Analysis of the range of medicines in the form of lyophilized powders
DOI:
https://doi.org/10.24959/sphhcj.23.299Keywords:
assortment analysis; medicines, lyophilized powders, lyophilization, products of genetic engineeringAbstract
Aim. To conduct the analysis of the range of medicines in the form of lyophilized powders at the pharmaceutical market of Ukraine.
Materials and methods. The methods of information and bibliographic search, analysis and generalization, statistical processing, as well as tabular and graphic means of visual data presentation were used. The analysis medicines registered in Ukraine in the form of lyophilized powders was based on the data of the State Register of Medicines of Ukraine, the Morion information search program, the ATC classification system of the electronic resource Compendium.online as of April 2023.
Results. The total number of medicines registered in Ukraine in the form of lyophilized powders is 215 trade names, excluding release and dosage forms, which are represented in 34 anatomical groups. The majority of products are found in groups L01 “Antineoplastic agents” (28.83 %), A02 “Drugs for acid related disorders” (14.42 %) and J01 “Antibacterials for systemic use” (11.16 %). The analysis by active substance revealed the proportion of active substances used most often, namely esomeprazole (5.12 %), gemcitabine and pantoprazole (4.65 % each), pemetrexed (3.72 %). The distribution of the market segment studied by producing countries was 22 % of domestic producers and 78 % products of importing countries, the leaders were India (35 %) and Turkey (6 %).
Conclusions. The analysis of the range of the medicines registered in the form of lyophilized powders as of April 2023 has been performed according to the ATC classification system. The market segment of lyophilized powders has been determined by active substance, composition (single-component, multi-component), the country of manufacture. The analysis of domestic manufacturers of medicines in the form of lyophilized powder has been performed, their branded specific product lines and production facilities have been determined. The absence of registration of medicines in the form of lyophilized powders in Ukraine based on doxycycline, protein drugs and a number of vaccines has been found. Thus, this situation forms promising areas for expanding the range of this group of medicines.
References
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Saliy, E. A., Honcharuk, A. Yu., Hetalo, O. V., Tarasenko, A. V. (2021). Razrabotka y otsenka lyofylyzyrovannoho poroshka dlia pryhotovlenyia rastvora dlia ynektsyi na osnove doksytsyklyna. Vestnyk Farmatsyy, 3 (93), 53–63. doi:10.52540/2074-9457.2021.3.53.
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Kommineni, N., Butreddy, A., Sainaga Jyothi, V. G. S., Angsantikul, P. (2022). Freeze-drying for the preservation of immunoengineering products. iScience, 25 (10), 105127. doi: 10.1016/j.isci.2022.105127.
Wang, Y., Grainger, D. W. (2019). Lyophilized liposome-based parenteral drug development: Reviewing complex product design strategies and current regulatory environments. Advanced Drug Delivery Reviews, 151–152, 56-71. doi: 10.1016/j.addr.2019.03.003.
Li, Z., Han, X., Hong, X., Li, X., Gao, J., Zhang, H. et al. (2021). Lyophilization Serves as an Effective Strategy for Drug Development of the α9α10 Nicotinic Acetylcholine Receptor Antagonist α-Conotoxin GeXIVA[1,2]. Marine drugs, 19(3), 121. doi: 10.3390/md19030121.
Lyophilized Injectable Drugs Market Size - Global Industry, Share, Analysis, Trends and Forecast 2022–2030. Available at: https://www.acumenresearchandconsulting.com/lyophilized-injectable-drugs-market.
Freeze Drying Equipment Market: Global Industry Analysis and Forecast (2022-2029). Available at: https:// www.maximizemarketresearch.com/market-report/global-freeze-drying-equipment-market/26995/.
Pisano, R. (2020). Continuous Manufacturing of Lyophilized Products: Why and How to Make it Happen. Available at: https://www.americanpharmaceuticalreview.com/Featured-Articles/563771-Continuous-Manufacturing-of-Lyophilized-Products-Why-and-How-to-Make-it-Happen.
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Bhambhani, A., Stanbro, J., Roth, D. Sullivan, E., Jones, M., Evans R. et al. (2021). Evaluation of Microwave Vacuum Drying as an Alternative to Freeze-Drying of Biologics and Vaccines: the Power of Simple Modeling to Identify a Mechanism for Faster Drying Times Achieved with Microwave. AAPS PharmSciTech, 22 (1), 52. doi: 10.1208/s12249-020-01912-9.
