Produced in Partnership with ERWEKAReviewed by Emily MageeJan 6 2025
Tablets are the most common solid dosage form of medication by far, with over one trillion produced annually.1 Tablets are mainly produced in round, flat, or oblong shapes, which are important for dosage accuracy, administration, and portability.2
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Tablet Hardness in Drug Development
Hardness is a key property of tablets and is assessed in all drug development stages.3
The hardness of a tablet is determined by its crushing strength property, measured by applying a compressional force until the tablet fractures or breaks.3
Hardness is a common but difficult quality check, as all tablets must be uniform during production to ensure safety and efficacy. Hard tablets can be difficult to swallow and have suboptimal disintegration time, lowering efficacy.4 Conversely, soft tablets cannot withstand the handling and processing stages of development.4 Therefore, it is essential that tablet hardness is consistently documented and optimized.
Hardness tester machines measure a range of parameters, including hardness, width, diameter, thickness, and weight.5 Through accurate and efficient documentation, tablet hardness testing informs each stage of the drug development process.
In R&D, tablets are required to be robust enough for transport and uptake into the body while maintaining efficacy. Tablets undergo rigorous testing during each stage of development to ensure compliance with pharmacopeial standards.6 This is often a long and challenging process, highlighting the need for more rapid and accurate hardness testing for pharmaceuticals.
Erweka offers multiple hardness testing machines, simplifying the testing process and saving time. The technology offered ranges from manual TBH125 hardness testers to fully automated units such as the MultiCheck 6, with functional customizability suiting all testing needs.
Manual and Semi-Automated Hardness Checking
Manual hardness testers provide easy operation and portable field application.6 Erweka’s TBH125 allows for manual testing of up to 99 samples and measures hardness, thickness and length/diameter.
The TBH325 offers the same features as the TBH125, with the addition of a robust, inbuilt keypad allowing for more precise hardness measurement and integrated memory for recall of past tests.
TBH325 is able to measure up to 100 tablets per run and has a force operation range of 3-500 N. The simplicity of TBH125 and TBH325 makes the units very robust, allowing for simple and quick on-site hardness testing.
Erweka also offers semi-automated TBH hardness testing, utilizing a star-shaped rotary magazine. The only manual step in the process is the insertion of the tablets into the machine. The TBH425 features a window, allowing all aspects of the hardness-measuring process to be strictly monitored for optimal efficiency.
TBH425 allows for 100 tablet-per-run testing and can be connected directly to a USB printer or a computer via LAN, enabling tablet hardness to be measured in multiple formats.
Automated Hardness Checking
Manual hardness checkers are usually insufficient for rapid, high-throughput testing.1 Drug development requires stringent analyses, which are time-consuming and labor-intensive when manual checking technology is employed.7
To overcome this issue, Erweka recently developed EasyCheck and MultiCheck automated hardness testing, allowing for faster and more accurate procedures.
The EasyCheck automated hardness tester allows for easy and completely automated testing of weight, length/diameter, width, hardness and thickness. It features the patented Oblong Slider® for adjustment and calibration and an easy touch support for setup and start.
EasyCheck is fully compliant with all standard pharmacopoeias and entirely customizable, featuring optional storage of up to 1 million results and the paperless audit trail light feature. Users can easily log information on each run, allowing for precise results and extensive documentation.
For users with more advanced requirements, Erweka offers the MultiCheck 6, an all-rounder that sets the new standard for automated tablet testing.
Similar to EasyCheck, MultiCheck offers full automation and customization, prioritizing user-friendly operation, high efficiency, and enhanced convenience.
What sets MultiCheck apart, however, is the Oblong Navigator®. This unique system uses patented alignment technology, enabling the testing of tablets in various shapes and sizes. Additionally, it delivers the quietest operation and cleanest technology available, making MultiCheck unmatched in terms of waste reduction and minimal noise.
Controlling Hardness Testing from the Desktop
The storage and categorization of data is an issue for tablet hardness testing. Each run must be cataloged to comply with 21 CFR Part 11. This is a time-consuming and wasteful process that can impact the rate and efficiency of drug development.
Mc.Net is a revolutionary software provided by Erweka as an extension to each hardness testing machine, providing external data control and storage.
Mc.Net provides a single database for the storage of multiple computers within the same network, enabling external centralization, alteration, and storage of the run.
Utilizing Mc.Net alongside TBH or Easy/MultiCheck technology ensures each run is 21 CFR Part 11 compliant. Mc.Net saves time and enables full modification of each run, as its user-friendly interface allows all data used by each hardness tester to be managed.
Tasks may be locked to authorized users and stored under a separate protocol number per stage. The electronic signature removes the need to generate and print signed documents manually, providing a more sustainable alternative to traditional hardness testing procedures.
References and Further Reading
- Chaturvedi, H., Garg, A., Rathore, U.S. (2022). Post-compression evaluation parameters for tablets-an overview, European Journal of Pharmaceutical and Medical Research, 4(11), pp.526-530. https://www.researchgate.net/profile/Mr-Garg-2/publication/359391872_POST-COMPRESSION_EVALUATION_PARAMETERS_FOR_TABLETS-AN_OVERVIEW/links/62397ba1781d2e6df7ac0b4a/POST-COMPRESSION-EVALUATION-PARAMETERS-FOR-TABLETS-AN-OVERVIEW.pdf
- Hummler, H. et al. (2023b). Impact of tablet size and shape on the swallowability in older adults, Pharmaceutics, 15(4), p. 1042. https://doi.org/10.3390/pharmaceutics15041042.
- Riippi, M. et al. (1998b). The effect of compression force on surface structure, crushing strength, friability and disintegration time of erythromycin acistrate tablets, European Journal of Pharmaceutics and Biopharmaceutics, 46(3), pp. 339–345. https://doi.org/10.1016/s0939-6411(98)00043-5.
- McCloskey, A.P. et al. (2022b). Identifying and addressing pill aversion in adults without physiological‐related dysphagia: A narrative review, British Journal of Clinical Pharmacology, 88(12), pp. 5128–5148. https://doi.org/10.1111/bcp.15463.
- Cooper, D. and Carter, S. Some Information on Tablet Hardness Testing Why test? [online] Available at: https://www.engsys.co.uk/pdfs/english/tablet-hardness-testing.pdf.
- Frank, S., Frehner, C., Akhlaghi, A. (2016). Equotip Application Booklet. Portable Hardness Testing Leeb, Portable Rockwell and UCI. Proceq. Available at: https://www.ashtead-technology.com/wp-content/uploads/2021/06/Proceq-Equotip-550-Hardness-Tester.pdf
- Sun, D. et al. (2022b). Why 90% of clinical drug development fails and how to improve it?, Acta Pharmaceutica Sinica B, 12(7), pp. 3049–3062. https://doi.org/10.1016/j.apsb.2022.02.002.
About ERWEKA
ERWEKA is an international manufacturer of test equipment for the pharmaceutical industry. In addition to large pharmaceutical and life science companies, we supply development and contract laboratories as well as universities around the world with equipment for the development and testing of medicines.
ERWEKA was founded in Germany in 1951 and has been an integral part of the Verder Scientific Division since 2023. As a manufacturer with extensive experience in the testing equipment industry, ERWEKA offers the full range of tablet testing devices for solid dosage forms. Our benchmark is top quality. From development, design and production to service for our devices, we are uncompromising in our commitment to premium quality. ERWEKA stands for excellent product quality, attractive design and individual customer care. Our customers have been relying on this for over 70 years.
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