Solid State Development
Nowadays, more and more pharmaceutical companies have discovered that solid-state research of APIs can dramatically accelerate and enhance your development program as well as your intellectual property, resulting in optimal preclinical formulation development as well as API production. Baseline screening and understanding will lead to a robust API isolation process that delivers the right form and the right particle size with the highest yield. At BOC Sciences, our team has expanded its capabilities in supporting API development projects by providing solid-state research and development services.
Figure 1. API solid form classification based on structure and composition. (Anna, K.; et al. 2018)
Our Services
To make it easier and better for researchers, BOC Sciences provides solid state development service in a competitive fashion. We have provided a more efficient way to increase the number of new drugs, greatly shorten the R&D cycle, and reduce the development costs
- With over 15 years of experience in the physicochemical characterization of solid-state APIs and advanced intermediates, BOC Sciences has the abilities in the screening of different APIs in solid form. Our team of highly qualified scientists in solid-state science (crystallography, materials science, formulation) can provide quality-based approaches for small molecule APIs at different stages of pharmaceutical development
- To support API solid form research and development projects, we apply high throughput screening technology to rapidly discover new polycrystalline forms, pharmaceutical salts, solvates, co-crystals, particle size engineering and development or automated crystallization scale-up development
- In addition, we are able to integrate synthetic process development, solid state development, preformulation and formulation development to provide a knowledge-based strategy for the entire API development and manufacturing process
Figure 3. Schematic representation of the structural relationship between the amorphous state, polymorphs, solvates-hydrates, salts and cocrystals. (Anna, K.; et al. 2018)
Salt and co-crystal screening can address undesirable properties such as low solubility, chemical instability and high hygroscopicity of APIs. Combined with our high throughput screening technique, we can investigate the formation of salts and co-crystals in different solvent mixtures with pharmacologically acceptable salts. In addition, a complete characterization can be delivered once we identify and confirm a leading candidate
Figure 3. Approaches for cocrystal prediction and screening. (Anna, K.; et al. 2018)
The importance of polymorphism for pharmaceutical products is critical, and comprehensive polymorphism studies facilitate the establishment of intellectual property. BOC Sciences provides reliable polymorph screening services and our dedicated team studies the separation and crystallization of APIs in a number of solvents with different properties and under various conditions to identify and characterize new solid forms (polymorphs, hydrates, solvates) and to understand the relationships between them
Crystal Structure Determination
Determining the crystal structure of a drug candidate is critical because structural information provides a solid foundation for further calculations and analysis of important physicochemical properties, including stability, solubility, and hygroscopicity. BOC Sciences offers a variety of techniques for accurate characterization of crystal structures, including microcrystalline electron diffraction, single X-ray diffraction (XRD), and more. We are able to complete a structure determination project within two to three weeks
Crystal Structure Prediction
Generally, crystal polymorphism studies rely almost entirely on experimental screening. However, determining the optimal crystalline form for drug development is often challenging under time and raw material constraints. We have built an elaborate crystal structure prediction tool that combines computational chemistry and artificial intelligence to identify the most stable crystal forms.
Why choose BOC Sciences?
Our dedicated CMC team has provided tailored solutions to our clients from engagement to launch. With many years of industry experience, we provide clients with the following:
- Comprehensive, integrated CMC services with a flexible service model that grows with your programs
- Knowledgeable industry experts who deliver scalable, actionable insights
- World-class facilities and equipment that remain at the forefront of the global pharmaceutical research, analytical and development standards
- Our comprehensive services support products at every stage of the product lifecycle, from early-stage discovery to full commercial cGMP manufacture
- A focus on risk management that is designed to ensure completion of your technical goals
BOC Sciences provides professional, rapid and high-quality services of solid state development at competitive prices for global customers. Personalized and customized services of solid state development can satisfy any innovative scientific study demands. Our clients have direct access to our staff and prompt feedback to their inquiries. If you are interested in our services, please contact us immediately!
Reference
- Anna, K; et al. Pharmaceutical Cocrystals: New Solid Phase Modification Approaches for the Formulation of APIs. Pharmaceutics. 2018. 10(1): 18.
