Absorption Studies for Pharmaceuticals

Based in Italy, ECSIN LAB – part of Mérieux NutriSciences Group – is an Innovation Lab that combines the attention toward the efficacy of the proposed solutions with the participation to international scientific strategic projects for the future.

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Absorption Studies for Pharmaceuticals: Our Lab

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**Absorption & Efficacy Studies by In Vitro Models**

In vitro testing and models support all pharmaceuticals manufacturing process, from the idea to the commercialization of a product. Thanks to different in vitro applications, it is possible to mimic the effects of drugs through biological models and absorption studies, performing several screening tests as:

Identifying the best active ingredient for a chosen purpose
Optimizing the formula to improve its biological activity and properties
Preliminary evaluation of bioaccessibility/bioavailability
Efficacy evaluation to preliminarily evaluate product, ingredient or formulation before proceeding with the next step evaluation (e.g. clinical trial).

Our experts can develop various and customized in vitro models for different applications able to mimic the effects of drugs through biological models and absorption studies, performing several screening tests to preliminarily evaluate product, ingredient or formulation before to proceed with the next step evaluation (e.g. clinical trial).

The biological models are composed of biological fluids that represent the digestive process, plasma serum, brain tissue, heart and blood, prostate and many others. The models are implementable and adaptable according to the type of fluid or study to be carried out, and according to the customer’s needs.

Screening Protocol Study

Dissolution Test:

Standard dissolution test according to EP/USP
Delayed/gradual release dissolution test according to EP/USP

Absorption Test Shot-Gun Analysis:

Preliminary bioavailability assessment – systemic level (for internal use information): Gastro-intestinal absorption study using a 2-step in vitro model.

Complete Protocol Study

Absorption Test Complete Study:

Bioavailability assessment – systemic level (regulatory and/or scientific-disseminating use): gastro-intestinal absorption study using a 2-step in vitro model.

Absorption Test Complete Study with Advanced Customized Model:

Bioavailability assessment – systemic level (for regulatory and/or scientific-disseminating use): Gastro-intestinal absorption study using a 2-step in vitro model.

BCS (Biopharmaceutics Classification System)-Based Biowaiver Approach

Two drug products containing the same drug substance(s) are considered bioequivalent if their bioavailability (rate and extent of drug absorption) after administration in the same molar dose lie within acceptable predefined limits. The BCS (Biopharmaceutics Classification System)-based biowaiver approach is intended to reduce the need for in vivo bioequivalence studies.

The BCS is a scientific approach based on the aqueous solubility and intestinal permeability characteristics of the drug substance(s). The BCS categorizes drug substances into one of four BCS classes as follows:

Class I: high solubility, high permeability – BCS APPLICABLE
Class II: low solubility, high permeability – BCS NOT APPLICABLE
Class III: high solubility, low permeability – BCS APPLICABLE
Class IV: low solubility, low permeability – BCS NOT APPLICABLE

Drug Topical Products

In Vitro Release Testing (IVRT) for Topical Formulations

In vitro release testing (IVRT) is a critical method for evaluating the performance of topical dosage forms, typically utilizing an open-chamber diffusion cell system such as a Franz cell. IVRT can be used as a research and development tool to optimise formulations, and as a quality control tool to assess manufacturing quality and consistency over time.

Experimental conditions -including membrane type, receptor medium, and sampling intervals- are optimized based on the API’s physicochemical properties:

The test product is applied to a synthetic membrane within the donor chamber and a receptor fluid is placed beneath the membrane in the receptor chamber.
Diffusion of the active pharmaceutical ingredient (API) across the membrane is monitored by sequentially collecting receptor fluid samples over time.
The release rate (flux) is calculated by plotting the average cumulative release against the square root of time.
This formulation-specific release rate supports quality control, product development, and validation of scale-up or post-approval changes.
Pre- and post-change batches are compared by calculating a 90 % confidence interval for the flux values, which should fall within the regulatory limits of 75 % to 133.33 % to demonstrate consistency.

