{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,8]],"date-time":"2026-09-08T14:18:06Z","timestamp":1788877086827,"version":"build-2803163510"},"reference-count":19,"publisher":"SAGE Publications","issue":"1","license":[{"start":{"date-parts":[[2025,9,4]],"date-time":"2025-09-04T00:00:00Z","timestamp":1756944000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["J Oncol Pharm Pract"],"published-print":{"date-parts":[[2026,2]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Many oral medications are manufactured as solid dosage forms, posing challenges for patients with dysphagia\u2014including older adults and children\u2014and 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/10781552251371292","type":"journal-article","created":{"date-parts":[[2025,9,4]],"date-time":"2025-09-04T13:28:20Z","timestamp":1756992500000},"page":"127-134","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":3,"title":["A novel closed-system drug-transfer device for oral dosage forms: Enhancing safety and administration of hazardous oral therapies in patients with dysphagia"],"prefix":"10.1177","volume":"32","author":[{"ORCID":"https:\/\/orcid.org\/0009-0006-2417-7240","authenticated-orcid":false,"given":"Salim","family":"Hadad","sequence":"first","affiliation":[{"name":"Rambam Health Care Campus; Rappaport Faculty of Medicine, Technion-Israel Institute of Technology"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Iyad","family":"Khamaysi","sequence":"additional","affiliation":[{"name":"Rambam Health Care Campus"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eyas","family":"Haddad","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology, Bnei Zion Hospital, Haifa, Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2025,9,4]]},"reference":[{"key":"e_1_3_4_2_2","first-page":"859","article-title":"Medication administration in patients with dysphagia: a review","volume":"11","author":"Wright D","year":"2002","unstructured":"Wright D. Medication administration in patients with dysphagia: a review. Br J Nurs 2002; 11: 859\u2013866.","journal-title":"Br J Nurs"},{"key":"e_1_3_4_3_2","doi-asserted-by":"publisher","DOI":"10.1001\/archotol.131.11.970"},{"key":"e_1_3_4_4_2","doi-asserted-by":"publisher","DOI":"10.2147\/CIA.S121905"},{"key":"e_1_3_4_5_2","first-page":"178","article-title":"Geriatric drug therapy: neglected factors in drug development and regulation","volume":"97","author":"Stegemann S","year":"2010","unstructured":"Stegemann S, Ecker F, Maio M, et al. Geriatric drug therapy: neglected factors in drug development and regulation. Health Policy 2010; 97: 178\u2013185.","journal-title":"Health Policy"},{"key":"e_1_3_4_6_2","doi-asserted-by":"publisher","DOI":"10.7748\/ns.16.42.33.s1"},{"key":"e_1_3_4_7_2","doi-asserted-by":"publisher","DOI":"10.1007\/s00228-012-1417-0"},{"key":"e_1_3_4_8_2","volume-title":"Aulton\u2019s Pharmaceutics: The Design and Manufacture of Medicines","author":"Aulton ME","year":"2018","unstructured":"Aulton ME, Taylor K. Aulton\u2019s Pharmaceutics: The Design and Manufacture of Medicines. 5th ed. Edinburgh: Elsevier, 2018.","edition":"5"},{"key":"e_1_3_4_9_2","unstructured":"European Pharmacopoeia 10.0. Chapter 2.9.8: Resistance to crushing of tablets."},{"key":"e_1_3_4_10_2","first-page":"1075","article-title":"Mechanical properties of tablets and influence on break force testing","volume":"98","author":"Hoag SW","year":"2009","unstructured":"Hoag SW, et al. Mechanical properties of tablets and influence on break force testing. J Pharm Sci 2009; 98: 1075\u20131086.","journal-title":"J Pharm Sci"},{"key":"e_1_3_4_11_2","unstructured":"United States Pharmacopeia (USP). General Chapter <800> Hazardous Drugs\u2014Handling in Healthcare Settings. USP43\u2013NF38. Rockville MD: United States Pharmacopeial Convention; 2020."},{"key":"e_1_3_4_12_2","unstructured":"European Medicines Agency (EMA). Guideline on the sterilisation of the medicinal product active substance excipient and primary container. EMA\/CHMP\/CVMP\/QWP\/850374\/2015. London: EMA; 2019."},{"key":"e_1_3_4_13_2","volume-title":"Guidance for industry: container closure systems for packaging human drugs and biologics","author":"U.S. Food and Drug Administration (FDA)","year":"1999","unstructured":"U.S. Food and Drug Administration (FDA). Guidance for industry: container closure systems for packaging human drugs and biologics. Rockville, MD: FDA, 1999."},{"key":"e_1_3_4_14_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2648.2011.05700.x"},{"key":"e_1_3_4_15_2","doi-asserted-by":"publisher","DOI":"10.1177\/1078155207082350"},{"key":"e_1_3_4_16_2","unstructured":"United States Pharmacopeia (USP). <1207.1> Package Integrity Testing \u2013 Technologies and Applications. USP 43\u2013NF38. Rockville MD: United States Pharmacopeial Convention; 2020."},{"key":"e_1_3_4_17_2","volume-title":"Q2(R1): Validation of analytical procedures: text and methodology","author":"International Conference on Harmonisation (ICH)","year":"2005","unstructured":"International Conference on Harmonisation (ICH). Q2(R1): Validation of analytical procedures: text and methodology. Geneva: ICH, 2005."},{"key":"e_1_3_4_18_2","unstructured":"United States Pharmacopeia (USP). <621> Chromatography. USP 43\u2013NF38. Rockville MD: United States Pharmacopeial Convention; 2020."},{"key":"e_1_3_4_19_2","first-page":"171","article-title":"Recommendations for using oral antineoplastic and immunomodulating agents in oncohematology by enteral tube administration","volume":"39","author":"Mart\u00ednez CL","year":"2022","unstructured":"Mart\u00ednez CL, Romero Jim\u00e9nez RM, V\u00e1zquez-L\u00f3pez C, et al. Recommendations for using oral antineoplastic and immunomodulating agents in oncohematology by enteral tube administration. Nutr Hosp 2022; 39: 171\u2013201.","journal-title":"Nutr Hosp"},{"key":"e_1_3_4_20_2","first-page":"358","article-title":"Hazard drug enteral device: a closed system device for crushing and dispersing hazardous tablets for enteral administration","volume":"26","author":"Vidal Lopez C","year":"2022","unstructured":"Vidal Lopez C, Rios Quito GL. Hazard drug enteral device: a closed system device for crushing and dispersing hazardous tablets for enteral administration. Int J Pharm Compd 2022; 26: 358\u2013362.","journal-title":"Int J Pharm Compd"}],"container-title":["Journal of Oncology Pharmacy Practice"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/10781552251371292","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/10781552251371292","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/10781552251371292","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,2]],"date-time":"2026-05-02T02:31:38Z","timestamp":1777689098000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/10781552251371292"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,9,4]]},"references-count":19,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2026,2]]}},"alternative-id":["10.1177\/10781552251371292"],"URL":"https:\/\/doi.org\/10.1177\/10781552251371292","relation":{},"ISSN":["1078-1552","1477-092X"],"issn-type":[{"value":"1078-1552","type":"print"},{"value":"1477-092X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,9,4]]}}}