NanoBase™ Rx

Formulation Class:

Compounding Pharmacy: Tri-domain + lamellar liquid crystal nano-delivery excipient base for 503A/503B prescription compounding Primary Function: Pre-processed nano-structured liquid base that transports APIs across the stratum corneum toward the viable epidermis, shipping "ready for APIs" so pharmacies add actives, preservative, and thickener downstream at room temperature with gentle stirring. Developed for compounded preparations requiring a pH 3.5–8.0 operating envelope, reproducible particle distribution, and maximum downstream API compatibility. Rx pairs pharma-grade monodispersity with adaptability to a wide range of API classes and pH windows.

Technical Foundation NanoBase™ Rx maintains a pre-processed nanoscale droplet/vesicle/micelle distribution in a freely pourable liquid base, so compounding pharmacies can incorporate APIs at room temperature without specialized processing. Engineered for pharma-grade monodispersity at a small, tightly controlled particle size, using three integrated nanodomains reinforced by a lamellar liquid crystal structure and a non-ionic steric shield.

  • Nanoemulsion domain: medium-chain triglyceride oil core stabilized by a multi-component emulsifier system for intercellular lipid fusion across the stratum corneum

  • Nanoliposomal domain: hydrogenated lecithin bilayer vesicles for protected delivery of hydrophilic and thermolabile APIs toward the viable epidermis

  • Nanomicellar domain: alkyl polyglucoside micellar capacity for mid-polarity APIs and co-solubilization

  • Lamellar liquid crystal structure: Cetearyl Olivate/Sorbitan Olivate reinforces the colloidal architecture and sustains release kinetics

  • Steric shield (Rx-exclusive): Polysorbate 80 + Vitamin E TPGS provide pH-independent non-ionic steric repulsion and antioxidant co-stabilization

Formulation Performance Observations

  • Tightly controlled particle size distribution with pharma-grade monodispersity; anionic zeta envelope for colloidal stability

  • Freely pourable liquid viscosity - not a finished cream; pharmacy applies thickener and rheology downstream

  • Widest operating pH envelope of any NanoBase™ model: 3.5–8.0 (vs. 5.3–6.0 cosmeceutical window)

  • Ships preservative-free for maximum Rx compatibility with sensitive APIs (proteins, peptides, biologics); pharmacy adds preservative per USP <795>

  • Can be customized at manufacturing

Formulation Compatibility

  • Robust to routine compounding workflow at room temperature with gentle stirring

  • pH stability range (as base architecture): ships at mildly acidic native pH; validated operating envelope 3.5–8.0 (pharmacy adjustable with dilute lactic acid / arginine)

  • Downstream addition capacity: ≤50% total additions at standard pH 4.5–7.0; ≤35% at pH extremes (3.5–4.5 or 7.0–8.0); NanoBase™ Rx typically 55–65% of the final compounded preparation

  • Compatible with: APIs added at 20–25 °C with gentle stirring, water-soluble excipients, lipophilic actives (pre-dispersed in propanediol), supplemental surfactants, pharmacy preservatives per USP <795>, downstream thickeners, pH adjusters in small increments

  • Not recommended with: high salt / high ionic strength additions without propanediol pre-dilution, undiluted strong acids/bases, processing temperatures above 40 °C, aggressive high-shear finishing, incompatible preservatives/solvents without 48h particle size verification, additions exceeding published downstream limits

Use Case Examples

  • Topical dermatology Rx (retinoids, immunomodulators, antifungals, antimicrobials)

  • Bioidentical hormone replacement preparations (estradiol, progesterone, testosterone)

  • Topical anesthetic and NSAID compounds (BLT, lidocaine/prilocaine, diclofenac, ketoprofen)

  • Depigmentation complexes (hydroquinone, tranexamic acid, kojic acid)

  • Protein/peptide/biologic preparations (preservative-free base enables sensitive actives)

  • Wide-pH preparations requiring the 3.5–8.0 operating envelope

  • +More per 503A patient-specific Rx / 503B outsourcing facility

Ingredients (INCI)

Aqua (Water), Caprylic/Capric Triglyceride, Hydrogenated Lecithin, Trehalose, Coco-Glucoside, Cetearyl Olivate, Sorbitan Olivate, Polysorbate 80, Isostearyl Isostearate, Tocofersolan, Tetrasodium Glutamate Diacetate, Lactic Acid, Arginine.

Notes on Customization

Classification & Regulatory Status NanoBase™ Rx ships as a single pre-processed excipient base, enabling compounding pharmacies to incorporate APIs, preservatives, thickeners, and pH adjusters at room temperature while retaining Rx's tri-domain + lamellar liquid crystal delivery, non-ionic steric architecture, and pharma-grade monodispersity.

Classified as a compounding excipient architecture (base) - not a finished drug product. NanoBase™ products do NOT fall under formal nanomaterial classification under EU Cosmetic Regulation (EC) No. 1223/2009 Article 2(1)(k) or FDA nanotechnology guidance, as the nano-structured domains are transient self-assembled colloidal architectures (lipid vesicles, micelles, emulsion droplets) rather than insoluble, persistent, or intentionally manufactured nanoscale particulate matter.