Derleme
BibTex RIS Kaynak Göster
Yıl 2023, , 303 - 313, 31.12.2023
https://doi.org/10.53600/ajesa.1382037

Öz

Kaynakça

  • Aksu, B., Yegen, G. (2014). New Quality Concepts in Pharmaceuticals. Journal of Marmara University Institute of Health Sciences, 4(2):96-104. DOI: 10.5455/musbed.20140327095117 Bastogne T. (2017). Quality-by-design of nanopharmaceuticals - a state of the art. Nanomedicine, 3(7):2151-2157. https://doi.org./10.1016/j.nano.2017.05.014
  • Beg, S., Hasnain, M. S., Rahman, M., & Swain, S. (2019). Introduction to Quality by Design (QbD): Fundamentals, Principles, and Applications. Pharmaceutical Quality by Design-Principles and Applications, 1-17. https://doi.org/10.1016/B978-0-12-815799-2.00001-0
  • Beg, S., Swain, S., Rahman, M., Hasnain, S., & Imam, S. S. (2019). Application of Design of Experiments (DoE) in Pharmaceutical Product and Process Optimization. In S. Beg, & M. S. Hasnain, Pharmaceutical Quality by Design-Principles and Applications (pp. 43-64). Academic Press. https://doi.org/10.1016/B978-0-12-815799-2.00003-4
  • Dhoot, A. S., Fernandes, G. J., Naha, A., Rathnanand, M., & Kumar, L. (2019). Design of Experiments in Pharmaceutical Development. Pharmaceutical Chemistry Journal, 53(8):730-735. Ekinci, M., Yegen, G., Aksu, B., Özdemir, D.İ. (2022). Preparation and Evaluation of Poly(lactic acid)/Poly(vinyl alcohol) Nanoparticles Using the Quality by Design Approach. ACS Omega, 7, 33793−33807. https://doi.org/10.1021/acsomega.2c02141
  • Fachel, F.N.S., Medeiros-Neves, B., Dal Prá, M., Schuh, R.S., Veras, K.S., Bassani, V.L., Koester, L.S., Henriques, A.T., Braganhol, E., Teixeira, H.F. (2019). Box-Behnken design optimization of mucoadhesive chitosan-coated nanoemulsions for rosmarinic acid nasal delivery—In vitro studies. Carbohydrate Polymers, 199: 572-582. https://doi.org/10.1016/j.carbpol.2018.07.054
  • Garg, N.K., Sharma, G., Singh, B., Nirbhavane, P., Tyagi, R.K., R., Katare, O.P. (2017). Quality by Design (QbD)-enabled development of aceclofenac loaded-nano structured lipid carriers (NLCs): An improved dermatokinetic profile for inflammatory disorder(s). International Journal of Pharmaceutics, 517(1–2): 413-431. https://doi.org/10.1016/j.ijpharm.2016.12.010
  • Grangeia, H.B., Silva, C., Simões, S.P., Reis, M.S. (2020). Quality by design in pharmaceutical manufacturing: A systematic review of current status, challenges and future perspectives. European Journal of Pharmaceutics and Biopharmaceutics, 147:19-37. https://doi.org/10.1016/j.ejpb.2019.12.007
  • Gündogdu, E., Demir, E. S., Özgenç, E., Yeğen, G., Aksu, B. (2020). Applying Quality by Design Principles in the Development and Preparation of a New Radiopharmaceutical: Technetium-99mImatinib Mesylate. ACS Omega, 5, 5297−5305. https://doi.org/10.1021/acsomega.9b04327
  • Garg, M., Rathore, A. S. (2021) Process development in the QbD paradigm: Implementing design of experiments (DoE) in anti-solvent crystallization for production of pharmaceuticals, Journal of Crystal Growth, 571: 126263. https://doi.org/10.1016/j.jcrysgro.2021.126263
  • Jiwa, N., Ozalp, Y., Yegen, G., & Aksu, B. (2021). Critical Tools in Tableting Research: Using Compaction Simulator and Quality by Design (QbD) to Evaluate Lubricants’ Effect in Direct Compressible Formulation. AAPS PharmSciTech, 22: 151. https://doi.org/10.1208/s12249-021-02004-y
  • Ozcan Bulbul, E., Husseın, H.A., Yegen G., Okur, M.E., Ustundag Okur, N., Aksu, A.B. (2022). Preparation and in vitro–in vivo evaluation of QbD based acemetacin loaded transdermal patch formulations for rheumatic diseases. Pharmaceutical Development and Technology, 27(10): 1016–1026. https://doi.org/10.1080/10837450.2022.2145308
  • Politis, S. N., Colombo, P., Colombo, G., Rekkas, D. M. (2017). Design of experiments (DoE) in pharmaceutical development. Drug Dev Ind Pharm, 43(6):889-901. https://doi.org/10.1080/03639045.2017.1291672
  • Portier, C., Pandelaere, K., Delaet, U., Vigh, T., Di Pretoro, G., De Beer, T., Vervaet, C., Vanhoorne, V. (2020). Continuous twin screw granulation: A complex interplay between formulation properties, process settings and screw design. International Journal of Pharmaceutics, 576: 119004. https://doi.org/10.1016/j.ijpharm.2019.119004
  • Tome, T., Časar, Z., Obreza, A. (2020). Development of a Unified Reversed-Phase HPLC Method for Efficient Determination of EP and USP Process-Related Impurities in Celecoxib Using Analytical Quality by Design Principles. Molecules, 13;25(4):809. https://doi.org/10.3390/molecules25040809
  • Walsh, I., Myint, M., Nguyen-Khuong, T., Ho, Y.S., Ng, S.K., Lakshmanan, M. (2022) Harnessing the potential of machine learning for advancing “Quality by Design” in biomanufacturing. MAbs, 14(1): 2013593. https://doi.org/10.1080/19420862.2021.2013593
  • Yeğen, G., Aksu, B., Cevher, E. (2021). Design of an orally disintegrating tablet formulation containing metoprolol tartrate in the context of quality by design approach. Journal of Research in Pharmacy, 25(5): 728-737. https://dx.doi.org/10.29228/jrp.63
  • Yu, L. X., Amidon, G., Khan, M. A., Hoag, S. W., Polli, J., Raju, G. K., & Woodcock, a. J. (2014). Understanding Pharmaceutical Quality by Design. The AAPS Journal, 16(4): 771–783. https://doi.org/10.1208/s12248-014-9598-3
  • Zagalo, D.M., Silva, B.M.A., Silva, C., Simões, S., Sousa J.J. (2022). A quality by design (QbD) approach in pharmaceutical development of lipid-based nanosystems: A systematic review. Journal of Drug Delivery Science and Technology, 70: 103207. https://doi.org/10.1016/j.jddst.2022.103207

