older woman with arms spread wide
older woman with arms spread wide

Transforming Overactive Bladder (OAB) treatment

A growing challenge with innovative solutions

Previous Next

Overactive Bladder (OAB) Treatment

Advances in therapies for overactive bladder (OAB) disease now offer more consistent relief to patients, with next-generation treatments delivering improved efficacy and tolerability.

However, developing and manufacturing some OAB treatments such as extended-release mirabegron, for example, can pose challenges including:

  • Chiral impurity management
  • Dissolution
  • Dosage uniformity protocols

OAB affects over 30% of adults aged 65 and older, leading to physical, emotional, and financial burdens. To successfully develop and release OAB products that meet patient needs as well as regulatory expectations, validated methods and highly characterized reference standards are critical.

USP’s proposed monograph for Mirabegron* includes validated methods for separating and quantifying chiral impurities using USP Mirabegron Related Compound A and USP Mirabegron Racemate Reference Standards.

Trust USP’s monographs, Reference Standards and other quality solutions to support your delivery of reliable, effective OAB treatments that help improve patients’ quality of life.

Explore USP solutions for mirabegron, oxybutynin and other treatments for OAB:

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Darifenacin

Darifenacin

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Fesoterodine

Fesoterodine

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Included General Chapters

Included Excipients

Flavoxate

Flavoxate

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Included General Chapters

Included Excipients

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

USP Monograph: Mirabegron

PAIs

Mirabegron Extended-Release Tablets

Included General Chapters

Included Excipients

Mirabegron

Mirabegron

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

USP Monograph: Mirabegron

PAIs

Mirabegron Extended-Release Tablets

Included General Chapters

Included Excipients

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Included General Chapters

Included Excipients

Oxybutynin

Oxybutynin

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Included General Chapters

Included Excipients

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Included General Chapters

Included Excipients

Solifenacin

Solifenacin

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Included General Chapters

Included Excipients

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Included General Chapters

Included Excipients

Tolterodine

Tolterodine

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Included General Chapters

Included Excipients

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Included General Chapters

Included Excipients

Trospium

Trospium

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Included General Chapters

Included Excipients

*Proposed monographs for Mirabegron and Mirabegron Extended-Release Tablets were published in Pharmacopeial Forum (PF) 48(5). Documents in PF are not official and not suitable to demonstrate compliance. They may never become official.