IriSys was commissioned to formulate a gel delivery system that was capable of delivering a precise dose of the peptide to the skin lesion, was esthetically appealing, and provided at least 12 months of stability.  It was quickly determined that the aqueous solubility of the peptide was sufficient to provide the entire range of desired final concentrations at all levels of pH.  Development began with a pH stability study.  It was determined that the pH of maximum stability was in the range of 5 to 6.  Subsequently, the effects of buffer species, buffer concentration, metal ions, and the presence of EDTA on stability were examined.  The suitability of three common gelling agents was investigated.  A combination of Methylparaben, and Propylparaben was incorporated as the preservative system, and propylene glycol was used as a processing aid to dissolve the parabens.  The gelling agent that provided the best stability results was chosen for the final formula.  The final packaging configuration was a 5 mL prefilled syringe.  A number of clinical supply batches were manufactured in the range of 10 kg to 20 kg (2500 to 5000 units).  The product is currently undergoing trials in Europe.

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