TY - JOUR

T1 - Opportunities for milk and milk-related systems as ‘new’ low-cost excipient drug delivery materials

AU - Salim, Malinda

AU - Eason, Thomas

AU - Boyd, Ben J.

N1 - Funding Information: TE is supported by a PhD stipend top up by Quotient Sciences, UK. BB is supported by a Novo Nordisk Foundation Laureate Research Fellowship. Malinda Salim is supported by an ARC Linkage Projects grant (LP180101147) and was supported by the Bill and Melinda Gates Foundation (OPP1160404) for our work in the field of this review. BB especially would like to thank Frank Szoka for great support throughout his career, for introducing him to Red Bull as an experiment-enhancing nutrition source and for some outstanding discussions in Somona and a lift to UC Davis that led indirectly to funding of much of the cited work through the Bill and Melinda Gates Foundation on milk and infant formula as a drug delivery system. Publisher Copyright: © 2022 The Author(s)

PY - 2022

Y1 - 2022

N2 - Milk is well recognised as an amazing delivery system for essential lipids, poorly soluble nutrients, sugars, amino acids and delivery of critical biological molecules to sustain the infant and adult alike. It is also a safe and abundant resource with potential to act as a low-cost material for formulation of medicines, especially for paediatric patients and those in low economy settings. However, its use in low cost formulations has never developed beyond preclinical evaluation. Reasons for this are several-fold including variable composition and therefore regulatory challenges, as well as a lack of clear understanding around when milk or milk-related materials like infant formula could best be deployed by linking drug properties with excipient composition attributes, especially when taking digestion into account. This review collects the current understanding around these issues. It is apparent from the evolving understanding that while milk may be a bridge too far for translation as an excipient, infant formula is positioned to play a key role in the future because, as a powder-based excipient, it has the performance benefits of milk powder together with the controlled specifications during manufacture and versatility of application to function as a low cost lipid excipient to enable potential translation for the oral delivery of poorly water soluble drugs for key populations including paediatrics and low economy medicines.

AB - Milk is well recognised as an amazing delivery system for essential lipids, poorly soluble nutrients, sugars, amino acids and delivery of critical biological molecules to sustain the infant and adult alike. It is also a safe and abundant resource with potential to act as a low-cost material for formulation of medicines, especially for paediatric patients and those in low economy settings. However, its use in low cost formulations has never developed beyond preclinical evaluation. Reasons for this are several-fold including variable composition and therefore regulatory challenges, as well as a lack of clear understanding around when milk or milk-related materials like infant formula could best be deployed by linking drug properties with excipient composition attributes, especially when taking digestion into account. This review collects the current understanding around these issues. It is apparent from the evolving understanding that while milk may be a bridge too far for translation as an excipient, infant formula is positioned to play a key role in the future because, as a powder-based excipient, it has the performance benefits of milk powder together with the controlled specifications during manufacture and versatility of application to function as a low cost lipid excipient to enable potential translation for the oral delivery of poorly water soluble drugs for key populations including paediatrics and low economy medicines.

KW - Digestion

KW - Formulation

KW - Infant formula

KW - Milk

KW - Poorly water-soluble drug

U2 - 10.1016/j.addr.2022.114139

DO - 10.1016/j.addr.2022.114139

M3 - Review

C2 - 35143892

AN - SCOPUS:85126127547

VL - 183

JO - Advanced Drug Delivery Reviews

JF - Advanced Drug Delivery Reviews

SN - 0169-409X

M1 - 114139

ER -