Adali, M. B., Barresi, A. A., Boccardo, G., Pisano, R. (2020). Spray Freeze-Drying as a Solution to Continuous Manufacturing of Pharmaceutical Products in Bulk. Processes, 8(6), 709. doi: 10.3390/pr8060709.
Tykhonov, O. I., Almakaieva, L. H., Shpychak, O. S. (2019). Rozrobka tekhnolohii liofilizovanoho poroshku dlia vyhotovlennia rozchynu dlia iniektsii na osnovi otruty bdzholynoi. Visnyk farmatsii, 2 (98). 20-28. doi: 10.24959/nphj.19.9.
Stasevych, M. V., Zvarych, V. I. (2021). Marketynhovyi analiz sehmenta rynku likarskykh zasobiv – pokhidnykh 9,10-antrakhinonu v Ukraini. Chemistry, Technology and Application of Substances, 4, 1, 116-125. doi: 10.23939/ctas2021.01.116.
Semenchuk, Yu. M., Stadnytska, N. Ye. (2022). Analiz asortymentu antybakterialnykh zasobiv dlia systemnoho zastosuvannia farmatsevtychnoho rynku Ukrainy. Chemistry, Technology and Application of Substances, 5, 1, 75-81. doi: 10.23939/ctas2022.01.075.
Saliy, O., Popova, M., Palchevska, T., Tarasenko, G. (2020). Analysis of the assortment of plasma-derived products on Ukraine pharmaceutical market. Farmatsevtychnyi Zhurnal, 4, 18-29. doi: 10.32352/0367-3057.4.20.02.
Rafalska, Y., Kosyachenko, K. (2021). Marketing research of the medicine market for the treatment of breast cancer in Ukraine. Ukrainian Scientific Medical Youth Journal, 127 (4), 77-83. doi: 10.32345.
Derzhavnyi reiestr likarskykh zasobiv Ukrainy. Available at: http://www.drlz.com.ua.
Kompendium: lekarstvennye preparaty. Available at: http://compendium.com.ua.
Srebro, J., Brniak, W., Mendyk, A. (2022). Formulation of Dosage Forms with Proton Pump Inhibitors: State of the Art, Challenges and Future Perspectives. Pharmaceutics, 14 (10), 2043. doi: 10.3390pharmaceutics14102043.
Juckers, A., Knerr, P., Harms, F., Strube, J. (2022). Emerging PAT for Freeze-Drying Processes for Advanced Process Control. Processes, 10 (10), 2059. doi:10.3390/pr10102059.
Saliy, E. A., Honcharuk, A. Yu., Hetalo, O. V., Tarasenko, A. V. (2021). Razrabotka y otsenka lyofylyzyrovannoho poroshka dlia pryhotovlenyia rastvora dlia ynektsyi na osnove doksytsyklyna. Vestnyk Farmatsyy, 3 (93), 53–63. doi:10.52540/2074-9457.2021.3.53.
Sheena, U., Parthiban, K. G., Selvakumar, R. (2018). Lyophilized injection: a modern approach of injectable dosage form. Journal of Drug Delivery and Therapeutics, 8 (5), 10-18. doi: 10.22270/jddt.v8i5.1829.
Kommineni, N., Butreddy, A., Sainaga Jyothi, V. G. S., Angsantikul, P. (2022). Freeze-drying for the preservation of immunoengineering products. iScience, 25 (10), 105127. doi: 10.1016/j.isci.2022.105127.
Wang, Y., Grainger, D. W. (2019). Lyophilized liposome-based parenteral drug development: Reviewing complex product design strategies and current regulatory environments. Advanced Drug Delivery Reviews, 151–152, 56-71. doi: 10.1016/j.addr.2019.03.003.
Li, Z., Han, X., Hong, X., Li, X., Gao, J., Zhang, H. et al. (2021). Lyophilization Serves as an Effective Strategy for Drug Development of the α9α10 Nicotinic Acetylcholine Receptor Antagonist α-Conotoxin GeXIVA[1,2]. Marine drugs, 19(3), 121. doi: 10.3390/md19030121.
Lyophilized Injectable Drugs Market Size - Global Industry, Share, Analysis, Trends and Forecast 2022–2030. Available at: https://www.acumenresearchandconsulting.com/lyophilized-injectable-drugs-market.
Freeze Drying Equipment Market: Global Industry Analysis and Forecast (2022-2029). Available at: https:// www.maximizemarketresearch.com/market-report/global-freeze-drying-equipment-market/26995/.
