Разработка и регистрация лекарственных средств (Jan 2019)
THREE-DIMENSIONAL PRINTING TECHNOLOGY FOR THE PRODUCTION OF DOSAGE FORMS
Abstract
The development of personalized medicine requires new approaches to the development of dosage forms (DF), one such approach is rapid prototyping or in a different way the three-dimensional printing of tablets, plasters and other DF. Since the principle of individual dosing, the exact spatial arrangement of the pharmaceutical substance (PS), the possibility of using various geometric tablet forms to adjust the release rate, depending on the patient's need, is also possible in this approach, moreover, when creating a DF for the presented technology, it is possible to create and Quickly adjust the release profile according to the patient's requirements. A special impetus to the development of this technology was the recognition of the scalability of rapid prototyping and the release in 2016 in the US: with the approval of the FDA (Food and Drug Administration) 3D-printed orodispersible tablet Spritam® (levetiracetam). In this review we present methods of production of DF by the method of three-dimensional printing, such as the Theriform® process, stereolithography, extrusion, continuous inkjet printing, impregnated thread printing, microprojection, etc., classification of 3D printing types and features of each type of printing and equipment, on which the main technological process is produced. For the sake of clarity of the processes, the compositions and auxiliary substances used (AS), for example biodegradable polymers such as PLA, PLGA, etc., compositions of «ink» and powder substrates required for each type of process are given, as well as experimental data obtained from literature sources, curves release and technological properties of model samples. The possibilities demonstrated by the 3D printing of drugs to researchers and developers of the DF, in particular the rapid development and production of combinations of several PS with pulsatile, controlled, immediate or any other type of sequential release of the present FS in one DF are demonstrated. The evaluation of design features, advantages and disadvantages is carried out and the main components of the equipment for 3D DF printing are shown, the main attention is paid to such elements as printheads. it is their speed, mechanism of action and device that determines the type of rapid prototyping and the properties of the received DF. Conclusions about the prospects of this direction, in general, and of each technology separately, are evaluated, the advantages and disadvantages of the presented methods of DF production are estimated.
