogi doseči zahtevo enakomernosti enoodmernih enot. S tega vidika je pomembno, da uporabljamo optimiziran proces oblaganja tabletnih jeder. Da bi se izognili nepričakovanim napakam pri izdelavi serij obloženih tablet in nedoseganju zahtevane kakovosti serij, moramo skrbno proučiti lastnosti procesa oblaganja tablet. Neustrezno načrtovanje procesa filmskega oblaganja lahko povzroči visoko variabilnost količine obloge med tabletami končnega izdelka. V izogib visoki variabilnosti količine obloge je potrebno ovrednotiti učinkovitost procesa oblaganja, določiti kritične procesne parametre ter razumeti njihov vpliv na kakovost obložene tablete. Namen magistrske naloge je ovrednotiti učinkovitost pilotnega oblagalnika tablet z vidika enakomernosti količine obloge med tabletami. Na podlagi taktično izbranih vrednosti procesnih spremenljivk procesa oblaganja in rigoroznega vrednotenja enakomernosti vsebnosti tablet smo postavili napovedna modela odvisnosti RSD količine obloge od kritične spremenljivke procesa oblaganja, t.j. od celokupnega števila obratov bobna. Izkazalo se je, da je vrednoten pilotni oblagalnik tablet učinkovit pri doseganju želene stopnje enakomernosti vsebnosti oz. količine obloge med tabletami. S pomočjo postavljenega modela za posamezno polnitev bobna lahko napovemo, kakšni so lahko pričakovani realno najboljši rezultati enakomernosti obloge pri izbranih pogojih oblaganja, upoštevaje tudi okvirje formulacije in omejitve procesne opreme, npr. najmanjši in največji pretok disperzije, ki lahko napaja šobo za razprševanje. Z izvedbo načrtovanega dela smo pokazali uporabnost eksperimentalnih napovednih modelov variabilnosti količine obloge pri vrednotenju učinkovitosti pilotnega oblagalnika tablet.

• Language: Slovenian
• Keywords: tablete, filmsko oblaganje, procesni parametri, perforiran boben, enakomernost obloge
• Work type: Master's thesis/paper
• Organization: FFA - Faculty of Pharmacy
• Year: 2021
• PID: 20.500.12556/RUL-128024
• Publication date in RUL: 01.07.2021

KOCJANČIČ, Tjaša, 2021, Vrednotenje in napoved procesne učinkovitosti pilotnega oblagalnika tablet z vidika enakomernosti nanosa količine obloge [online]. Master’s thesis. [Accessed 22 March 2025]. Retrieved from: https://repozitorij.uni-lj.si/IzpisGradiva.php?lang=eng&id=128024

Secondary language

• Language: English
• Title: Evaluation and prediction of a pilot scale tablet drum coater efficiency in terms of inter-tablet coating mass uniformity

Abstract

Due to an ageing population and co-morbidity the pharmaceutical industry needs to constantly adapt and develop new pharmaceutical products, including fixed-dose combination products. Most of the oral medications are in a form of a tablet, with film-coated tablets being the most common ones. During the tablet film coating we apply a thin polymer coat to the tablet core, which can have an impact on the functionality of the final product, or it can be applied for aesthetic reason. Either way, we must ensure an even application of the coating due to the quality assurance, as the even appearance of coated tablets is one of the important attributes of the quality of film-coated tablets. If there is an active ingredient included in the tablet coating, the requirement of uniformity of dosage units must also be met for the active substance in the coating. From this point of view, it is important to use an optimized tablet core coating process. To avoid possible mistakes when producing batches of film-coated tablets and nonachievement of the required batch quality, we need to carefully study the properties of the tablet coating process. Improper planning of the film coating process can result in high variability in the amount of coating between tablets of the final product. In order to avoid high variability of coating amount, it is necessary to evaluate the efficiency of the coating process, determine critical process parameters, and understand their impact on the quality of the coated tablet. The purpose of the master's thesis is to evaluate the effectiveness of the pilot scale tablet pan coater in terms of uniformity of the amount of coating between tablets. Based on tactically selected values of process variables of the coating process and rigorous evaluation of the uniformity of tablet content, we set up predictive models of the dependence of the amount of coating RSD on the critical variable of the coating process, i.e. of the total number of drum revolutions. It turned out that the evaluated pilot version of the tablet coater is effective in achieving the desired degree of uniformity of content or the amount of coating between the tablets. With the help of the set model for individual drum filling, we can predict what can be expected realistically in terms of the best results of uniformity of the coating under selected coating conditions, also taking into account the formulation design and limitations of process equipment, e.g. the minimum and maximum dispersion flow that can supply the spray nozzle. By performing the experimental work, we demonstrated the applicability of the experimental predictive models of the coating amount variability in evaluating the performance of the pilot scale tablet coater.

• Keywords: tablets, film coating, process parameters, perforated pan, coating uniformity