Stability of nevirapine suspension in prefilled oral syringes used for reduction of mother-to-child HIV transmission.
OBJECTIVE
To reduce mother-to-child transmission (MTCT) of HIV, we assessed the stability of nevirapine suspension in an oral dosing syringe over a range of storage conditions.


METHODS
A mother-to-child transmission dosing kit, containing a maternal nevirapine tablet and infant nevirapine suspension in an oral syringe that can be dispensed to the pregnant woman to use at delivery. However, the manufacturer only packages nevirapine in 240 mL, multidose containers and there are no published stability data for nevirapine suspension repackaged in an oral syringe.


METHODS
Nevirapine suspension 6 mg/0.6 mL in 3 mL amber BAXA Exacta-Med Oral Dispensers (Baxa Corporation, Englewood, CO) were stored under the following conditions: 26 degrees C/high relative humidity (RH), 40 degrees C/low RH, 40 degrees C/high RH, refrigerated and frozen -30 degrees C for 6 months. The samples were assayed monthly for nevirapine by HPLC-UV. At 3, 4, and 6 months the samples were cultured for pathogens.


RESULTS
: There were no significant decreases in nevirapine concentrations in the prefilled syringes compared with baseline. Nevirapine became more concentrated in syringes incubated at 40 degrees C/low RH due to evaporation resulting in the suspension becoming more viscous. No pathogens were cultured.


CONCLUSIONS
Nevirapine suspension is stable and pathogen free at varying conditions for 6 months in Baxa Exacta-Med Oral Dispensers.
Rexroad
Vivian E
VE
Department of Pharmacy, Johns Hopkins Hospital, Baltimore, MD 21287-6180, USA. vrexroa@jhmi.edu
Parsons
Teresa L
TL
Hamzeh
Fayez M
FM
Li
Xianbin
X
Dreyfuss
Michele L
ML
Stamper
Paul D
PD
Gray
Ronald H
RH
D000284:Administration, Oral; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000627:therapeutic use; D004349:Drug Packaging; D004355:Drug Stability; D004356:Drug Storage; D005260:Female; D015658:HIV Infections / Q000517:prevention & control / Q000635:transmission*; D006801:Humans; D007223:Infant; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D019829:Nevirapine / Q000008:administration & dosage / Q000627:therapeutic use*; D018743:Perinatal Care / Q000592:standards; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy*; D012646:Self Administration; D013535:Suspensions; D013594:Syringes; D013696:Temperature
D019380:Anti-HIV Agents; D013535:Suspensions; D019829:Nevirapine