Synergy Bioscience prides itself on bolstering scientific advancement within the pharmaceutical industry. One of our most recent achievement showcases our ability to accelerate drug product development, surpassing technical hurdles to drive our client’s success. Here’s a journey into our collaborative efforts in bringing an innovative solution for peptic and duodenal ulcer treatment to the forefront.
Our client reached out to us during a challenging phase of their product formulation. Keen to expedite the development of their drug product, they sought our scientific expertise and developmental support. Without delay, we set sail on this pharmaceutical voyage, fully dedicated to transforming the challenges into rewarding outcomes.
Our initial step involved a comprehensive review of the pre-formulation studies. Through careful scrutiny, we evaluated the physical and chemical properties of the drug, both in isolation and in combination with various excipients. Following this, an analytical method was devised for the Active Pharmaceutical Ingredient (API) using the Orbitrap LC-MS/MS technique.
To enhance the drug product’s homogeneity, we ingeniously prepared the drug substane-loaded nanoparticles using a polylactide acid (PLA) polymer backbone grafted with Polyethylene Glycol (PEG), at a 1.5% molar ratio. To ascertain the new formulations’ shelf-life, freshly sealed vials were stored in a stability chamber set at 25°C ±2°C with 60% relative humidity.
The mixture of the drug substance (API), HPMC polymer, sodium bicarbonate, and lactose was next. It was masterfully combined on a molten mass. We then moved onto the scale-up study, employing a sophisticated fluidized-bed granulator operating at a rotation speed of 1500 rpm. Select formulations were then subject to a 90-day stability test under controlled temperature and moisture conditions, maintained at 40±5°C and 70±2% humidity, respectively.
In parallel with these rigorous activities, our dedicated QA/RA team prepared and submitted an abbreviated new drug application (ANDA). The application was meticulously backed by statistical analysis to establish bioequivalence with the brand-name drug, along with other essential validation information.
We are proud to report that, within just nine months, our client’s drug product received the regulatory approval for manufacturing and commercialization. It’s not just a testament to our client’s vision but a striking example of how Synergy Bioscience turns scientific challenges into remarkable breakthroughs in drug product development. This journey stands as a testament to our unwavering dedication, scientific prowess, and innovative approach. Welcome to the future of pharmaceuticals with Synergy Bioscience.
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