Physicochemical Characterization
A comprehensive understanding of the physicochemical properties of APIs is critical for reliable drug product manufacturing. These properties play important roles in rationalizing and streamlining formulation processes. By combining this knowledge with biopharmaceutical properties, our teams can make informed decisions about pre-formulation development and final performance of drug products. Moreover, BOC Sciences has been equipped with advanced development laboratories, our experts are therefore capable of providing valuable insights for process development and manufacturing.
Figure 1. Pharmaceutical Cocrystal (Panzade, P. S.; Shendarkar, G. R. 2017)
Our Services
To make it easier and better for researchers, BOC Sciences provides physicochemical characterization 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. Our capabilities include fundamental characterization of drug substance and drug products to support preclinical, clinical dosage form and manufacturing process development
Solubility studies
A large percentage of experimental drugs have low solubility, which poses a challenge for the development of parenteral formulations and leads to poor solubility, low and unstable bioavailability, and prandial effects in oral formulations. Thus, effective development strategies for solubility issues will increase the likelihood of advancing promising molecules
- pH solubility
- Solubility in FaSSIF
- Solubility in FeSSIF
- Solubility SGF
- Turbidimetric solubility
- Solubility in suspension vehicles, co-solvent, surfactants, lipids, and others
- Thermodynamic equilibrium solubility in water, organic solvents, buffers, formulation solvents, simulated body fluids
Stability studies
The chemical and physical stability of drug substances and drug products is critical to the success of compounds. BOC Sciences utilizes a variety of methods to characterize the stability of drugs:
Stability in solution
The stability behavior of the solution state informs formulation and process development as well as the complexity, time and cost associated with product development. We calculate the chemical stability in solution (temperature, pH, hydrolysis, oxidation, light-catalysed degradation)
pH-stability profiles
pH-stability profiles are essential for understanding how compounds behave in different environments and provide a reference for formulation development, process development, drug product stability, and delivery routes for molecules
Solid state stability
The stability of the solid form is an important factor to consider early in the translational stage, as there are serious and costly implications if the form changes
Photo stability
Excipient compatibility
By conducting a extensive excipient screening at the pre-formulation stage, our team of scientists can identify potential problems and determine boundary conditions for formulation screening. As a result, fewer formulations are examined, saving significant resources
Figure 2. Physicochemical and In Vitro Profiling of Drug Product (Bao, Q.; Burgess, D. J. 2018)
Inherent properties
- pKa, LogP/LogD
- Intrinsic dissolution
- Intrinsic dissolution
- Moisture sorption
Power characterization
- Particle size and size distribution
- Particle morphology
- Repose angle
- Bulk density
- Tap density
- Surface area
- Flow ability
- Compressibility
- Wettability
- Mechanical stability
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 physicochemical characterization at competitive prices for global customers. Personalized and customized services of physicochemical characterization 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!
References
- Panzade, P. S.; Shendarkar, G. R. Pharmaceutical Cocrystal: An Antique and Multifaceted Approach. Current Drug Delivery. 2017. 14(8): 1097-1105
- Bao, Q.; Burgess, D. J. Perspectives on Physicochemical and In Vitro Profiling of Ophthalmic Ointments. Pharmaceutical Research. 2018. 35(12).