APPLICATIONS OF MATHEMATICAL MODELLING IN PHARMACEUTICAL FORMULATION AND PROCESS DEVELOPMENT

Yıl 2023, , 303 - 313, 31.12.2023
https://doi.org/10.53600/ajesa.1382037

Öz

Pharmaceutical development and authorization stages have high requirements that increase labour and costs. Risks for product quality and process robustness also increase in parallel with complex practices existing in the pharmaceutical industry and emerging as a result of developments. Although it is challenging to eliminate parameters leading to increased risks, there is need to appropriately manage the risks likewise arrange decision making processes. Designing and optimizing formulation and production processes to deliver the predetermined product quality is known as Quality by Design (QbD) in pharmaceutical development. In terms of data and knowledge, QbD can be carried out using a variety of technologies in this process. Mathematical modelling is one of these tools allows for the quick formation of subject knowledge, which may subsequently be used in an independent or integrated manner and to produce Design of Experiments (DOE). Response surface method (RSM), Artificial Neural Network (ANN), Genetic Algorithm (GA) are some of the assistive technologies used in mathematical modelling that enables to enlighten the effect of formulation and process variables on product quality attributes. The use of advanced mathematical modelling techniques in formulation and process development has become widespread and it appears to be beneficial in different areas of pharmaceutical development.

