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Razvoj modela za izbor kombinacije barvil v filmskih oblogah za doseganje ciljne barve filmsko obloženih tablet
ID Bajc, Grega (Author), ID Vrečer, Franc (Mentor) More about this mentor... This link opens in a new window, ID Korasa, Klemen (Co-mentor)

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Abstract
Barva je zelo pomembna karakteristika filmsko obloženih tablet (FOT), ki zagotavlja lažjo prepoznavo zdravila, težjo poneverbo in pogosto boljšo sprejemljivost za pacienta. V razvoju izdelka naletimo na oviro, ko želimo reproducirati ciljni odtenek barve. Ustrezno obarvanost FOT dosegamo z uporabo najrazličnejših barvil, katerih nabor se v zadnjih letih, zaradi ugotovitev potencialne toksičnosti nekaterih, krči. V naši magistrski nalogi smo se lotili priprave filmskih oblog različnih barv z različnimi barvili – rdečim, rumenim, črnim železovim oksidom in indigo karminom. S pomočjo metode načrtovanja eksperimentov smo postavili dva modela za napovedovanje parametrov barve v CIEL*a*b* barvnem prostoru. Rumeno-rdeči model napoveduje barvo pri uporabi bele osnove (vključuje polimer, plastifikator, drsilo in titanov dioksid) ter rdečega in rumenega železovega oksida, skupni model pa poleg omenjenih treh komponent vključuje še črni železov oksid in indigo karmin. Z modeloma smo dokazali, da uporaba metode načrtovanja eksperimentov ob zadostnem številu poskusov omogoča postavitev modela, ki dobro predvidi parametre barve. Preverili smo ali sta modela uporabna tudi v obratni smeri, torej za napovedovanje sestave barvil iz podatkov o ciljni barvi. Izmerili smo barvo referenčnih tablet, postavljeni model pa je na podlagi rezultata meritve napovedal optimalno sestavo barvil za doseganje ciljne barve FOT. Ožji model z vključenima le rumenim in rdečim železovim oksidom je dobro napovedal sestavo barvil, saj so bile tri testne serije tablet analitsko opisane enako kot referenčne tablete. Širši skupni model je sestavo napovedal manj točno, saj je bila testna FOT drugačne barve, smo pa s tem potrdili, da obširnejši model zahteva tudi večje število poskusov oziroma točk v eksperimentalnem prostoru. Poleg postavitve in ovrednotenja modelov smo preverili tudi hipoteze, ki se navezujejo na uporabnost modelov. Med drugim smo preverili ponovljivost filmskega oblaganja z vidika barve FOT, vplive spremenjenega reliefa površine tabletnih jeder in različne obarvanosti tabletnega jedra na barvo FOT. Preverili smo tudi vpliv zamenjave polimera v sestavi filmske obloge na obarvanost FOT. Z namenom ugotavljanja časovno učinkovitega procesa oblaganja za zagotovitev ciljne barve FOT pa smo preverili tudi, kako se spreminja barva FOT in enakomernost barve znotraj serije tablet med procesom filmskega oblaganja.

Language:Slovenian
Keywords:filmsko oblaganje, barva filmske obloge, barvila, CIELab barvni sistem, kolorimetrija, načrtovanje eksperimentov
Work type:Master's thesis/paper
Organization:FFA - Faculty of Pharmacy
Year:2022
PID:20.500.12556/RUL-136927 This link opens in a new window
Publication date in RUL:25.05.2022
Views:460
Downloads:131
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Secondary language

Language:English
Title:Development of a colourants selection model in film coating for achieving targeted colour of film coated tablets
Abstract:
Color is a very important characteristic of film coated tablets. It ensures easier recognition, harder forgery and it often leads to better patient compliance. Developing a product, an obstacle is often encountered, in how to reliably reproduce the desired shade of color. The desired coloring of a film coated tablet is achieved by using an abundance of pigments. In recent years, though, this is becoming increasingly more difficult due to new toxicological studies suggesting some of those pigments are unsafe. In this Master’s thesis, the preparation of film coatings of different colors, using following pigments: red, yellow and black iron oxide and indigo carmine was studied. Using design of experiments methodology, 2 models were set up for color parameter prediction in the CIEL*a*b* color space. The yellow-red model predicts the color while using a white base (including the polymer, plasticizer, lubricant and titanium dioxide) plus the yellow or red iron oxide pigment; while the comprehensive model additionally includes the rest of the pigments: black iron oxide and indigo carmine. Building these models, it was successfully shown that design of experiments methodology can be used to predict color parameters, providing the number of experiments is large enough. Additionally, the models were tested for their use in the reverse fashion as well, meaning predicting pigment composition from data of a certain targeted color. The color of reference tablets was measured and the designed model then used to predict the optimal composition of pigments to achieve the desired color of film coated tablets. The yellow-red model fared well in this test, successfully predicting the optimal pigment composition. The analytical descriptiors of reference tablets and tablets produced by the results of this model were virtually identical. The comprehensive model proved less reliable in this fashion and did not predict the pigment composition correctly. Suggesting the comprehensive model requires a larger data set. Further, additional hypotheses that relate to usefulness of these models were tested. For example, the reproducibility of film coating in terms of the color, the impact of changes in the relief of tablet cores and various coloring of the tablet core on the color of film coated tablets. The impact on the color of film coated tablets when switching the polymer was also checked. To optimize the process of film coating time-wise, it was additionally tested how the color of the tablets and the evenness of coloring changes during the process of film coating.

Keywords:film coating, colour of film coated tablets, colourants, CIELab colour space, colorimetry, design of experiments

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