The ENA In Four Steps
New tool
Vitro Tool
Patented invention
New in vitro tool
The Enabling Absorption Device (ENA) is a new in vitro tool that captures the
complex dynamics between digestion and absorption in the gastro-intestinal tract.
Physiologically relevant
Monitoring
Physiologically relevant
The ENA monitors digestion, dissolution/release and permeation in the same assay,
enabling a more physiologically relevant evaluation of the absorption of API´s, drug
loaded formulations, and excipients in vitro
Dynamic
Sink conditions
Dynamic
The ENA provides a dynamic representation of conditions in the small intestine. It
provides ”sink conditions” for adequate absorption assessment, and it captures
potential membrane-mediated excipient effects.
Enables comparison
Comparison
Enables comparison
The ENA tests the complete dosage form, it enables comparison beween different formulation principles, and it can be used with difficult drug classes (BCS class II).
ENA - The Enabling Absorption Device
Oral administration is the most convenient and least invasive route of drug administration. Most API candidates have low solubility, translating into low bioavailability when delivered orally. Enabling formulations increase their solubility, but current in vitro methods fail to predict the best dosage form for optimal in vivo performance. Enphasys has developed, patented and validated the Enabling Absorption Device, a smart benchtop assay that mimics digestion and absorption and provides superior in vitro in vivo correlation (IVIVC).
Fewer animal experiments
The vast majority of animals used in drug development are consumed in
formulation testing. The ENA will significantly reduce these numbers
Faster time to market
Finding the optimal formulation of a drug candidate using standard methods is
laborious and time consuming. A comprehensive analysis with the
ENA takes just a few weeks
Gold standard
The ENA is validated in several species and demonstrates superior IVIVIC to
standard methods. It correctly picks the top performing formulation amongst
your candidates
Better drugs - lower cost
The ENA correctly identifies the best performing formulation candidate regardless of type and provides detailed mechanistic information on formulation performance for further optimization. An optimal formulation
increases chances of successful clinical trials, the most expensive part of drug development
Our publications
in vitro digestion assays for the evaluation of ritonavir loaded solid lipid-based formulations.
European Journal of Pharmaceutical Sciences. 2023, 189(106524).
doi.org/10.1016/j.ejps.2023.106524
Keemink J, Hedge OJ, Bianco V, Hubert M, Bergström CAS. Comparison of cellular
monolayers and an artificial membrane as absorptive membranes in the in vitro lipolysis-
permeation assay. Journal of Pharmaceutical Sciences. 2022, 111(1):175-184. doi:
10.1016/j.xphs.2021.09.009.
Alvebratt C, Bergström CAS. Dissolution-digestion-permeation models for biorelevant
profiling of advanced drug delivery systems. CRS India Chapter Newsletter 2022, p 20-22.
Hedge, Oliver. Predicting oral performance of lipid-based formulations using in
vitro methods. Doctoral Thesis 2021. Uppsala University, Disciplinary Domain of Medicine
and Pharmacy, Faculty of Pharmacy, Department of Pharmacy.
Alvebratt, Caroline Advanced Methods for Evaluation of the Performance of Complex Drug
Delivery System Doctoral thesis 2021. Uppsala University, Disciplinary Domain of Medicine
and Pharmacy, Faculty of Pharmacy, Department of Pharmacy.
Hedge OJ, Bergström CAS. Suitability of artificial membranes in lipolysis-permeation assays
of oral lipid-based formulations. Pharmaceutical Research, 2020, 37(6), p99 (1-14). doi:
10.1007/s11095-020-02833-9.
Alskär L, et al. Effect of lipids on absorption of carvedilol in dogs: Is co-administration of lipids as efficient
as a lipid-based formulation? Journal of Controlled Release, 2019, 304, 90-100.
Doi:10.1016/j.conrel.2019.04.038.
Keemink J, Mårtensson E, Bergström CAS. A lipolysis-permeation setup for simultaneous
study of digestion and absorption in vitro. Molecular Pharmaceutics, 2019, 16(3), 921-930.
doi: 10.1021/acs.molpharmaceut.8b00811.
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