1. Cross-linked polymeric shell (thickness in microns), such as poly(vinyl alcohol) (PVA), poly(p-xylylene), poly(lactic acid) (PLA), poly(lactic-co-glycolic acid) (PLGA), poly(ε-caprolactone) (PVL), poly(p-dioxanone) (PDS), poly(hydroxyvalerate) (PHV), poly(hydroxybutyrate) (PHB), and poly(malic acid) (PMLA), incorporating cross-linking groups like vinyl, allyl, acrylate, cinnamate, diacrylate, or oligoacrylate. The polymeric shell (2-10% w/w of polymeric shell) typically has a thickness measured in microns. 2. Crystalline API core, composed of a pharmaceutically acceptable salt or ester, which may exist either as a single large crystal or as multiple smaller crystals.

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Based on the pharmacokinetic clinical trials of EP104, 57% of the treatment population had one or more Treatment Emerging Adverse Events (TEAE), However, the effects on serum glucose and cortisol concentrations were minimal.

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With a patent for manufacturing filed in 2019, the production facility is projected to achieve commercial-scale operations optimized for low cost of goods. Euphraxia has allocated a budget of 2.8 million Canadian dollars for the development of this manufacturing unit.

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Manufacturing (ISO 14644-1; Grade 8 cleanroom) involves: 1) Forming API microparticles (using any 1 method) a. Solvent Evaporation/ extraction techniques b. In-water drying technique c. Organic phase separation technique d. Air suspension technique e. Dip coating technique 2) Coating of the API core with the polymeric shell using the dip coating technique with Multifunctional multi-polymeric continuous composition spectrum surfactant 3) Microparticles are agitated with PVA polymer via stirring. 4) Vacuum filtration 5) Heated at 220 ºC for a period of at least 1 hour

1) The dissolution Test is performed using a US Pharmacopoeia Type II apparatus where the condition is standardized at 3mg of microparticles in 200 ml of dissolution medium (70% methanol + 30% water) at 25 °C. The dissolution rate of the microparticles is observed at 160° C, 190° C, 220° C, and 250° C. 2) PVA content analysis using NMR spectroscopy 3) Drug content analysis using NMR system - Bruker Spectrospin 300 MHz magnet , Bruker B - ACS 120 autosampler , Bruker Avance II 300 console , and a Bruker BBO 300 MHz Si 5 mm with Z gradient probe. 4) Praticle transfer efficiency measured by HPLC

No proprietary excipient used

No novel excipient or existing excipient used

No residual solvent used

No delivery device

• Biodegradable
• Drug-eluting
• Monolithic
• Room temperature storage
• At least 1 year shelf life

The drug is released at a constant rate following zero-order kinetics from the polymeric shell. Diffusphere has favorable PK parameters mainly because of the low/no initial burst. Clinical studies of EP104 showed that the plasma concentrations of fluticasone propionate (EP104) had a blunted initial peak with a terminal half-life of approximately 18–20 weeks.

Diffusphere is an Intra-articular via ultrasound-guided injectable formulation that requires a 22-25 gauge needle with a length of 1-1.5 inches.

At least 2 years of proven stability at room temperature storage.

Diffusphere doesn't require cold chain storage or transport.