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UPORABA STROJNEGA VIDA ZA SPREMLJANJE PROCESOV FILMSKEGA OBLAGANJA FARMACEVTSKIH TABLET IN MINI TABLET
ID PODREKAR, GREGOR (Author), ID Tomaževič, Dejan (Mentor) More about this mentor... This link opens in a new window

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Abstract
Tablete predstavljajo najpogosteje uporabljeno farmacevtsko obliko, ki jo odlikujejo enostavnost, nizka cena izdelave in pakiranja ter njena relativna stabilnost. Tablete s premerom manjšim od treh milimetrov imenujemo mini tablete. Izdelava tablet in mini tablet vključuje niz zaporednih procesnih korakov, s katerimi vhodne surovine v obliki praškov oblikujemo v končno obliko. Danes so tablete in mini tablete pogosto filmsko obložene. Debelina in enakomernost filmske obloge predstavljata pomemben kriterij kakovosti filmske obloge. Njena ustreznost je zlasti pomembna v primerih, ko obloga služi doseganju prirejenega sproščanja zdravilne učinkovine. Kljub temu ustrezno končno debelino filmske obloge danes še vedno večinoma zagotavljamo empirično in na podlagi nezanesljivih teoretičnih preračunov, uspešnost procesov oblaganja pa je velikokrat odvisna tudi od usposobljenosti in izkušenosti operaterja, ki upravlja s procesom. Na pobudo ameriškega Zveznega urada za hrano in zdravila, ki je farmacevtsko industrijo v obliki smernic dobre proizvodne prakse pozval tudi k razvoju in uporabi novih tehnik za medprocesno merjenje kritičnih procesnih parametrov in lastnosti vhodnih materialov, so bili v preteklosti predlagani različni pristopi za medprocesno merjenje debeline filmske obloge. Predlagani pristopi se zanašajo na različne tehnologije, ki so omejene bodisi na določene tipe in minimalne ter maksimalne debeline oblog bodisi zahtevajo izgradnjo kompleksnih kalibracijskih modelov. Strojni vid lahko definiramo kot področje, usmerjeno v realizacijo sistemov z računalniškim vidom, namenjenih za uporabo v industrijskih okoljih, pogosto za namene samodejne vizualne kontrole izdelkov. Kljub temu, da je njegova dosedanja uporaba za namene medprocesnega spremljanja procesov oblaganja tablet in mini tablet redka, po našem mnenju predstavlja ustrezno tehniko, s katero je mogoče premostiti vse pomanjkljivosti ostalih, v preteklosti predlaganih tehnik. Izvirni prispevki te doktorske disertacije tako združujejo razvoj in vrednotenje sistemov in pristopov za medprocesno spremljanje oblagalnih procesov filmskega oblaganja tablet in mini tablet z uporabo strojnega vida, pri čemer je delo osredotočeno na merjenje debeline filmske obloge, ki kot taka lahko predstavlja kritičen parameter kakovosti obloženih tablet in mini tablet. Izvirni prispevki so na kratko predstavljeni v nadaljevanju.

Language:Slovenian
Keywords:strojni vid, filmsko oblaganje, tablete, mini tablete, konvolucijske nevronske mreže, ocena 3D orientacije
Work type:Doctoral dissertation
Organization:FE - Faculty of Electrical Engineering
Year:2019
PID:20.500.12556/RUL-113294 This link opens in a new window
Publication date in RUL:19.12.2019
Views:1921
Downloads:240
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Secondary language

Language:English
Title:MACHINE VISION BASED MONITORING OF FILM COATING PROCESS OF PHARMACEUTICAL TABLETS AND MINITABLETS
Abstract:
Tablets are the most common pharmaceutical dosage form of today. Their advantages are simplicity, low production and packaging cost and their relative stability. Tablets with less than three millimeters of diameter are called minitablets. The production of tablets and minitablets involves a series of sequential process steps during which the incoming raw materials in form of powders are formulated into a final dosage form. Tablets and minitablets are nowadays often film coated. The thickness and the uniformity of the film coating represent an important quality attribute of the coating. Its suitability is particularly important in cases where the coating serves to achieve the modified release of the active ingredient. Despite this, the appropriate final thickness of the coating is still mostly ensured empirically and on the basis of unreliable theoretical calculations, while the success of the coating processes often depends on the competence and experience of the operator managing the process. Different approaches for in-line and on-line film coating thickness estimation have been proposed in the past by the U.S. Food and Drug Administration through the good manufacturing practices guidelines, what encouraged the pharmaceutical industry to develop and use new techniques for in-line and on-line measurement of the critical process parameters and properties of the incoming raw materials. The proposed approaches rely on different technologies, which are either limited to specific types and minimum and maximum coating thicknesses or require the construction of complex calibration models. Machine vision can be defined as a field focused on the realization of computer vision systems intended to be used in industrial environments, often for the purpose of automated visual inspection. We believe that despite its rare up-to-date use for such purposes, machine vision represents a promising approach for in-line and on-line monitoring of coating processes that can overcome all the shortcomings of techniques proposed in the past. The contributions of this dissertation therefore combine the development and the evaluation of machine vision systems and approaches for in-line and on-line monitoring of pharmaceutical tablets and minitablets film coating processes. The work focuses on the estimation of the coating thickness, which as such can represent a critical quality parameter for coated tablets and minitablets. The contributions are briefly presented below.

Keywords:machine vision, film coating process, tablets, minitablets, convolutional neural networks, 3D orientation estimation

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