APPLICATIONS OF MATHEMATICAL MODELLING IN PHARMACEUTICAL FORMULATION AND PROCESS DEVELOPMENT

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 i...

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Published inAURUM Journal of Engineering Systems and Architecture Vol. 7; no. 2; pp. 119 - 143
Main Authors YEĞEN, Gizem, SENEL, Cagla, PABUCCUOĞLU, Saadet Kevser, AKSU, Buket
Format Journal Article
LanguageEnglish
Published 08.11.2023
Online AccessGet full text
ISSN2564-6397
DOI10.53600/ajesa.1382037

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Abstract 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.
AbstractList 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.
Author PABUCCUOĞLU, Saadet Kevser
AKSU, Buket
SENEL, Cagla
YEĞEN, Gizem
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Cites_doi 10.1080/03639045.2017.1291672
10.1016/j.ejpb.2019.12.007
10.1016/j.jcrysgro.2021.126263
10.1016/B978-0-12-815799-2.00001-0
10.1016/B978-0-12-815799-2.00003-4
10.1016/j.carbpol.2018.07.054
10.1016/j.ijpharm.2016.12.010
10.1016/j.jddst.2022.103207
10.1007/s11094-019-02070-4
10.1080/19420862.2021.2013593
10.1016/j.ijpharm.2019.119004
10.1021/acsomega.2c02141
10.3390/molecules25040809
10.1080/10837450.2022.2145308
10.29228/jrp.63
10.1021/acsomega.9b04327
10.1016/j.nano.2017.05.014
10.1208/s12249-021-02004-y
10.5455/musbed.20140327095117
10.1208/s12248-014-9598-3
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ref12
ref15
ref14
ref11
ref10
ref2
ref17
ref16
ref18
ref8
ref7
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  doi: 10.1080/03639045.2017.1291672
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  doi: 10.1016/j.jcrysgro.2021.126263
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  doi: 10.1016/B978-0-12-815799-2.00001-0
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  doi: 10.1016/B978-0-12-815799-2.00003-4
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  doi: 10.1021/acsomega.2c02141
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  doi: 10.3390/molecules25040809
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  doi: 10.29228/jrp.63
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  doi: 10.1021/acsomega.9b04327
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  doi: 10.1016/j.nano.2017.05.014
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  doi: 10.1208/s12249-021-02004-y
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  doi: 10.5455/musbed.20140327095117
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  doi: 10.1208/s12248-014-9598-3
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