Designing a sustained-release solid oral formulation for overactive bladder treatment: a quality by design approach

Neeraj Sharma; Daksh  Bhatia; Sharda Shambhakar; Pavitra  Solanki

doi:10.69857/joapr.v13i1.820

Authors

Neeraj Sharma Department of Pharmaceutics, Banasthali Vidyapith, P.O. Banasthali Vidyapith, Rajasthan-304022, India
Daksh Bhatia Department of Pharmacognosy, KIET School of Pharmacy, Ghaziabad, Uttar Prdaesh-201206, India
Sharda Shambhakar epartment of Pharmaceutics, Banasthali Vidyapith, P.O. Banasthali Vidyapith, Rajasthan-304022, India
Pavitra Solanki Department of Pharmaceutics, Delhi Pharmaceutical Sciences and Research University, New Delhi-110017, India

DOI:

https://doi.org/10.69857/joapr.v13i1.820

Keywords:

Overactive bladder, Quality by Design, Mirabegron, Sustained release tablet, Polyethylene oxide, Oral Drug delivery

Abstract

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.

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