In vitro performance evaluation of a self-emulsifying anhydrous suspension vehicle for enteral drug administration

Résumé fourni par la source

Administration of oral medications through enteral feeding tubes presents many challenges. Although anhydrous suspension vehicles may offer advantages for poorly water-soluble or hydrolysis-sensitive drugs, their suitability for enteral administration has not been well characterized. This study evaluated the performance of a self-emulsifying anhydrous suspension vehicle. Metronidazole 50 mg/mL suspensions prepared in the self-emulsifying anhydrous suspension vehicle and two commonly used non-self-emulsifying anhydrous vehicles were compared for residual deposition and drug recovery following administration through feeding tubes. Based on preliminary findings, the self-emulsifying vehicle was further evaluated using five representative formulations - metronidazole 50 mg/mL, doxycycline 100 mg/mL, nifedipine 4 mg/mL, chloroquine 10 mg/mL, and valacyclovir 50 mg/mL - for potency, content uniformity, tube occlusion risk, drug recovery, osmolality, and compatibility with feeding tube materials using various tube types and sizes. For the metronidazole formulation, the self-emulsifying vehicle showed minimal residual deposition after repeated administration and more consistent drug recovery. All tested formulations demonstrated acceptable potency and content uniformity. Drug recovery exceeded 90% across all evaluated formulations. Tube occlusion was formulation- and tube size-dependent. Due to its anhydrous nature, the self-emulsifying vehicle itself had no measurable osmolality. After 1:5 dilution, all tested formulations exhibited osmolality below or around 300 mOsm/kg. No evidence of degradation or structural changes in feeding tube materials was observed following vehicle exposure. The self-emulsifying anhydrous suspension vehicle demonstrated favorable performance for enteral drug administration. These findings support its potential as an alternative vehicle for enteral administration of challenging oral medications.

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