The ENA In Four Steps

01

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.

Image of the ENA device
02

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

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03

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.

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04

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).

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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).

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Fewer animal experiments

The vast majority of animals used in drug development are consumed in
formulation testing. The ENA will significantly reduce these numbers

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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

Illustration of the ENA device
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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

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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

Andreadis I, Schulzen A, Quodbach J, Bergström CAS. Exploring the use of modified
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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© 2022 Enphasys AB. All right reserved.  Phent
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This project has recieved funding by the European Union's Horizon 2020 research and innovation programme under grant agreement No 836869
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