Crushability Analysis of Immediate-Release Oral Tablets and Capsules Approved by FDA in 2020-2022

Authors

Kamaladdin Saei, St. John Fisher UniversityFollow
Anne Schweighardt, St. John Fisher UniversityFollow
Fang Zhao, St. John Fisher UniversityFollow

Document Type

Poster Presentation

Publication Date

12-2023

Department

Pharmacy

Abstract

Healthcare providers often need to explore dosage form options for patients who are unable to swallow whole tablets or capsules. Most newly approved immediate-release (IR) oral solid drugs carry a "do not crush" warning or similar language in their labeling due to the lack of supporting clinical data. A 2021 publication by Uttaro et al. presented a crushability analysis strategy for risk assessment and demonstrated its utility for the questionable drugs on the ISMP do-not-crush list. This study aimed to extend the crushability analysis to newly FDA-approved drugs.

Comments

Poster presented at ASHP Midyear Clinical Meeting, Dec. 2023.

Supplement data can be found: https://fisherpub.sjf.edu/doctoral_ext_pub/83/

Articles referencing this data: https://fisherpub.sjf.edu/doctoral_ext_pub/78/

Publication Information

Saei, Kamaladdin; Schweighardt, Anne; and Zhao, Fang, "Crushability Analysis of Immediate-Release Oral Tablets and Capsules Approved by FDA in 2020-2022" (2023). Doctoral External Publications. Paper 81.
https://fisherpub.sjf.edu/doctoral_ext_pub/81

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