NanoBase™ Epilingual

Formulation Class: Sublingual / Epilingual nano-delivery base for oral consumption.

Primary Function: Nano-structuring base that forms a stable nanoscale dispersed system with phospholipid-associated domains to enhance mucosal residency, permeation, and active availability, while remaining gentle, mucosa-comfortable, and taste-tunable.

Developed to deliver 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 rapid wetting, film formation, and consistent sublingual/buccal delivery.

Technical Foundation

NanoBase Epilingual maintains a controlled nanoscale droplet/structure distribution (typically 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 assemblies that associate with hydrophilic and amphiphilic actives and help protect labile molecules during mucosal transport.

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

Formulation Performance Observations

  • Produces tight-range, 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-disperse with a warmed aqueous aliquot; 10 min hydrate.

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

    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.