Kaynakça

  • Aksu, B., Yegen, G. (2014). New Quality Concepts in Pharmaceuticals. Journal of Marmara University Institute of Health Sciences, 4(2):96-104. DOI: 10.5455/musbed.20140327095117 Bastogne T. (2017). Quality-by-design of nanopharmaceuticals - a state of the art. Nanomedicine, 3(7):2151-2157. https://doi.org./10.1016/j.nano.2017.05.014
  • Beg, S., Hasnain, M. S., Rahman, M., & Swain, S. (2019). Introduction to Quality by Design (QbD): Fundamentals, Principles, and Applications. Pharmaceutical Quality by Design-Principles and Applications, 1-17. https://doi.org/10.1016/B978-0-12-815799-2.00001-0
  • Beg, S., Swain, S., Rahman, M., Hasnain, S., & Imam, S. S. (2019). Application of Design of Experiments (DoE) in Pharmaceutical Product and Process Optimization. In S. Beg, & M. S. Hasnain, Pharmaceutical Quality by Design-Principles and Applications (pp. 43-64). Academic Press. https://doi.org/10.1016/B978-0-12-815799-2.00003-4
  • Dhoot, A. S., Fernandes, G. J., Naha, A., Rathnanand, M., & Kumar, L. (2019). Design of Experiments in Pharmaceutical Development. Pharmaceutical Chemistry Journal, 53(8):730-735. Ekinci, M., Yegen, G., Aksu, B., Özdemir, D.İ. (2022). Preparation and Evaluation of Poly(lactic acid)/Poly(vinyl alcohol) Nanoparticles Using the Quality by Design Approach. ACS Omega, 7, 33793−33807. https://doi.org/10.1021/acsomega.2c02141
  • Fachel, F.N.S., Medeiros-Neves, B., Dal Prá, M., Schuh, R.S., Veras, K.S., Bassani, V.L., Koester, L.S., Henriques, A.T., Braganhol, E., Teixeira, H.F. (2019). Box-Behnken design optimization of mucoadhesive chitosan-coated nanoemulsions for rosmarinic acid nasal delivery—In vitro studies. Carbohydrate Polymers, 199: 572-582. https://doi.org/10.1016/j.carbpol.2018.07.054
  • Garg, N.K., Sharma, G., Singh, B., Nirbhavane, P., Tyagi, R.K., R., Katare, O.P. (2017). Quality by Design (QbD)-enabled development of aceclofenac loaded-nano structured lipid carriers (NLCs): An improved dermatokinetic profile for inflammatory disorder(s). International Journal of Pharmaceutics, 517(1–2): 413-431. https://doi.org/10.1016/j.ijpharm.2016.12.010
  • Grangeia, H.B., Silva, C., Simões, S.P., Reis, M.S. (2020). Quality by design in pharmaceutical manufacturing: A systematic review of current status, challenges and future perspectives. European Journal of Pharmaceutics and Biopharmaceutics, 147:19-37. https://doi.org/10.1016/j.ejpb.2019.12.007
  • Gündogdu, E., Demir, E. S., Özgenç, E., Yeğen, G., Aksu, B. (2020). Applying Quality by Design Principles in the Development and Preparation of a New Radiopharmaceutical: Technetium-99mImatinib Mesylate. ACS Omega, 5, 5297−5305. https://doi.org/10.1021/acsomega.9b04327
  • Garg, M., Rathore, A. S. (2021) Process development in the QbD paradigm: Implementing design of experiments (DoE) in anti-solvent crystallization for production of pharmaceuticals, Journal of Crystal Growth, 571: 126263. https://doi.org/10.1016/j.jcrysgro.2021.126263
