ODT product quality management on the example of automatic control of tablet weight uniformity

• Autorzy: Janas Sławomir , Kowalska Małgorzata , Woźniak Magdalena

Identyfikatory

DOI

10.29119/1641-3466.2023.172.19

• Języki publikacji: EN

Abstrakty

EN

Purpose: The aim of the work was to present the automation of the mass measurement process as a factor that can significantly affect the quality and speed of analyzes in pharmaceutical industry. Design/methodology/approach: In this study, two methods were presented for testing the mass uniformity of tablets whose weight ranged from 13 mg to 2580 mg. The first method involved determining the weight of 20 randomly selected tablets of pharmaceutical preparations by statically measuring the weight of these tablets. In the second method, an automatic tablet feeder type PA-04/H was used, in which, as a result of vibration, successive tablets were automatically moved via a special chute onto the weighing pan. Findings: No significant differences were found in the weight measurements performed by the manual and automatic methods. The largest differences were noted at the 0.5% level. All tablets tested met the United States Pharmacopeia requirements for their mass uniformity. For orally disintegrating tablets, the largest percentage deviations in weight from the mean value were -4.47% for tablet F6, - 4.26%, for tablet F1 and 3.31% for tablet F2. The differences in accuracy and precision between the automatic and manual methods were insignificant. Research limitations/implications: Mass measurement by the manual method is one of the most frequently performed measurements in the laboratory. The final result from this measurement method may be subject to error caused, for example, by human error, i.e. reading, writing or calculation error. For this reason, process automation is increasingly being used, which eliminates the possibility of error to a large extent. Practical implications: The automation of weight measurement reduces the effort required for product inspection. Thus, it can be an important factor in the process of optimization and product quality management. Originality/value: The description of the research method and its results can be a valuable guideline for people who deal with product quality control in the pharmaceutical industry. It has been shown that automation to be effective does not have to be complicated but well designed.

Słowa kluczowe

EN

mass; measurement; mass uniformity; tablet; accuracy; weighing; time management

PL

masa; pomiar; jednorodność masy; tabletka; dokładność; ważenie; zarządzanie czasem

• Wydawca: Wydawnictwo Politechniki Śląskiej
• Czasopismo: Zeszyty Naukowe. Organizacja i Zarządzanie / Politechnika Śląska
• Rocznik: 2023
• Tom: z. 172
• Strony: 299--310
• Opis fizyczny: Bibliogr. 30 poz.

Twórcy

autor

Janas Sławomir

• Radwag Metrology Research and Certification Center, Radom

• https://orcid.org/0000-0001-8045-3242

autor

Kowalska Małgorzata

• Faculty of Chemical Engineering and Commodity Science, Kazimierz Pulaski University of Technology and Humanities in Radom

• https://orcid.org/0000-0001-8947-2861

autor

Woźniak Magdalena

• Faculty of Chemical Engineering and Commodity Science, Kazimierz Pulaski University of Technology and Humanities in Radom
• Medicofarma S.A., Radom

