50 years of oral lipid-based formulations: provenance, progress and future perspectives

Feeney, Orlagh M.; Crum, Matthew F.; McEvoy, Claire L.; Trevaskis, Natalie L.; Williams, Hywel D.; Pouton, Colin W.; Charman, William N.; Bergström, Christel A.S.; Porter, Christopher J.H.

doi:10.1016/j.addr.2016.04.007

Cited by 432Drug Solubulity and Delivery SystemsAdvanced Drug Delivery SystemsDrug Transport and Resistance Mechanisms

50 years of oral lipid-based formulations: provenance, progress and future perspectives

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Feeney, Orlagh M., Crum, Matthew F., McEvoy, Claire L., Trevaskis, Natalie L., Williams, Hywel D., Pouton, Colin W., Charman, William N., Bergström, Christel A.S. +1 more·2016·Advanced Drug Delivery Reviews

DOI 10.1016/j.addr.2016.04.007

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Abstract

Lipid based formulations (LBF) provide well proven opportunities to enhance the oral absorption of drugs and drug candidates that sit close to, or beyond, the boundaries of Lipinski's 'rule-of-five' chemical space. Advantages in permeability, efflux and presystemic metabolism are evident; however, the primary benefit is in increases in dissolution and apparent intestinal solubility for lipophilic, poorly water soluble drugs. This review firstly details the inherent advantages of LBF, their general properties and classification, and provides a brief retrospective assessment of the development of LBF over the past fifty years. More detailed analysis of the ability of LBF to promote intestinal solubilisation, supersaturation and absorption is then provided alongside review of the methods employed to assess formulation performance. Critical review of the ability of simple dispersion and more complex in vitro digestion methods to predict formulation performance subsequently reveals marked differences in the correlative ability of in vitro tests, depending on the properties of the drug involved. Notably, for highly permeable low melting drugs e.g. fenofibrate, LBF appear to provide significant benefit in all cases, and sustained ongoing solubilisation may not be required. In other cases, and particularly for higher melting point drugs such as danazol, where re-dissolution of crystalline precipitate drug is likely to be slow, correlations with ongoing solubilisation and supersaturation are more evident. In spite of their potential benefits, one limitation to broader use of LBF is low drug solubility in the excipients employed to generate formulations. Techniques to increase drug lipophilicity and lipid solubility are therefore explored, and in particular those methods that provide for temporary enhancement including lipophilic ionic liquid and prodrug technologies. The transient nature of these lipophilicity increases enhances lipid solubility and LBF viability, but precludes enduring effects on receptor promiscuity and off target toxicity. Finally, recent efforts to generate solid LBF are briefly described as a means to circumvent the need to encapsulate in soft or hard gelatin capsules, although the latter remain popular with consumers and a proven means of LBF delivery.

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A limited number (50%) of in vitro-in vivo correlations have been observed for lipid-based drug delivery systems based on comparing drug solubilisation in the aqueous phase of the digestion medium from the standard in vitro lipolysis model and in vivo drug absorption.
“Despite the advances in optimising digestion conditions to more closely match the in vivo scenario, overall a limited number (50%) of in vitro -in vivo correlations (IVIVC) have been observed for LBDDS based on comparing drug solubilisation in the aqueous phase of the digestion medium from the standard in vitro lipolysis model and the in vivo drug absorption (Feeney et al., 2016).”
From Exploring impact of supersaturated lipid-based drug delivery systems of celecoxib on in vitro permeation across PermeapadⓇ membrane and in vivo absorption (2020) · cites this paper as Feeney et al., 2016

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Authors: Feeney, O. M., Crum, M. F., McEvoy, C. L., Trevaskis, N. L., Williams, H. D., Pouton, C. W., Charman, W. N., Bergström, C. A. S., & Porter, C. J. H.
Affiliations: Monash University (AU)
Uppsala University (SE)
Corresponding author: Porter, Christopher J.H.
ORCID: Feeney, Orlagh M.
Crum, Matthew F.
Trevaskis, Natalie L.
Williams, Hywel D.
Pouton, Colin W.
Charman, William N.
Bergström, Christel A.S.
Porter, Christopher J.H.
Venue: Advanced Drug Delivery Reviews
Publisher: Elsevier BV
Published: 2016-06
Volume: 101
Pages: 167-194
ISSN: 0169-409X (ISSN-L)
DOI: 10.1016/j.addr.2016.04.007
OpenAlex: W2339649458
Cited by: 426
References: 289
Citations by year: 2026: 28 · 2025: 45 · 2024: 43 · 2023: 39 · 2022: 50 · 2021: 46 · 2020: 63 · 2019: 33 · 2018: 41 · 2017: 27 · 2016: 10
FWCI: 3.15
Type: journal article
Language: en
Open access: green
research.monash.edu
Licence: other-oa
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations: Advanced Drug Delivery Reviews (publishedVersion)
PubMed (publishedVersion)
Monash University Research Portal (Monash University) (submittedVersion, other-oa)
Funders: Australian Research Council (CE140100036, DP110103969)
National Health and Medical Research Council (00010544)
Capsugel
Lipid Formulation Classification System (LFCS) Consortium
Pfizer and GSK
Topics: Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmaceutical Science › Drug Solubulity and Delivery Systems
Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmaceutical Science › Advanced Drug Delivery Systems
Health Sciences › Medicine › Oncology › Drug Transport and Resistance Mechanisms
Keywords: lipid-based formulations, oral drug absorption, poorly water-soluble drugs, supersaturation, dissolution enhancement, in vitro digestion, in vitro-in vivo correlation, ionic liquids, prodrugs, gelatin capsules, pharmaceutical excipients, drug-metabolizing enzymes, drug permeability
MeSH terms: Administration, Oral, Drug Compounding, Pharmaceutical Preparations, Emulsions, Lipids, Fenofibrate, Solubility, Drug Delivery Systems, Hydrophobic and Hydrophilic Interactions

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