The Physicochemical Compatibility of Sildenafil Injection with Parenteral Medications Used in Neonatal Intensive Care Settings

Author:

De Silva D. Thisuri N.1,Strunk Tobias234,Petrovski Michael5,Page-Sharp Madhu1,Moore Brioni R.1236,Batty Kevin T.16ORCID

Affiliation:

1. Curtin Medical School, Curtin University, Bentley 6102, Australia

2. Medical School, The University of Western Australia, Crawley 6009, Australia

3. Wesfarmers Centre for Vaccines and Infectious Diseases, Telethon Kids Institute, Nedlands 6009, Australia

4. Neonatal Directorate, King Edward Memorial Hospital, Child and Adolescent Health Service, Subiaco 6008, Australia

5. Pharmacy Department, King Edward Memorial Hospital, Women and Newborn Health Service, Subiaco 6008, Australia

6. Curtin Health Innovation Research Institute, Curtin University, Bentley 6102, Australia

Abstract

Sildenafil is used to treat pulmonary hypertension in neonatal intensive care unit (NICU) settings. As multiple intravenous (IV) medications are co-administered in NICU settings, we sought to investigate the physicochemical compatibility of sildenafil with a range of IV drugs. Sildenafil 600 mcg/mL or 60 mcg/mL was mixed 1:1 with the secondary drug solution to simulate Y-site co-administration procedures. Physical compatibility was evaluated by visual observation against a black and white background and under polarized light for two hours for changes in colour, precipitation, haze and evolution of gas. Chemical compatibility was determined from sildenafil concentrations, using a validated, stability-indicating high-performance liquid chromatography assay. Sildenafil 600 mcg/mL was physicochemically compatible with 29 of the 45 drugs tested at ‘high-end’ clinical concentrations and physically incompatible with 16 drugs and six ‘2-in-1’ parenteral nutrition solutions. Sildenafil 600 mcg/mL was compatible with lower, clinically relevant concentrations of calcium gluconate, heparin and hydrocortisone. Aciclovir, amoxicillin, ampicillin, ibuprofen lysine, indometacin, phenobarbitone and rifampicin were incompatible with sildenafil 600 mcg/mL, however these IV medications were compatible with sildenafil 60 mcg/mL. Sildenafil 600 mcg/mL and 60 mcg/mL were incompatible with amphotericin, flucloxacillin, furosemide, ibuprofen, meropenem and sodium bicarbonate. Sildenafil compatibility with commonly used syringe filters was also investigated. Sildenafil solution was compatible with nylon syringe filters, however, absorption/adsorption loss occurred with polyethersulfone and cellulose ester filters.

Publisher

MDPI AG

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