A nipple shield delivery system for oral drug delivery to breastfeeding infants: microbicide delivery to inactivate HIV.
A new drug delivery method for infants is presented which incorporates an active pharmaceutical ingredient (API)-loaded insert into a nipple shield delivery system (NSDS). The API is released directly into milk during breastfeeding. This study investigates the feasibility of using the NSDS to deliver the microbicide sodium dodecyl sulfate (SDS), with the goal of preventing mother-to-child transmission (MTCT) of HIV during breastfeeding in low-resource settings, when there is no safer alternative for the infant but to breastfeed. SDS has been previously shown to effectively inactivate HIV in human milk. An apparatus was developed to simulate milk flow through and drug release from a NSDS. Using this apparatus milk was pulsed through a prototype device containing a non-woven fiber insert impregnated with SDS and the microbicide was rapidly released. The total SDS release from inserts ranged from 70 to 100% of the average 0.07 g load within 50 ml (the volume of a typical breastfeed). Human milk spiked with H9/HIV(IIIB) cells was also passed through the same set-up. Greater than 99% reduction of cell-associated HIV infectivity was achieved in the first 10 ml of milk. This proof of concept study demonstrates efficient drug delivery to breastfeeding infants is achievable using the NSDS.
BioScience Engineering Research Group, Department of Chemical Engineering and Biotechnology, University of Cambridge, New Museums Site, Pembroke Street, Cambridge, United Kingdom. stephen.gerrard@cantab.net
Stephen E
SE
Gerrard
Mary Lynn
ML
Baniecki
David C
DC
Sokal
Mary K
MK
Morris
Sandra
S
Urdaneta-Hartmann
Fred C
FC
Krebs
Brian
B
Wigdahl
Barbara F
BF
Abrams
Carl V
CV
Hanson
Nigel K H
NK
Slater
Alexander D
AD
Edwards
D000818:Animals; D019380:Anti-HIV Agents / Q000008:administration & dosage* / Q000494:pharmacology; D001942:Breast Feeding / Q000379:methods; D002417:Cattle; D016503:Drug Delivery Systems; D005240:Feasibility Studies; D005260:Female; D015658:HIV Infections / Q000517:prevention & control* / Q000635:transmission / Q000821:virology; D015497:HIV-1 / Q000187:drug effects; D006801:Humans; D007223:Infant; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control; D008895:Milk, Human / Q000821:virology; D009558:Nipples; D012967:Sodium Dodecyl Sulfate / Q000008:administration & dosage* / Q000494:pharmacology; D013501:Surface-Active Agents / Q000008:administration & dosage / Q000494:pharmacology
D019380:Anti-HIV Agents; D013501:Surface-Active Agents; D012967:Sodium Dodecyl Sulfate