**Our Scientific Writing on Absorption & Efficacy Studies by In Vitro Models**

In vitro studies to assess the capacity of the nanocomplexes to control the release of the associated insulin – “Bioinspired orthogonal-shaped protein–biometal nanocrystals enable oral protein absorption” – M Durán-Lobato et. Al. Journal of Controlled Release 377, 17-36
In-vitro effect of a novel combination of active substances – “Effects of a novel combination of magnesium, tryptophan, resveratrol, and saffron on oxidative stress, prostaglandin F2α, and intracellular Ca²⁺ levels in an in-vitro model of myometrium” – S Battaglia, M Cozzi, FR Ranieri, E Gaio, F Benetti, V Curti. Minerva Biotechnology & Biomolecular Research 35 (4)
In vitro model to evaluate the digestive process and fermentation using simulated digestive fluids and Caco-2 cells – “Evaluation of Short Chain Fatty Acids (SCFAs) intestinal absorption, following digestion and fermentation of a novel medical device containing partially-hydrolyzed Guar gum plus simethicone” – Benetti, F., Micheletto, M., Tedesco, E., Gaio, E., & Ciprandi, G. (2023). Journal of Biological Research – Bollettino Della Società Italiana Di Biologia Sperimentale, 96 (1)
In vitro study for urothelial inflammation treatment – “Micronized Palmitoylethanolamide, Hempseed Oil, and Maritime Pine Bark Dry Extract (Pelvipea^®) for Pelvic Pain: An In Vitro Study for Urothelial Inflammation Treatment” – Tafuri, A.; Panunzio, A.; De Mitri, R.; Benetti, F.; Gaio, E.; Pagliarulo, V. – Cells 2023, 12, 616
In vitro behaviour of chitosan coated liposomes – “Analysis of operating conditions influencing the morphology and in vitro behaviour of chitosan coated liposomes” – J Nanomed Nanotechnol 5: 211
In vitro efficacy testing to understand the mechanism of action – “Capryloyl glycine and soy isoflavonoids in hypertrichosis: an experimental and placebo-controlled clinical study”, DOI: 10.1111/jocd.14096 -J Cosmet Dermatol. 2021;20(Suppl. 1):18–22
Digestive model through an integrated in vitro approach – “Comparative evaluation of intestinal absorption and functional value of iron dietary supplements and drug with different delivery systems”, Molecules 2020, 25(24), 5989
In vitro models that compare different commercial dietary supplements containing stabilized OSA to ascertain their bioaccessibility, bioavailability, and safety in a model of human intestinal epithelium – “In vitro evaluation of different organic matrices used to modulate silicon bioavailability”, The FASEB Journal. 2020;34:12229–12238
Iron bioaccessibility, bioavailability, and intestinal absorption mechanisms – “Comparative Evaluation of Intestinal Absorption and Functional Value of Iron Dietary Supplements and Drug with Different Delivery Systems”, Molecules, 25, 5989
In vitro toxicity assessment of oral nanocarriers – “In vitro toxicity assessment of oral nanocarriers”, Advanced Drug Delivery Reviews, Volume 106, Part B, 2016, Pages 381-401, ISSN 0169-409X

The In Vitro Model

Mérieux NutriSciences can support all your projects with a wide range of in vitro models that can be implemented and adapted according to the type of fluid or study to be carried out, and based on the customer’s needs.

In vitro oral model: oral and sublingual absorption or irritation
In vitro nasal model: nasal absorption or irritation
In vitro digestive model: bioaccessibility
In vitro intestinal absorption model: bioavailability
In vitro model: skin model for absorption & efficacy studies
In vitro model: gut model
In vitro model: hepatic model
In vitro model: brain model
In vitro model: prostate model
In vitro model: heart and blood vessel models
In vitro model: monocytes and macrophages