Vpliv izbranih procesnih parametrov na enakomernost obloge in izkoristek procesa pri oblaganju tablet s tehnologijo perforiranega bobna

Kerin, Jurij (author), Dreu, Rok (mentor)

Na tablete pogosto nanesemo filmsko oblogo. Za oblaganje tablet navadno uporabljamo tehnologijo perforiranega bobna. Za učinkovito nanašanje obloge in izdelavo enakomerno obloženih tablet visoke kakovosti je nujno poznavanje vpliva kritičnih procesnih spremenljivk na proces oblaganja. Enakomernost obloge in izkoristek procesa oblaganja lahko izboljšamo z optimizacijo časa oblaganja, razprševanja disperzije, gibanja tablet in hitrosti sušenja. Z namenom vrednotenja vpliva izbranih procesnih parametrov na enakomernost mase obloge med tabletami in na izkoristek procesa oblaganja tablet smo izvedli poskuse na laboratorijskem oblagalniku tablet z 0,8 L perforiranim bobnom. Enakomernost obloge med tabletami smo vrednotili z relativno standardno deviacijo (RSD) količine obloge. Oblaganja tablet smo sistematično izvedli pri dveh različnih polnitvah, treh obodnih hitrostih vrtenja bobna in dveh številih mešalnih stopnic ter proces zaključili ob različnih časih, da smo na tablete naložili tri različne debeline obloge. Enakomernost količine obloge med tabletami in izkoristek procesa oblaganja smo vrednotili s spektrofotometrično in gravimetrično metodo. Pri vrednotenju vplivov izbranih procesnih parametrov na RSD obloge smo preverjali skladnost eksperimentalnih rezultatov z modelom za napovedovanje RSD obloge. Pri vrednotenju vpliva procesnih parametrov na izkoristek smo iskali vzroke za izgube pri procesu oblaganja tablet. Spektrofotometrična metoda se je v primerjavi z gravimetrično metodo izkazala kot bolj primerna za analizo izkoristka procesa oblaganja tablet. Prva daje v povprečju za 2,27 % višje rezultate izkoristka. Rezultati izvedenih poskusov filmskih oblaganj so pokazali, da je RSD količine obloge obratno sorazmeren s korenom časa oblaganja. RSD količine obloge se zniža z zvišanjem hitrosti vrtenja bobna, a le pri nižji polnitvi bobna. Volumska polnitev in število mešalnih stopnic vplivata na RSD količine obloge le, če vplivata na učinkovitost mešanja tablet. Manjši perforiran boben (0,8 L) se je v primerjavi s predhodno ovrednotenim večjim bobnom (1,6L) izkazal kot bolj učinkovit pri zagotavljanju enakomernosti mase obloge med tabletami. Vpliv hitrosti vrtenja bobna, volumske polnitve bobna in števila mešalnih stopnic na izkoristek procesa oblaganja se kaže predvsem kot njihov posredni vpliv na tvorjenje polimernega filma na površini bobna. Količina tvorjenega filma na površini bobna se poveča, z njo pa zmanjša izkoristek procesa, pri zmanjšanju polnitve in povišanju hitrosti bobna. Čas oblaganja vpliva na izkoristek oblaganja le do dosege ravnotežnega stanja temperature v oblagalnem bobnu.

• Language: Slovenian
• Keywords: oblaganje tablet, 0, 8 L perforiran boben, enakomernost obloge med tabletami, izkoristek oblaganja, kritične procesne spremenljivke
• Work type: Master's thesis/paper
• Organization: FFA - Faculty of Pharmacy
• Year: 2019
• PID: 20.500.12556/RUL-108325
• Publication date in RUL: 28.06.2019

KERIN, Jurij, 2019, Vpliv izbranih procesnih parametrov na enakomernost obloge in izkoristek procesa pri oblaganju tablet s tehnologijo perforiranega bobna [online]. Master’s thesis. [Accessed 22 March 2025]. Retrieved from: https://repozitorij.uni-lj.si/IzpisGradiva.php?lang=eng&id=108325

Secondary language

• Language: English
• Title: Tablet coating uniformity and process yield as a function of selected perforated drum coater process parameters

Abstract

Tablets are often film-coated. Perforated coating drums are commonly used for tablet film coating. To apply coating effectively and produce uniformly coated tablets of high quality, the knowledge of the impact of critical process parameters on the coating process is of utmost importance. Both the coating uniformity and the coating process yield can be improved by optimizing coating time, dispersion spraying, tablet movement and drying speed. To evaluate the impact of the selected process parameters on the inter-tablet coating uniformity and on the coating process yield, we carried out a set of experiments in the lab scale coater with 0.8 L perforated drum. We verified the coating uniformity with the relative standard deviation (RSD) of the tablets individual coating masses. Tablets were coated at two different drum fillings, three peripheral speed of the drum and two numbers of mixing baffles and with different process end times to apply three different coating thicknesses. The inter-tablet coating mass uniformity and the coating process yield were evaluated by the spectrofotometric and gravimetric methods. When assessing impacts of the selected process parameters on the coating mass RSD, a conformity check of the experimental results with a prediction model of the coating mass RSD was carried out. When evaluating impacts of the process parameters on the process yield, key causes for the tablet coating process losses were sought after. The spectrophotometric method has proved to be more appropriate than gravimetric, when analysing the tablet coating yield. First method has on average given by 2.27 % higher process yiled results. Experimental values of the coating mass RSD was found to be inversely proportional to the square root of the total time of coating. The coating mass RSD is reduced by increasing the drum rotational speed, however only at lower drum filling. The drum filling and the number of mixing baffles will impact the of the coating mass RSD only if the efficiency of the tablets mixing is impacted. 0.8L perforated drum has in comparison with the previously evaluated 1.6L drum demonstrated higher efficiency in assuring inter-tablet coating mass uniformity. The impact of the drum rotational speed, drum filling and of the number of mixing baffles on the coating process yield will mainly be reflected as an impact on forming a polymer film on the drum’s surface. The amount of the film on the drum’s surface will increase leading to lower process yield at lower drum filling and increased drum rotational speed. The coating process time will impact the coating yield only until the steady-state temperature in the coating drum is reached.

• Keywords: tablet coating, 0.8 L perforated drum, inter-tablet coating uniformity, coating yield, critical process parameters