At Synergy Bioscience, we specialize in transforming complex pharmaceutical challenges into remarkable achievements. In this case study, we highlight our collaboration with a client focused on developing a generic drug aimed at treating a broad range of bacterial infections, including those related to skin and gynecological health.
Our journey began with a focus on enhancing the technological process, improving production efficiency, and increasing overall yield. Our team worked to perfect the preparation method for a critical beta-lactam inhibitor. This involved dissolving the active compound in cooling water at controlled temperatures between 6-15°C, combining it with a salt-forming agent, and maintaining precise temperature control throughout the process. The final step was lyophilization, which produced the desired compound in powder form.
To ensure the long-term stability of the drug, we prepared a solution of the active ingredient in a 5% dextrose (D5) solution under sterile conditions. This was stored at -20°C for three months, then thawed and maintained at 5°C ± 3°C for an additional 58 days, ensuring consistency over time.
Our next focus was to measure the concentrations of the active components using HPLC technology. We utilized an Agilent 1200 system with a DAD detector to carry out these analyses. In addition, our team designed and executed a comprehensive dissolution profiling study using advanced instrumentation, including a dissolution apparatus, auto-sampler, and the Agilent HPLC 1200 for organoleptic and spectrophotometric evaluations.
We also performed a detailed microscopic examination of the particles after reconstitution, analyzing their properties after standing for four hours at room temperature. Chemical stability was rigorously assessed using HPLC methods, and by optimizing the processing conditions, we significantly increased the yield of the final product, reaching 37.09%—an improvement from previous batch yields of 30.93%—while enhancing the safety and reliability of the process.
Our commitment to precision and quality was rewarded when, just eight months after submitting the ANDA application, our client received FDA approval to commercialize the generic drug.
This case study showcases Synergy Bioscience’s expertise in drug development, demonstrating our ability to turn complex pharmaceutical projects into successful, market-ready solutions. Partner with Synergy Bioscience, and let us help bring your pharmaceutical innovations to life.
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