Pre-formulation Development
Preformulation studies involve the study of physical, chemical and pharmaceutical properties of the molecule, and provide methods regarding the appropriate optimization of the drug substance to represent better properties. Appropriate modification of drug molecules can yield more effective, safe, stable and reliable pharmaceutical formulations. Therefore, pre-formulation studies are an useful approach to generate successful pharmaceutical formulations. BOC Sciences has established a "one-stop" formulation and product development platform to help accelerate your drug candidates move from the pre-clinical stage to the IND filing stage. Aiming to drive decision making in formulation development and help predict the best formulation approach, our scientists can provide various pre-formulation solutions that combine chemical and physical characterization with biological characterization to elucidate the properties of drug candidates.
Figure 1. Cash flow 'Valley of Death': Preclinical development. (Steinmetz, K. L.; Spack, E. G. 2009)
Our Services
To make it easier and better for researchers, BOC Sciences provides pre-formulation 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. We have introduced a fully equipped process safety labs capable of performing rigorous, data-driven and comprehensive process and operational safety assessments to give our customers peace of mind throughout their partnership
Pre-formulation and discovery support
- Physicochemical property determinations
Solubility, stability, compatibility, pH and logP/ logD/ logK testing
- Solid form screening and selection
Each drug molecule exhibits inherent physicochemical properties that need to be considered prior to the development of a pharmaceutical formulation. Evaluating and selecting the solid form of an API can also reduce the risk of formulation problems that may arise in future development. BOC Sciences is able to select the correct solid state for early formulation studies and our capabilities include crystalline and salt form screening
- Physicochemical analysis, drug capability assessment
- Polymorph screening
Our early formulation development combines API properties such as crystallinity and morphology conversion with drug product design such as solubility, dissolution and stability
- Screening and development of PK and Tox formulations, such as solution, suspension and excipients
Figure 2. Preclinical drug development stages. (Steinmetz, K. L.; Spack, E. G. 2009)
What we offer?
Characterization for Drug Substances
Aiming to optimize the API production process and improve product quality and production efficiency, our process department adopts QbD principles for API process development and strives to select the best route for our customers
Analytical Testing for Drug Substances
The physicochemical properties of a drug substance is the basis of a successful formulation development. Our job is to leverage our expertise in pre-formulation development to give your molecule the best chance of success. Our extensive pre-formulation service supports your development program from early candidate selection, through preclinical and entry into the clinic
Infrastructure & Equipment
- Physical characterization: XRPD, SEM, PSD
- Solid state characterization: PXRD, TGA, DSC, Polarized Light Microscope (PLM), Dynamic Vapor Sorption (DVS/hygroscopicity), and Particle Size Analysis (PSA)
- Structure characterization: LC-MS, full range of proton and carbon NMR techniques, single crystal x-ray analysis, chiral purity
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 pre-formulation development at competitive prices for global customers. Personalized and customized services of pre-formulation 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
- Steinmetz, K. L.; Spack, E. G. The basics of preclinical drug development for neurodegenerative disease indications. BMC Neurology. 2009. 9(1): 1-13.
