Advanced peptide delivery technology

Most peptides never survive the trip.

Unformulated peptides lose almost everything to gastric acid, mucus and tight junctions — oral bioavailability below 1–2%. The Stasis ION™ System is a protic ionic liquid excipient platform, built from citric acid and amino acids, designed to help peptides cross mucosal barriers. So far it has only been tested in the lab: on pig skin in a dish, in mice and in cells. The results are below, with their limits.

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~57×More peptide crossed pig skin in 24 h (lab dish)

200–300 nmOne of two particle size peaks (DLS); the other is 5–10 nm

1 hourDye signal in mouse organs after an oral dose

2 monthsOne test peptide at room temperature, no large loss seen (outside lab)

80–100%Cells stayed viable (CCK-8, 24 h & 48 h)

The delivery challenge

Six barriers stand between a peptide and the bloodstream

Each one is a separate failure mode. The only peptide tested with Stasis ION™ so far was very small (2–5 amino acids).

Enzymatic degradation

Proteases throughout the GI tract, nasal mucosa and sublingual epithelium cleave peptide bonds. Gastric acid at pH 1.5–3.5 causes direct hydrolysis before absorption can occur.

The mucus barrier

A viscoelastic hydrogel of cross-linked mucin covers every mucosal surface. Calcium cross-links raise viscosity and trap large molecules before they reach epithelial cells.

Epithelial tight junctions

Claudins and occludins seal the space between cells. Molecules above ~1 kDa cannot pass paracellularly — which excludes most therapeutic peptides at 1–50 kDa.

First-pass metabolism

Peptides absorbed from the gut enter portal circulation and pass through the liver before reaching systemic circulation. Sublingual and nasal routes bypass this entirely.

Peptide aggregation

In aqueous solution peptides form macro-aggregates. Only the outermost surface interacts with tissue — interior molecules stay inaccessible, cutting effective concentration.

Mucociliary clearance

In the nasal cavity, ciliated cells sweep mucus toward the nasopharynx continuously — limiting the absorption window to minutes for non-mucoadhesive formulations.

Platform architecture

A protic ionic liquid made from citric acid, lysine and arginine

The system forms through a proton transfer reaction between citric acid — a Krebs cycle intermediate — and the amino acids lysine and arginine. The result is a room-temperature liquid with a dense three-dimensional network of electrostatic and hydrogen-bonding interactions around the peptide cargo.

No novel synthetic chemical entities. All three are found in food and in the body, have a long record as food and pharmacopeial (USP/NF) ingredients, and are metabolised through normal biochemical pathways.

Citric acid3 carboxyl groups, 1 hydroxyl. A Krebs cycle intermediate; the anion.
L-Lysine2 amino groups, 1 carboxyl. An essential amino acid (from the diet); a cation.
L-ArginineA guanidino group, an amino group, 1 carboxyl. Conditionally essential; a cation.

How this class of excipient is thought to work

These mechanisms are proposed from chemistry. Mucus thinning and tight-junction opening were seen in a published study of a different ionic liquid. None has been measured with Stasis ION™.

Mucus fluidization

Proposed: citrate may bind the Ca²⁺ ions that cross-link mucin fibres and so thin the mucus. Mucus thinning was seen with a different ionic liquid, which has no citrate; not measured with Stasis ION™.

Tight junction modulation

Proposed: the amino acid cations may briefly loosen the tight junctions between cells. A different ionic liquid, which contains no amino acids, did this reversibly in a lab test on gut cell layers. Not measured with Stasis ION™.

Mucoadhesion

Proposed: the positively charged amino acids may stick to negatively charged sialic acid in nasal and sublingual mucosa, keeping the dose in place longer. Theory only; not tested.

Enzyme protection

Proposed: citrate binds Ca²⁺ and Zn²⁺, which many digestive enzymes need, so it may slow them. Theory only; no enzyme test was done.

pH buffering

Proposed: citric acid may buffer the pH right around the peptide and reduce acid damage in the stomach. Not tested.

Nanoparticle self-assembly

Measured: two size peaks, about 200–300 nm and 5–10 nm. Proposed, not tested: that the particles carry peptide, release it slowly or pass through mucus.

Preclinical evidence

What the data shows — and where each number comes from

Findings below are from one outside lab's report, plus the manufacturer's own data where marked. The one tile marked “Context only” describes a different ionic liquid and is not a measurement of this platform.

Stasis ION™ data

~57×

More peptide crossed pig skin vs. control

Ex vivo, 0.5 mm pig skin in a lab dish: 4.59% of the peptide crossed in 24 h with Stasis ION™ vs 0.08% without. Repeats were not reported. Not living tissue, not mucosa, and not a bioavailability figure.

