Oral Drug Product Administration via Enteral Feeding Tubes: In Vitro Testing

Kozeniecki M, Fritzshall R. Enteral nutrition for adults in the hospital setting. Nutr Clin Pract. 2015;30(5):634–51.

Article  PubMed  Google Scholar 

Miller KR, McClave SA, Kiraly LN, Martindale RG, Benns MV. A tutorial on enteral access in adult patients in the hospitalized setting. JPEN J Parenter Enteral Nutr. 2014;38(3):282–95.

Article  PubMed  Google Scholar 

Stegemann S, Gosch M, Breitkreutz J. Swallowing dysfunction and dysphagia is an unrecognized challenge for oral drug therapy. Int J Pharm. 2012;430(1–2):197–206.

Article  CAS  PubMed  Google Scholar 

Ojo O. The challenges of home enteral tube feeding: a global perspective. Nutrients. 2015;7(4):2524–38.

Article  PubMed  PubMed Central  Google Scholar 

Mundi MS, Pattinson A, McMahon MT, Davidson J, Hurt RT. Prevalence of home parenteral and enteral nutrition in the United States. Nutr Clin Pract. 2017;32(6):799–805.

Article  PubMed  Google Scholar 

Hubbard GP, Andrews S, White S, Simpson G, Topen S, Carnie L, Murphy C, Collins R, Davies J, Owen A, Barker J, Green L, Patel I, Ridgway J, Lenchner J, Faerber J, Pearce L, Meanwell H, Kominek N, Stark L, Best H, Simons R, Cross T, Stratton RJ. A survey of bolus tube feeding prevalence and practice in adult patients requiring home enteral tube feeding. Br J Nutr. 2019;122(11):1271–8.

Article  CAS  PubMed  Google Scholar 

Teder K, Jõhvik L, Meos A, Saar M, Visbek A, Volmer D, Karjagin J. Solid oral medications’ suitability for use in enteral feeding tubes. Nurs Crit Care. 2022;27(5):698–705.

Article  PubMed  Google Scholar 

Song Y, Chang M, Suzuki A, Frost RJ, Kelly A, LaCreta F, Frost C. Evaluation of crushed tablet for oral administration and the effect of food on apixaban pharmacokinetics in healthy adults. Clin Ther. 2016;38(7):1674-1685.e1.

Article  CAS  PubMed  Google Scholar 

Williams NT. Medication administration through enteral feeding tubes. Am J Health Syst Pharm. 2008;65(24):2347–57.

Article  CAS  PubMed  Google Scholar 

NIOSH list of antineoplastic and other hazardous drugs in healthcare settings. Centers for Disease Control and Prevention, Publication Number 2016-161. 2016. https://www.cdc.gov/niosh/docs/2016-161/default.html.

Guideline on pharmaceutical development of medicines for paediatric use. European medicines Agency; EMA/CHMP/QWP/805880/2012 Rev. 2. 2013. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-pharmaceutical-development-medicines-paediatric-use_en.pdf.

Quality of medicines questions and answers: part 2 - administration of oral immediate release medicinal products through enteral feeding tubes NEW December 2018. European Medicines Agency. https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/scientific-guidelines/quality-medicines-qa-introduction/quality-medicines-questions-and-answers-part-2#ema-inpage-item-6963.

Oral drug products administered via enteral feeding tube: in vitro testing and labeling recommendations. Draft Guidance for Industry, U.S. Food & Drug Administration, A. Docket Number: FDA-2021-D-0391. 2021. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/oral-drug-products-administered-enteral-feeding-tube-in-vitro-testing-and-labeling-recommendations.

Klek S, Pawlowska D, Dziwiszek G, Komon H, Compala P, Nawojski M. The evolution of home enteral nutrition (HEN) in Poland during five years after implementation: a multicentre study. Nutr Hosp. 2015;32(1):196–201.

PubMed  Google Scholar 

White R, Bradnam V. Handbook of drug administration via enteral feeding tubes, 3rd ed. Aust Prescr. 2016;39(2):53. https://doi.org/10.18773/austprescr.2016.004.

