A novel closed-system drug-transfer device for oral dosage forms: Enhancing safety and administration of hazardous oral therapies in patients with dysphagia

Abstract

Background

Many oral medications are manufactured as solid dosage forms, posing challenges for patients with dysphagia—including older adults and children—and creating occupational hazards for healthcare workers who must crush or manipulate hazardous drugs. Existing methods for preparing such medications often involve open systems, exposing staff to cytotoxic agents and risking cross-contamination.

Objective

To develop and evaluate a novel, single-use closed-system drug-transfer device (CSTD) designed to crush and dissolve or suspend solid oral medications within a sealed environment, enhancing safety for healthcare workers and improving medication access for patients with swallowing difficulties.

Methods

We developed a prototype CSTD comprising a 20 mL transparent barrel, a mechanical crushing piston with an integrated mesh, one-way fluid inlet, and a sealed outlet port for administration. Device sealing integrity was evaluated using vacuum methylene blue ingress testing, while drug extraction efficiency was quantified using high-performance liquid chromatography (HPLC) analysis of paracetamol solutions prepared with the device.

Results

Sealing integrity tests demonstrated no dye ingress under vacuum conditions, confirming a robust closed system. HPLC analysis of paracetamol solutions showed recoveries exceeding 98%, indicating effective crushing and dissolution. The device offers a practical closed-system approach for handling hazardous oral medications and enables safe administration via oral or enteral routes.

Conclusion

This novel CSTD represents a promising innovation to improve occupational safety during hazardous drug handling and to enhance treatment accessibility for patients with dysphagia. Further clinical evaluation and regulatory review are underway.