Stasis ION™ data

200–300 nm

One of two size peaks (DLS)

DLS found two size peaks: about 200–300 nm and 5–10 nm. The supplier's analysis puts more particles in the 5–10 nm peak. Whether either carries peptide or passes through mucus has not been tested.

Stasis ION™ data

Organs with dye signal, one hour after an oral dose

Fluorescent (FITC) labelled peptide in mice: stomach, intestine, liver, lungs, kidneys. Water control showed little signal. The dye shows where the label went, not that intact peptide arrived; no blood levels were measured.

Stasis ION™ data

~101–102%

Of the intended amount, one test peptide at room temperature

101.1% at 1 and 2 months (outside lab); 101.2% at 3 months and 101.9% at 4 months (manufacturer's own data). One unnamed 2–5 amino-acid peptide; temperature control not reported; starting amount not measured. The test method read 112% on a known sample, so this shows no large loss — not 100% potency, and not a shelf life. 105.8% after 3 days at 37 °C and 104.6% after 10 days of sunlight are measurement variation, not gains.

Stasis ION™ data

80–100%

Cell viability, CCK-8 assay

80–100% of cells stayed viable at 24 h and 48 h — above the 70% line ISO 10993-5 uses. Cell type and dose were not reported.

Context only

A different ionic liquid

A published study of a different ionic liquid (choline-glycolate, given with antibodies to rats; Angsantikul et al., 2020) is often cited for how this kind of excipient might work. Its results do not apply to Stasis ION™.

Delivery routes

One composition, four routes

The same ionic liquid is intended for each of these routes. Route-specific testing has not been done.

Oral / gastrointestinalPrimary

Intended to protect the peptide in the gut and help it cross the intestinal wall — not yet shown for Stasis ION™. In the mouse dye study, signal appeared inside intestinal villi and in several organs an hour after an oral dose.

Intranasal / mucosalHigh priority

Nasal delivery skips first-pass metabolism in the liver. Stasis ION™ has not been tested in the nose, and mucoadhesion has not been tested.

Sublingual / buccalHigh priority

Thin (~0.1 mm), highly vascularised, bypasses first-pass metabolism, and avoids the proteolytic environment of the gut. Mucoadhesion is intended to counter the tendency of sublingual formulations to be swallowed before absorption; it has not been tested.

Topical / external skinSupporting

The only permeation test used 0.5 mm pig skin in a lab dish; it has not been tested on living skin. Possible uses include collagen-stimulating, wound-healing and other bioactive peptides for the skin. The platform's primary focus remains oral, nasal and sublingual.

Composition & regulatory position

Excipients with an existing regulatory record

Every component is already used in food, pharmaceutical, cosmetic and supplement products. That record helps, but it is not an approval of the excipient itself.

Regulatory status of Stasis ION™ System components
Component	FDA status	USP/NF	EU food additive	Proposed role
Citric acid	GRAS (21 CFR 184.1033)	Monograph	E330	Anion; Ca²⁺ chelator; pH buffer; mucus fluidizer
L-Lysine	Food additive (21 CFR 172.320)	Monograph	Permitted amino acid	Cation; mucoadhesive; tight junction modulator
L-Arginine	Food additive (21 CFR 172.320)	Monograph	Permitted amino acid	Cation; mucoadhesive; tight junction modulator

Application categories

Its components are permitted in dietary-supplement (FDA DSHEA, EFSA), cosmetic (21 CFR 700, EU Cosmetics Regulation) and research-use-only products. Use in a drug product would need its own regulatory review.

Manufacturing

Stasis ION™ comes from a supplier whose facility holds NSF/ANSI 455-2, a GMP certificate for dietary supplements (capsules, gummies, ingestible liquids). It covers that facility only — not the Stasis ION™ System or any finished product.

Scope of these findings

We would rather you know the limits up front than discover them in due diligence.

No human clinical data exists for this platform. All findings are preclinical. Clinical translation would require IND-enabling studies, Phase I safety evaluation and route-specific pharmacokinetics in human subjects.
The in vivo data is qualitative. Dye signal was seen in several organs by fluorescence imaging; the peptide itself was not measured. The study does not provide plasma concentration, absolute bioavailability, or PK parameters.
Permeation data is ex vivo, generated in a porcine skin model; in vivo data was generated in mice. Interspecies differences mean direct extrapolation to human pharmacokinetics requires clinical validation.
One model compound. Stability and permeation used one short test peptide (2–5 amino acids). Results for other peptides, including larger ones, have not been tested.
Direct protease inhibition assay data is not included in the preclinical package; that effect is proposed from the ionic liquid literature, not measured.
No claims of therapeutic efficacy, disease treatment or clinical bioavailability are made or implied. The Stasis ION™ System is excipient technology; Stasis does not manufacture drugs.

The full preclinical dossier

The 52-page technical dossier is being revised so that every figure matches the limits set out on this page. Ask us for the current technical summary.

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Revision in progress · October 2026

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