Crushability Assessment of Immediate-Release Oral Tablets and Capsules Approved by the FDA in 2024

Document Type

Poster Presentation

Publication Date

4-17-2026

Keywords

fsc2026

Abstract

Purpose: Crushing oral solid dosage forms is often necessary for patients with dysphagia. However, many newly approved immediate-release (IR) tablets and capsules carry broad “do not crush” warnings, without supporting rationale. This lack of clarity complicates care and delays safe, effective medication administration, particularly when no alternative formulations are available. Building upon previous student-led research evaluating crushability of medications approved between 2020 and 2023, this study expands the analysis to novel drugs approved by the FDA in 2024. The goal is to provide an additional resource to support evidence-based decision-making in clinical settings and advocate for greater transparency in labeling practices.

Methods: The list of 2024 FDA novel drug approvals was screened to identify those formulated as IR oral tablets or capsules. Of the 50 approvals, 20 met inclusion criteria. Each drug was then evaluated using a standardized checklist considering several factors, such as availability of alternative dosage forms, presence of special formulation characteristics, suspected chemical/physical stability concerns, pharmacokinetic implications, and potential hazardous drug exposure concerns. Primary sources of information included FDA labeling, Orange Book patents, and the NIOSH list of hazardous drugs. Manufacturers were also contacted for additional safety and stability data. Drugs that included explicit crush instructions in their labeling were excluded from formal analysis, but noted in the results.

Results: Of the 20 identified oral IR products, 2 were available in alternative formulations. Among the remaining 18, 2 included clear instructions for preparing a liquid dosage form, 10 carried non-specific “do not crush” warnings, and 6 were silent on this topic. Thus, crushability analysis was performed on the remaining 16 medications, of which 5 were identified as high risk for crushing. Of these 5 drugs, 3 presented a chemical stability concern and 2 posed a physical and pharmacokinetic stability concern. The remaining 11 medications were deemed lower risk for crushing based on currently available data. A structured summary table was created to document the rationale behind each classification and provide final recommendations regarding crushing, including any occupational exposures that may arise in practice, while doing so.

Conclusion: This study extends prior institutional research by evaluating 2024 FDA approved IR oral dosage forms for safe manipulation. While our findings suggest that many medications exhibit low risk for crushing, several present significant risk if manipulated. The results reinforce the need for manufacturers to provide clear, evidence-based recommendations when including “do not crush” warnings. By providing updated evaluations for novel drugs, this work supports pharmacists and clinicians in making informed decisions, when treating patients with swallowing difficulties.

Comments

Poster presented at the 2026 Fisher Showcase, St. John Fisher University, April 17, 2026.

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