With SAXTM we have designed Combination Particles with every intention of manufacturing them for a brand new way to treat Asthma/COPD. The process virtually eliminates the variability associated with blending of 2 or more micronized powders.
Thus multiple APIs in the correct dose ratio can be symbiotically crystallized in a single perfect particle. We have assessed the in vitro delivery (using Next Generation Impactor, NGI) of individual components derived from combination particles via carrier based DPI formulations using the Monohaler. In all cases the Fine Particle Dose was consistently higher than when using individual micronized powders, and more so with respect to overall particle stability over a 4 week period: For Seretide equivalent particles we can show 30% increase in FPD when using well engineered combination SAX particles compared with micronized Fluticasone propionate (FP) and Salmeterol xinafoate (SX) 5:1 powders dry blended.
Other benefits with Symbicort (Budesonide – Formoterol fumarate) and Seretide type combination particles, consisting of cortcosteroid (CS) and long acting beta agonist (LABA) include:
* Uniformity of CS - LABA doses for lower stages of an NGI
* Dose balance for formulations of CS and LABA is extremely consistent between stages
* Non-variability in the delivery of CS with respect to LABA on the lower stages
* Uniformity of CS - LABA upon storage
* Accelerated stability conditions do not affect the dose balance of CS - LABA combination formulations
* SAX particles maintain high content uniformity for both CS and LABA
With combination particles asthma and COPD treatment will undergo some massive changes, not just for the APIs but for the actual delivery devices – simpler DPI devices for complex engineered particles.
For perfect Combination particles with consistent dose of 2 or more APIs and at the right synergistic ratio for inhalation, partner with Prosonix today!
