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, that carries peptide cargo across mucosal barriers without disrupting them.
The delivery challenge
Six barriers stand between a peptide and the bloodstream
Each one is a separate failure mode. A delivery system that solves only one of them doesn't move the number.
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 built from two things the body already makes
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. Every component carries established GRAS and USP/NF status and is metabolised through normal biochemical pathways.
Six mechanisms, working together
Permeation enhancement occurs through ionic microenvironment effects and reversible protein–ion interactions — not membrane disruption, lipid extraction or cytotoxic mechanisms.
Mucus fluidization
The citrate anion chelates the Ca²⁺ ions that cross-link mucin fibres, lowering viscosity so the peptide–PIL complex can reach the epithelial surface. Reversible on dilution.
Tight junction modulation
Amino acid cations interact electrostatically with claudin domains, triggering transient actin reorganisation that widens paracellular gaps. TEER returns to baseline afterward.
Mucoadhesion
Cationic groups adhere to negatively charged sialic acid in nasal and sublingual mucosa, extending residence time and counteracting mucociliary clearance.
Protease inhibition
High ionic strength plus local pH modulation reversibly inhibits digestive proteases; citrate sequesters the Ca²⁺ and Zn²⁺ cofactors many proteases depend on.
pH buffering
Citric acid maintains a protective microenvironment through the acidic gastric phase (pH 1.5–3.5), preventing acid-induced hydrolysis of peptide bonds in transit.
Nanoparticle self-assembly
Bimodal distribution: 200–300 nm peptide-loaded vehicles for sustained release, plus a sub-10 nm population small enough to pass through mucus gel pores directly.
Preclinical evidence
What the data shows — and where each number comes from
Findings below are from independent third-party laboratory studies. Class-level figures from the peer-reviewed ionic liquid literature are marked separately and are not measurements of this platform.
Delivery routes
One composition, four routes
The same ionic liquid addresses the barriers common to every mucosal and epithelial surface.
Oral / gastrointestinalPrimary
Protects the peptide through gastric acid and proteases, fluidizes intestinal mucus and modulates tight junctions. Multi-organ systemic distribution confirmed in the mouse FITC study, with signal localised inside intestinal villi rather than the lumen.
Intranasal / mucosalHigh priority
Nasal epithelium is ~0.1 mm against the 0.5 mm test model, and the route bypasses hepatic first-pass metabolism entirely. Mucoadhesive amino acid cations extend residence time against mucociliary clearance.
Sublingual / buccalHigh priority
Thin (~0.1 mm), highly vascularised, bypasses first-pass metabolism, and avoids the proteolytic environment of the gut. Mucoadhesion counteracts the tendency of sublingual formulations to be swallowed before absorption.
Topical / external skinSupporting
The >57× enhancement was itself measured across full-thickness skin. Suitable where the target is the skin — collagen-stimulating, wound-healing and other bioactive peptides. The platform's primary differentiation remains oral, nasal and sublingual.
Composition & regulatory position
Excipients with an existing regulatory record
Because every component is already accepted across food, pharmaceutical, cosmetic and nutraceutical categories, the pathway is materially shorter than for a novel synthetic delivery system.
| Component | FDA GRAS | USP/NF | EU food additive | Role in system |
|---|---|---|---|---|
| Citric acid | GRAS (21 CFR 184.1033) | Monograph | E330 | Anion; Ca²⁺ chelator; pH buffer; mucus fluidizer |
| L-Lysine | GRAS (dietary supplement) | Monograph | Permitted amino acid | Cation; mucoadhesive; tight junction modulator |
| L-Arginine | GRAS (dietary supplement) | Monograph | Permitted amino acid | Cation; mucoadhesive; tight junction modulator |
Application categories
Fully compatible with nutraceutical/dietary supplement (FDA DSHEA, EFSA), cosmetic/cosmeceutical (21 CFR 700, EU Cosmetics Regulation) and research-use-only frameworks. Compatible with pharmaceutical development via the 505(b)(2) pathway using pharmacopoeial excipients.
Manufacturing
Finished product is manufactured at a facility holding NSF/ANSI 455-2 GMP certification for dietary supplements. That certificate covers the facility and its quality systems — it is held by the contract manufacturer, and it is not a certification of the Stasis ION™ System or of any finished product. Certificate details are reproduced in Appendix B of the dossier.
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. The oral distribution study confirms multi-organ distribution by fluorescence imaging. It does not provide plasma concentration, absolute bioavailability, or PK parameters.
- Permeation data is ex vivo, generated in a porcine tissue 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 a short-chain therapeutic peptide (2–5 amino acids). The stabilisation mechanism is sequence-independent, but formulators working above ~10 kDa should request peptide-specific evaluation.
- Direct protease inhibition assay data is not included in the preclinical package; that effect is inferred from stability and permeation data and supported by the ionic liquid literature.
- 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
52 pages: platform architecture and ionic chemistry, analytical validation and the 1,000× dilution QC method, nanoparticle characterisation, stability studies, the in vivo distribution study, cytotoxicity, the ex vivo permeation model, delivery route applications, study limitations, regulatory positioning, and the complete third-party test report.
Enquiries
Talk to us about your formulation
Tell us the peptide, the route and the format you have in mind. Technical questions reach the people who ran the studies.