Developmental strategy for swellable/erodible matrix tablet of mirabegron: quality by design approach with various geometric properties and pharmacokinetic evaluation

Kim, Ji Yeon; Kim, Tae Hwan; Kim, Eunbin; Choi, Du Hyung

doi:10.1007/s40005-023-00642-x

J. Pharm. Investig.

2023

DOI: 10.1007/s40005-023-00642-x

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Developmental strategy for swellable/erodible matrix tablet of mirabegron: quality by design approach with various geometric properties and pharmacokinetic evaluation

Ji Yeon Kim,

Tae Hwan Kim,

Eunbin Kim

et al.

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2024

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Cited by 3 publications

References 39 publications

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Ryu

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International Journal of Pharmaceutics

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Core-shell tablets designed for modified and sequential release of ibuprofen and rabeprazole

Khan,

Choi,

Ryu

et al. 2024

International Journal of Pharmaceutics

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Environmentally safe chemometric evaluation and data analysis for the kinetic investigation of mirabegron stability

Sami,

Rostom,

Yehia

et al. 2024

Sustainable Chemistry and Pharmacy

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Unveiling Swelling and Erosion Dynamics: Early Development Screening of Mirabegron Extended Release Tablets

Sousa,

Serra,

Estevens

et al. 2024

AAPS PharmSciTech

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Although the development of extended release (ER) matrices has been extensively investigated, understanding the most appropriate mechanism of drug release to achieve the desired release remains a cost- and time-consuming challenge in the early stages of formulation development. This study aimed to investigate the early stage of developing ER hydrophilic matrix tablets containing mirabegron as a model drug, focusing on the effects of polymer type, diluent type, and polymer amount on critical quality attributes (CQAs), namely, tablet swelling and erosion behavior. A full factorial design was employed to explore the interactions of control factors through multivariate regression analysis, emphasizing the application of quality by design (QbD) principles. The swelling and erosion performances of 72 formulations were evaluated. The swelling data were fitted to the Vergnaud model. Finally, in vitro drug release profiles were investigated for four of the formulations studied. The polymer type, diluent type, and polymer amount had distinct effects on the swelling and erosion behavior of the ER matrix tablets. Compared with those with isomalt (G720) or dextrate (DXT), formulations with polyethylene glycol 8000 (P8000) consistently exhibited greater swelling. Additionally, higher molecular weight was correlated with increased swelling within the same polymer type. Hydroxypropylmethylcellulose (HPMC) and polyethylene oxide (PEO)-based formulations showed higher swelling rates, while polyvinyl alcohol (PVA-80) displayed the highest erosion percentage. The findings highlight the significance of incorporating early-stage screening designs to maximize efficiency and optimize time and resource. This approach enables the development of a comprehensive understanding of drug release mechanisms from ER matrix tablets. Graphical abstract

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Developmental strategy for swellable/erodible matrix tablet of mirabegron: quality by design approach with various geometric properties and pharmacokinetic evaluation

Cited by 3 publications

References 39 publications

Core-shell tablets designed for modified and sequential release of ibuprofen and rabeprazole

Core-shell tablets designed for modified and sequential release of ibuprofen and rabeprazole

Environmentally safe chemometric evaluation and data analysis for the kinetic investigation of mirabegron stability

Unveiling Swelling and Erosion Dynamics: Early Development Screening of Mirabegron Extended Release Tablets

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