NanoBase™ Epilingual

Formulation Class: Sublingual / Epilingual Nano‑delivery base for oral consumption.

Primary Function: Nano‑structuring base that forms a stable, nanoscale oil‑in‑water system with phospholipid domains to enhance residence time, permeation, and presentation of actives to the oral epithelium, while remaining gentle, iso‑to‑mildly hypotonic, and taste‑tunable.

Developed to carry sensitive and hydrophilic actives, small molecules, and bioactives across the oral mucosa without injections or GI first‑pass. The base pairs nanoscale stability with a low‑irritation polyol matrix for fast wetting, film formation, and consistent sublingual/buccal delivery.

Technical Foundation

NanoBase Epilingual maintains a controlled nanoscale droplet/vesicle distribution (typ. DLS Z‑avg 50–200 nm; PDI ≤0.25) within a buffered, polyol‑rich aqueous phase. Engineered with three distinct domains—nanoemulsion, nanoliposomal, and nanomicellar, to stabilize a broad chemistry set and improve mucosal contact and transport.

  • Nanoemulsion domain: finely sized O/W droplets (CCT + olive + antioxidants) for rapid wetting and spread; supports lipophilic carriers and taste‑masking.

  • Nanoliposomal domain: hydrated phospholipid structures to associate/encapsulate hydrophilic actives and protect labile molecules.

  • Nanomicellar domain: nonionic surfactant/solubilization capacity for small/mid‑polarity actives and flavors without high alcohols.

Formulation Performance Observations

  • Produces uniform, opalescent nano‑dispersions with tight size control (50–200 nm)

  • Gentle on oral tissue: buffered to ~pH 5.2–5.5 (adjustable), polyol‑dominant, low ethanol; supports repeated dosing.

  • Supports residence time via optional low‑level bioadhesive polymers (e.g., HPC/alginate) with minimal impact on free‑preservative availability (verified by HPLC).

  • Maintains physical stability under temperature and handling; compatible with nitrogen headspace and amber fill for oxidative protection.

Formulation Compatibility

  • Stable under high shear and ultrasonication; robust to post‑add mixing of taste/cooling components.

  • pH stability range (base): ~5.0–6.0 typical for mucosa comfort; can be tuned per active.

  • Compatible with: peptides, small molecules, polyols (propanediol/glycerin/trehalose), phospholipids, mild buffers (citrate), chelators (phytate), cooling agents (menthyl lactate/peppermint), low‑dose mucoadhesives (HPC, alginate stock), benign salts (NaCl at trace levels), nonionic solubilizers for flavors.

  • Not compatible with: high‑alcohol systems; harsh anionics; strong oxidants; high calcium with alginate (avoid gelation/precipitation).

Use Case Examples

  • Peptide delivery prototypes

  • Buccal/sublingual small‑molecule actives (sleep/anxiety, B‑vitamins, nootropics) with taste‑masking

  • Oral care actives (enamel/caries/gingival support) with extended contact

  • Nutraceutical actives needing rapid systemic access without GI first‑pass

  • Cooling/taste‑forward sublingual sprays (menthyl lactate/peppermint variants)

Method Highlights (from pilots)

  • Aqueous matrix: buffer/preservatives/chelator → polyols → osmotic tuning; pH aim ~5.3

  • Oil phase: CCT + olive + tocopherol; dissolve ascorbyl palmitate

  • Phospholipid hydration: pre‑paste with warm aqueous aliquot; 10 min hydrate

  • Pre‑emulsion: staged addition under overhead mixing to slight opalescence

  • Ultrasonication (Q2000, 1" probe): 80–90% amplitude; 5 s ON/2 s OFF; bulk 48–52 °C; 200–250 J/mL

  • Preservation: Benzoate/sorbate buffered system validated via free‑preservative HPLC; PET per USP <51>/ISO 11930

Customization Notes

  • Residence time: add low‑level HPC (e.g., 0.2% w/w) and/or alginate (e.g., 0.075% via 5% stock) post‑sonication to increase mucosal retention while preserving free preservative (screen by HPLC).

  • Active handling: heat‑sensitive actives (peptides) are added post-process at ≤30–35 °C; protect from foaming and oxygen; consider amber fill and nitrogen purge.

  • pH/comfort tuning: adjust citrate buffer to match active stability and mucosal comfort (typ. 5.0–6.0).

  • Flavor/cooling: introduce menthyl lactate/peppermint after size reduction; verify no interference with preservative assays.

Positioning Statement

NanoBase Epilingual is a sublingual/buccal nano‑delivery base that lets you prototype and scale oral‑mucosa products with pharmaceutical discipline and cosmetic simplicity: three‑domain nano‑architecture, tight size control, mucosa‑gentle polyol matrix, and post‑sonication active addition. Plug in your active, taste system, and (optionally) a light mucoadhesive and you have a stable, fast‑acting epilingual format without rebuilding the base.