Pisano, R. (2020). Continuous Manufacturing of Lyophilized Products: Why and How to Make it Happen. Available at: https://www.americanpharmaceuticalreview.com/Featured-Articles/563771-Continuous-Manufacturing-of-Lyophilized-Products-Why-and-How-to-Make-it-Happen.
Sharma, A., Khamar, D., Cullen, S., Hayden, A., Hughes, H. (2021). Innovative Drying Technologies for Biopharmaceuticals. International Journal of Pharmaceutics. 609, 121115. doi: 10.1016/j.ijpharm.2021.121115.
Bhambhani, A., Stanbro, J., Roth, D. Sullivan, E., Jones, M., Evans R. et al. (2021). Evaluation of Microwave Vacuum Drying as an Alternative to Freeze-Drying of Biologics and Vaccines: the Power of Simple Modeling to Identify a Mechanism for Faster Drying Times Achieved with Microwave. AAPS PharmSciTech, 22 (1), 52. doi: 10.1208/s12249-020-01912-9.
Adali, M. B., Barresi, A. A., Boccardo, G., Pisano, R. (2020). Spray Freeze-Drying as a Solution to Continuous Manufacturing of Pharmaceutical Products in Bulk. Processes, 8(6), 709. doi: 10.3390/pr8060709.
Tykhonov, O. I., Almakaieva, L. H., Shpychak, O. S. (2019). Rozrobka tekhnolohii liofilizovanoho poroshku dlia vyhotovlennia rozchynu dlia iniektsii na osnovi otruty bdzholynoi. Visnyk farmatsii, 2 (98). 20-28. doi: 10.24959/nphj.19.9.
Stasevych, M. V., Zvarych, V. I. (2021). Marketynhovyi analiz sehmenta rynku likarskykh zasobiv – pokhidnykh 9,10-antrakhinonu v Ukraini. Chemistry, Technology and Application of Substances, 4, 1, 116-125. doi: 10.23939/ctas2021.01.116.
Semenchuk, Yu. M., Stadnytska, N. Ye. (2022). Analiz asortymentu antybakterialnykh zasobiv dlia systemnoho zastosuvannia farmatsevtychnoho rynku Ukrainy. Chemistry, Technology and Application of Substances, 5, 1, 75-81. doi: 10.23939/ctas2022.01.075.
Saliy, O., Popova, M., Palchevska, T., Tarasenko, G. (2020). Analysis of the assortment of plasma-derived products on Ukraine pharmaceutical market. Farmatsevtychnyi Zhurnal, 4, 18-29. doi: 10.32352/0367-3057.4.20.02.
Rafalska, Y., Kosyachenko, K. (2021). Marketing research of the medicine market for the treatment of breast cancer in Ukraine. Ukrainian Scientific Medical Youth Journal, 127 (4), 77-83. doi: 10.32345.
Derzhavnyi reiestr likarskykh zasobiv Ukrainy. Available at: http://www.drlz.com.ua.
Kompendium: lekarstvennye preparaty. Available at: http://compendium.com.ua.
Srebro, J., Brniak, W., Mendyk, A. (2022). Formulation of Dosage Forms with Proton Pump Inhibitors: State of the Art, Challenges and Future Perspectives. Pharmaceutics, 14 (10), 2043. doi: 10.3390pharmaceutics14102043.
Juckers, A., Knerr, P., Harms, F., Strube, J. (2022). Emerging PAT for Freeze-Drying Processes for Advanced Process Control. Processes, 10 (10), 2059. doi:10.3390/pr10102059.
Saliy, E. A., Honcharuk, A. Yu., Hetalo, O. V., Tarasenko, A. V. (2021). Razrabotka y otsenka lyofylyzyrovannoho poroshka dlia pryhotovlenyia rastvora dlia ynektsyi na osnove doksytsyklyna. Vestnyk Farmatsyy, 3 (93), 53–63. doi:10.52540/2074-9457.2021.3.53.
Sheena, U., Parthiban, K. G., Selvakumar, R. (2018). Lyophilized injection: a modern approach of injectable dosage form. Journal of Drug Delivery and Therapeutics, 8 (5), 10-18. doi: 10.22270/jddt.v8i5.1829.
Kommineni, N., Butreddy, A., Sainaga Jyothi, V. G. S., Angsantikul, P. (2022). Freeze-drying for the preservation of immunoengineering products. iScience, 25 (10), 105127. doi: 10.1016/j.isci.2022.105127.
