Technical Articles
08 Oct 2023
Case Study on Development and Production Applications of Amorphous Solid Dispersions - Hot Melt Extrusion
08 Oct 2023
en
By Damain Garde
From Fierce Biotech
PRINCETON, N.J. & SUZHOU, China--Crystal Pharmatech, a technology-driven solid-state research contract research organization (CRO) based in Suzhou, China, announced a partnership with Particle Sciences, one of the world's leading contract drug development companies focused on the formulation and support of advanced drug delivery solutions. The partnership, one of many that Crystal Pharmatech is forging with research driven organizations, combines a level of expertise previously not available to CRO's that will increase the success rate for the development of insoluble pharmaceutical compounds. Both will now offer clients an optimal solution for developing low solubility pharmaceutical compounds.
Over the past five years, approximately 65% of pharmaceutical compounds under development have been sparingly soluble to practically insoluble in water. This has led to the need for more innovative formulation including preclinical formulation development and solubilization techniques. As scientific complexity of drug development increases, finding the appropriate CRO to bring about the optimal development path for both drug substance (API) and drug product (formulation) is of utmost importance. Crystal Pharmatech, a preferred provider among innovator pharmaceutical companies, has extensive experience selecting the appropriate solid phase of a wide range of compounds. The company has a proven track record among its customers to provide fundamental material property evaluation, in addition to screening, evaluating and selecting the optimal form for pharmaceutical method development. Particle Sciences brings over two decades of experience in formulating active pharmaceutical ingredients (APIs) and multiple delivery/formulation formats. In addition, the company is able to identify common obstacles in drug product development and provide a resource of delivery technologies to address these obstacles.
"Whether the best way to develop your product is a co-crystal or nano-suspension depends on the material properties of your drug and the delicate interplay between API and formulation development," explains Alex Chen, CEO of Crystal Pharmatech. Robert Lee, Vice President, Pharmaceutical Development at Particle Sciences adds, "Often times, a client will work with a CRO to find a path forward for API development, only to realize that the chosen path is unacceptable for formulation development and, as a result, the project goes over the allocated time and budget." Both Crystal Pharmatech and Particle Sciences vetted a number of potential partners prior to aligning with each other and each company will utilize the other's core expertise to seamlessly offer clients the optimal program for their drug candidates.
Crystal Pharmatech, headquartered in Suzhou, China with an office in Princeton, NJ, is a technology-driven CRO that offers materials research service for active pharmaceutical ingredients and formulations used in drug discovery. It provides its customers with data derived from experiments and also partners with clients to ensure comprehensive solutions for their research needs based on sound scientific understanding.
Particle Sciences is an integrated provider of drug development services. Through a full range of formulation, analytic and manufacturing services, it provides pharmaceutical companies with a complete and seamless development solution that minimizes the time and risk between discovery and the clinic.
