Designing a sustained-release solid oral formulation for overactive bladder treatment: a quality by design approach
Background: Mirabegron, a first-in-class β3-adrenergic agonist used for managing overactive bladder (OAB), is well-documented in the literature. However, its low oral permeability results in poor bioavailability, limiting patient compliance and tolerability. To address this, the present study focuse...
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| Language: | English |
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Creative Pharma Assent
2025-02-01
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| Series: | Journal of Applied Pharmaceutical Research |
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| Online Access: | https://japtronline.com/index.php/joapr/article/view/820 |
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| author | Neeraj Sharma Daksh Bhatia Sharda Shambhakar Pavitra Solanki |
| author_facet | Neeraj Sharma Daksh Bhatia Sharda Shambhakar Pavitra Solanki |
| author_sort | Neeraj Sharma |
| collection | DOAJ |
| description | Background: Mirabegron, a first-in-class β3-adrenergic agonist used for managing overactive bladder (OAB), is well-documented in the literature. However, its low oral permeability results in poor bioavailability, limiting patient compliance and tolerability. To address this, the present study focuses on developing a sustained-release (SR) tablet of mirabegron with enhanced oral effectiveness. In this research, mirabegron was combined with polyethylene oxide to improve permeability and formulated as an HPC-loaded SR tablet, promising improved bioavailability and anti-OAB efficacy. Methods: Tablet design and optimization were carried out using the Box-Behnken Design (Design Expert® 12 software) to refine formulation parameters. The study aimed to create a commercially viable SR tablet with improved intestinal permeability, bioavailability, and clinical acceptance. Results: The optimized formulation showed a 34.8% increase in bioavailability compared to the marketed tablet. In vivo pharmacokinetic studies demonstrated a 31.77% increase in plasma concentration over the marketed formulation. Conclusion: The developed formulation is safe and effective, offering improved therapeutic potential for treating overactive bladder. This work represents a significant advancement in OAB management and highlights the commercial viability of the emerging mirabegron SR tablet in meeting current therapeutic needs. |
| format | Article |
| id | doaj-art-4938117659824234ab35e77f440aed2c |
| institution | DOAJ |
| issn | 2348-0335 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | Creative Pharma Assent |
| record_format | Article |
| series | Journal of Applied Pharmaceutical Research |
| spelling | doaj-art-4938117659824234ab35e77f440aed2c2025-08-20T02:55:16ZengCreative Pharma AssentJournal of Applied Pharmaceutical Research2348-03352025-02-0113112313510.69857/joapr.v13i1.820821Designing a sustained-release solid oral formulation for overactive bladder treatment: a quality by design approachNeeraj Sharma0Daksh Bhatia1Sharda Shambhakar2Pavitra Solanki3Department of Pharmaceutics, Banasthali Vidyapith, P.O. Banasthali Vidyapith, Rajasthan-304022, IndiaDepartment of Pharmacognosy, KIET School of Pharmacy, Ghaziabad, Uttar Prdaesh-201206, Indiaepartment of Pharmaceutics, Banasthali Vidyapith, P.O. Banasthali Vidyapith, Rajasthan-304022, IndiaDepartment of Pharmaceutics, Delhi Pharmaceutical Sciences and Research University, New Delhi-110017, IndiaBackground: Mirabegron, a first-in-class β3-adrenergic agonist used for managing overactive bladder (OAB), is well-documented in the literature. However, its low oral permeability results in poor bioavailability, limiting patient compliance and tolerability. To address this, the present study focuses on developing a sustained-release (SR) tablet of mirabegron with enhanced oral effectiveness. In this research, mirabegron was combined with polyethylene oxide to improve permeability and formulated as an HPC-loaded SR tablet, promising improved bioavailability and anti-OAB efficacy. Methods: Tablet design and optimization were carried out using the Box-Behnken Design (Design Expert® 12 software) to refine formulation parameters. The study aimed to create a commercially viable SR tablet with improved intestinal permeability, bioavailability, and clinical acceptance. Results: The optimized formulation showed a 34.8% increase in bioavailability compared to the marketed tablet. In vivo pharmacokinetic studies demonstrated a 31.77% increase in plasma concentration over the marketed formulation. Conclusion: The developed formulation is safe and effective, offering improved therapeutic potential for treating overactive bladder. This work represents a significant advancement in OAB management and highlights the commercial viability of the emerging mirabegron SR tablet in meeting current therapeutic needs.https://japtronline.com/index.php/joapr/article/view/820overactive bladderquality by designmirabegronsustained release tabletpolyethylene oxideoral drug delivery |
| spellingShingle | Neeraj Sharma Daksh Bhatia Sharda Shambhakar Pavitra Solanki Designing a sustained-release solid oral formulation for overactive bladder treatment: a quality by design approach Journal of Applied Pharmaceutical Research overactive bladder quality by design mirabegron sustained release tablet polyethylene oxide oral drug delivery |
| title | Designing a sustained-release solid oral formulation for overactive bladder treatment: a quality by design approach |
| title_full | Designing a sustained-release solid oral formulation for overactive bladder treatment: a quality by design approach |
| title_fullStr | Designing a sustained-release solid oral formulation for overactive bladder treatment: a quality by design approach |
| title_full_unstemmed | Designing a sustained-release solid oral formulation for overactive bladder treatment: a quality by design approach |
| title_short | Designing a sustained-release solid oral formulation for overactive bladder treatment: a quality by design approach |
| title_sort | designing a sustained release solid oral formulation for overactive bladder treatment a quality by design approach |
| topic | overactive bladder quality by design mirabegron sustained release tablet polyethylene oxide oral drug delivery |
| url | https://japtronline.com/index.php/joapr/article/view/820 |
| work_keys_str_mv | AT neerajsharma designingasustainedreleasesolidoralformulationforoveractivebladdertreatmentaqualitybydesignapproach AT dakshbhatia designingasustainedreleasesolidoralformulationforoveractivebladdertreatmentaqualitybydesignapproach AT shardashambhakar designingasustainedreleasesolidoralformulationforoveractivebladdertreatmentaqualitybydesignapproach AT pavitrasolanki designingasustainedreleasesolidoralformulationforoveractivebladdertreatmentaqualitybydesignapproach |