  • Jiwa, N., Ozalp, Y., Yegen, G., & Aksu, B. (2021). Critical Tools in Tableting Research: Using Compaction Simulator and Quality by Design (QbD) to Evaluate Lubricants’ Effect in Direct Compressible Formulation. AAPS PharmSciTech, 22: 151. https://doi.org/10.1208/s12249-021-02004-y
  • Ozcan Bulbul, E., Husseın, H.A., Yegen G., Okur, M.E., Ustundag Okur, N., Aksu, A.B. (2022). Preparation and in vitro–in vivo evaluation of QbD based acemetacin loaded transdermal patch formulations for rheumatic diseases. Pharmaceutical Development and Technology, 27(10): 1016–1026. https://doi.org/10.1080/10837450.2022.2145308
  • Politis, S. N., Colombo, P., Colombo, G., Rekkas, D. M. (2017). Design of experiments (DoE) in pharmaceutical development. Drug Dev Ind Pharm, 43(6):889-901. https://doi.org/10.1080/03639045.2017.1291672
  • Portier, C., Pandelaere, K., Delaet, U., Vigh, T., Di Pretoro, G., De Beer, T., Vervaet, C., Vanhoorne, V. (2020). Continuous twin screw granulation: A complex interplay between formulation properties, process settings and screw design. International Journal of Pharmaceutics, 576: 119004. https://doi.org/10.1016/j.ijpharm.2019.119004
  • Tome, T., Časar, Z., Obreza, A. (2020). Development of a Unified Reversed-Phase HPLC Method for Efficient Determination of EP and USP Process-Related Impurities in Celecoxib Using Analytical Quality by Design Principles. Molecules, 13;25(4):809. https://doi.org/10.3390/molecules25040809
  • Walsh, I., Myint, M., Nguyen-Khuong, T., Ho, Y.S., Ng, S.K., Lakshmanan, M. (2022) Harnessing the potential of machine learning for advancing “Quality by Design” in biomanufacturing. MAbs, 14(1): 2013593. https://doi.org/10.1080/19420862.2021.2013593
  • Yeğen, G., Aksu, B., Cevher, E. (2021). Design of an orally disintegrating tablet formulation containing metoprolol tartrate in the context of quality by design approach. Journal of Research in Pharmacy, 25(5): 728-737. https://dx.doi.org/10.29228/jrp.63
  • Yu, L. X., Amidon, G., Khan, M. A., Hoag, S. W., Polli, J., Raju, G. K., & Woodcock, a. J. (2014). Understanding Pharmaceutical Quality by Design. The AAPS Journal, 16(4): 771–783. https://doi.org/10.1208/s12248-014-9598-3
  • Zagalo, D.M., Silva, B.M.A., Silva, C., Simões, S., Sousa J.J. (2022). A quality by design (QbD) approach in pharmaceutical development of lipid-based nanosystems: A systematic review. Journal of Drug Delivery Science and Technology, 70: 103207. https://doi.org/10.1016/j.jddst.2022.103207
Toplam 18 adet kaynakça vardır.

Ayrıntılar

Birincil Dil İngilizce
Konular Kimya Mühendisliği (Diğer)
Bölüm Derleme
Yazarlar

Gizem Yeğen 0000-0003-0427-8918

Cagla Senel 0000-0003-0427-8918

Saadet Kevser Pabuccuoğlu 0000-0002-1793-0859

Buket Aksu 0000-0001-7555-0603

Yayımlanma Tarihi 31 Aralık 2023
Gönderilme Tarihi 27 Ekim 2023
Kabul Tarihi 8 Kasım 2023
Yayımlandığı Sayı Yıl 2023

Kaynak Göster

APA Yeğen, G., Senel, C., Pabuccuoğlu, S. K., Aksu, B. (2023). APPLICATIONS OF MATHEMATICAL MODELLING IN PHARMACEUTICAL FORMULATION AND PROCESS DEVELOPMENT. AURUM Journal of Engineering Systems and Architecture, 7(2), 303-313. https://doi.org/10.53600/ajesa.1382037