Projects / Programmes
Visual analysis of orderless pharmaceutical tablets in mass production processes
| Code |
Science |
Field |
Subfield |
| 2.06.00 |
Engineering sciences and technologies |
Systems and cybernetics |
|
| Code |
Science |
Field |
| T111 |
Technological sciences |
Imaging, image processing |
| Code |
Science |
Field |
| 2.02 |
Engineering and Technology |
Electrical engineering, Electronic engineering, Information engineering |
image analysis, automatic quality inspection, process analytical technology, contactless tablet analysis
Researchers (17)
Organisations (2)
Abstract
The majority of solid dosage forms, representing 85 % of all medications and estimated market value in excess of $300 billion per year, are coated pharmaceutical tablets that are produced in mass production processes. The coating can have a number of different roles, such as improving the aesthetic appearance, masking the unpleasant taste or odor, making the tablet easier to ingest, control the release rate of drug, protect the tablet from the environment, providing the means for identification and the ability to co-formulate inherently incompatible materials. While the requirements and specifications of the coatings for aesthetic or masking purposes are not demanding, coatings used for controlling the rate of drug release or for protection of active ingredients from the environment are subject to strict thickness and uniformity requirements. In order to fulfill these requirements, the coating process needs to be efficient and well-controlled. However, the majority of currently used coating processes are run with no real-time feedback on the coating thickness and uniformity, instead measurements are made retrospectively in analytical laboratories by employing time consuming, destructive and environment-harmful methods, such high performance liquid chromatography and microscopy. These methods do not provide the required in-line measurements, essential for effectively designing, controlling and optimizing the coating process, thereby frequently leading to out-of-specification batches that result in significant loss of revenues and additional unnecessary burden on the environment. In order to overcome these limitations, FDA has started the process analytical technologies (PAT) initiative in 2004, promoting novel non-invasive, non-destructive and environment friendly in-line analytical tools. The main goal of the initiative is to provide better understanding of the pharmaceutical processes and ultimately optimize the process in terms of throughput and product quality. A number of novel PAT compatible analytical tools for the assessment of tablet coating thickness and uniformity, have been considered, yet only a few producing accurate and reliable in-line measurements. Additionally, highly complex and impractical multivariate calibration procedures, requiring custom production batches, render these methods unattractive for routine use in pharmaceutical industry. Therefore, a lot effort is being spent to develop novel analytical tools for direct assessment of coating thickness. Our hypothesis is that methods utilizing reconstruction of 3D information from 2D images, which are frequently used in the fields of machine vision, medical imaging and robotics, have the potential to accurately characterize the geometrical and surface properties of tablets and thereby of the coating thickness, even when applied to images acquired in highly complex environments such as in the coating pan. The final goal of the proposed project is to develop state-of-the-art PAT compatible systems for visual analysis of orderless pharmaceutical tablets in mass production processes that will facilitate design, optimization and control of the tablet coating processes, thereby assuring the safety, quality and consistency of the final products. This will result in higher productivity and environment friendly production, boosting the local economy, promoting the science and generating new jobs all in the accordance with the guidelines of the Slovenian Research Agency. Our strong connections to the pharmaceutical industry, extensive experience and outstanding scientific achievements in the fields of machine vision and medical imaging, and numerous successful past research projects that resulted in the state-of-the-art machine vision systems used in the leading pharmaceutical companies worldwide (see www.sensum.eu), are the best guarantee that the proposed applied project is going to be carried out successfully, both on the scientific and practical level.
Significance for science
During the research project, the project team has published several papers in peer reviewed SCI journals and international and domestic scientific conferences. We except that the published papers will be frequently cited and thereby significantly contribute to the international visibility and reputation of the University of Ljubljana and republic of Slovenia and contribute to the development of the technical and natural sciences. Besides, the project has provided a unique opportunity for junior researchers and younger PhDs to work on challenging research problems, gain new theoretical knowledge and apply it to solve practical problems. The results of the research project are mainly important for the development of new and improvement of existing methods in the field of quality control by computer vision. Especially interesting and promising is inline testing, which enables analysis, development and optimization of modern manufacturing processes and technologies in the pharmaceutical and food industry. The novel methods for visual analysis of orderless pharmaceutical tablets in mass production processes that were developed as part of the project offer numerous opportunities for development of new products with high value added that are fully compatible with the process analytical technologies (PAT) initiative that promotes novel nondestructive and environment friendly inline analytical tools. Besides, the timely information provided by such novel systems will enable new studies that were not possible by utilizing the existing analytical tools.
Significance for the country
The project has further enhanced and strengthen the cooperation between R&D institutions and enterprises, and significantly contributed to the transfer of top scientific knowledge to industry, where we expect it will enable the development of new high-tech products with high value added, contribute to accelerated economic growth, and lead to more well-paid employments. The first important steps in that direction were already undertaken during the project by developing and implementing an advanced prototype system and novel methods for visual analysis of orderless tablets in the coating process. Since the proposed unique solutions were proved to be highly efficient and robust, we expect that the results of the project will serve as an excellent basis for development of new products, in particular of modern high-tech control systems and instruments for simultaneous monitoring, understanding and optimization of mass production processes in the pharmaceutical industry. Last but not least, the project has also significantly contributed to the education of younger scientists and researchers that is of the utmost importance for future R&D of complex systems and for the efficient transfer of knowledge and technology from academia to industry and entrepreneurship.
Most important scientific results
Annual report
2014,
2015,
final report
Most important socioeconomically and culturally relevant results
Final report
