Stability of nevirapine suspension in prefilled oral syringes used for reduction of mother-to-child HIV transmission

Vivian E. Rexroad, Teresa L. Parsons, Fayez M. Hamzeh, Xianbin Li, Michele L. Dreyfuss, Paul Stamper, Ronald H Gray

Research output: Contribution to journalArticle

Abstract

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. DESIGN: 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°C/high relative humidity (RH), 40°C/low RH, 40°C/high RH, refrigerated and frozen -30°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°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.

Original languageEnglish (US)
Pages (from-to)373-375
Number of pages3
JournalJournal of Acquired Immune Deficiency Syndromes
Volume43
Issue number3
DOIs
StatePublished - Nov 2006

Fingerprint

Nevirapine
Syringes
Suspensions
Mothers
HIV
Humidity
Prefil
Amber
Carbon Monoxide
Tablets
Pregnant Women
High Pressure Liquid Chromatography

Keywords

  • Africa
  • Mother-to-child HIV transmission (MTCT)
  • Nevirapine
  • Nevirapine stability in oral syringes
  • Vertical HIV transmission

ASJC Scopus subject areas

  • Virology
  • Immunology

Cite this

Stability of nevirapine suspension in prefilled oral syringes used for reduction of mother-to-child HIV transmission. / Rexroad, Vivian E.; Parsons, Teresa L.; Hamzeh, Fayez M.; Li, Xianbin; Dreyfuss, Michele L.; Stamper, Paul; Gray, Ronald H.

In: Journal of Acquired Immune Deficiency Syndromes, Vol. 43, No. 3, 11.2006, p. 373-375.

Research output: Contribution to journalArticle

Rexroad, Vivian E. ; Parsons, Teresa L. ; Hamzeh, Fayez M. ; Li, Xianbin ; Dreyfuss, Michele L. ; Stamper, Paul ; Gray, Ronald H. / Stability of nevirapine suspension in prefilled oral syringes used for reduction of mother-to-child HIV transmission. In: Journal of Acquired Immune Deficiency Syndromes. 2006 ; Vol. 43, No. 3. pp. 373-375.
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abstract = "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. DESIGN: 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°C/high relative humidity (RH), 40°C/low RH, 40°C/high RH, refrigerated and frozen -30°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°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.",
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T1 - Stability of nevirapine suspension in prefilled oral syringes used for reduction of mother-to-child HIV transmission

AU - Rexroad, Vivian E.

AU - Parsons, Teresa L.

AU - Hamzeh, Fayez M.

AU - Li, Xianbin

AU - Dreyfuss, Michele L.

AU - Stamper, Paul

AU - Gray, Ronald H

PY - 2006/11

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N2 - 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. DESIGN: 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°C/high relative humidity (RH), 40°C/low RH, 40°C/high RH, refrigerated and frozen -30°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°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.

AB - 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. DESIGN: 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°C/high relative humidity (RH), 40°C/low RH, 40°C/high RH, refrigerated and frozen -30°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°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.

KW - Africa

KW - Mother-to-child HIV transmission (MTCT)

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