• https://orcid.org/0000-0002-5873-0319

Bibliografia

• 1. Abouzeid, A., Petersen, S., Ulrich, J. (2014).Utilizing melt crystallization fundamentals in the development of a new compressing technology. Frontiers of Chemical Science and Engineering, 8, 346-352. http://doi.org.10.1007/s11705-014-1443-9.
• 2. Antonyuk, S., Heinrich, S., Tomas, J., Niels, D., Buijtenen, M., Kuipers, H. (2010). Energy Absorption During Compression and Impact of Dry Elastic-Plastic Spherical Granules. Granular Matter, 12, 15-47. http://doi.org.10.1007/s10035-009-0161-3.
• 3. Anushka, J., Aishwarya, R., Preeti, V., Shobhit, S., Sharma, U, .Sudhanshu, M. (2021). Quality by Design - A Tool for Pharmaceutical Industry that Has No Near End. International Journal of Pharmaceutical Research, 13(3), 77-85. http://doi.org.10.31838/ ijpr/2021.13.03.027.
• 4. Baroutaji, A., Bryan, K., Sajjia, M., Lenihan, S. (2017). Mechanics and Computational Modeling of Pharmaceutical Compressing Process. Reference Module in Materials Science and Materials Engineering. http://doi.org.10.1016/B978-0-12-803581-8.09269-9.
• 5. EMA/CHMP/ICH/24235/2006. ICH guideline Q9 on quality risk management, Step 5. https://www.ema.europa.eu/en/documents/scientific-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use_en-3.pdf.
• 6. Etman, M., Gamal, M., Nada, A., Shams-Elden, M. (2014). Formulation of desloratadine oral disintegrating tablets. Journal of Applied Pharmaceutical Science, 4, 54-61. http://doi.org.10.7324/JAPS.2014.4110.
• 7. European Pharmacopoeia 10th Edition (2019). Uniformity of mass of single-dose preparations, 335-336.
• 8. European Pharmacopoeia (2019). C.O. E, Strasbourg, 10th ed.
• 9. Ganesh, R.G., Vaishali, K., Ghume, Bhakti, B.B., Aarti R.G. (2021). 3D Printing Technology in Pharmaceutical Drug Delivery. Int. J. Pharm. Sci. Rev. Res., 68(1), 15-20.
• 10. Guidance for Industry-Orally Disintegrating Tablets (2008). Office of Pharmaceutical Science in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration: Silver Spring, MD, USA.
• 11. ISO 5725-6 (2002). Accuracy (trueness and precision) of measurement methods and results - Part 6: Use in practice of accuracy values.
• 12. Katzhendler, I., Mader, K., Friedman, M. (2000). Structure and hydration properties of hydroxypropylmethylcellulose matrices containing naproxen and naproxen sodium. Int. J. Pharm., 200, 161-179. https://doi.org/10.1016/S0378-5173(00)00360-4.
• 13. Kishor, O., Vishal, G., Kajal, N., Amruta, M., Trushali, M., Mrunalini, K., Shubhashree, M., Priyanka, N., Vasundhara K., Student, M. (2022). Quality by Design: Modern Concept for Quality Assurance. Journal of Pharmaceutical Quality Assurance and Quality Control, 2(2), 26-38.
• 14. Levina, M., Rajabi-Siahboomi, A.R. (2004). The influence of excipients on drug release from hydroxypropyl methylcellulose matrices. J. Pharm. Sci., 93, 2746-2754. https://doi.org/10.1002/jps.20181.
• 15. Mohammadali Poursharifi Ghourichay, Kiaie, S.H., , Nokhodchi, A., Javadzadeh, Y. (2021). Formulation and Quality Control of Orally Disintegrating Tablets (ODTs): Recent Advances and Perspectives. BioMed Research International, 1-12. https://doi.org/10.1155/ 2021/6618934.
• 16. Mohit, Md Sadique, H., Gurleen, K., Tanushka, K., Ather, A., Chandan, M. Abhigyan, P. (2021). Overview of 3d printing technology in pharma industry. World Journal of Pharmaceutical Research, 10, 236-245. http://doi.org.10.20959/wjpps20219-21009.
• 17. Partheniadis, I., Vasiliki, T., Ioannis N. (2022). Finite Element Analysis and Modeling in Pharmaceutical Tableting. Pharmaceutics, 14(3), 673. https://doi.org.10.3390/pharmaceutics14030673.
• 18. Peciar, P., Eckert, M., Fekete, R., Hrnciar, V. (2016). Analysis of Pharmaceutical Excipient MCC Avicel PH102 Using Compaction Equations. Journal of Mechanical Engineering, 66, 65-82. https://doi.org/10.1515/scjme-2016-0012.
• 19. Pritam, K., Shubham, K. (2022). A concept of quality by design in pharmaceuticals. International Research Journal of Modernization in Engineering Technology and Science, 4(2), 801-806.
• 20. Raghuram, R.K., Srinivas, M., Srinivas, R. (2003). Once-Daily Sustained-Release Matrix Tablets of Nicorandil: Formulation and In vitro evaluation. AAPS Pharm. Sci. Tech., 4, 61. http://doi.org.10.1208/pt040461.
• 21. Sangmun, S., Du Hyung, Ch., Nguyen Khoa, T., Nam Ah, K., Kyung Rok, Ch., Seong Hoon, J. (2011). Time-oriented experimental design method to optimize hydrophilic matrix formulations with gelation kinetics and drug release profiles. Int. J. Pharm., 407, 53-62. http://doi.org.10.1016/j.ijpharm.2011.01.013.
• 22. Schmitt, S. (2018). Quality Systems and Knowledge Management. In: V.S. Schlindwein, M. Gibson (Eds.), Pharmaceutical Quality by Design: A Practical Approach (pp. 47-60). Advances in Pharmaceutical Technology.
• 23. Sipos, E., Oltean, A.R., Szabó, Z.-I., Rédai, E.-M., Dónáth Nagy, G. (2017). Application of SeDeM expert systems in preformulation studies of pediatric ibuprofen ODT tablets. Acta Pharm., 67, 237-246. http://doi.org.10.1515/acph-2017-0017.
• 24. Snee, R.D. (2016). Quality by Design - Building Quality into Products and Processes. In: L. Zhang (Eds.), Non-Clinical Statistics for Pharmaceutical and Biotechnology Industries. New York, NY: Springer Publishing, http://doi.org.10.1007/978-3-319-23558-5_18.
• 25. Teaima, M., Hababeh, S., Khanfar, M., Alanazi, F., Alshora, D., El-Nabrawi, M. (2022). Design and Optimization of Pioglitazone Hydrochloride Self-Nanoemulsifying Drug Delivery System (SNEDDS) Incorporated into an Orally Disintegrating Tablet. Pharmaceutics, 14, 425. https://doi.org/10.3390/pharmaceutics14020425.
• 26. The Dow Chemical Company (2000). Using Methocel Cellulose Ethers for Controlled Release of Drugs in Hydrophilic Matrix Systems, 10-25. https://www.colorcon.com/ markets/pharmaceuticals/download/677/2063/34?method=view, 2.11.2022.
• 27. US Pharmacopeia (2011). Uniformity of dosage units. https://www.usp.org/sites/default/ files/usp/document/harmonization/gen-method/q0304_stage_6_monograph_ 25_feb_2011.pdf, 1.11.2022.
• 28. Van der Haven, D., 0rtoft, F., Naelapää, K., Fragkopoulos, I., Elliott, J. (2022). Predictive modelling of powder compaction for binary mixtures using the finite element method. Powder Technology, 403(6), 117381. http://doi.org.10.1016/j.powtec.2022.117381.
• 29. Van Drie, J. (2007). The Deming approach to quality - Enhancing productivity in pharmaceutical research by a focus on process and quality. Drug Discovery World Fall, 8, 20-25.
• 30. Viridén, A., Larsson, A., Schagerlöf, H., Wittgren, B. (2010). Model drug release from matrix tablets composed of HPMC with different substituent heterogeneity. Int. J. Pharm., 386, 52-60. https://doi.org/10.1016/j.ijpharm.2010.09.017.