Drug product development processes are often challenged by deficient solid state properties of an Active Pharmaceutical Ingredient (API) such as solubility, physical stability, chemical stability, hygroscopicity, mechanical properties, purification, isolation/filterability, manufacturability etc. Crystallization, polymorph screening, salt formation, cocrystallization and amorphorization technologies are generally implemented to generate the optimal solid form of an API. Solid form screening and selection of an optimal solid form is a multi-step process that needs to be designed, performed and evaluated carefully based on the molecular level of understanding of an API and the complete drug development program. If not evaluated carefully, the decision of selecting the solid form may have serious consequences in the drug product development and its lifecycle management.
In this regard, Seven Star Pharmaceutical Services works with our clients to ensure comprehensive solutions for their needs in drug development program using these technologies (Crystallization, polymorph screening, salt formation, cocrystallization and amorphorization). Based on the molecular level understanding of materials, we guide clients in the discovery and selection of the optimal solid form for drug development using all aspects of pre-formulation studies, including API process development, regulatory support and intellectual property protection. We are flexible and deliver timely, practical, and cost-effective solutions.
Our programs include:
Form screening (salt screening, co-crystal screening, crystallization screening, polymorph screening, amorphization) and selection of an optimal form
Physico-chemical properties testing
Structure elucidation of solid forms by single crystal X-ray diffraction studies