Wang, Y., Grainger, D. W. (2019). Lyophilized liposome-based parenteral drug development: Reviewing complex product design strategies and current regulatory environments. Advanced Drug Delivery Reviews, 151–152, 56-71. doi: 10.1016/j.addr.2019.03.003.
Li, Z., Han, X., Hong, X., Li, X., Gao, J., Zhang, H. et al. (2021). Lyophilization Serves as an Effective Strategy for Drug Development of the α9α10 Nicotinic Acetylcholine Receptor Antagonist α-Conotoxin GeXIVA[1,2]. Marine drugs, 19(3), 121. doi: 10.3390/md19030121.
Lyophilized Injectable Drugs Market Size - Global Industry, Share, Analysis, Trends and Forecast 2022–2030. Available at: https://www.acumenresearchandconsulting.com/lyophilized-injectable-drugs-market.
Freeze Drying Equipment Market: Global Industry Analysis and Forecast (2022-2029). Available at: https:// www.maximizemarketresearch.com/market-report/global-freeze-drying-equipment-market/26995/.
Pisano, R. (2020). Continuous Manufacturing of Lyophilized Products: Why and How to Make it Happen. Available at: https://www.americanpharmaceuticalreview.com/Featured-Articles/563771-Continuous-Manufacturing-of-Lyophilized-Products-Why-and-How-to-Make-it-Happen.
Sharma, A., Khamar, D., Cullen, S., Hayden, A., Hughes, H. (2021). Innovative Drying Technologies for Biopharmaceuticals. International Journal of Pharmaceutics. 609, 121115. doi: 10.1016/j.ijpharm.2021.121115.
Bhambhani, A., Stanbro, J., Roth, D. Sullivan, E., Jones, M., Evans R. et al. (2021). Evaluation of Microwave Vacuum Drying as an Alternative to Freeze-Drying of Biologics and Vaccines: the Power of Simple Modeling to Identify a Mechanism for Faster Drying Times Achieved with Microwave. AAPS PharmSciTech, 22 (1), 52. doi: 10.1208/s12249-020-01912-9.
Adali, M. B., Barresi, A. A., Boccardo, G., Pisano, R. (2020). Spray Freeze-Drying as a Solution to Continuous Manufacturing of Pharmaceutical Products in Bulk. Processes, 8(6), 709. doi: 10.3390/pr8060709.
Tykhonov, O. I., Almakaieva, L. H., Shpychak, O. S. (2019). Rozrobka tekhnolohii liofilizovanoho poroshku dlia vyhotovlennia rozchynu dlia iniektsii na osnovi otruty bdzholynoi. Visnyk farmatsii, 2 (98). 20-28. doi: 10.24959/nphj.19.9.
Stasevych, M. V., Zvarych, V. I. (2021). Marketynhovyi analiz sehmenta rynku likarskykh zasobiv – pokhidnykh 9,10-antrakhinonu v Ukraini. Chemistry, Technology and Application of Substances, 4, 1, 116-125. doi: 10.23939/ctas2021.01.116.
Semenchuk, Yu. M., Stadnytska, N. Ye. (2022). Analiz asortymentu antybakterialnykh zasobiv dlia systemnoho zastosuvannia farmatsevtychnoho rynku Ukrainy. Chemistry, Technology and Application of Substances, 5, 1, 75-81. doi: 10.23939/ctas2022.01.075.
Saliy, O., Popova, M., Palchevska, T., Tarasenko, G. (2020). Analysis of the assortment of plasma-derived products on Ukraine pharmaceutical market. Farmatsevtychnyi Zhurnal, 4, 18-29. doi: 10.32352/0367-3057.4.20.02.
Rafalska, Y., Kosyachenko, K. (2021). Marketing research of the medicine market for the treatment of breast cancer in Ukraine. Ukrainian Scientific Medical Youth Journal, 127 (4), 77-83. doi: 10.32345.
Derzhavnyi reiestr likarskykh zasobiv Ukrainy. Available at: http://www.drlz.com.ua.
Kompendium: lekarstvennye preparaty. Available at: http://compendium.com.ua.
Srebro, J., Brniak, W., Mendyk, A. (2022). Formulation of Dosage Forms with Proton Pump Inhibitors: State of the Art, Challenges and Future Perspectives. Pharmaceutics, 14 (10), 2043. doi: 10.3390pharmaceutics14102043.
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