48 NOVEMBER 2018 www.dissolutiontech.com INTRODUCTION T he number of studies concerning applicaton of three dimensional (3D) printng techniques in pharmaceutcal technology has grown contnuously since 2005, but the main interest in applicaton of these techniques is focused on the manufacturing of new customized dosage forms ( 1 ). As a successful example of applying this technology, the frst 3D-printed drug product containing leviteracetam, Spritam, was approved by U.S. Food and Drug Administraton (FDA) in 2015 ( 2). Although the direct manufacturing of dosage forms using 3D technology is a fascinatng topic, it does not exhaust the possibilites ofered by 3D printng for pharmaceutcal technology. Among possible optons, rapid prototyping and rapid tooling should be taken under consideraton. When using traditonal methods for preparaton of 3D objects, it is necessary to remove excess material by machining or forming objects with a castng technique. Both of these techniques require the involvement of highly specialized equipment such as drills, milling machines, grinders, or usage of high temperatures during injecton molding of the materials to the appropriate forms, which prevents their use in random manufacturing sites. The 3D printng technology is devoid of such disadvantages. The important area where the rapid prototyping and tooling may fnd a wide range of applicatons is the development of analytcal equipment dedicated for specifc dosage forms and for nonstandard applicatons. The variety of novel drug delivery systems (e.g., orodispersible tablets and flms, intraoral mucoadhesive tablets, etc.) generates serious problems with the relevant dissoluton testng ( 3 , 4). Moreover, some specifc testng methods of drug delivery systems require dedicated tools (e.g., holders) ( 5). Dissoluton studies belong to the most frequently applied biopharmaceutcal tests for the evaluaton of solid dosage forms. The pharmacopoeial methodology of dissoluton testng, although well established, is ofen insufcient for evaluaton of new drug delivery systems. Despite this fact, the possibility of development of instrumentaton dedicated for specifc drug delivery systems with 3D printng is practcally not explored. The frst and only atempt of applicaton of fused depositon modeling as 3D Printing for Fast Prototyping of Pharmaceutical Dissolution Testing Equipment for Nonstandard Applications Przemysław Dorożyński 1* , Witold Jamróz 2 , Władysław P. Węglarz 3 , Wojciech Kulinowski 4 , Mateusz Zaborowski 2 , and Piotr Kulinowski 4 1 Pharmaceutcal Research Insttute, Warszawa, Poland 2 Department of Pharmaceutcal Technology and Biopharmaceutcs, Jagiellonian University Medical College, Kraków, Poland 3 Department of Magnetc Resonance Imaging, Insttute of Nuclear Physics, Polish Academy of Sciences, Kraków, Poland 4 Department of Mathematcs, Physics and Technical Science, Insttute of Technology, Pedagogical University of Cracow, Kraków, Poland ABSTRACT Purpose of the research was to assess feasibility of fused depositon techniques (3D printng) for development of analytcal equipment dedicated for specifc dosage forms and for nonstandard applicatons. Dissoluton profles as well as 3D magnetc resonance imaging (MRI) of the buccal tablets during hydraton in dissoluton medium were analyzed. The principal result of the study was the frst working example of rapid 3D prototyping of dedicated, MRI-compatble dissoluton equipment for mucoadhesive buccal tablets. Rapid prototyping techniques were found to be a fast, inexpensive way to develop a dedicated dissoluton testng setup. KEYWORDS: additve manufacturing, 3D printng, solid free-form fabricaton, buccal bioadhesive tablets, 3D ultra- short echo tme magnetc resonance imaging (3D UTE MRI), pharmaceutcal dissoluton testng equipment dx.doi.org/10.14227/DT250418P48 e-mail: mfdorozy@cyf-kr.edu.pl *Corresponding author