In-use stability for SI-053 is ensured
Double Bond Pharmaceutical reports that a European GMP-certified contract manufacturer has examined the highest dose of the SI-053 formulation, the results show that the formulation is stable over time (8 hours). "Formulation stability is quite often a challenge in drug delivery system products and we are happy for this success" - commented Sayeh Erfan, CMC, Operations & Quality Specialist at DBP. "With this study, we have now technically shown a product stability during use in a Phase 1 clinical trial, which is one of the most important milestones in product development" - commented