Subcutaneous administration of cefepime.

Area of Science:

• Pharmacology
• Drug Delivery Systems
• Clinical Pharmacy

Background:

• Symptomatic infections require effective management, often involving palliative care.
• Traditional cefepime administration (intravenous, intramuscular) may be challenging in non-institutional settings.
• Novel drug delivery methods are needed for home-based patient care.

Purpose of the Study:

• To evaluate the pharmacokinetics and tolerability of cefepime administered via subcutaneous infusion.
• To assess the feasibility of subcutaneous cefepime for patients outside traditional healthcare facilities, such as in home hospice.
• To compare subcutaneous cefepime pharmacokinetics to existing administration routes.

Main Methods:

• Ten healthy adult volunteers received a 1g subcutaneous cefepime infusion over 30 minutes.
• Serial serum samples were collected for 12 hours post-infusion and analyzed using high-performance liquid chromatography (HPLC).
• Population pharmacokinetic analysis was performed using the Non-Parametric Adaptive Grid (NPAG) program; tolerability and acceptability were assessed via subjective grading and site observation.

Main Results:

• Pharmacokinetic parameters (mean [median]): Cmax 36.1 (30.9) mg/L, beta-t1/2 2.34 (2.56) hours, AUC0-oo 134.8 (125.3) h*mg/L, total clearance 7.42 (7.98) L/h.
• Subcutaneous infusions were well-tolerated, with no reported side effects or administration difficulties.
• All participants reported high global acceptability ('strongly agreeable') for the subcutaneous administration route.

Conclusions:

• Subcutaneous cefepime infusion exhibits pharmacokinetic properties similar to intramuscular administration.
• The method is highly tolerable and acceptable to subjects, suggesting potential for outpatient and home care settings.
• Further clinical investigation is warranted to confirm the efficacy and safety of subcutaneous cefepime infusion in patient populations.