Pharma Crystallization
BOC Sciences is a recognized industry leader in crystallization studies, crystallization process development, preclinical formulation development, particle engineering, and drug substance-drug product co-processing. Our crystallization experts and scientific staffs with extensive expertise can provide effective solutions to the crystallization, and are committed to studying the underlying mechanisms. At BOC Sciences, our experienced team offers comprehensive support for crystallization process development including but not limited to polymorphism, crystal size distribution, purity, residual solvent, filtration and drying studies to ensure a reliable crystallization processes that deliver APIs with the desired performance.
Figure 1. Methods for characterization of co-crystals. (Thayyil, A. R.; et al. 2020)
Our Services
To make it easier and better for researchers, BOC Sciences provides pharma crystallization 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
Solid form screening and studies
Solid forms display significantly different physicochemical properties that greatly affect the performance of drug products Due to differences in crystal structure. Correct identification and selection of the solid form with desired solid state properties such as crystallinity, hygroscopicity, solubility, stability and processability, formulation design is of viral importance. BOC Sciences has applied our expertise and experience with various types of molecules to solve the problems caused by polymorphisms of the APIs and/or intermediate molecules throughout the development process of a drug candidate.
- Design and maximize our screening space based on simulation/prediction and experimental data input
- Perform well-rationalized, detail-oriented and results-driven screening
- Identify the most suitable solid-state form: Polymorph screening, salt screening, co-crystal screening and amorphous solid dispersion screening
- Solid form evaluation: We use phase diagrams to define the thermodynamic stability space of selected solid forms
Crystallization process development
Crystallization process, a quality-control step for API products, should be designed and controlled to meet predetermined product quality attributes to ensure the safety and efficacy of the final drug product. BOC Sciences experts have applied proper process design and control to meet predefined CQAs such as purity, crystal form, PSD, crystal morphology or shape, and bulk density. Our in-depth understanding of the thermodynamics and kinetics of specific (polycrystalline/solvent) systems helps to design the right process to solve problems that arise during process development, scale-up and technology transfer.
- We offer process analytical technologies (PATs) to provide better understanding and control of the crystallization process by monitoring and analyzing real-time information in-process
- BlazeMetrics: Timely detection of hidden complications in isolation of a target crystal form
- Process Raman and ReactIR: Detection of a metastable form produced in the early stages of the process
Figure 2. Methods of preparation of co-crystals. (Thayyil, A. R.; et al. 2020)
Early formulation development
The physicochemical properties of each drug molecule need to be considered prior to the development of a drug formulation. Our team of experts are able to reduce the risk of potential formulation problems in future development by evaluating and selecting the solid form for an API.
- During early formulation development, we fully consider API properties (e.g., crystallinity and form transformation) and drug product design (e.g., solubility, dissolution, and stability)
- We have extensive experience in screening and developing PK and Tox formulations, such as solutions, suspensions and enabling formulations
- BOC Sciences supports a variety of formulation technologies such as in situ salt formation, pH adjustment, co-solvents, cyclodextrin complexation, particle size reduction, amorphous solid dispersions, lipid-based formulations and nano-suspensions
Particle engineering and drug substance-drug product co-processing
Drug substance-drug product co-processing technologies are widely applied to bridge the gap between APIs and to overcome potential barriers in drug development. Recently, co-processing is a novel area of particle engineering where commonly used excipients can be combined with APIs in a more deliberate and controlled manner to design a pharmaceutical composite material. This approach combines two or more materials in a specific manner to produce a composite material with improved physical or chemical properties.
- We design a process to address some of the common problems associated with solid dosage form production, such as material flow, stability, compressibility, release profiles, bioavailability, food effects, content uniformity, taste, and even containment issues associated with potent or toxic compounds
- For amorphous compounds, the end-point APIs are co-processed intermediates in a dispersions with appropriate formulation excipients to provide enhanced physical and chemical properties such as stability, flow and bioavailability
- BOC Sciences also applies additional controlled crystallization processes such as spherical crystallization and wet milling applications including spray dried dispersions, microsphere formation, crystallization within porous excipients, and excipient modified crystallization
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 pharma crystallization at competitive prices for global customers. Personalized and customized services of pharma crystallization 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
- Thayyil, A. R.; et al. Pharmaceutical Co-Crystallization: Regulatory Aspects, Design, Characterization, and Applications. Advanced Pharmaceutical Bulletin. 2020. 10(2): 203-212.
