Abstract

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 2022, this study expands the analysis to novel drugs approved by the United States Food and Drug Administration (FDA) in 2023 and 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 FDA novel drug approvals was screened to identify those formulated as IR oral tablets or capsules. Of the 105 approvals, 41 met inclusion criteria. Each drug was then evaluated using a standardized checklist considering 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 National Institute for Occupational Safety and Health (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 41 identified oral IR products, 2 were available in alternative liquid formulations, and 4 included clear instructions for preparing a liquid dosage form. Crushability analysis was performed on the remaining 35 medications, of which 11 were identified as high risk for crushing. Of these 11 drugs, 4 presented a chemical stability concern, and 7 posed a physical stability/pharmacokinetic concern. The remaining 24 medications were deemed low 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.

CONCLUSION: This study extends prior institutional research by evaluating 2023 and 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 in their labeling. By providing updated evaluations for novel drugs, this work supports pharmacists and clinicians in making informed decisions, when treating patients with swallowing difficulties.

Related Keywords

• Tzikas Christina
• Saei Kamaladdin
• Zhao Fang
• Schweighardt Anne
• Crushability
• Immediate-release
• Dysphagia
• Oral Solid Dosage Forms
• Medication Manipulation

Related Categories

• PEER-REVIEWED
• QUALITY CONTROL
• DOSAGE FORMS/DRUG CARRIERS