Folwarski M, Kłęk S, Zoubek-Wójcik A, Szafrański W, Bartoszewska L, Figuła K, et al. Home enteral nutrition in adults-nationwide multicenter survey. Nutrients 2020;12(7). https://doi.org/10.3390/nu12072087.

Ojo O. Managing patients on enteral feeding tubes in the community. Br J Community Nurs. 2010;15:S6–13.

Article  Google Scholar 

McIntyre CM, Monk HM. Medication absorption considerations in patients with postpyloric enteral feeding tubes. Am J Health-Syst Pharm. 2014;71(7):549–56.

Article  CAS  PubMed  Google Scholar 

Crushing tablets or opening capsules: many uncertainties, some established dangers. Prescrire Int 2014;23(152):209–11, 213–4. https://pubmed.ncbi.nlm.nih.gov/25325120/#:~:text=The%20active%20ingredient%20released%20may,They%20are%20sometimes%20allergenic.

Use of liquids and/or soft foods as vehicles for drug administration: general considerations for selection and in vitro methods for product quality assessments. U.S. Food & Drug Administration, Docket Number: FDA-2018-D-2544. 2018. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-liquids-andor-soft-foods-vehicles-drug-administration-general-considerations-selection-and-vitro.

Powers JE, Cascella PJ. Comparison of methods used to prepare tablets for nasogastric tube administration. J Pharm Technol. 1990;6(2):60–2.

Article  Google Scholar 

Salmon D, Pont E, Chevallard H, Diouf E, Tall ML, Pivot C, Pirot F. Pharmaceutical and safety considerations of tablet crushing in patients undergoing enteral intubation. Int J Pharm. 2013;443(1–2):146–53.

Article  CAS  PubMed  Google Scholar 

Boullata JI. Enteral medication for the tube-fed patient: making this route safe and effective. Nutr Clin Pract. 2021;36(1):111–32.

Article  PubMed  Google Scholar 

Wallace T, Steward DK. Gastric tube use and care in the NICU. Newborn Infant Nurs Rev. 2014;14:103–8.

Article  Google Scholar 

Guha S, Niswander W, Herman A, Antonino MJ, Venkataraman Rao P, White K, Haugen S, Vesnovsky O. Assessing dosing errors in legacy and low dose tip ENFit(®) syringes. J Clin Pharm Ther. 2022;47(2):218-227.

Hofstetter J, Allen LV Jr. Causes of non-medication-induced nasogastric tube occlusion. Am J Hosp Pharm. 1992;49(3):603–7.

CAS  PubMed  Google Scholar 

Smith AL, Santa Ana CA, Fordtran JS, Guileyardo JM Unsuitability of sump tubes for delivery of enteral nutrition and medications to intensive care unit patients. Proc (Bayl Univ Med Cent) 2021;34(5):560-565.

Elia M, Crozier C, Martin S, Neale G. Flow and aspiration of artificial feeds through nasogastric tubes. Clin Nutr. 1984;2(3–4):159–66.

Article  CAS  PubMed  Google Scholar 

Gaither KA, Tarasevich BJ, Goheen SC. Modification of polyurethane to reduce occlusion of enteral feeding tubes. J Biomed Mater Res B Appl Biomater. 2009;91(1):135–42.

Article  PubMed  Google Scholar 

Hoover A, Chitranshi P, Momot M, Tyner K, Wokovich A. In vitro evaluation of enteral tube administration of lansoprazole orally disintegrating tablets. Pharm Dev Technol. 2021;26(8):846–51.

Article  CAS  PubMed  Google Scholar 

Karkossa F, Lehmann N, Klein S. A systematic approach for assessing the suitability of enteral feeding tubes for the administration of controlled-release pellet formulations. Int J Pharm. 2022;612: 121286.

Article  CAS  PubMed  Google Scholar 

GEDSA Unified ENFit Conversion Message Book 20220628. 2022. https://stayconnected.org/gedsa-unified-enfit-conversion-message-book-20220628/.

Guenter P, Lyman B. ENFit enteral nutrition connectors: benefits and challenges. Nutr Clin Pract. 2016;31(6):769–72.

