Welcome to an exploration of Synergy Bioscience’s pharmaceutical expertise. This case study highlights our role in developing an advanced aminoglycoside antibiotic designed to treat severe bacterial infections. Our journey showcases how we combined scientific acumen with innovative techniques to overcome significant challenges, bringing a powerful antibacterial solution to life.
The product in this study demonstrated remarkable antibacterial activity when delivered using two active pharmaceutical ingredients (APIs) coated with zinc oxide nanoparticles (ZnO NPs). Our skilled team thoroughly analyzed the potent interaction between the APIs and the nanoparticles, optimizing this combination to achieve an ideal therapeutic effect.
Leveraging cutting-edge pharmaceutical technologies, we significantly streamlined the development and laboratory-scale production process. We reduced the purification and isolation time from a standard 120-135 hours to an impressive 17 hours. This not only ensured high reproducibility but also dramatically increased the yield of the final product, boosting it from 37-40% to an outstanding 60-65%.
Our next focus was on ensuring the product’s stability and biocompatibility. We conducted detailed studies at 1 mg/mL and 0.2 mg/mL concentrations over 24 and 48-hour periods at 25°C. This comprehensive analysis confirmed the long-term efficacy and safety of the product.
We then applied a reversed-phase liquid chromatography (RP-LC) method, using a mobile phase containing a per-fluorinated ion-pair, combined with our state-of-the-art Orbitrap mass spectrometer for in-depth chemical characterization. Additional advanced instruments, such as GC-MS, were utilized to generate a highly accurate and detailed profile of the product.
To further ensure quality, we carried out a dissolution study to investigate the in vitro drug release characteristics of the product’s two APIs. These were spectrophotometrically analyzed using our cutting-edge dissolution apparatus (Agilent 708-DS Dissolution Apparatus and 850-DS Sampling Station), fully compliant with 21 CFR Part 11 requirements.
Seven months into this project, our client received approval to begin manufacturing the drug. This case study stands as a testament to Synergy Bioscience’s commitment to excellence and innovation in pharmaceutical development. Join us on the journey to the future of healthcare, and let’s work together to transform your vision into reality.
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