Article  PubMed  Google Scholar 

Potential for medication overdose with ENFit low dose tip syringe: FDA safety communication; November 18, 2021 update. https://www.fda.gov/medical-devices/safety-communications/potential-medication-overdose-enfit-low-dose-tip-syringe-fda-safety-communication.

Guha S, Herman A, Antonino M, Silverstein JS, Venkataraman-Rao P, Myers MR. Synthesis of research on ENFit gastrostomy tubes with potential implications for US patients using these devices. Nutr Clin Pract. 2022;37(4):752–61.

Article  PubMed  Google Scholar 

Feeding Tube Awareness Foundation, What you need to know now: a parent’s introduction to tube feeding. https://jldtherapy.com/wp-content/uploads/2021/08/ParentGuide-English.pdf.

Thomson FC, Naysmith MR, Lindsay A. Managing drug therapy in patients receiving enteral and parenteral nutrition. Hospital Pharmacist. 2000;7:155–64.

Google Scholar 

Dandeles LM, Lodolce AE. Efficacy of agents to prevent and treat enteral feeding tube clogs. Ann Pharmacother. 2011;45(5):676–80.

Article  PubMed  Google Scholar 

Lord LM. Restoring and maintaining patency of enteral feeding tubes. Nutr Clin Pract. 2003;18(5):422–6.

Article  PubMed  Google Scholar 

Boullata JI, Carrera AL, Harvey L, Escuro AA, Hudson L, Mays A, McGinnis C, Wessel JJ, Bajpai S, Beebe ML, Kinn TJ, Klang MG, Lord L, Martin K, Pompeii-Wolfe C, Sullivan J, Wood A, Malone A, Guenter P. ASPEN safe practices for enteral nutrition therapy. JPEN J Parenter Enteral Nutr. 2017;41(1):15–103.

Article  PubMed  Google Scholar 

Chiwele I, Jones BE, Podczeck F. The shell dissolution of various empty hard capsules. Chem Pharm Bull. 2000;48(7):951–6.

Article  CAS  Google Scholar 

Kunieda K, Kurata N, Yoshimatsu Y, Ohno T, Shigematsu T, Fujishima I. A safe way to administer drugs through a nutrition tube—the simple suspension method. Dysphagia. 2022;37(2):318–22.

Article  PubMed  Google Scholar 

Ankrum JA, Olechowski A, Canseco JA, Greenblatt E, Roberts MP, Hanumara NC, et al. Nasogastric tube design to reduce clogging and simplify flushing. J Med Devices 2011;5(2).

Avanos enteral nutrition delivery. https://avanosmedicaldevices.com/product-catalog/digestive-health/nicu-and-pharmacy/enteral-nutrition-delivery/. Accessed Jul 2023.

Kangaroo™ neonatal & pediatric feeding system, pp. https://www.cardinalhealth.com/en/product-solutions/medical/enteral-feeding/kangaroo-neonatal-pediatric-feeding-system/kangaroo-polyurethane-feeding-tubes-with-safe-enteral-connections.html. Accessed Jul 2023.

Pediatric nasogastric feeding tubes. https://www.vescomedical.com/copy-of-ng-tubes. Accessed Jul 2023.

USP 〈1111〉 Microbiological examination of nonsterile products: acceptance criteria for pharmaceutical preparations and substances for pharmaceutical use. Official Prior to 2023. https://online.uspnf.com/uspnf/document/1_GUID-5D1EDF19-6C70-4F74-A474-07D9B25B1C58_1_en-US?source=Quick%20Search&highlight=usp%201111.

ISO 10993-17:2023, Biological evaluation of medical devices — part 17: Toxicological risk assessment of medical device constituents.

ISO 10993-12:2021 Biological evaluation of medical devices — part 12: Sample preparation and reference materials.

Instructions for Use — Patient labeling for human prescription drug and biological products — content and format. U.S. Food & Drug Administration; Docket Number: FDA-2019-D-1615. 2022. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/instructions-use-patient-labeling-human-prescription-drug-and-biological-products-content-and-format.

https://www.ema.europa.eu/en/documents/assessment-report/ravicti-epar-public-assessment-report_en.pdf.

pi_eliquis.pdf(bms.com)

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